Details
Stereochemistry | ACHIRAL |
Molecular Formula | 5CN.Fe.NO.2H4N |
Molecular Weight | 252.015 |
Optical Activity | NONE |
Defined Stereocenters | 0 / 0 |
E/Z Centers | 0 |
Charge | 0 |
SHOW SMILES / InChI
SMILES
[NH4+].[NH4+].[Fe++].[C-]#N.[C-]#N.[C-]#N.[C-]#N.[C-]#N.N#[O+]
InChI
InChIKey=SKHRZYYFQXQCTL-UHFFFAOYSA-P
InChI=1S/5CN.Fe.NO.2H3N/c5*1-2;;1-2;;/h;;;;;;;2*1H3/q5*-1;+2;+1;;/p+2
Molecular Formula | H3N |
Molecular Weight | 17.0305 |
Charge | 0 |
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 |
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 | CHN |
Molecular Weight | 27.0253 |
Charge | 0 |
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 |
---|---|---|
[The classic anti-anginal agents and molsidomine]. | 1983 Feb |
|
Prostaglandin I2 and the nitric oxide donor molsidomine have synergistic effects on thromboresistance in man. | 1992 Mar |
|
Nitric oxide donors antagonize N-nitro-L-arginine and haloperidol catalepsy: potential implication for the treatment of Parkinsonism? | 1997 Aug |
|
Nitric oxide (NO) pathway and locomotor hyperactivity towards dopaminomimetics in rats. | 1997 Sep-Oct |
|
[The effect of nitric oxide administration on pateints with pulmonary hypertension: a dose-response study]. | 1998 Feb |
|
Sodium nitroprusside-induced seizure and taurine release from rat hippocampus. | 2000 |
|
The potential role of nitric oxide in the hypertrophic growth of the left ventricle. | 2000 |
|
Nitric oxide-compromised hypertension: facts and enigmas. | 2000 |
|
Nociceptin receptor activation produces nitric oxide-mediated systemic hypotension. | 2000 |
|
Protective role of intracellular glutathione against nitric oxide-induced necrosis in rat gastric mucosal cells. | 2000 Apr |
|
Angiotensin in the nucleus tractus solitarii contributes to neurogenic hypertension caused by chronic nitric oxide synthase inhibition. | 2000 Aug |
|
Nitric oxide metabolites, prostaglandins and trigeminal vasoactive peptides in internal jugular vein blood during spontaneous migraine attacks. | 2000 Dec |
|
Residual pulmonary hypertension in children after treatment with inhaled nitric oxide: a follow-up study regarding cardiopulmonary and neurological symptoms. | 2000 Dec |
|
Cytokines induce apoptosis in beta-cells isolated from mice lacking the inducible isoform of nitric oxide synthase (iNOS-/-). | 2000 Jul |
|
Metallothionein-III prevents glutamate and nitric oxide neurotoxicity in primary cultures of cerebellar neurons. | 2000 Jul |
|
Recovery from withdrawal of inhaled nitric oxide and kinetics of nitric oxide-induced inhibition of nitric oxide synthase activity in vitro. | 2000 Mar |
|
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 |
|
The neurogenic vasodilator response to endothelin-1: a study in human skin in vivo. | 2000 Nov |
|
Female sex steroids: effects upon microglial cell activation. | 2000 Nov 1 |
|
Synergy between ethanol and grape polyphenols, quercetin, and resveratrol, in the inhibition of the inducible nitric oxide synthase pathway. | 2000 Nov 15 |
|
Inhibition of inducible nitric oxide synthase gene expression by indomethacin or ibuprofen in beta-amyloid protein-stimulated J774 cells. | 2000 Nov 17 |
|
Endothelins and endothelin receptor antagonists: therapeutic considerations for a novel class of cardiovascular drugs. | 2000 Nov 7 |
|
High-calcium diet enhances vasorelaxation in nitric oxide-deficient hypertension. | 2000 Sep |
|
Nitric oxide-induced headache in patients with chronic tension-type headache. | 2000 Sep |
|
Regulation of diaphragmatic nitric oxide synthase expression during hypobaric hypoxia. | 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 |
|
Stimulation of cyclooxygenase-2-activity by nitric oxide-derived species in rat chondrocyte: lack of contribution to loss of cartilage anabolism. | 2001 Apr 15 |
