GENERIC NAME OF THE MEDICINAL PRODUCT:

Valsartan Hydrochlorothiazide Tablets USP 80mg/12.5 mg
Valsartan Hydrochlorothiazide Tablets USP 160mg/12.5 mg
Valsartan Hydrochlorothiazide Tablets USP 320mg/12.5 mg
Valsartan Hydrochlorothiazide Tablets USP 80mg/25mg
Valsartan Hydrochlorothiazide Tablets USP 160mg/25 mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Valsartan Hydrochlorothiazide Tablets USP 80mg/12.5 mg
Each film coated tablets contains:
Valsartan USP………………….80mg
Hydrochlorothiazide USP……………12.5mg
excipients……………………………………. q.s.
colures: Red Oxide iron

b) Valsartan Hydrochlorothiazide Tablets USP 160mg/12.5 mg
Each film coated tablets contains:
Valsartan USP…………………….…160mg
Hydrochlorothiazide USP………………12.5mg
excipients………………………………………q.s.
colures: Iron Oxide Yellow

c) Valsartan Hydrochlorothiazide Tablets USP 320mg/12.5 mg
Each film coated tablets contains:
Valsartan USP……………………….320mg
Hydrochlorothiazide USP………………….12.5mg
excipients…………………………………………. q.s.
colures: F&D Blue (Indigo Carmine).

d) Valsartan Hydrochlorothiazide Tablets USP 80mg/25mg
Each film coated tablets contains:
Valsartan USP……………………….80mg
Hydrochlorothiazide USP………………...25mg
excipients………………………………………q.s.
colures: titanium dioxide USP

e) Valsartan Hydrochlorothiazide Tablets USP 160mg/25 mg
Each film coated tablets contains:
Valsartan USP………………………160mg
Hydrochlorothiazide USP…………………...25mg
excipients………………………………………...q.s.
colures: FD&C Red 4.

THERAPEUTIC INDICATIONS:

Treatment of essential hypertension in adults.
valsartan hct fixed-dose combination is indicated in patients whose blood pressure is not adequately controlled on valsartan or hydrochlorothiazide monotherapy.

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: Do not store above 30°C.
Store in the original package in order to protect from moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end county.

Valsartan and Hydrochlorothiazide Tablets USP Technical Specification:

Product Name: Valsartan and Hydrochlorothiazide Tablets USP
Brand Name: Valsartan HCT
Strength: 80mg/12.5mg, 160mg/12.5mg, 320mg/12.5mg, 80mg/25mg, 160mg/25mg
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: Do not store above 30°C. Store in the original package in order to protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Valsartan Hydrochlorothiazide Tablets USP 80mg/12.5 mg
  • Valsartan Hydrochlorothiazide Tablets USP 160mg/12.5 mg
  • Valsartan Hydrochlorothiazide Tablets USP 320mg/12.5 mg
  • Valsartan Hydrochlorothiazide Tablets USP  80mg/25mg
  • Valsartan Hydrochlorothiazide Tablets USP 160mg/25 mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

a) Valsartan Hydrochlorothiazide Tablets USP 80mg/12.5 mg
Each film coated tablets contains:
Valsartan USP………………….80mg
Hydrochlorothiazide USP……………12.5mg
excipients……………………………………. q.s.
colures: Red Oxide iron

b) Valsartan Hydrochlorothiazide Tablets USP 160mg/12.5 mg
Each film coated tablets contains:
Valsartan USP…………………….…160mg
Hydrochlorothiazide USP………………12.5mg
excipients………………………………………q.s.
colures: Iron Oxide Yellow

c) Valsartan Hydrochlorothiazide Tablets USP 320mg/12.5 mg
Each film coated tablets contains:
Valsartan USP……………………….320mg
Hydrochlorothiazide USP………………….12.5mg
excipients…………………………………………. q.s.
colures: F&D Blue (Indigo Carmine).

d) Valsartan Hydrochlorothiazide Tablets USP 80mg/25mg
Each film coated tablets contains:
Valsartan USP……………………….80mg
Hydrochlorothiazide USP…………………25mg
excipients………………………………………q.s.
colures: titanium dioxide USP

e) Valsartan Hydrochlorothiazide Tablets USP 160mg/25 mg
Each film coated tablets contains:
Valsartan USP………………………160mg
Hydrochlorothiazide USP……………………25mg
excipients…………………………………………q.s.
colures: FD&C Red 4.

THERAPEUTIC INDICATIONS:

  • Treatment of essential hypertension in adults.valsartan hct fixed-dose combination is indicated in patients whose blood pressure is not adequately controlled on valsartan or hydrochlorothiazide monotherapy.

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: Do not store above 30°C. Store in the original package in order to protect from moisture.
  • Dosage: As directed by the Physician.
Attach dispensing label as per end county.