Nifedipine Retard Tablets 10mg
Categories: , , , , ,
Date:

Nifedipine Retard Tablets 10mg Technical Specification:

Product Name:Nifedipine Retard Tablets 10mg
Brand Name:Generic
Strength:10mg, 20mg, 30mg, 40mg, 60mg, 90mg
Dosage Form:Tablets (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 Retard Tablets 10mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Nifedipine Retard Tablets 10mg
    Each film-coated tablet contains:
    Nifedipine USP ………….10mg
    Excipients …………………q. s
    Color: Sunset yellow FCF

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: SWALLOW WHOLE DO NOT CHEW OR CRUSH.

Read enclosed leaflet before use.

Dispense in a tight, light-resistant containers as defined in the USP.

Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.

Keep medicine out of reach of children.

STORAGE & DOSAGE:

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.

Dosage: As directed by the Physician.

Attach dispensing label as per end country.

GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Nifedipine Retard Tablets 10mg
B. Nifedipine Retard Tablets 20mg
C. Nifedipine Retard Tablets 30mg
D. Nifedipine Retard Tablets 40mg
E. Nifedipine Retard Tablets 60mg
F. Nifedipine Retard Tablets 90mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Nifedipine Retard Tablets 10mg
Each film-coated tablet contains:
Nifedipine USP ………….10mg
Excipients …………………q. s
Color: Sunset yellow FCF

B. Nifedipine Retard Tablets 20mg
Each film-coated tablet contains:
Nifedipine USP …………20mg
Excipients ………………q. s
Color: Ferric oxide red

C. Nifedipine Retard Tablets 30mg
Each film-coated tablet contains:
Nifedipine USP…………….30mg
Excipients ……………………. q. s
Color: Orange G

D. Nifedipine Retard Tablets 40mg
Each film-coated tablet contains:
Nifedipine USP………….40mg
Excipients …………………. q. s
Color: Ponceau 2 R

E. Nifedipine Retard Tablets 60mg
Each film-coated tablet contains:
Nifedipine USP…………….60mg
Excipients……………………q. s
Color: Ponceau 4 R

F. Nifedipine Retard Tablets 90mg
Each film-coated 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: SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Read enclosed leaflet before use.
Dispense in a tight, light-resistant containers as defined in the USP.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
KEEP MEDICINE OUT OF REACH OF CHILDREN.

STORAGE & DOSAGE:

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.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.