|
Lipopolysaccharide and interferon-gamma-induced nitric oxide production and protein oxidation in mouse peritoneal macrophages are affected by glutathione peroxidase-1 gene knockout. | 2001 Aug 15 |
|
Role for endothelin-1-induced superoxide and peroxynitrite production in rebound pulmonary hypertension associated with inhaled nitric oxide therapy. | 2001 Aug 17 |
|
Effects of molsidomine on scopolamine-induced amnesia and hypermotility in the rat. | 2001 Aug 31 |
|
The phosphodiesterase inhibitors pentoxifylline and rolipram suppress macrophage activation and nitric oxide production in vitro and in vivo. | 2001 Feb |
|
Comparison of the effects of nitric oxide, nitroprusside, and nifedipine on hemodynamics and right ventricular contractility in patients with chronic pulmonary hypertension. | 2001 Jan |
|
Gastric mucosal resistance to acute injury in experimental portal hypertension. | 2001 Jan |
|
Ethanol inhibits cytokine-induced iNOS and sPLA2 in immortalized astrocytes: evidence for posttranscriptional site of ethanol action. | 2001 Jan-Feb |
|
15-Deoxy-delta12,14-PGJ2, but not troglitazone, modulates IL-1beta effects in human chondrocytes by inhibiting NF-kappaB and AP-1 activation pathways. | 2001 Jul 13 |
|
Effects of Ginkgo biloba extract (EGb 761) and quercetin on lipopolysaccharide-induced release of nitric oxide. | 2001 Jul 31 |
|
Prostaglandins and nitric oxide mediate superoxide-induced myocardial contractile dysfunction in isolated rat hearts. | 2001 Jun |
|
Nitric oxide inhalation increases alveolar gas exchange by decreasing deadspace volume. | 2001 Jun |
|
Neonatal pulmonary hypertension--urea-cycle intermediates, nitric oxide production, and carbamoyl-phosphate synthetase function. | 2001 Jun 14 |
|
Expression of inducible nitric oxide synthase in primary culture of rat bladder smooth muscle cells by plasma from cyclophosphamide-treated rats. | 2001 Mar 23 |
|
Sildenafil (viagra) facilitates weaning of inhaled nitric oxide following placement of a biventricular-assist device. | 2001 May |
|
Nitric oxide and chronic HCV and HIV infections. | 2001 May |
|
Acetylcholine and bradykinin enhance hypotension and affect the function of remodeled conduit arteries in SHR and SHR treated with nitric oxide donors. | 2005 Jun |
|
The nitric oxide (NO) donor molsidomine antagonizes scopolamine and L-NAME-induced performance deficits in a spatial memory task in the rat. | 2009 Jun 8 |
|
Selective regulation of cardiac organic cation transporter novel type 2 (OCTN2) in dilated cardiomyopathy. | 2011 Jun |
|
Pharmacological screening using an FXN-EGFP cellular genomic reporter assay for the therapy of Friedreich ataxia. | 2013 |
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
Sat Dec 16 09:54:16 GMT 2023
by
admin
on
Sat Dec 16 09:54:16 GMT 2023
|
Record UNII |
KOH7170ZJM
|
Record Status |
Validated (UNII)
|
Record Version |
|
-
Download
Name | Type | Language | ||
---|---|---|---|---|
|
Common Name | English | ||
|
Common Name | English | ||
|
Common Name | English | ||
|
Common Name | English | ||
|
Systematic Name | English | ||
|
Systematic Name | English | ||
|
Common Name | English |
Code System | Code | Type | Description | ||
---|---|---|---|---|---|
|
KOH7170ZJM
Created by
admin on Sat Dec 16 09:54:16 GMT 2023 , Edited by admin on Sat Dec 16 09:54:16 GMT 2023
|
PRIMARY | |||
|
122706877
Created by
admin on Sat Dec 16 09:54:16 GMT 2023 , Edited by admin on Sat Dec 16 09:54:16 GMT 2023
|
PRIMARY | |||
|
14402-70-1
Created by
admin on Sat Dec 16 09:54:16 GMT 2023 , Edited by admin on Sat Dec 16 09:54:16 GMT 2023
|
PRIMARY | |||
|
14645-66-0
Created by
admin on Sat Dec 16 09:54:16 GMT 2023 , Edited by admin on Sat Dec 16 09:54:16 GMT 2023
|
SUPERSEDED |