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
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).
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.
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.
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.
Dosage: As directed by the Physician.
Attach dispensing label as per end country.
