Details
Stereochemistry | |
Molecular Formula | 5CN.Fe.NO |
Molecular Weight | 215.938 |
Optical Activity | NONE |
Defined Stereocenters | 0 / 0 |
E/Z Centers | 0 |
Charge | -2 |
SHOW SMILES / InChI
SMILES
[Fe++].[C-]#N.[C-]#N.[C-]#N.[C-]#N.[C-]#N.N#[O+]
InChI
InChIKey=YEESUBCSWGVPCE-UHFFFAOYSA-N
InChI=1S/5CN.Fe.NO/c5*1-2;;1-2/q5*-1;+2;+1
Molecular Formula | CHN |
Molecular Weight | 27.0253 |
Charge | 0 |
Count |
|
Stereochemistry | ACHIRAL |
Additional Stereochemistry | No |
Defined Stereocenters | 0 / 0 |
E/Z Centers | 0 |
Optical Activity | NONE |
Molecular Formula | Fe |
Molecular Weight | 55.845 |
Charge | 2 |
Count |
|
Stereochemistry | ACHIRAL |
Additional Stereochemistry | No |
Defined Stereocenters | 0 / 0 |
E/Z Centers | 0 |
Optical Activity | NONE |
Molecular Formula | NO |
Molecular Weight | 30.0061 |
Charge | 1 |
Count |
|
Stereochemistry | ACHIRAL |
Additional Stereochemistry | No |
Defined Stereocenters | 0 / 0 |
E/Z Centers | 0 |
Optical Activity | NONE |
DescriptionSources: http://www.ncbi.nlm.nih.gov/pubmed/6985697http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020845s016s017lbl.pdfhttp://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020215s024lbl.pdfhttps://www.drugs.com/pro/sodium-nitroprusside.html |
https://www.ncbi.nlm.nih.gov/pubmed/7598246https://www.ncbi.nlm.nih.gov/pubmed/8644642 | https://www.ncbi.nlm.nih.gov/pubmed/7504768 | https://www.ncbi.nlm.nih.gov/pubmed/1724528 | https://adisinsight.springer.com/drugs/800001151https://worldwide.espacenet.com/publicationDetails/biblio?DB=EPODOC&II=0&ND=3&adjacent=true&locale=en_EP&FT=D&date=19601018&CC=US&NR=2957021A&KC=A | https://worldwide.espacenet.com/publicationDetails/biblio?DB=EPODOC&II=0&ND=3&adjacent=true&locale=en_EP&FT=D&date=20020124&CC=WO&NR=0205795A2&KC=A2https://adisinsight.springer.com/drugs/800005482 | https://www.ncbi.nlm.nih.gov/pubmed/9845803https://www.ncbi.nlm.nih.gov/pubmed/19732062 | https://www.ncbi.nlm.nih.gov/pubmed/28988245 | https://www.ncbi.nlm.nih.gov/pubmed/24923291 | https://www.ncbi.nlm.nih.gov/pubmed/19563531http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019790s011lbl.pdfhttp://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021134s004lbl.pdfhttps://www.ncbi.nlm.nih.gov/pubmed/13426891 | https://www.ncbi.nlm.nih.gov/pubmed/13284675www.ncbi.nlm.nih.gov/pubmed/24071762Curator's Comment: description was created based on several sources, including, http://www.ncbi.nlm.nih.gov/pubmed/13106442
Sources: http://www.ncbi.nlm.nih.gov/pubmed/6985697http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020845s016s017lbl.pdfhttp://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020215s024lbl.pdfhttps://www.drugs.com/pro/sodium-nitroprusside.html |
https://www.ncbi.nlm.nih.gov/pubmed/7598246https://www.ncbi.nlm.nih.gov/pubmed/8644642 | https://www.ncbi.nlm.nih.gov/pubmed/7504768 | https://www.ncbi.nlm.nih.gov/pubmed/1724528 | https://adisinsight.springer.com/drugs/800001151https://worldwide.espacenet.com/publicationDetails/biblio?DB=EPODOC&II=0&ND=3&adjacent=true&locale=en_EP&FT=D&date=19601018&CC=US&NR=2957021A&KC=A | https://worldwide.espacenet.com/publicationDetails/biblio?DB=EPODOC&II=0&ND=3&adjacent=true&locale=en_EP&FT=D&date=20020124&CC=WO&NR=0205795A2&KC=A2https://adisinsight.springer.com/drugs/800005482 | https://www.ncbi.nlm.nih.gov/pubmed/9845803https://www.ncbi.nlm.nih.gov/pubmed/19732062 | https://www.ncbi.nlm.nih.gov/pubmed/28988245 | https://www.ncbi.nlm.nih.gov/pubmed/24923291 | https://www.ncbi.nlm.nih.gov/pubmed/19563531http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019790s011lbl.pdfhttp://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021134s004lbl.pdfhttps://www.ncbi.nlm.nih.gov/pubmed/13426891 | https://www.ncbi.nlm.nih.gov/pubmed/13284675www.ncbi.nlm.nih.gov/pubmed/24071762
Curator's Comment: description was created based on several sources, including, http://www.ncbi.nlm.nih.gov/pubmed/13106442
Pentaerythritol tetranitrate is an organic nitrate that has been used for the treatment of angina pectoris. Upon administration, the drug undergoes exstensive metabolism to NO which causes vasodilation and the relaxation of smooth muscle cells. The compound belongs to a familiy of explosive substances and may be used accordingly.
CNS Activity
Sources: https://www.ncbi.nlm.nih.gov/pubmed/11396481https://www.ncbi.nlm.nih.gov/pubmed/15036360
Curator's Comment: NO can be generated in large quantities and has detrimental effects on the CNS. NO has been shown to increase permeability of the BBB, allowing substances to enter into the brain passively.
Originator
Sources: http://adisinsight.springer.com/drugs/800017960http://www.reading.ac.uk/nitricoxide/intro/no/discovery.htmhttps://adisinsight.springer.com/drugs/800001151https://adisinsight.springer.com/drugs/800005482 | https://www.ncbi.nlm.nih.gov/pubmed/8839219https://www.ncbi.nlm.nih.gov/pubmed/22040938https://www.ncbi.nlm.nih.gov/pubmed/14848782
Curator's Comment: Was first prepared and studied by Junkmann in Germany, and has been suggested as a possible substitute for other nitrites and nitrates in the treatment of angina pectoris.
