Details
Stereochemistry | RACEMIC |
Molecular Formula | C14H11ClN2O4S |
Molecular Weight | 338.766 |
Optical Activity | ( + / - ) |
Defined Stereocenters | 0 / 1 |
E/Z Centers | 0 |
Charge | 0 |
SHOW SMILES / InChI
SMILES
NS(=O)(=O)C1=C(Cl)C=CC(=C1)C2(O)NC(=O)C3=C2C=CC=C3
InChI
InChIKey=JIVPVXMEBJLZRO-UHFFFAOYSA-N
InChI=1S/C14H11ClN2O4S/c15-11-6-5-8(7-12(11)22(16,20)21)14(19)10-4-2-1-3-9(10)13(18)17-14/h1-7,19H,(H,17,18)(H2,16,20,21)
Molecular Formula | C14H11ClN2O4S |
Molecular Weight | 338.766 |
Charge | 0 |
Count |
|
Stereochemistry | RACEMIC |
Additional Stereochemistry | No |
Defined Stereocenters | 0 / 1 |
E/Z Centers | 0 |
Optical Activity | ( + / - ) |
Chlorthalidone is a diuretic that is used for the treatment of hypertansion and edema. The drug is approved by FDA and either prescribed alone (Chlorthalidone trade name) or in combination with atenolol (Tenoretic trade name), azilsartan kamedoxomil (Edarbyclor) and clonidin (Clorpres). The mechanism of action is associated with activation of sodium and chloride renal excretion.
Approval Year
Targets
Primary Target | Pharmacology | Condition | Potency |
---|---|---|---|
Target ID: GO:0035812 |
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Target ID: GO:0006821 |
Conditions
Condition | Modality | Targets | Highest Phase | Product |
---|---|---|---|---|
Palliative | CHLORTHALIDONE Approved UseDiuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Launch Date3.51907185E11 |
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Palliative | CHLORTHALIDONE Approved UseDiuretics such as chlorthalidone are indicated in the management of hypertension either as the sole therapeutic agent or to enhance the effect of other antihypertensive drugs in the more severe forms of hypertension. Chlorthalidone is indicated as adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction, such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. Launch Date3.51907185E11 |
Cmax
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
1529 μg/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/4067856 |
25 mg single, oral dose: 25 mg route of administration: Oral experiment type: SINGLE co-administered: |
CHLORTHALIDONE plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
AUC
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
93.3 μg × h/mL EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/4067856 |
25 mg single, oral dose: 25 mg route of administration: Oral experiment type: SINGLE co-administered: |
CHLORTHALIDONE plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
T1/2
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
54 h EXPERIMENT https://pubmed.ncbi.nlm.nih.gov/4067856 |
25 mg single, oral dose: 25 mg route of administration: Oral experiment type: SINGLE co-administered: |
CHLORTHALIDONE plasma | Homo sapiens population: HEALTHY age: ADULT sex: MALE food status: FASTED |
|
50 h |
CHLORTHALIDONE plasma | Homo sapiens population: UNKNOWN age: UNKNOWN sex: UNKNOWN food status: UNKNOWN |
Funbound
Value | Dose | Co-administered | Analyte | Population |
---|---|---|---|---|
25% |
CHLORTHALIDONE plasma | Homo sapiens population: UNKNOWN age: UNKNOWN sex: UNKNOWN food status: UNKNOWN |
Doses
Dose | Population | Adverse events |
---|---|---|
400 mg 1 times / day multiple, oral Highest studied dose Dose: 400 mg, 1 times / day Route: oral Route: multiple Dose: 400 mg, 1 times / day Sources: |
unhealthy, mean age 47 years n = 10 Health Status: unhealthy Condition: hypertension Age Group: mean age 47 years Sex: M+F Population Size: 10 Sources: |
Other AEs: Hypokalemia... |
200 mg 1 times / day multiple, oral Studied dose Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, mean age 53.6 years n = 37 Health Status: unhealthy Condition: hypertension Age Group: mean age 53.6 years Sex: M+F Population Size: 37 Sources: |
Other AEs: Dry mouth, Energy decreased... Other AEs: Dry mouth Sources: Energy decreased Muscle cramps Nausea Dizziness postural Indigestion Dreaming excessive Constipation Nervousness Headaches Gas Tiredness Trouble falling asleep Urination frequency of Decreased appetite |
75 mg 1 times / day multiple, oral Studied dose Dose: 75 mg, 1 times / day Route: oral Route: multiple Dose: 75 mg, 1 times / day Sources: |
unhealthy, mean age 55.3 years n = 19 Health Status: unhealthy Condition: hypertension Age Group: mean age 55.3 years Sex: M+F Population Size: 19 Sources: |
Other AEs: Headaches, Dizziness... Other AEs: Headaches (5.3%) Sources: Dizziness (15.8%) Cramps (5.3%) Orthostatic hypotension (10.5%) Dry mouth (5.3%) |
25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age 57.2 years n = 156 Health Status: unhealthy Condition: hypertension Age Group: mean age 57.2 years Sex: M+F Population Size: 156 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
Other AEs: Blood creatinine increased, Dizziness... Other AEs: Blood creatinine increased (18.6%) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95Dizziness (13.5%) Headache (5.8%) Hypokalemia (3.2%) Blood creatine phosphokinase increased (6.4%) Blood uric acid increased (4.5%) Blood urea increased (5.1%) Diarrhea (3.2%) Fatigue (3.8%) Nasopharyngitis (4.5%) Upper respiratory infection (4.5%) Hyperuricemia (1.9%) Blood potassium decreased (1.9%) |
25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.99 |
