| Product Name: | Valsartan and Hydrochlorothiazide Tablets USP |
| Brand Name: | Valsartan and Hydrochlorothiazide HCT |
| Strength: | 80mg+12.5mg, 160mg+12.5mg, 320mg+12.5mg |
| Dosage Form: | Tablets (Film-coated) |
| Route of Administration: | Via Oral Route |
| Packing: | 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: | Anti-hypertensive, Diuretics, Enzyme Inhibitor, Cardiovascular System. |
| Indication: | Valsartan and Hydrochlorothiazide are indicated for the treatment of hypertension, to lower blood pressure. |
| Storage: | Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Store in the original package in order to protect it from moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Valsartan and Hydrochlorothiazide Tablets USP 80mg+12.5 mg
- Valsartan and Hydrochlorothiazide Tablets USP 160mg+12.5 mg
- Valsartan and Hydrochlorothiazide Tablets USP 320mg+12.5 mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Valsartan and Hydrochlorothiazide Tablets USP 80mg+12.5mg
Each film-coated tablet contains:
Valsartan USP………………….80mg
Hydrochlorothiazide USP……………12.5mg
Excipients……………………………………. q.s.
Colours: Red Oxide iron - Valsartan and Hydrochlorothiazide Tablets USP 160mg+12.5mg
Each film-coated tablet contains:
Valsartan USP…………………….…160mg
Hydrochlorothiazide USP………………12.5mg
Excipients………………………………………q.s.
Colours: Iron Oxide Yellow - Valsartan and Hydrochlorothiazide Tablets USP 320mg+12.5mg
Each film-coated tablet contains:
Valsartan USP……………………….320mg
Hydrochlorothiazide USP………………….12.5mg
Excipients…………………………………………. q.s.
Colours: F&D Blue (Indigo Carmine).
THERAPEUTIC INDICATIONS:
Treatment of essential hypertension in adults.
Valsartan and Hydrochlorothiazide combination is indicated in patients whose blood pressure is not adequately controlled on valsartan or hydrochlorothiazide monotherapy.
CAUTION & WARNING:
CAUTION:
Read the enclosed leaflet before use.
Keep the 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: Do not store above 30°C.
Store in the original package in order to protect it from moisture.
Dosage: As directed by the Physician.