Losartan Potassium Tablets USP 50mg Technical Specification:

Product Name:Losartan Potassium Tablets USP 50mg
Brand Name:Generic
Strength:(12.5mg), (25mg), (50mg), (100mg)
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, Nephrology
Indication: Losartan is used to treat high blood pressure (hypertension) and to help protect the kidneys from damage due to diabetes. It is also used to lower the risk of strokes in patients with high blood pressure and an enlarged heart. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems.
Storage:Store at 20°C 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.

GENERIC NAME OF THE MEDICINAL PRODUCT:

  • Losartan Potassium Tablets USP 50mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Losartan Potassium Tablets USP 50mg
    Each film-coated tablet contains:
    Losartan Potassium USP……………50mg
    Excipients………………………………….q.s
    Color: Sunset yellow lake

THERAPEUTIC INDICATIONS:

Losartan is used to treat high blood pressure (hypertension) and to help protect the kidneys from damage due to diabetes. It is also used to lower the risk of strokes in patients with high blood pressure and an enlarged heart. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
DISPENSE INA TIGHT, LIGHT-RESISTANT CONTAINER WITH A CHILD RESISTANT CLOSURE.

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 Tablets USP 12.5mg
2. Losartan Potassium Tablets USP 25mg
3. Losartan Potassium Tablets USP 50mg
4. Losartan Potassium Tablets USP 100mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

1. Losartan Potassium Tablets USP 12.5mg
Each film-coated tablet contains:
Losartan Potassium USP……………12.5mg
Excipients………………………………….q.s
Color: Sunset yellow FCF

2. Losartan Potassium Tablets USP 25mg
Each film-coated tablet contains:
Losartan Potassium USP……………25mg
Excipients………………………………….q.s
Color: Sunset yellow

3. Losartan Potassium Tablets USP 50mg
Each film-coated tablet contains:
Losartan Potassium USP……………50mg
Excipients………………………………….q.s
Color: Sunset yellow lake


4. Losartan Potassium Tablets USP 100mg
Each film-coated tablet contains:
Losartan Potassium USP……………100mg
Excipients………………………………….q.s
Color: Sunset yellow aluminum lake

THERAPEUTIC INDICATIONS:

Losartan is used to treat high blood pressure (hypertension) and to help protect the kidneys from damage due to diabetes. It is also used to lower the risk of strokes in patients with high blood pressure and an enlarged heart. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems.

CAUTION & WARNING:

CAUTION: Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH.
DISPENSE INA TIGHT, LIGHT-RESISTANT CONTAINER WITH A CHILD RESISTANT CLOSURE.
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.