unhealthy, mean age 57.2 years n = 156 Health Status: unhealthy Condition: hypertension Age Group: mean age 57.2 years Sex: M+F Population Size: 156 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.99 |
Disc. AE: Blood creatinine increased, Dizziness... AEs leading to discontinuation/dose reduction: Blood creatinine increased (6.4%) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.99Dizziness (3.8%) Hypotension (0.6%) Blood urea increased (0.6%) Headache (0.6%) Fatigue (0.6%) Diarrhea (0.6%) |
25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.99 |
unhealthy, mean age 57.2 years n = 160 Health Status: unhealthy Condition: hypertension Age Group: mean age 57.2 years Sex: M+F Population Size: 160 Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.99 |
Disc. AE: Blood creatinine increased, Blood urea increased... AEs leading to discontinuation/dose reduction: Blood creatinine increased (0.6%) Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.99Blood urea increased (0.6%) Headache (0.6%) Hypokalemia (1.3%) |
25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 181 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 181 Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
Other AEs: Dizziness, Headache... Other AEs: Dizziness (3.3%) Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95Headache (7.2%) Plasminogen activator inhibitor increased (1.7%) Hypokalemia (6.1%) Dyslipidemia (2.2%) Asthenia (1.1%) Urinary tract infection (1.7%) Back pain (1.1%) Fatigue (2.8%) Blood uric acid increased (1.1%) Muscle spasms (0.6%) Peripheral edema (2.2%) Upper respiratory tract infection (1.1%) Blood creatine phosphokinase increased (1.7%) Palpitations (2.2%) Hematuria (0.6%) Hypertriglyceridemia (1.1%) Blood potassium decreased (1.7%) Edema (0.6%) |
25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 184 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 184 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
Other AEs: Dizziness, Headache... Other AEs: Dizziness (8.7%) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95Headache (4.3%) Plasminogen activator inhibitor increased (6.5%) Hypokalemia (1.1%) Dyslipidemia (3.8%) Asthenia (3.3%) Urinary tract infection (1.6%) Back pain (3.8%) Fatigue (3.3%) Blood uric acid increased (2.2%) Muscle spasms (2.7%) Peripheral edema (2.2%) Upper respiratory tract infection (2.2%) Blood creatine phosphokinase increased (0.5%) Palpitations (1.6%) Hematuria (1.6%) Hypertriglyceridemia (0.5%) Blood creatinine increased (2.7%) Diarrhea (2.2%) C-reactive protein increased (2.2%) Hypotension (2.2%) |
600 mg 1 times / day single, oral Highest studied dose Dose: 600 mg, 1 times / day Route: oral Route: single Dose: 600 mg, 1 times / day Sources: |
healthy n = 1 Health Status: healthy Population Size: 1 Sources: |
|
25 mg 1 times / day steady, oral Dose: 25 mg, 1 times / day Route: oral Route: steady Dose: 25 mg, 1 times / day Sources: |
unhealthy n = 13 Health Status: unhealthy Condition: Hypertension Population Size: 13 Sources: |
Other AEs: Hypokalemia, Hyponatremia... Other AEs: Hypokalemia (below serious, 1 patient) Sources: Hyponatremia (below serious, 1 patient) |
AEs
AE | Significance | Dose | Population |
---|---|---|---|
Hypokalemia | 400 mg 1 times / day multiple, oral Highest studied dose Dose: 400 mg, 1 times / day Route: oral Route: multiple Dose: 400 mg, 1 times / day Sources: |
unhealthy, mean age 47 years n = 10 Health Status: unhealthy Condition: hypertension Age Group: mean age 47 years Sex: M+F Population Size: 10 Sources: |
|
Constipation | 200 mg 1 times / day multiple, oral Studied dose Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, mean age 53.6 years n = 37 Health Status: unhealthy Condition: hypertension Age Group: mean age 53.6 years Sex: M+F Population Size: 37 Sources: |
|
Decreased appetite | 200 mg 1 times / day multiple, oral Studied dose Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, mean age 53.6 years n = 37 Health Status: unhealthy Condition: hypertension Age Group: mean age 53.6 years Sex: M+F Population Size: 37 Sources: |
|
Dizziness postural | 200 mg 1 times / day multiple, oral Studied dose Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, mean age 53.6 years n = 37 Health Status: unhealthy Condition: hypertension Age Group: mean age 53.6 years Sex: M+F Population Size: 37 Sources: |
|
Dreaming excessive | 200 mg 1 times / day multiple, oral Studied dose Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, mean age 53.6 years n = 37 Health Status: unhealthy Condition: hypertension Age Group: mean age 53.6 years Sex: M+F Population Size: 37 Sources: |
|
Dry mouth | 200 mg 1 times / day multiple, oral Studied dose Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, mean age 53.6 years n = 37 Health Status: unhealthy Condition: hypertension Age Group: mean age 53.6 years Sex: M+F Population Size: 37 Sources: |
|
Energy decreased | 200 mg 1 times / day multiple, oral Studied dose Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, mean age 53.6 years n = 37 Health Status: unhealthy Condition: hypertension Age Group: mean age 53.6 years Sex: M+F Population Size: 37 Sources: |
|
Gas | 200 mg 1 times / day multiple, oral Studied dose Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, mean age 53.6 years n = 37 Health Status: unhealthy Condition: hypertension Age Group: mean age 53.6 years Sex: M+F Population Size: 37 Sources: |
|
Headaches | 200 mg 1 times / day multiple, oral Studied dose Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, mean age 53.6 years n = 37 Health Status: unhealthy Condition: hypertension Age Group: mean age 53.6 years Sex: M+F Population Size: 37 Sources: |
|
Indigestion | 200 mg 1 times / day multiple, oral Studied dose Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, mean age 53.6 years n = 37 Health Status: unhealthy Condition: hypertension Age Group: mean age 53.6 years Sex: M+F Population Size: 37 Sources: |
|
Muscle cramps | 200 mg 1 times / day multiple, oral Studied dose Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, mean age 53.6 years n = 37 Health Status: unhealthy Condition: hypertension Age Group: mean age 53.6 years Sex: M+F Population Size: 37 Sources: |
|
Nausea | 200 mg 1 times / day multiple, oral Studied dose Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, mean age 53.6 years n = 37 Health Status: unhealthy Condition: hypertension Age Group: mean age 53.6 years Sex: M+F Population Size: 37 Sources: |
|
Nervousness | 200 mg 1 times / day multiple, oral Studied dose Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, mean age 53.6 years n = 37 Health Status: unhealthy Condition: hypertension Age Group: mean age 53.6 years Sex: M+F Population Size: 37 Sources: |
|
Tiredness | 200 mg 1 times / day multiple, oral Studied dose Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, mean age 53.6 years n = 37 Health Status: unhealthy Condition: hypertension Age Group: mean age 53.6 years Sex: M+F Population Size: 37 Sources: |
|
Trouble falling asleep | 200 mg 1 times / day multiple, oral Studied dose Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, mean age 53.6 years n = 37 Health Status: unhealthy Condition: hypertension Age Group: mean age 53.6 years Sex: M+F Population Size: 37 Sources: |
|
Urination frequency of | 200 mg 1 times / day multiple, oral Studied dose Dose: 200 mg, 1 times / day Route: oral Route: multiple Dose: 200 mg, 1 times / day Sources: |
unhealthy, mean age 53.6 years n = 37 Health Status: unhealthy Condition: hypertension Age Group: mean age 53.6 years Sex: M+F Population Size: 37 Sources: |
|
Orthostatic hypotension | 10.5% | 75 mg 1 times / day multiple, oral Studied dose Dose: 75 mg, 1 times / day Route: oral Route: multiple Dose: 75 mg, 1 times / day Sources: |
unhealthy, mean age 55.3 years n = 19 Health Status: unhealthy Condition: hypertension Age Group: mean age 55.3 years Sex: M+F Population Size: 19 Sources: |
Dizziness | 15.8% | 75 mg 1 times / day multiple, oral Studied dose Dose: 75 mg, 1 times / day Route: oral Route: multiple Dose: 75 mg, 1 times / day Sources: |
unhealthy, mean age 55.3 years n = 19 Health Status: unhealthy Condition: hypertension Age Group: mean age 55.3 years Sex: M+F Population Size: 19 Sources: |
Cramps | 5.3% | 75 mg 1 times / day multiple, oral Studied dose Dose: 75 mg, 1 times / day Route: oral Route: multiple Dose: 75 mg, 1 times / day Sources: |
unhealthy, mean age 55.3 years n = 19 Health Status: unhealthy Condition: hypertension Age Group: mean age 55.3 years Sex: M+F Population Size: 19 Sources: |
Dry mouth | 5.3% | 75 mg 1 times / day multiple, oral Studied dose Dose: 75 mg, 1 times / day Route: oral Route: multiple Dose: 75 mg, 1 times / day Sources: |
unhealthy, mean age 55.3 years n = 19 Health Status: unhealthy Condition: hypertension Age Group: mean age 55.3 years Sex: M+F Population Size: 19 Sources: |
Headaches | 5.3% | 75 mg 1 times / day multiple, oral Studied dose Dose: 75 mg, 1 times / day Route: oral Route: multiple Dose: 75 mg, 1 times / day Sources: |
unhealthy, mean age 55.3 years n = 19 Health Status: unhealthy Condition: hypertension Age Group: mean age 55.3 years Sex: M+F Population Size: 19 Sources: |
Blood potassium decreased | 1.9% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age 57.2 years n = 156 Health Status: unhealthy Condition: hypertension Age Group: mean age 57.2 years Sex: M+F Population Size: 156 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
Hyperuricemia | 1.9% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age 57.2 years n = 156 Health Status: unhealthy Condition: hypertension Age Group: mean age 57.2 years Sex: M+F Population Size: 156 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
Dizziness | 13.5% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age 57.2 years n = 156 Health Status: unhealthy Condition: hypertension Age Group: mean age 57.2 years Sex: M+F Population Size: 156 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
Blood creatinine increased | 18.6% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age 57.2 years n = 156 Health Status: unhealthy Condition: hypertension Age Group: mean age 57.2 years Sex: M+F Population Size: 156 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
Diarrhea | 3.2% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age 57.2 years n = 156 Health Status: unhealthy Condition: hypertension Age Group: mean age 57.2 years Sex: M+F Population Size: 156 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
Hypokalemia | 3.2% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age 57.2 years n = 156 Health Status: unhealthy Condition: hypertension Age Group: mean age 57.2 years Sex: M+F Population Size: 156 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
