GENERIC NAME OF THE MEDICINAL PRODUCT:
B. Amlodipine Tablets IP 5mg
C. Amlodipine Tablets IP 10mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each uncoated tablet contains:
Amlodipine Besylate IP
Equivalent to Amlodipine……………2.5mg
Colour: Lake of sunset yellow FCF
Excipients…………………………………...q.s
B) Amlodipine Tablets IP 5mg
Each uncoated tablet contains:
Amlodipine Besylate IP
Equivalent to Amlodipine……………5mg
Colour: Quinoline Yellow
Excipients…………………………………...q.s
C) Amlodipine Tablets IP 10mg
Each uncoated tablet contains:
Amlodipine Besylate IP
Equivalent to Amlodipine……………10mg
Colour: Tartrazine
Excipients…………………………………...q.s
THERAPEUTIC INDICATIONS:
CAUTION & SCHEDULE:
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Tablet to be swallowed as a whole, and not to be chewed or crushed.
SCHEDULE: SCHEDULE H PRESCRIPTION DRUG CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Store in cool, dry & dark place.
Protect from Light & moisture.
Dosage: As directed by the Physician.
Amlodipine Tablets IP 5mg Technical Specification:
| Product Name: | Amlodipine Tablets IP |
| Brand Name: | Generic |
| Strength: | (2.5mg), (5mg), (10mg) |
| Dosage Form: | Tablets (uncoated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10 strips of 10 Tablets Each |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet) |
| Regulatory Documents: | COA, MOA, Stability Studies, GMP |
| Therapeutic use: | Antihypertensive |
| Indication: | Amlodipine is used alone or in combination with other medications to treat high blood pressure in adults and children 6 years and older. It is also used to treat certain types of anginas (chest pain) and coronary artery disease (narrowing of the blood vessels that supply blood to the heart). |
| Storage: | Store below 30℃. Store in cool, dry & dark place. Protect from Light & moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Amlodipine Tablets IP 5mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Amlodipine Tablets IP 5mg
Each uncoated tablet contains:
Amlodipine Besylate IP
Equivalent to Amlodipine……………5mg
Colour: Quinoline Yellow
Excipients……………………………………q.s
THERAPEUTIC INDICATIONS:
Amlodipine is used alone or in combination with other medications to treat high blood pressure in adults and children 6 years and older. It is also used to treat certain types of anginas (chest pain) and coronary artery disease (narrowing of the blood vessels that supply blood to the heart).
CAUTION & SCHEDULE:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
Tablet to be swallowed as a whole, and not to be chewed or crushed.
SCHEDULE: SCHEDULE H PRESCRIPTION DRUG CAUTION: Not to be sold by retail without the prescription of a Registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store below 30℃.
Store in cool, dry & dark place.
Protect from Light & moisture.
Dosage: As directed by the Physician.
NOTE:
The usual initial dose in 5mg once daily. Which may be increased depending on the patient’s response.
