GENERIC NAME OF THE MEDICINAL PRODUCT:

Captopril Tablets USP 100mg
Captopril Tablets USP 50mg
Captopril Tablets USP 25mg
Captopril Tablets USP 12.5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Captopril Tablets USP 100mg
Each uncoated tablet contains:
Captopril USP……………100mg
Excipients…………………. q.s.

b) Captopril Tablets USP 50mg
Each uncoated tablet contains:
Captopril USP…………………...50mg
Excipients………………………...q.s.

c) Captopril Tablets USP 25mg
Each uncoated tablet contains:
Captopril USP…………………25mg
Excipients……………………......q.s.

d) Captopril Tablets USP 12.5mg
Each uncoated tablet contains:
Captopril USP…………………...12.5mg
Excipients………………………...q.s.

THERAPEUTIC INDICATIONS:

Hypertension: The management of mild to moderate hypertension. In severe hypertension it should be used where standard therapy is ineffective or inappropriate.
Congestive heart failure: Captopril is indicated for the treatment of congestive heart failure. The drug should be used together with diuretics and, when appropriate, digitalis and beta-blockers.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage:Do not store above 25°C. Store in the original package in order to protect from moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end county.

Captopril Tablets USP Technical Specification:

Product Name: Captopril Tablets USP
Brand Name: CAPOTAJ
Strength: 12.5mg, 25mg, 50mg, 100mg
Dosage Form: Tablets
Route of Administration: Via oral route
Packing: 30s, 90s, 100s, 500s
Pack Insert/Leaflet: PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics).
Regulatory Documents: COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use: Anti-hypertensive, Cardiology, Cardiovascular System.
Indication: Captopril is used to treat high blood pressure (hypertension).
Storage: Do not store above 25°C. Store in the original package in order to protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Captopril Tablets USP 100mg
  • Captopril Tablets USP 50mg
  • Captopril Tablets USP 25mg
  • Captopril Tablets USP 12.5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Captopril Tablets USP 100mg
Each uncoated tablet contains:
Captopril USP……………………100mg
Excipients…………………. q.s.

b) Captopril Tablets USP 50mg
Each uncoated tablet contains:
Captopril USP…………………………50mg
Excipients…………………………q.s.

c) Captopril Tablets USP 25mg
Each uncoated tablet contains:
Captopril USP…………………………25mg
Excipients…………………………q.s.

d) Captopril Tablets USP 12.5mg
Each uncoated tablet contains:
Captopril USP…………………………12.5mg
Excipients…………………………q.s.

THERAPEUTIC INDICATIONS:

  • Hypertension: The management of mild to moderate hypertension. In severe hypertension it should be used where standard therapy is ineffective or inappropriate.
  • Congestive heart failure: Captopril is indicated for the treatment of congestive heart failure. The drug should be used together with diuretics and, when appropriate, digitalis and beta-blockers. In patients on doses of over 100 mg daily plus or minus a diuretic, in those with severe renal impairment or those with severe congestive heart failure use of captopril should be under specialist supervision.

CAUTION & WARNING:

  • CAUTION:
    Read enclosed leaflet before use.
    Keep medicine out of reach of children.
    SWALLOW WHOLE DO NOT CHEW OR CRUSH.
  • Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

  • Storage: Do not store above 25°C. Store in the original package in order to protect from moisture.
  • Dosage: As directed by the Physician.
Attach dispensing label as per end county.