Fatigue | 3.8% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age 57.2 years n = 156 Health Status: unhealthy Condition: hypertension Age Group: mean age 57.2 years Sex: M+F Population Size: 156 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
Blood uric acid increased | 4.5% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age 57.2 years n = 156 Health Status: unhealthy Condition: hypertension Age Group: mean age 57.2 years Sex: M+F Population Size: 156 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
Nasopharyngitis | 4.5% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age 57.2 years n = 156 Health Status: unhealthy Condition: hypertension Age Group: mean age 57.2 years Sex: M+F Population Size: 156 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
Upper respiratory infection | 4.5% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age 57.2 years n = 156 Health Status: unhealthy Condition: hypertension Age Group: mean age 57.2 years Sex: M+F Population Size: 156 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
Blood urea increased | 5.1% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age 57.2 years n = 156 Health Status: unhealthy Condition: hypertension Age Group: mean age 57.2 years Sex: M+F Population Size: 156 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
Headache | 5.8% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age 57.2 years n = 156 Health Status: unhealthy Condition: hypertension Age Group: mean age 57.2 years Sex: M+F Population Size: 156 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
Blood creatine phosphokinase increased | 6.4% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age 57.2 years n = 156 Health Status: unhealthy Condition: hypertension Age Group: mean age 57.2 years Sex: M+F Population Size: 156 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
Blood urea increased | 0.6% Disc. AE |
25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.99 |
unhealthy, mean age 57.2 years n = 156 Health Status: unhealthy Condition: hypertension Age Group: mean age 57.2 years Sex: M+F Population Size: 156 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.99 |
Diarrhea | 0.6% Disc. AE |
25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.99 |
unhealthy, mean age 57.2 years n = 156 Health Status: unhealthy Condition: hypertension Age Group: mean age 57.2 years Sex: M+F Population Size: 156 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.99 |
Fatigue | 0.6% Disc. AE |
25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.99 |
unhealthy, mean age 57.2 years n = 156 Health Status: unhealthy Condition: hypertension Age Group: mean age 57.2 years Sex: M+F Population Size: 156 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.99 |
Headache | 0.6% Disc. AE |
25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.99 |
unhealthy, mean age 57.2 years n = 156 Health Status: unhealthy Condition: hypertension Age Group: mean age 57.2 years Sex: M+F Population Size: 156 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.99 |
Hypotension | 0.6% Disc. AE |
25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.99 |
unhealthy, mean age 57.2 years n = 156 Health Status: unhealthy Condition: hypertension Age Group: mean age 57.2 years Sex: M+F Population Size: 156 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.99 |
Dizziness | 3.8% Disc. AE |
25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.99 |
unhealthy, mean age 57.2 years n = 156 Health Status: unhealthy Condition: hypertension Age Group: mean age 57.2 years Sex: M+F Population Size: 156 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.99 |
Blood creatinine increased | 6.4% Disc. AE |
25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.99 |
unhealthy, mean age 57.2 years n = 156 Health Status: unhealthy Condition: hypertension Age Group: mean age 57.2 years Sex: M+F Population Size: 156 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.99 |
Blood creatinine increased | 0.6% Disc. AE |
25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.99 |
unhealthy, mean age 57.2 years n = 160 Health Status: unhealthy Condition: hypertension Age Group: mean age 57.2 years Sex: M+F Population Size: 160 Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.99 |
Blood urea increased | 0.6% Disc. AE |
25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.99 |
unhealthy, mean age 57.2 years n = 160 Health Status: unhealthy Condition: hypertension Age Group: mean age 57.2 years Sex: M+F Population Size: 160 Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.99 |
Headache | 0.6% Disc. AE |
25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.99 |
unhealthy, mean age 57.2 years n = 160 Health Status: unhealthy Condition: hypertension Age Group: mean age 57.2 years Sex: M+F Population Size: 160 Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.99 |
Hypokalemia | 1.3% Disc. AE |
25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.99 |
unhealthy, mean age 57.2 years n = 160 Health Status: unhealthy Condition: hypertension Age Group: mean age 57.2 years Sex: M+F Population Size: 160 Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.99 |
