Losartan Potassium and Hydrochlorothiazide Tablets USP 50mg+12.5mg Technical Specification:

Product Name:Losartan Potassium and Hydrochlorothiazide Tablets USP 50mg+12.5mg
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 50mg+12.5mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • 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

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

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

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.