Candesartan Cilexetil Tablets USP 16mg Technical Specification:
| Product Name: | Candesartan Cilexetil Tablets USP |
| Brand Name: | Generics |
| Strength: | 4mg, 8mg, 16mg, 32mg |
| Dosage Form: | Tablets |
| Route of Administration: | Via Oral Route |
| Packing: | 30s, 90s, 100s |
| 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, Cardiovascular System. |
| Indication: | Candesartan is used to treat high blood pressure (hypertension) |
| Storage: | Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Candesartan Cilexetil Tablets USP 16mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Candesartan Cilexetil Tablets USP 16mg
Each Uncoated tablet contains:
Candesartan Cilexetil Tablets USP……………….16mg
Excipients…………………………………………q.s
THERAPEUTIC INDICATIONS:
Candesartan Cilexetil is indicated for the:
Treatment of essential hypertension in adults
Treatment of hypertension in children and adolescents aged 6 to 18 years.
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: Store at 25°C (77°F); excursions permitted to 15 to 30°C (59-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed.
Dosage: As directed by the Physician.
| Attach dispensing label as per end county. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
B) Candesartan Cilexetil Tablets USP 16mg
C) Candesartan Cilexetil Tablets USP 8mg
D) Candesartan Cilexetil Tablets USP 4mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each Uncoated tablet contains:
Candesartan Cilexetil Tablets USP…………….32mg
Excipients………………………………………...q.s
B) Candesartan Cilexetil Tablets USP 16mg
Each Uncoated tablet contains:
Candesartan Cilexetil Tablets USP……………….16mg
Excipients…………………………………………q.s
C) Candesartan Cilexetil Tablets USP 8mg
Each Uncoated tablet contains:
Candesartan Cilexetil Tablets USP……………….8mg
Excipients…………………………………………q.s
D) Candesartan Cilexetil Tablets USP 4mg
Each Uncoated tablet contains:
Candesartan Cilexetil Tablets USP……………….4mg
Excipients…………………………………………q.s
THERAPEUTIC INDICATIONS:
Treatment of essential hypertension in adults
Treatment of hypertension in children and adolescents aged 6 to 18 years.
CAUTION & WARNING:
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:
Dosage: As directed by the Physician.
Attach dispensing label as per end county.