Approval Year
Targets
Primary Target | Pharmacology | Condition | Potency |
---|---|---|---|
Target ID: liberation of NO Sources: http://www.ncbi.nlm.nih.gov/pubmed/2242448 |
|||
Target ID: CHEMBL2111348 Sources: www.ncbi.nlm.nih.gov/pubmed/18574453 |
0.1 µM [EC50] | ||
Target ID: CHEMBL2111348 Sources: https://www.ncbi.nlm.nih.gov/pubmed/24560804 |
|||
Target ID: CHEMBL1988 Sources: https://www.ncbi.nlm.nih.gov/pubmed/12419094 |
|||
Target ID: CHEMBL2111348 Sources: https://www.ncbi.nlm.nih.gov/pubmed/10553632 |
|||
Target ID: CHEMBL2111348 |
|||
Target ID: CHEMBL2111348 Sources: https://www.google.com/patents/EP2805730A1 |
Conditions
Condition | Modality | Targets | Highest Phase | Product |
---|---|---|---|---|
Primary | NIPRIDE Approved UseSodium Nitroprusside injection is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. Concomitant longer-acting antihypertensive medication should be administered so that the duration of treatment with Sodium Nitroprusside can be minimized. Sodium Nitroprusside injection is also indicated for producing controlled hypotension in order to reduce bleeding during surgery. Sodium Nitroprusside injection is also indicated for the treatment of acute congestive heart failure. Launch Date1974 |
|||
Primary | NIPRIDE Approved UseSodium Nitroprusside injection is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. Concomitant longer-acting antihypertensive medication should be administered so that the duration of treatment with Sodium Nitroprusside can be minimized. Sodium Nitroprusside injection is also indicated for producing controlled hypotension in order to reduce bleeding during surgery. Sodium Nitroprusside injection is also indicated for the treatment of acute congestive heart failure. Launch Date1974 |
|||
Palliative | INOMAX Approved UseINOmax is a vasodilator indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents. Launch Date1999 |
|||
Primary | DILATRATE-SR Approved Usedilatrate®-SR sustained release capsules are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of controlled-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode. Launch Date1998 |
|||
Primary | MONOKET Approved Usemonoket® is indicated for the prevention and treatment of angina pectoris due to coronary artery disease. The onset of action of oral isosorbide mononitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode. Launch Date1993 |
|||
Primary | Unknown Approved UseUnknown |
|||
Primary | Unknown Approved UseUnknown |
|||
Primary | NITROSTAT Approved UseAcute relief of angina pectoris secondary to CAD; acute prophylactic management in situations likely to provoke angina attacks; and long-term prophylactic management of angina pectoris. Launch Date2000 |
|||
Primary | NITROGLYCERIN Approved UseManagement of patients with acute myocardial infarction (MI). Nitroglycerin is one of the principal initial therapies of MI. Launch Date1981 |
|||
Primary | NITROGLYCERIN Approved UseIV nitroglycerin is used to control BP in perioperative hypertension, especially hypertension associated with cardiovascular procedures; to control BP in patients with severe hypertension† or in hypertensive crises for the immediate reduction of BP in patients in whom such reduction is considered an emergency (hypertensive emergencies), especially those associated with coronary complications (e.g., coronary ischemia, acute coronary insufficiency, acute left ventricular failure, postoperative hypertension [especially following coronary bypass surgery]); and to produce controlled hypotension during surgical procedures. Launch Date1981 |
|||
Primary | NITROGLYCERIN Approved UseIV nitroglycerin has been used in the management of acutely decompensated (e.g., congestive) heart failure and other low cardiac-output states. Launch Date1981 |
|||
Primary | Metamine Approved Usehttps://www.ncbi.nlm.nih.gov/pubmed/13426891 | https://www.ncbi.nlm.nih.gov/pubmed/13284675 |
|||
Primary | PERITRATE Approved UseUnknown |
Cmax
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
35 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/8573222/ |
100 mg single, oral dose: 100 mg route of administration: Oral experiment type: SINGLE co-administered: |
PENTAERYTHRITOL MONONITRATE plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
|
79 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/8573222/ |
100 mg single, oral dose: 100 mg route of administration: Oral experiment type: SINGLE co-administered: |
PENTAERYTHRITOL MONONITRATE plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
|
1151 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/7614524/ |
120 mg 1 times / day steady-state, oral dose: 120 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
ISOSORBIDE MONONITRATE plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
557 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/7614524/ |
60 mg 1 times / day steady-state, oral dose: 60 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
ISOSORBIDE MONONITRATE plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
388 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/6713775/ |
20 mg single, oral dose: 20 mg route of administration: Oral experiment type: SINGLE co-administered: |
ISOSORBIDE MONONITRATE plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
356 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/6713775/ |
20 mg single, intravenous dose: 20 mg route of administration: Intravenous experiment type: SINGLE co-administered: |
ISOSORBIDE MONONITRATE plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
1.7 pg/mL |
800 μg single, sublingual dose: 800 μg route of administration: Sublingual experiment type: SINGLE co-administered: |
NITROGLYCERIN plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
|
17 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/8573222/ |
100 mg single, oral dose: 100 mg route of administration: Oral experiment type: SINGLE co-administered: |
PENTAERYTHRITOL DINITRATE plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
|
7.5 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/8573222/ |
100 mg single, oral dose: 100 mg route of administration: Oral experiment type: SINGLE co-administered: |
PENTAERYTHRITOL DINITRATE plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
|
187 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/24851040 |
20 mg single, oral dose: 20 mg route of administration: Oral experiment type: SINGLE co-administered: |
ISOSORBIDE DINITRATE plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
84 ng/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/2111749/ |
13 mg single, oral dose: 13 mg route of administration: Oral experiment type: SINGLE co-administered: |
GLYCERYL 1,2-DINITRATE plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
AUC
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
14241 ng × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/7614524/ |
120 mg 1 times / day steady-state, oral dose: 120 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
ISOSORBIDE MONONITRATE plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
6979 ng × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/7614524/ |
60 mg 1 times / day steady-state, oral dose: 60 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
ISOSORBIDE MONONITRATE plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
2524 ng × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/6713775/ |
20 mg single, oral dose: 20 mg route of administration: Oral experiment type: SINGLE co-administered: |
ISOSORBIDE MONONITRATE plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
2647 ng × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/6713775/ |
20 mg single, intravenous dose: 20 mg route of administration: Intravenous experiment type: SINGLE co-administered: |
ISOSORBIDE MONONITRATE plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
12.3 pg × min/mL |
800 μg single, sublingual dose: 800 μg route of administration: Sublingual experiment type: SINGLE co-administered: |
NITROGLYCERIN plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
|
1458 ng × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/24851040 |
20 mg single, oral dose: 20 mg route of administration: Oral experiment type: SINGLE co-administered: |