Edema | 0.6% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 181 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 181 Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
Hematuria | 0.6% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 181 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 181 Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
Muscle spasms | 0.6% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 181 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 181 Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
Asthenia | 1.1% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 181 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 181 Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
Back pain | 1.1% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 181 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 181 Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
Blood uric acid increased | 1.1% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 181 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 181 Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
Hypertriglyceridemia | 1.1% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 181 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 181 Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
Upper respiratory tract infection | 1.1% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 181 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 181 Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
Blood creatine phosphokinase increased | 1.7% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 181 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 181 Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
Blood potassium decreased | 1.7% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 181 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 181 Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
Plasminogen activator inhibitor increased | 1.7% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 181 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 181 Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
Urinary tract infection | 1.7% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 181 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 181 Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
Dyslipidemia | 2.2% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 181 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 181 Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
Palpitations | 2.2% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 181 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 181 Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
Peripheral edema | 2.2% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 181 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 181 Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
Fatigue | 2.8% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 181 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 181 Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
Dizziness | 3.3% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 181 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 181 Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
Hypokalemia | 6.1% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 181 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 181 Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
Headache | 7.2% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 181 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 181 Sources: Page: nda/2011/202331Orig1s000MedR.pdf - p.95 |
Blood creatine phosphokinase increased | 0.5% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 184 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 184 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
Hypertriglyceridemia | 0.5% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 184 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 184 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
Hypokalemia | 1.1% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 184 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 184 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
Hematuria | 1.6% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 184 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 184 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
Palpitations | 1.6% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 184 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 184 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
Urinary tract infection | 1.6% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 184 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 184 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
Blood uric acid increased | 2.2% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 184 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 184 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
C-reactive protein increased | 2.2% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 184 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 184 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
Diarrhea | 2.2% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 184 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 184 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
