Candesartan Cilexetil Tablets USP 32mg 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 32mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Candesartan Cilexetil Tablets USP 32mg
    Each Uncoated tablet contains:
    Candesartan Cilexetil Tablets USP…………….32mg
    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:

A) Candesartan Cilexetil Tablets USP 32mg
B) Candesartan Cilexetil Tablets USP 16mg
C) Candesartan Cilexetil Tablets USP 8mg
D) Candesartan Cilexetil Tablets USP 4mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Candesartan Cilexetil Tablets USP 32mg
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:

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.