ISOSORBIDE DINITRATE plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
3380 ng × min/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/2111749/ |
13 mg single, oral dose: 13 mg route of administration: Oral experiment type: SINGLE co-administered: |
GLYCERYL 1,2-DINITRATE plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
T1/2
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
2 min |
single, intravenous |
NITROPRUSSIDE plasma | Rattus norvegicus population: HEALTHY age: ADULT sex: UNKNOWN food status: UNKNOWN |
|
10.5 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/8573222/ |
100 mg single, oral dose: 100 mg route of administration: Oral experiment type: SINGLE co-administered: |
PENTAERYTHRITOL MONONITRATE plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
|
10.5 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/8573222/ |
100 mg single, oral dose: 100 mg route of administration: Oral experiment type: SINGLE co-administered: |
PENTAERYTHRITOL MONONITRATE plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
|
6.2 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/7614524/ |
120 mg 1 times / day steady-state, oral dose: 120 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
ISOSORBIDE MONONITRATE plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
6.2 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/7614524/ |
60 mg 1 times / day steady-state, oral dose: 60 mg route of administration: Oral experiment type: STEADY-STATE co-administered: |
ISOSORBIDE MONONITRATE plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
4 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/6713775/ |
20 mg single, oral dose: 20 mg route of administration: Oral experiment type: SINGLE co-administered: |
ISOSORBIDE MONONITRATE plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
4 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/6713775/ |
20 mg single, intravenous dose: 20 mg route of administration: Intravenous experiment type: SINGLE co-administered: |
ISOSORBIDE MONONITRATE plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
40 min |
800 μg single, sublingual dose: 800 μg route of administration: Sublingual experiment type: SINGLE co-administered: |
NITROGLYCERIN plasma | Homo sapiens population: HEALTHY age: ADULT sex: FEMALE / MALE food status: UNKNOWN |
|
4.5 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/8573222/ |
100 mg single, oral dose: 100 mg route of administration: Oral experiment type: SINGLE co-administered: |
PENTAERYTHRITOL DINITRATE plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
|
4.5 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/8573222/ |
100 mg single, oral dose: 100 mg route of administration: Oral experiment type: SINGLE co-administered: |
PENTAERYTHRITOL DINITRATE plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
|
303 min EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/24851040 |
20 mg single, oral dose: 20 mg route of administration: Oral experiment type: SINGLE co-administered: |
ISOSORBIDE DINITRATE plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
50 min EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/2111749/ |
13 mg single, oral dose: 13 mg route of administration: Oral experiment type: SINGLE co-administered: |
GLYCERYL 1,2-DINITRATE plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: UNKNOWN |
Funbound
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
100% |
ISOSORBIDE DINITRATE plasma | Homo sapiens population: UNKNOWN age: UNKNOWN sex: UNKNOWN food status: UNKNOWN |
Doses
Dose | Population | Adverse events |
---|---|---|
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: label/2005/020727lbl.pdf - p.13 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: label/2005/020727lbl.pdf - p.13 |
Other AEs: Headache, Dizziness... Other AEs: Headache (50%) Sources: Page: label/2005/020727lbl.pdf - p.13Dizziness (32%) Asthenia (14%) Nausea (10%) Bronchitis (8%) Hypotension (8%) Sinusitis (4%) Ventricular tachycardia (4%) Hyperglycemia (4%) Rhinitis (4%) Paresthesia (4%) Vomiting (4%) Amblyopia (3%) Hyperlipidemia (3%) Tachycardia (2%) |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
Disc. AE: Chest pain, Heart arrest... AEs leading to discontinuation/dose reduction: Chest pain (0.6%) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56Heart arrest (0.6%) Heart failure (0.6%) Hypotension (0.6%) Kidney failure (0.6%) Infection (0.4%) Ventricular fibrillation (0.4%) Dizziness (0.4%) Arrhythmia (0.2%) Cerebrovascular accident (0.2%) Syncope (0.2%) Gastroenteritis (0.2%) Myasthenia (0.2%) Dyspnea (0.2%) Edema lung (0.2%) Angioedema (0.2%) Breast carcinoma (0.2%) Uremia (0.2%) |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Other AEs: Neurolysis, Ophthalmitis... Other AEs: Neurolysis (0.2%) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57Ophthalmitis (0.2%) Chest pain (6.4%) Heart failure (3.1%) Ventricular tachycardia (2.7%) Pneumonia (2.3%) Syncope (2.1%) Dyspnea (1.9%) Arrhythmia (1.7%) Hypotension (1.5%) Heart arrest (1.4%) Cerebrovascular accident (1.4%) Dizziness (1.4%) Cellulite (1.2%) Cerebral ischemia (1%) Coronary artery disease (1%) Anemia (1%) Bronchitis (1%) Dehydration (1%) Angina pectoris (1%) Hyperglycemia (1%) Hypoglycemia (1%) Infection (1%) Acute kidney failure (1%) Neoplasm (0.8%) Gout (0.8%) Atrial fibrillation (0.8%) Gastrointestinal hemorrhage (0.8%) Kidney failure (0.8%) Myocardial infarct (0.8%) Sepsis (0.6%) Asthma (0.6%) Accidental injury (0.6%) Cholecystitis (0.6%) Cholelithiasis (0.6%) Supraventricular tachycardia (0.6%) Esophagitis (0.4%) Edema lung (0.4%) Headache (0.4%) Osteomyelitis (0.4%) Peripheral vascular disease (0.4%) Bradycardia (0.4%) Digitalis intoxication (0.4%) Gastroenteritis (0.4%) Hyperkalemia (0.4%) Hemorrhage subarachnoid (0.4%) Deep thrombophlebitis (0.4%) Angioedema (0.4%) Ascites (0.4%) Infection (0.4%) Fibrillation ventricular (0.4%) Anomaly vascular (0.2%) Coagulation disorder (0.2%) Creatinine increased (0.2%) Hyponatremia (0.2%) Diarrhea (0.2%) Failure liver (0.2%) Neoplasm of the prostate (0.2%) Myasthenia (0.2%) Palpitations (0.2%) Urinary tract infection (0.2%) Dyspepsia (0.2%) Function kidney abnormal (0.2%) Anemia iron deficiency (0.2%) Alkalosis (0.2%) Arrhythmia nodal (0.2%) Arthralgia (0.2%) Breast carcinoma (0.2%) Hypokalemia (0.2%) Ketosis (0.2%) Cerebral infarct (0.2%) Emotional lability (0.2%) Edema face (0.2%) Gastritis hemorrhagic (0.2%) Abnormal gait (0.2%) Hematemesis (0.2%) Herpes zoster (0.2%) Uremia (0.2%) Leucopenia (0.2%) Thrombocytopenia (0.2%) Disorder parathyroid (0.2%) Disorder respiratory system (0.2%) Skin ulcer (0.2%) Abnormal thinking (0.2%) Vascular disorder NOS (0.2%) Wrist drop (0.2%) Gastritis (0.2%) |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Disc. AE: Asthenia, Headache... AEs leading to discontinuation/dose reduction: Asthenia (2.3%) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59Headache (7.4%) Dizziness (3.7%) Pain (0.8%) Chest pain (1.5%) Nausea (1.5%) Hypotension (1.4%) Abdominal pain (0.4%) Chills (0.4%) Kidney failure (0.4%) Malaise (0.4%) Heart arrest (0.6%) Confusion (0.4%) Diarrhea (0.4%) Gastroenteritis (0.2%) Back pain (0.2%) Acute kidney failure (0.2%) Myasthenia (0.2%) Nervousness (0.2%) Pruritus (0.2%) Heart failure (0.6%) Dyspepsia (0.2%) Cerebrovascular accident (0.2%) Constipation (0.2%) Dyspnea (0.2%) Vomiting (0.6%) Paresthesia (0.6%) Function kidney abnormal (0.4%) Palpitations (0.4%) Syncope (0.4%) Rash (0.6%) Rectal hemorrhage (0.4%) Ventricular fibrillation (0.4%) Angioedema (0.2%) Amblyopia (0.2%) Anorexia (0.2%) Neck pain (0.2%) Carcinoma (0.2%) Breast carcinoma (0.2%) Dehydration (0.2%) Edema face (0.2%) Edema peripheral (0.2%) Edema lung (0.2%) Fever (0.2%) Hyperglycemia (0.2%) Hypertension (0.2%) Infection (0.2%) Fungal infection (0.2%) Impotence (0.2%) Ketosis (0.2%) Breast neoplasm (0.2%) Lab test abnormal (0.2%) Myalgia (0.2%) Photophobia (0.2%) Pleural effusion (0.2%) Somnolence (0.2%) Sweaty (0.2%) Vasodilation (0.2%) Weight decrease (0.2%) Uremia (0.2%) |
240 mg 1 times / day steady, oral Highest studied dose Dose: 240 mg, 1 times / day Route: oral Route: steady Dose: 240 mg, 1 times / day Sources: |
unhealthy, adult n = 312 Health Status: unhealthy Condition: chronic stable angina pectoris Age Group: adult Sex: unknown Population Size: 312 Sources: |
