| Product Name: | Nifedipine Extended Release Tablets USP |
| Brand Name: | Generic |
| Strength: | 10mg, 30mg, 60mg, 90mg |
| Dosage Form: | Tablets (Extended Release film-coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 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: | Antihypertensive, Antianginal |
| Indication: | Nifedipine is used to treat high blood pressure and to control angina (chest pain). Nifedipine is in a class of medications called calcium-channel blockers. It lowers blood pressure by relaxing the blood vessels so the heart does not have to pump as hard. |
| Storage: | Store at 20°C to 25°C (68° to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Store in dry place protected from light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Nifedipine Extended Release Tablets USP 10mg
- Nifedipine Extended Release Tablets USP 30mg
- Nifedipine Extended Release Tablets USP 60mg
- Nifedipine Extended Release Tablets USP 90mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Nifedipine Extended Release Tablets USP 10mg
Each film-coated Extended Release tablet contains:
Nifedipine USP ………………..10mg
Excipients …………………………..q.s
Color: Sunset yellow FCF - Nifedipine Extended Release Tablets USP 30mg
Each film-coated Extended Release tablet contains:
Nifedipine USP……………….30mg
Excipients ……………………….q.s
Color: Orange G - Nifedipine Extended Release Tablets USP 60mg
Each film-coated Extended Release tablet contains:
Nifedipine USP……………….60mg
Excipients ……………………….q.s
Color: Ponceau 4 R - Nifedipine Extended Release Tablets USP 90mg
Each film-coated Extended Release tablet contains:
Nifedipine USP……………….90mg
Excipients ………………………..q.s
Color: Red oxide of iron
THERAPEUTIC INDICATIONS:
Nifedipine is used to treat high blood pressure and to control angina (chest pain). Nifedipine is in a class of medications called calcium-channel blockers. It lowers blood pressure by relaxing the blood vessels so the heart does not have to pump as hard.
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Dispense in a tight, light-resistant container as defined in the USP.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F)
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician.