A. Amlodipine Tablets 2.5mg
B. Amlodipine Tablets 5mg
C. Amlodipine Tablets 10mg
GENERIC NAME OF THE MEDICINAL PRODUCT:
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A. Amlodipine Besylate Tablets USP 2.5mg
Each uncoated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine ………. 2.5mg
Excipients ……………………………... q.s
Color: Sunset yellow FCF
B. Amlodipine Besylate Tablets USP 5mg
Each uncoated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine…………...5mg
Excipients………………………………… q.s
Color: Ponceau 4R
C. Amlodipine Besylate Tablets USP 10mg
Each uncoated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine …………...10mg
Excipients …………………………………... q.s
Color: Ponceau 2R
Each uncoated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine ………. 2.5mg
Excipients ……………………………... q.s
Color: Sunset yellow FCF
B. Amlodipine Besylate Tablets USP 5mg
Each uncoated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine…………...5mg
Excipients………………………………… q.s
Color: Ponceau 4R
C. Amlodipine Besylate Tablets USP 10mg
Each uncoated tablet contains:
Amlodipine Besylate USP
Equivalent to Amlodipine …………...10mg
Excipients …………………………………... q.s
Color: Ponceau 2R
THERAPEUTIC INDICATIONS:
Amlodipine Besylate tablet is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
CAUTION & WARNING:
CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Read enclosed leaflet before use.
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.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
Read enclosed leaflet before use.
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.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
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.
Attach dispensing label as per end country.
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
Amlodipine Besylate Tablets USP 10mg Technical Specification:
| Product Name: | Amlodipine Tablets 10mg |
| Brand Name: | Generic |
| Strength: | 2.5mg, 5mg, 10mg |
| Dosage Form: | Tablets (uncoated) |
| 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 |
| Indication: | Amlodipine Besylate tablet is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. |
| Storage: | Store at 20° to 25°C (68° to 77°F). Store in dry place protected from light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Amlodipine Besylate Tablets USP 2.5mg
- Amlodipine Besylate Tablets USP 5mg
- Amlodipine Besylate Tablets USP 10mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Amlodipine Besylate Tablets USP 2.5mg
Each uncoated tablet contains:
Amlodipine Besylate USP
Equivalent to
Amlodipine………………………………2.5mg
Excipients………………………………..q.s
Color: Sunset yellow FCF - Amlodipine Besylate Tablets USP 5mg
Each uncoated tablet contains:
Amlodipine Besylate USP
Equivalent to
Amlodipine………………………………5mg
Excipients………………………………..q.s
Color: Ponceau 4R - Amlodipine Besylate Tablets USP 10mg
Each uncoated tablet contains:
Amlodipine Besylate USP
Equivalent to
Amlodipine………………………………10mg
Excipients………………………………..q.s
Color: Ponceau 2R
THERAPEUTIC INDICATIONS:
Amlodipine Besylate tablet is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
CAUTION & WARNING:
CAUTION: SWALLOW WHOLE DO NOT CHEW OR CRUSH.
Read enclosed leaflet before use.
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.
Keep medicine out of reach of children.
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.
Attach dispensing label as per end country.