Other AEs: Headache... |
60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, adult n = 267 Health Status: unhealthy Condition: chronic stable angina pectoris Age Group: adult Sex: unknown Population Size: 267 Sources: |
Disc. AE: Headache... AEs leading to discontinuation/dose reduction: Headache (6 patients) Sources: |
20 mg 1 times / day steady, oral Dose: 20 mg, 1 times / day Route: oral Route: steady Dose: 20 mg, 1 times / day Sources: |
unhealthy, adult n = 159 Health Status: unhealthy Condition: myocardial infarction or congestive heart failure Age Group: adult Sex: unknown Population Size: 159 Sources: |
Disc. AE: Headache, Nausea... AEs leading to discontinuation/dose reduction: Headache (5%) Sources: Nausea (2%) |
5 mg 1 times / day steady, oral Dose: 5 mg, 1 times / day Route: oral Route: steady Dose: 5 mg, 1 times / day Sources: |
unhealthy, adult n = 54 Health Status: unhealthy Condition: myocardial infarction or congestive heart failure Age Group: adult Sex: unknown Population Size: 54 Sources: |
Disc. AE: Rash, Pruritus... AEs leading to discontinuation/dose reduction: Rash (2%) Sources: Pruritus (2%) |
1 ug/kg/min multiple, intravenous (starting) Dose: 1 ug/kg/min Route: intravenous Route: multiple Dose: 1 ug/kg/min Sources: |
pregnant, 26 years n = 16 Health Status: pregnant Condition: Preterm labor Age Group: 26 years Sex: F Population Size: 16 Sources: |
Disc. AE: Hypotension... AEs leading to discontinuation/dose reduction: Hypotension (4 patients) Sources: |
8 ug/kg/min multiple, intravenous Dose: 8 ug/kg/min Route: intravenous Route: multiple Dose: 8 ug/kg/min Sources: |
pregnant, 26 years n = 1 Health Status: pregnant Condition: Preterm labor Age Group: 26 years Sex: F Population Size: 1 Sources: |
Disc. AE: Nausea, Vomiting... AEs leading to discontinuation/dose reduction: Nausea (severe, 1 patient) Sources: Vomiting (severe, 1 patient) Headache (severe, 1 patient) |
35 ug/kg/min single, intravenous Dose: 35 ug/kg/min Route: intravenous Route: single Dose: 35 ug/kg/min Sources: |
unhealthy, 50 years (range: 19 ± 74 years) n = 105 Health Status: unhealthy Age Group: 50 years (range: 19 ± 74 years) Sex: M+F Population Size: 105 Sources: |
Disc. AE: Hemodynamic test abnormal... AEs leading to discontinuation/dose reduction: Hemodynamic test abnormal (8 patients) Sources: |
0.6 mg/h 1 times / day multiple, transdermal Highest studied dose Dose: 0.6 mg/h, 1 times / day Route: transdermal Route: multiple Dose: 0.6 mg/h, 1 times / day Sources: |
unhealthy, 51.4 ±4.3 years n = 11 Health Status: unhealthy Condition: menopausal hot flashes Age Group: 51.4 ±4.3 years Sex: F Population Size: 11 Sources: |
|
2 % 6 times / day multiple, topical Dose: 2 %, 6 times / day Route: topical Route: multiple Dose: 2 %, 6 times / day Sources: |
unhealthy, 57 - 71 years n = 2 Health Status: unhealthy Age Group: 57 - 71 years Sex: M Population Size: 2 Sources: |
Disc. AE: Pruritic rash, Erythema edematous... AEs leading to discontinuation/dose reduction: Pruritic rash (2 patients) Sources: Erythema edematous (2 patients) Vesicular eruption (2 patients) |
40 mg single, oral Overdose Dose: 40 mg Route: oral Route: single Dose: 40 mg Sources: |
unhealthy, 80 years n = 1 Health Status: unhealthy Condition: angina pectoris Age Group: 80 years Sex: M Population Size: 1 Sources: |
Other AEs: Methemoglobinemia... Other AEs: Methemoglobinemia (grade 5, 1 patient) Sources: |
0.2 mg/h 1 times / day multiple, transdermal (starting) Recommended Dose: 0.2 mg/h, 1 times / day Route: transdermal Route: multiple Dose: 0.2 mg/h, 1 times / day Sources: |
unhealthy, adult n = 307 Health Status: unhealthy Age Group: adult Sex: M+F Population Size: 307 Sources: |
Other AEs: Headache, Lightheadedness... Other AEs: Headache (63%) Sources: Lightheadedness (6%) Hypotension (4%) Syncope (4%) |
1.5 mg 2 times / day multiple, rectal Dose: 1.5 mg, 2 times / day Route: rectal Route: multiple Dose: 1.5 mg, 2 times / day Sources: |
unhealthy, adult Health Status: unhealthy Age Group: adult Sources: |
Disc. AE: Hypotension... AEs leading to discontinuation/dose reduction: Hypotension Sources: |
5 ug/kg 1 times / day single, subcutaneous Dose: 5 ug/kg, 1 times / day Route: subcutaneous Route: single Dose: 5 ug/kg, 1 times / day Sources: |
unhealthy, pediatric n = 57 Health Status: unhealthy Age Group: pediatric Population Size: 57 Sources: |
AEs
AE | Significance | Dose | Population |
---|---|---|---|
Nausea | 10% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: label/2005/020727lbl.pdf - p.13 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: label/2005/020727lbl.pdf - p.13 |
Asthenia | 14% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: label/2005/020727lbl.pdf - p.13 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: label/2005/020727lbl.pdf - p.13 |
Tachycardia | 2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: label/2005/020727lbl.pdf - p.13 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: label/2005/020727lbl.pdf - p.13 |
Amblyopia | 3% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: label/2005/020727lbl.pdf - p.13 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: label/2005/020727lbl.pdf - p.13 |
Hyperlipidemia | 3% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: label/2005/020727lbl.pdf - p.13 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: label/2005/020727lbl.pdf - p.13 |
Dizziness | 32% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: label/2005/020727lbl.pdf - p.13 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: label/2005/020727lbl.pdf - p.13 |
Hyperglycemia | 4% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: label/2005/020727lbl.pdf - p.13 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: label/2005/020727lbl.pdf - p.13 |
Paresthesia | 4% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: label/2005/020727lbl.pdf - p.13 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: label/2005/020727lbl.pdf - p.13 |
Rhinitis | 4% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: label/2005/020727lbl.pdf - p.13 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: label/2005/020727lbl.pdf - p.13 |
Sinusitis | 4% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: label/2005/020727lbl.pdf - p.13 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: label/2005/020727lbl.pdf - p.13 |
Ventricular tachycardia | 4% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: label/2005/020727lbl.pdf - p.13 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: label/2005/020727lbl.pdf - p.13 |
Vomiting | 4% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: label/2005/020727lbl.pdf - p.13 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: label/2005/020727lbl.pdf - p.13 |
Headache | 50% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: label/2005/020727lbl.pdf - p.13 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: label/2005/020727lbl.pdf - p.13 |
Bronchitis | 8% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: label/2005/020727lbl.pdf - p.13 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: label/2005/020727lbl.pdf - p.13 |
Hypotension | 8% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: label/2005/020727lbl.pdf - p.13 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: label/2005/020727lbl.pdf - p.13 |
Angioedema | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
Arrhythmia | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
Breast carcinoma | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
Cerebrovascular accident | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
Dyspnea | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
Edema lung | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
Gastroenteritis | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
Myasthenia | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
Syncope | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
Uremia | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
Dizziness | 0.4% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
Infection | 0.4% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
Ventricular fibrillation | 0.4% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
Chest pain | 0.6% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
