Valsartan Tablets USP 80mg Technical Specification:

Product Name:                  Valsartan Tablets USP 80mg
Brand Name:Generics
Strength:40mg, 80mg, 160mg, 320mg
Dosage Form:Tablets (Film-coated)
Route of Administration:Via oral Route
Packing:30s, 90s, 100s, 500s, 1000s
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 is indicated for the treatment of hypertension, to lower blood pressure.
Storage:Protect form moisture at a temperature not exceeding 30˚C.Do not freeze. Keep the container tightly closed in order to protect from moisture.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Valsartan Tablets USP 80mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Valsartan Hydrochlorothiazide Tablets USP 80mg
    Each film coated tablets contains:
    Valsartan USP…………………….…80mg
    Excipients………………………………………q.s.
    colures: Red Oxide iron

THERAPEUTIC INDICATIONS:

Treatment of essential hypertension in adults.
Valsartan fixed-dose combination is indicated in patients whose blood pressure is not adequately controlled on valsartan 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: Protect form moisture at a temperature not exceeding 30˚C. Do not freeze. Keep the container tightly closed in order to protect from moisture.

Dosage: As directed by the Physician.

Attach dispensing label as per end country.

 

 

 

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Valsartan Tablets USP 40mg
B) Valsartan Tablets USP 80mg
C) Valsartan Tablets USP 160mg
D) Valsartan Tablets USP 320mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Valsartan Hydrochlorothiazide Tablets USP 40mg
Each film coated tablets contains:
Valsartan USP…………………….…40mg
Excipients………………………………………q.s.
colures: Iron Oxide Yellow

B) Valsartan Hydrochlorothiazide Tablets USP 80mg
Each film coated tablets contains:
Valsartan USP………………….80mg
Excipients……………………………………. q.s.
colures: Red Oxide iron


C) Valsartan Hydrochlorothiazide Tablets USP 160mg
Each film coated tablets contains:
Valsartan USP…………………….…160mg
Excipients………………………………………q.s.
colures: Iron Oxide Yellow

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

THERAPEUTIC INDICATIONS:

Treatment of essential hypertension in adults.
Valsartan fixed-dose combination is indicated in patients whose blood pressure is not adequately controlled on valsartan 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: Protect form moisture at a temperature not exceeding 30˚C. Do not freeze. Keep the container tightly closed in order to protect from moisture.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.