| Product Name: | Lisinopril and Hydrochlorothiazide Tablets USP |
| Brand Name: | Generic |
| Strength: | 10mg+12.5mg, 20mg+12.5mg, 20mg+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 |
| Indication: | The combination of lisinopril and hydrochlorothiazide is used to treat high blood pressure. Lisinopril is in a class of medications called angiotensin-converting enzyme (ACE) inhibitors. It works by decreasing certain chemicals that tighten the blood vessels, so blood flows more smoothly. |
| Storage: | Store at 20°C to 25°C (68° to 77°F). Store in a dry place protected from light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Lisinopril and Hydrochlorothiazide Tablets USP 10mg+12.5mg
- Lisinopril and Hydrochlorothiazide Tablets USP 20mg+12.5mg
- Lisinopril and Hydrochlorothiazide Tablets USP 20mg+25mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Lisinopril and Hydrochlorothiazide Tablets USP 10mg+12.5mg
Each uncoated tablet contains:
Lisinopril Dihydrate USP
Equivalent to
Lisinopril Anhydrous……………………..10mg
Hydrochlorothiazide USP……………….12.5mg
Excipients………………………………………q.s
Colour: Titanium Dioxide. - Lisinopril and Hydrochlorothiazide Tablets USP 20mg+12.5mg
Each uncoated tablet contains:
Lisinopril Dihydrate USP
Equivalent to
Lisinopril Anhydrous………………………20mg
Hydrochlorothiazide USP……………….12.5mg
Excipients………………………………………q.s
Colour: Ponceau 4R. - Lisinopril and Hydrochlorothiazide Tablets USP 20mg+25mg
Each uncoated tablet contains:
Lisinopril Dihydrate USP
Equivalent to
Lisinopril Anhydrous……………………….20mg
Hydrochlorothiazide USP………………..25mg
Excipients……………………………………….q.s
Colour: Ponceau 2R.
THERAPEUTIC INDICATIONS:
The combination of lisinopril and hydrochlorothiazide is used to treat high blood pressure. Lisinopril is in a class of medications called angiotensin-converting enzyme (ACE) inhibitors. It works by decreasing certain chemicals that tighten the blood vessels, so blood flows more smoothly.
CAUTION & WARNING:
CAUTION:
Read the enclosed leaflet before use.
Keep the medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
DISPENSE IN A TIGHT, LIGHT-RESISTANT CONTAINER ACCORDING TO USP.
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only. It is dangerous to take this preparation except under medical supervision.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F).
Store in a dry place protected from light and moisture.
Dosage: As directed by the Physician.