Heart arrest | 0.6% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
Heart failure | 0.6% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
Hypotension | 0.6% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
Kidney failure | 0.6% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.56 |
Abnormal gait | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Abnormal thinking | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Alkalosis | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Anemia iron deficiency | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Anomaly vascular | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Arrhythmia nodal | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Arthralgia | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Breast carcinoma | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Cerebral infarct | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Coagulation disorder | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Creatinine increased | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Diarrhea | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Disorder parathyroid | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Disorder respiratory system | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Dyspepsia | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Edema face | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Emotional lability | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Failure liver | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Function kidney abnormal | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Gastritis hemorrhagic | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Gastritis | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Hematemesis | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Herpes zoster | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Hypokalemia | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Hyponatremia | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Ketosis | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Leucopenia | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Myasthenia | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Neoplasm of the prostate | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Neurolysis | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Ophthalmitis | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Palpitations | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Skin ulcer | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Thrombocytopenia | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Uremia | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Urinary tract infection | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Vascular disorder NOS | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Wrist drop | 0.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Angioedema | 0.4% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Ascites | 0.4% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Bradycardia | 0.4% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Deep thrombophlebitis | 0.4% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Digitalis intoxication | 0.4% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Edema lung | 0.4% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Esophagitis | 0.4% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Fibrillation ventricular | 0.4% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Gastroenteritis | 0.4% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Headache | 0.4% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Hemorrhage subarachnoid | 0.4% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Hyperkalemia | 0.4% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Infection | 0.4% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Osteomyelitis | 0.4% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Peripheral vascular disease | 0.4% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Accidental injury | 0.6% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Asthma | 0.6% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Cholecystitis | 0.6% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Cholelithiasis | 0.6% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Sepsis | 0.6% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Supraventricular tachycardia | 0.6% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Atrial fibrillation | 0.8% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Gastrointestinal hemorrhage | 0.8% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Gout | 0.8% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Kidney failure | 0.8% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Myocardial infarct | 0.8% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Neoplasm | 0.8% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Acute kidney failure | 1% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Anemia | 1% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Angina pectoris | 1% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Bronchitis | 1% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Cerebral ischemia | 1% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Coronary artery disease | 1% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Dehydration | 1% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Hyperglycemia | 1% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Hypoglycemia | 1% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Infection | 1% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Cellulite | 1.2% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Cerebrovascular accident | 1.4% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Dizziness | 1.4% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Heart arrest | 1.4% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Hypotension | 1.5% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Arrhythmia | 1.7% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Dyspnea | 1.9% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Syncope | 2.1% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Pneumonia | 2.3% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Ventricular tachycardia | 2.7% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Heart failure | 3.1% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Chest pain | 6.4% | 75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.57 |
Acute kidney failure | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Amblyopia | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Angioedema | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Anorexia | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Back pain | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Breast carcinoma | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Breast neoplasm | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Carcinoma | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Cerebrovascular accident | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Constipation | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Dehydration | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Dyspepsia | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Dyspnea | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Edema face | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Edema lung | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Edema peripheral | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Fever | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Fungal infection | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Gastroenteritis | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Hyperglycemia | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Hypertension | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Impotence | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Infection | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Ketosis | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Lab test abnormal | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Myalgia | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Myasthenia | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Neck pain | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Nervousness | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Photophobia | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Pleural effusion | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Pruritus | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Somnolence | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Sweaty | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Uremia | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Vasodilation | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Weight decrease | 0.2% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Abdominal pain | 0.4% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Chills | 0.4% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Confusion | 0.4% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Diarrhea | 0.4% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Function kidney abnormal | 0.4% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Kidney failure | 0.4% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Malaise | 0.4% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Palpitations | 0.4% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Rectal hemorrhage | 0.4% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Syncope | 0.4% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Ventricular fibrillation | 0.4% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Heart arrest | 0.6% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Heart failure | 0.6% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Paresthesia | 0.6% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Rash | 0.6% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Vomiting | 0.6% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Pain | 0.8% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Hypotension | 1.4% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Chest pain | 1.5% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Nausea | 1.5% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Asthenia | 2.3% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Dizziness | 3.7% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Headache | 7.4% Disc. AE |
75 mg 3 times / day multiple, oral Recommended|MTD Dose: 75 mg, 3 times / day Route: oral Route: multiple Dose: 75 mg, 3 times / day Co-administed with:: isosorbide dinitrate(40 mg; 3/day) Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
unhealthy, mean age 57 years n = 517 Health Status: unhealthy Condition: heart failure Age Group: mean age 57 years Sex: M+F Population Size: 517 Sources: Page: nda/2005/020727_S000_Bidil_MedR.pdf - p.59 |
Headache | 57% | 240 mg 1 times / day steady, oral Highest studied dose Dose: 240 mg, 1 times / day Route: oral Route: steady Dose: 240 mg, 1 times / day Sources: |
unhealthy, adult n = 312 Health Status: unhealthy Condition: chronic stable angina pectoris Age Group: adult Sex: unknown Population Size: 312 Sources: |
Headache | 6 patients Disc. AE |
60 mg 1 times / day steady, oral Recommended Dose: 60 mg, 1 times / day Route: oral Route: steady Dose: 60 mg, 1 times / day Sources: |
unhealthy, adult n = 267 Health Status: unhealthy Condition: chronic stable angina pectoris Age Group: adult Sex: unknown Population Size: 267 Sources: |
Nausea | 2% Disc. AE |
20 mg 1 times / day steady, oral Dose: 20 mg, 1 times / day Route: oral Route: steady Dose: 20 mg, 1 times / day Sources: |
unhealthy, adult n = 159 Health Status: unhealthy Condition: myocardial infarction or congestive heart failure Age Group: adult Sex: unknown Population Size: 159 Sources: |
Headache | 5% Disc. AE |
20 mg 1 times / day steady, oral Dose: 20 mg, 1 times / day Route: oral Route: steady Dose: 20 mg, 1 times / day Sources: |
unhealthy, adult n = 159 Health Status: unhealthy Condition: myocardial infarction or congestive heart failure Age Group: adult Sex: unknown Population Size: 159 Sources: |
Pruritus | 2% Disc. AE |
5 mg 1 times / day steady, oral Dose: 5 mg, 1 times / day Route: oral Route: steady Dose: 5 mg, 1 times / day Sources: |
unhealthy, adult n = 54 Health Status: unhealthy Condition: myocardial infarction or congestive heart failure Age Group: adult Sex: unknown Population Size: 54 Sources: |
Rash | 2% Disc. AE |
5 mg 1 times / day steady, oral Dose: 5 mg, 1 times / day Route: oral Route: steady Dose: 5 mg, 1 times / day Sources: |
unhealthy, adult n = 54 Health Status: unhealthy Condition: myocardial infarction or congestive heart failure Age Group: adult Sex: unknown Population Size: 54 Sources: |
Hypotension | 4 patients Disc. AE |
1 ug/kg/min multiple, intravenous (starting) Dose: 1 ug/kg/min Route: intravenous Route: multiple Dose: 1 ug/kg/min Sources: |
pregnant, 26 years n = 16 Health Status: pregnant Condition: Preterm labor Age Group: 26 years Sex: F Population Size: 16 Sources: |
Headache | severe, 1 patient Disc. AE |
8 ug/kg/min multiple, intravenous Dose: 8 ug/kg/min Route: intravenous Route: multiple Dose: 8 ug/kg/min Sources: |
pregnant, 26 years n = 1 Health Status: pregnant Condition: Preterm labor Age Group: 26 years Sex: F Population Size: 1 Sources: |
Nausea | severe, 1 patient Disc. AE |
8 ug/kg/min multiple, intravenous Dose: 8 ug/kg/min Route: intravenous Route: multiple Dose: 8 ug/kg/min Sources: |
pregnant, 26 years n = 1 Health Status: pregnant Condition: Preterm labor Age Group: 26 years Sex: F Population Size: 1 Sources: |
Vomiting | severe, 1 patient Disc. AE |
8 ug/kg/min multiple, intravenous Dose: 8 ug/kg/min Route: intravenous Route: multiple Dose: 8 ug/kg/min Sources: |
pregnant, 26 years n = 1 Health Status: pregnant Condition: Preterm labor Age Group: 26 years Sex: F Population Size: 1 Sources: |
Hemodynamic test abnormal | 8 patients Disc. AE |
35 ug/kg/min single, intravenous Dose: 35 ug/kg/min Route: intravenous Route: single Dose: 35 ug/kg/min Sources: |
unhealthy, 50 years (range: 19 ± 74 years) n = 105 Health Status: unhealthy Age Group: 50 years (range: 19 ± 74 years) Sex: M+F Population Size: 105 Sources: |
Erythema edematous | 2 patients Disc. AE |
2 % 6 times / day multiple, topical Dose: 2 %, 6 times / day Route: topical Route: multiple Dose: 2 %, 6 times / day Sources: |
unhealthy, 57 - 71 years n = 2 Health Status: unhealthy Age Group: 57 - 71 years Sex: M Population Size: 2 Sources: |
Pruritic rash | 2 patients Disc. AE |
2 % 6 times / day multiple, topical Dose: 2 %, 6 times / day Route: topical Route: multiple Dose: 2 %, 6 times / day Sources: |
unhealthy, 57 - 71 years n = 2 Health Status: unhealthy Age Group: 57 - 71 years Sex: M Population Size: 2 Sources: |
Vesicular eruption | 2 patients Disc. AE |
2 % 6 times / day multiple, topical Dose: 2 %, 6 times / day Route: topical Route: multiple Dose: 2 %, 6 times / day Sources: |
unhealthy, 57 - 71 years n = 2 Health Status: unhealthy Age Group: 57 - 71 years Sex: M Population Size: 2 Sources: |
Methemoglobinemia | grade 5, 1 patient | 40 mg single, oral Overdose Dose: 40 mg Route: oral Route: single Dose: 40 mg Sources: |
unhealthy, 80 years n = 1 Health Status: unhealthy Condition: angina pectoris Age Group: 80 years Sex: M Population Size: 1 Sources: |
Hypotension | 4% | 0.2 mg/h 1 times / day multiple, transdermal (starting) Recommended Dose: 0.2 mg/h, 1 times / day Route: transdermal Route: multiple Dose: 0.2 mg/h, 1 times / day Sources: |
unhealthy, adult n = 307 Health Status: unhealthy Age Group: adult Sex: M+F Population Size: 307 Sources: |
Syncope | 4% | 0.2 mg/h 1 times / day multiple, transdermal (starting) Recommended Dose: 0.2 mg/h, 1 times / day Route: transdermal Route: multiple Dose: 0.2 mg/h, 1 times / day Sources: |
unhealthy, adult n = 307 Health Status: unhealthy Age Group: adult Sex: M+F Population Size: 307 Sources: |
Lightheadedness | 6% | 0.2 mg/h 1 times / day multiple, transdermal (starting) Recommended Dose: 0.2 mg/h, 1 times / day Route: transdermal Route: multiple Dose: 0.2 mg/h, 1 times / day Sources: |
unhealthy, adult n = 307 Health Status: unhealthy Age Group: adult Sex: M+F Population Size: 307 Sources: |
Headache | 63% | 0.2 mg/h 1 times / day multiple, transdermal (starting) Recommended Dose: 0.2 mg/h, 1 times / day Route: transdermal Route: multiple Dose: 0.2 mg/h, 1 times / day Sources: |
