| Product Name: | Irbesartan & Hydrochlorothiazide Tablets USP |
| Brand Name: | Generic |
| Strength: | 75+6.25mg, 150+12.5mg, 300+12.5mg, 150+25mg |
| Dosage Form: | Tablets (Uncoated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 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: | Antihypertensive, Diuretics |
| Indication: | Irbesartan and hydrochlorothiazide combination is used alone or together with other medicines to treat high blood pressure (hypertension). |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Irbesartan & Hydrochlorothiazide Tablets USP 75mg+6.25mg
- Irbesartan & Hydrochlorothiazide Tablets USP 150mg+12.5mg
- Irbesartan & Hydrochlorothiazide Tablets USP 300mg+12.5mg
- Irbesartan & Hydrochlorothiazide Tablets USP 150mg+25mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Irbesartan & Hydrochlorothiazide Tablets USP 75mg+6.25mg
Each uncoated tablet contains:
Irbesartan USP…………….75mg
Hydrochlorothiazide……6.25mg
Excipients………………. q.s.
Colour: Ferric Oxide red USP-NF. - Irbesartan & Hydrochlorothiazide Tablets USP 150mg+12.5mg
Each uncoated tablet contains:
Irbesartan USP…………….150mg
Hydrochlorothiazide……12.5mg
Excipients………………. q.s.
Colour: Ferric Oxide red USP-NF. - Irbesartan & Hydrochlorothiazide Tablets USP 300mg+12.5mg
Each uncoated tablet contains:
Irbesartan USP……………300mg
Hydrochlorothiazide……12.5
Excipients………………q.s.
Colour: Indigo carmine. - Irbesartan & Hydrochlorothiazide Tablets USP 150mg+25mg
Each uncoated tablet contains:
Irbesartan USP…………….150mg
Hydrochlorothiazide……25mg
Excipients………………. q.s.
Colour: Ferric Oxide red USP-NF.
THERAPEUTIC INDICATIONS:
Irbesartan and hydrochlorothiazide combination is used alone or together with other medicines to treat high blood pressure (hypertension).
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: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dosage: As directed by the Physician.