Hypotension | 2.2% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 184 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 184 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
Peripheral edema | 2.2% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 184 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 184 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
Upper respiratory tract infection | 2.2% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 184 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 184 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
Blood creatinine increased | 2.7% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 184 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 184 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
Muscle spasms | 2.7% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 184 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 184 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
Asthenia | 3.3% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 184 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 184 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
Fatigue | 3.3% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 184 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 184 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
Back pain | 3.8% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 184 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 184 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
Dyslipidemia | 3.8% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 184 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 184 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
Headache | 4.3% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 184 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 184 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
Plasminogen activator inhibitor increased | 6.5% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 184 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 184 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
Dizziness | 8.7% | 25 mg 1 times / day multiple, oral Recommended Dose: 25 mg, 1 times / day Route: oral Route: multiple Dose: 25 mg, 1 times / day Co-administed with:: azilsartan medoxomil(40 mg; 1/day) Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
unhealthy, mean age >59 years n = 184 Health Status: unhealthy Condition: hypertension Age Group: mean age >59 years Sex: M+F Population Size: 184 Sources: Page: /nda/2011/202331Orig1s000MedR.pdf - p.95 |
Hypokalemia | below serious, 1 patient | 25 mg 1 times / day steady, oral Dose: 25 mg, 1 times / day Route: oral Route: steady Dose: 25 mg, 1 times / day Sources: |
unhealthy n = 13 Health Status: unhealthy Condition: Hypertension Population Size: 13 Sources: |
Hyponatremia | below serious, 1 patient | 25 mg 1 times / day steady, oral Dose: 25 mg, 1 times / day Route: oral Route: steady Dose: 25 mg, 1 times / day Sources: |
unhealthy n = 13 Health Status: unhealthy Condition: Hypertension Population Size: 13 Sources: |
PubMed
Title | Date | PubMed |
---|---|---|
Hypokalemia associated with diuretic use and cardiovascular events in the Systolic Hypertension in the Elderly Program. | 2000 May |
|
Effects of chlorthalidone and diltiazem on myocardial ischemia in elderly patients with hypertension and coronary artery disease. | 2001 Apr |
|
[Alpha-blockers in therapy of arterial hypertension. No longer the drug of first choice]. | 2001 May 31 |
|
Screening for 18 diuretics and probenecid in doping analysis by liquid chromatography-tandem mass spectrometry. | 2002 Dec |
|
Changes in renal resistive index and urinary albumin excretion in hypertensive patients under long-term treatment with lisinopril or nifedipine GITS. | 2002 Feb |
|
[Results of clinical evidence: Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)]. | 2003 |
|
[Primary prevention of stroke. What helps--what does not help? The guidelines of the German Society of Neurology briefly summarized]. | 2003 |
|
Renal hypomagnesemia, hypercalciuria and nephrocalcinosis in a middle-aged man. | 2003 |
|
Diuretics: older, cheaper, better. | 2003 Apr |
|
ALLHAT--all hit or all miss? Key questions still remain. | 2003 Aug 1 |
|
[Recent intervention studies with antihypertensive drugs and their influence on guidelines]. | 2003 Dec 15 |
|
Back to thiazide-diuretics for hypertension: reflections after a decade of irrational prescribing. | 2003 Dec 23 |
|
[Consequences of ALLHAT: Thiazides rehabilitated--time to change prescription patterns]. | 2003 Feb 6 |
|
The Cuban experience in focusing pharmaceuticals policy to health population needs: initial results of the National Pharmacoepidemiology Network (1996-2001). | 2003 Jul-Aug |
|
Trandolapril: a newer angiotensin-converting enzyme inhibitor. | 2003 Mar |
|
A cheaper way to control high blood pressure. | 2003 Mar |
|
Benign intracranial hypertension in association with acute lymphoblastic leukemia. | 2003 Mar |
|
ALLHAT. Is it all hat? | 2003 Mar-Apr |
|
Diuretics: drugs of choice for the initial management of patients with hypertension. | 2003 May |
|
What are the best first-line antihypertensives: answers and more questions from the ALLHAT study. | 2003 May |