unhealthy, adult n = 307 Health Status: unhealthy Age Group: adult Sex: M+F Population Size: 307 Sources: |
Hypotension | Disc. AE | 1.5 mg 2 times / day multiple, rectal Dose: 1.5 mg, 2 times / day Route: rectal Route: multiple Dose: 1.5 mg, 2 times / day Sources: |
unhealthy, adult Health Status: unhealthy Age Group: adult Sources: |
Overview
CYP3A4 | CYP2C9 | CYP2D6 | hERG |
---|---|---|---|
OverviewOther
Other Inhibitor | Other Substrate | Other Inducer |
---|---|---|
Drug as perpetrator
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
no | ||||
Page: abstract |
no | |||
Sources: https://link.springer.com/article/10.1007/BF00497774 Page: abstract |
yes | |||
Page: abstract |
yes | |||
Page: abstract |
yes | |||
Sources: https://www.nature.com/articles/aps201225 Page: abstract |
yes |
Drug as victim
Target | Modality | Activity | Metabolite | Clinical evidence |
---|---|---|---|---|
major | ||||
minor | ||||
minor | ||||
minor | ||||
minor | ||||
minor | ||||
minor | ||||
no |
PubMed
Title | Date | PubMed |
---|---|---|
Nitric oxide donors antagonize N-nitro-L-arginine and haloperidol catalepsy: potential implication for the treatment of Parkinsonism? | 1997 Aug |
|
N-Acetyl-cysteine inhibition of encephalomyelitis Theiler's virus-induced nitric oxide and tumour necrosis factor-alpha production by murine astrocyte cultures. | 1999 |
|
Effects of amlodipine on nitric oxide synthase mRNA expression and coronary microcirculation in prolonged nitric oxide blockade-induced hypertensive rats. | 1999 Aug |
|
Increased vulnerability of neuronal cell lines to sodium nitroprusside-mediated toxicity is caused by the decreased level of nitric oxide metabolites. | 1999 Aug-Oct |
|
[Nitric oxide-induced neurotoxicity versus neuroprotection; relationship with selective motor neuronal death]. | 1999 Dec |
|
Nitric oxide induces apoptosis via Ca2+-dependent processes in the pancreatic beta-cell line MIN6. | 1999 Dec |
|
Endogenous endothelial cell nitric-oxide synthase modulates apoptosis in cultured breast cancer cells and is transcriptionally regulated by p53. | 1999 Dec 31 |
|
The analgesic NSAID lornoxicam inhibits cyclooxygenase (COX)-1/-2, inducible nitric oxide synthase (iNOS), and the formation of interleukin (IL)-6 in vitro. | 1999 Jul |
|
Sildenafil ameliorates effects of inhaled nitric oxide withdrawal. | 1999 Jul |
|
Spinal antinociceptive effect of epidural nonsteroidal antiinflammatory drugs on nitric oxide-induced hyperalgesia in rats. | 1999 Jul |
|
Aortic connexin43 is decreased during hypertension induced by inhibition of nitric oxide synthase. | 1999 Jul |
|
Critical role of sulfenic acid formation of thiols in the inactivation of glyceraldehyde-3-phosphate dehydrogenase by nitric oxide. | 1999 Jul 1 |
|
Arterial function in nitric oxide-deficient hypertension: influence of long-term angiotensin II receptor antagonism. | 1999 Jun |
|
Nitric oxide suppresses apoptosis via interrupting caspase activation and mitochondrial dysfunction in cultured hepatocytes. | 1999 Jun 11 |
|
Platelet nitric oxide metabolites in migraine. | 1999 May |
|
An enhancement of nitric oxide production regulates energy metabolism in rat hepatocytes after a partial hepatectomy. | 1999 May |
|
Modifications induced by LDL from type 1 diabetic patients on endothelial cells obtained from human umbilical vein. | 1999 Nov |
|
Beta2-adrenergic receptor stimulation inhibits nitric oxide generation by Mycobacterium avium infected macrophages. | 1999 Nov 1 |
|
Nitric oxide induces Zn2+ release from metallothionein by destroying zinc-sulphur clusters without concomitant formation of S-nitrosothiol. | 1999 Nov 15 |
|
Nitric oxide inhalation inhibits pulmonary apoptosis but not inflammatory injury in porcine meconium aspiration. | 1999 Oct |
|
Glyceryl trinitrate induces attacks of migraine without aura in sufferers of migraine with aura. | 1999 Sep |
|
Nitric oxide stimulates ACTH secretion and the transcription of the genes encoding for NGFI-B, corticotropin-releasing factor, corticotropin-releasing factor receptor type 1, and vasopressin in the hypothalamus of the intact rat. | 1999 Sep 1 |
|
The potential role of nitric oxide in the hypertrophic growth of the left ventricle. | 2000 |
|
Protective role of intracellular glutathione against nitric oxide-induced necrosis in rat gastric mucosal cells. | 2000 Apr |
|
Nitric oxide induces thymocyte apoptosis via a caspase-1-dependent mechanism. | 2000 Aug 1 |
|
Nitric oxide metabolites, prostaglandins and trigeminal vasoactive peptides in internal jugular vein blood during spontaneous migraine attacks. | 2000 Dec |
|
Vasopressin does not effect hypertension caused by long-term nitric oxide inhibition. | 2000 Feb |
|
Copper-dependent formation of disulfide-linked dimer of S100B protein. | 2000 Feb 15 |
|
[Anorectics and pulmonary hypertension]. | 2000 Feb 16 |
|
Dexamethasone blocks sepsis-induced protection of the heart from ischemia reperfusion injury. | 2000 Jan |
|
Nitric oxide synthase in toxic epidermal necrolysis and Stevens-Johnson syndrome. | 2000 Jan |
|
Nitric oxide synthase inhibitors attenuate ozone-induced airway inflammation in guinea pigs. Possible role of interleukin-8. | 2000 Jan |
|
Nitric oxide-producing CD11b(+)Ly-6G(Gr-1)(+)CD31(ER-MP12)(+) cells in the spleen of cyclophosphamide-treated mice: implications for T-cell responses in immunosuppressed mice. | 2000 Jan 1 |
|
Glyceryl trinitrate induced headache in migraineurs - relation to attack frequency. | 2000 Jul |
|
Metallothionein-III prevents glutamate and nitric oxide neurotoxicity in primary cultures of cerebellar neurons. | 2000 Jul |
|
Nitric oxide induces apoptosis in megakaryocytic cell lines. | 2000 Jun 1 |
|
Acetaminophen inhibits iNOS gene expression in RAW 264.7 macrophages: differential regulation of NF-kappaB by acetaminophen and salicylates. | 2000 Jun 16 |
|
Protective effect of bilobalide against nitric oxide-induced neurotoxicity in PC12 cells. | 2000 May |
|
Nitric oxide inhibits apoptosis via AP-1-dependent CD95L transactivation. | 2000 May 1 |
|
Nitric oxide inhibits tumor necrosis factor-alpha-induced apoptosis by reducing the generation of ceramide. | 2000 May 9 |
|
Endothelins and endothelin receptor antagonists: therapeutic considerations for a novel class of cardiovascular drugs. | 2000 Nov 7 |
|
Nitric oxide-induced headache in patients with chronic tension-type headache. | 2000 Sep |
|
Inhibition of nitric oxide synthase inhibitors and lipopolysaccharide induced inducible NOS and cyclooxygenase-2 gene expressions by rutin, quercetin, and quercetin pentaacetate in RAW 264.7 macrophages. | 2001 |
|
Beneficial effect of 1,25 dihydroxyvitamin D3 on cytokine-treated human pancreatic islets. | 2001 Apr |
|
Induction of JAB/SOCS-1/SSI-1 and CIS3/SOCS-3/SSI-3 is involved in gp130 resistance in cardiovascular system in rat treated with cardiotrophin-1 in vivo. | 2001 Apr 13 |
|
Role for endothelin-1-induced superoxide and peroxynitrite production in rebound pulmonary hypertension associated with inhaled nitric oxide therapy. | 2001 Aug 17 |
|
Comparison of the effects of nitric oxide, nitroprusside, and nifedipine on hemodynamics and right ventricular contractility in patients with chronic pulmonary hypertension. | 2001 Jan |
|
Ethanol inhibits cytokine-induced iNOS and sPLA2 in immortalized astrocytes: evidence for posttranscriptional site of ethanol action. | 2001 Jan-Feb |
|
Effects of Ginkgo biloba extract (EGb 761) and quercetin on lipopolysaccharide-induced release of nitric oxide. | 2001 Jul 31 |
|
Expression of inducible nitric oxide synthase in primary culture of rat bladder smooth muscle cells by plasma from cyclophosphamide-treated rats. | 2001 Mar 23 |
Patents
Sample Use Guides
In Vivo Use Guide
Sources: http://www.ncbi.nlm.nih.gov/pubmed/16644612
twice-daily 8-mg tablet
Route of Administration:
Intravenous
In Vitro Use Guide
Sources: http://www.ncbi.nlm.nih.gov/pubmed/6199592
Curator's Comment: In epithelial cells, NO increased apoptosis by 2.1 +/- 0.2-fold, augmented mRNA expression of Bax, and reduced expression of Bcl-2 compared with basal cultures. In stromal cells, NO increased cell proliferation in a dose-dependent manner, an effect that was blocked by a NO synthase inhibitor.
