| Product Name: | Captopril Tablets USP |
| Brand Name: | CAPOTAJ |
| Strength: | 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:
a) Captopril Tablets USP 25mg
b) Captopril Tablets USP 50mg
c) Captopril Tablets USP 100mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
a) Captopril Tablets USP 25mg
Each uncoated tablet contains:
Captopril USP……………25mg
Excipients…………………. q.s.
b) Captopril Tablets USP 50mg
Each uncoated tablet contains:
Captopril USP……………………50mg
Excipients…………………………q.s.
c) Captopril Tablets USP 100mg
Each uncoated tablet contains:
Captopril USP……………………100mg
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.