|
Characteristics and lipid distribution of a large, high-risk, hypertensive population: the lipid-lowering component of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). | 2003 Nov-Dec |
|
Amlodipine or lisinopril was not better than chlorthalidone in lowering CHD risk in hypertension. | 2003 Nov-Dec |
|
Hypothetical economic analysis of screening for left ventricular hypertrophy in high-risk normotensive populations. | 2004 Feb |
|
Guidelines for antihypertensive treatment: an update after the ALLHAT study. | 2004 Jan |
|
Relationship between blood glucose control, pathogenesis and progression of diabetic nephropathy. | 2004 Jan |
|
Hydrochlorothiazide versus chlorthalidone: evidence supporting their interchangeability. | 2004 Jan |
|
Blockade of the angiotensin II type 1 receptor stabilizes atherosclerotic plaques in humans by inhibiting prostaglandin E2-dependent matrix metalloproteinase activity. | 2004 Mar 30 |
Sample Use Guides
Hypertension: starting dose is 25 mg once daily. Edema: 100 mg daily, or 100 mg on alternate days.
Route of Administration:
Oral
In Vitro Use Guide
Sources: http://link.springer.com/article/10.1007/BF00561547
The binding of chlorthalidone to human blood components has been studied in vitro. When the concentration of chlorthalidone in blood was less than 15–20 ug/ml, more than 98% of the compound was bound to red cells. In human serum at 37C, over a concentration range of 0.02–7.7 ug/ml, 75.7% of chlorthalidone was bound to proteins. The association constant with carbonic anhydrase was 2.76×10(6) l/mole.
Substance Class |
Chemical
Created
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Edited
Fri Dec 15 17:32:21 UTC 2023
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Fri Dec 15 17:32:21 UTC 2023
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Record UNII |
Q0MQD1073Q
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WHO-VATC |
QC03BA04
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NCI_THESAURUS |
C49185
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NDF-RT |
N0000175420
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WHO-ATC |
C03EA06
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NDF-RT |
N0000175359
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WHO-ATC |
C03BA04
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WHO-VATC |
QC03EA06
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LIVERTOX |
199
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WHO-ATC |
C03BB04
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WHO-VATC |
QC03BB04
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2409
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PRIMARY | RxNorm | ||
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m3470
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1125
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3035
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625
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CHLORTHALIDONE
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PRIMARY | Description: A white to yellowish white, crystalline powder; odourless or almost odourless.Solubility: Practically insoluble in water and ether R; soluble in methanol R; slightly soluble in ethanol (~750 g/l) TS.Category: Diuretic.Storage: Chlortalidone should be kept in a well-closed container. | ||
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DTXSID4022812
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DB00310
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SUB06212MIG
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Chlorthalidone
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77-36-1
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CHLORTALIDONE
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C47449
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3654
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Q0MQD1073Q
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CHEMBL1055
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2732
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1130006
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201-022-5
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100000092578
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7147
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Related Record | Type | Details | ||
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BINDER->LIGAND |
BINDING
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ENANTIOMER -> RACEMATE |
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ENANTIOMER -> RACEMATE |
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IMPURITY -> PARENT |
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IMPURITY -> PARENT |
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IMPURITY -> PARENT |
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IMPURITY -> PARENT |
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ACTIVE MOIETY |
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Name | Property Type | Amount | Referenced Substance | Defining | Parameters | References |
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Biological Half-life | PHARMACOKINETIC |
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