Was studied the action of the biologically active metabolite of molsidomine, N-morpholino-N-nitrosoamino-acetonitrile (SIN), on eicosanoid formation and functional behavior of bovine coronary arteries and human platelets in vitro. Molsidomine itself was inactive
Substance Class |
Chemical
Created
by
admin
on
Edited
Fri Dec 15 15:35:12 GMT 2023
by
admin
on
Fri Dec 15 15:35:12 GMT 2023
|
Record UNII |
169D1260KM
|
Record Status |
Validated (UNII)
|
Record Version |
|
-
Download
Name | Type | Language | ||
---|---|---|---|---|
|
Common Name | English | ||
|
Common Name | English | ||
|
Common Name | English |
Classification Tree | Code System | Code | ||
---|---|---|---|---|
|
NCI_THESAURUS |
C29707
Created by
admin on Fri Dec 15 15:35:12 GMT 2023 , Edited by admin on Fri Dec 15 15:35:12 GMT 2023
|
||
|
LIVERTOX |
NBK548613
Created by
admin on Fri Dec 15 15:35:12 GMT 2023 , Edited by admin on Fri Dec 15 15:35:12 GMT 2023
|
||
|
NCI_THESAURUS |
C1937
Created by
admin on Fri Dec 15 15:35:12 GMT 2023 , Edited by admin on Fri Dec 15 15:35:12 GMT 2023
|
||
|
FDA ORPHAN DRUG |
112498
Created by
admin on Fri Dec 15 15:35:12 GMT 2023 , Edited by admin on Fri Dec 15 15:35:12 GMT 2023
|
||
|
WHO-ATC |
C02DD01
Created by
admin on Fri Dec 15 15:35:12 GMT 2023 , Edited by admin on Fri Dec 15 15:35:12 GMT 2023
|
||
|
WHO-VATC |
QC02DD01
Created by
admin on Fri Dec 15 15:35:12 GMT 2023 , Edited by admin on Fri Dec 15 15:35:12 GMT 2023
|
||
|
NDF-RT |
N0000175940
Created by
admin on Fri Dec 15 15:35:12 GMT 2023 , Edited by admin on Fri Dec 15 15:35:12 GMT 2023
|
Code System | Code | Type | Description | ||
---|---|---|---|---|---|
|
100000079999
Created by
admin on Fri Dec 15 15:35:12 GMT 2023 , Edited by admin on Fri Dec 15 15:35:12 GMT 2023
|
PRIMARY | |||
|
Nitroprusside
Created by
admin on Fri Dec 15 15:35:12 GMT 2023 , Edited by admin on Fri Dec 15 15:35:12 GMT 2023
|
PRIMARY | |||
|
169D1260KM
Created by
admin on Fri Dec 15 15:35:12 GMT 2023 , Edited by admin on Fri Dec 15 15:35:12 GMT 2023
|
PRIMARY | |||
|
DB00325
Created by
admin on Fri Dec 15 15:35:12 GMT 2023 , Edited by admin on Fri Dec 15 15:35:12 GMT 2023
|
PRIMARY | |||
|
7596
Created by
admin on Fri Dec 15 15:35:12 GMT 2023 , Edited by admin on Fri Dec 15 15:35:12 GMT 2023
|
PRIMARY | |||
|
4631
Created by
admin on Fri Dec 15 15:35:12 GMT 2023 , Edited by admin on Fri Dec 15 15:35:12 GMT 2023
|
PRIMARY | |||
|
Nitroprusside
Created by
admin on Fri Dec 15 15:35:12 GMT 2023 , Edited by admin on Fri Dec 15 15:35:12 GMT 2023
|
PRIMARY | |||
|
169D1260KM
Created by
admin on Fri Dec 15 15:35:12 GMT 2023 , Edited by admin on Fri Dec 15 15:35:12 GMT 2023
|
PRIMARY | |||
|
124081848
Created by
admin on Fri Dec 15 15:35:12 GMT 2023 , Edited by admin on Fri Dec 15 15:35:12 GMT 2023
|
PRIMARY | |||
|
D009599
Created by
admin on Fri Dec 15 15:35:12 GMT 2023 , Edited by admin on Fri Dec 15 15:35:12 GMT 2023
|
PRIMARY | |||
|
DTXSID2046963
Created by
admin on Fri Dec 15 15:35:12 GMT 2023 , Edited by admin on Fri Dec 15 15:35:12 GMT 2023
|
PRIMARY | |||
|
7476
Created by
admin on Fri Dec 15 15:35:12 GMT 2023 , Edited by admin on Fri Dec 15 15:35:12 GMT 2023
|
PRIMARY | RxNorm | ||
|
SUB14660MIG
Created by
admin on Fri Dec 15 15:35:12 GMT 2023 , Edited by admin on Fri Dec 15 15:35:12 GMT 2023
|
PRIMARY | |||
|
15078-28-1
Created by
admin on Fri Dec 15 15:35:12 GMT 2023 , Edited by admin on Fri Dec 15 15:35:12 GMT 2023
|
PRIMARY | |||
|
C77153
Created by
admin on Fri Dec 15 15:35:12 GMT 2023 , Edited by admin on Fri Dec 15 15:35:12 GMT 2023
|
PRIMARY |
Related Record | Type | Details | ||
---|---|---|---|---|
|
METABOLITE ACTIVE -> PRODRUG |
|
Related Record | Type | Details | ||
---|---|---|---|---|
|
ACTIVE MOIETY |
|
Name | Property Type | Amount | Referenced Substance | Defining | Parameters | References |
---|---|---|---|---|---|---|
Biological Half-life | PHARMACOKINETIC |
|
Elimination PHARMACOKINETIC |
|
||