Losartan Potassium and Hydrochlorothiazide Tablets USP 100mg+25mg Technical Specification:
| Product Name: | Losartan Potassium and Hydrochlorothiazide Tablets USP |
| Brand Name: | Generic |
| Strength: | (50mg+12.5mg), (100mg+12.5mg), (100mg+25mg) |
| Dosage Form: | Tablets (film-coated) |
| 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: | Losartan Potassium / Hydrochlorothiazide is indicated for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on losartan or hydrochlorothiazide alone. |
| Storage: | Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Store in dry place protected from light and moisture. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
- Losartan Potassium and Hydrochlorothiazide Tablets USP 100mg+25mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- Losartan Potassium and Hydrochlorothiazide Tablets USP 100mg+25mg
Each film-coated tablet contains:
Losartan Potassium USP…………………..100mg
Hydrochlorothiazide USP………………….25mg
Excipients…………………………………………q.s
Colour: Ponceau 4R
THERAPEUTIC INDICATIONS:
Losartan Potassium / Hydrochlorothiazide is indicated for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on losartan or hydrochlorothiazide alone.
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
DISPENSE IN A TIGHT, LIGHT-RESISTANT CONTAINER WITH A CHILD-RESISTANT CLOSURE.
KEPP THE CONTAINER TIGHTLY CLOSED.
IT IS DANGEROUS TO TAKE THIS PREPARATION EXCEPT UNDER MEDICAL SUPERVISION.
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) ); excursions permitted to 15°C to 30°C (59°F to 86°F)
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end country.
GENERIC NAME OF THE MEDICINAL PRODUCT:
1. Losartan Potassium and Hydrochlorothiazide Tablets USP 50mg+12.5mg
2. Losartan Potassium and Hydrochlorothiazide Tablets USP 100mg+12.5mg
3. Losartan Potassium and Hydrochlorothiazide Tablets USP 100mg+25mg
2. Losartan Potassium and Hydrochlorothiazide Tablets USP 100mg+12.5mg
3. Losartan Potassium and Hydrochlorothiazide Tablets USP 100mg+25mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
1. Losartan Potassium and Hydrochlorothiazide Tablets USP 50mg+12.5mg
Each film-coated tablet contains:
Losartan Potassium USP…………………..50mg
Hydrochlorothiazide USP………………….12.5mg
Excipients…………………………………………q.s
Colour: Sunset yellow FCF
2. Losartan Potassium and Hydrochlorothiazide Tablets USP 100mg+12.5mg
Each film-coated tablet contains:
Losartan Potassium USP…………………..100mg
Hydrochlorothiazide USP………………….12.5mg
Excipients…………………………………………q.s
Colour: Ponceau 2R
3. Losartan Potassium and Hydrochlorothiazide Tablets USP 100mg+25mg
Each film-coated tablet contains:
Losartan Potassium USP…………………..100mg
Hydrochlorothiazide USP………………….25mg
Excipients…………………………………………q.s
Colour: Ponceau 4R
Each film-coated tablet contains:
Losartan Potassium USP…………………..50mg
Hydrochlorothiazide USP………………….12.5mg
Excipients…………………………………………q.s
Colour: Sunset yellow FCF
2. Losartan Potassium and Hydrochlorothiazide Tablets USP 100mg+12.5mg
Each film-coated tablet contains:
Losartan Potassium USP…………………..100mg
Hydrochlorothiazide USP………………….12.5mg
Excipients…………………………………………q.s
Colour: Ponceau 2R
3. Losartan Potassium and Hydrochlorothiazide Tablets USP 100mg+25mg
Each film-coated tablet contains:
Losartan Potassium USP…………………..100mg
Hydrochlorothiazide USP………………….25mg
Excipients…………………………………………q.s
Colour: Ponceau 4R
THERAPEUTIC INDICATIONS:
Losartan Potassium / Hydrochlorothiazide is indicated for the treatment of essential hypertension in patients whose blood pressure is not adequately controlled on losartan or hydrochlorothiazide alone.
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
DISPENSE IN A TIGHT, LIGHT-RESISTANT CONTAINER WITH A CHILD-RESISTANT CLOSURE.
KEPP THE CONTAINER TIGHTLY CLOSED.
IT IS DANGEROUS TO TAKE THIS PREPARATION EXCEPT UNDER MEDICAL SUPERVISION.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
DISPENSE IN A TIGHT, LIGHT-RESISTANT CONTAINER WITH A CHILD-RESISTANT CLOSURE.
KEPP THE CONTAINER TIGHTLY CLOSED.
IT IS DANGEROUS TO TAKE THIS PREPARATION EXCEPT UNDER MEDICAL SUPERVISION.
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) ); excursions permitted to 15°C to 30°C (59°F to 86°F)
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end country.
Store in dry place protected from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end country.
