Losartan Potassium/Hydrochlorothiazide 50mg/12.5mg, 100mg/12.5mg, 100mg/25mg Tablets Taj Pharma-SmPC

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Losartan Potassium/Hydrochlorothiazide tablets USP 50mg/12.5 mg/100mg/12.5mg/100mg/25mg

4. Clinical particulars

1. Name of the medicinal product

4.2 Posology and method of administration Losartan Potassium/Hydrochlorothiazide may be administered with other antihypertensive agents.

Losartan Potassium/Hydrochlorothiazide 50mg/12.5mg tablets USP Taj Pharma Losartan Potassium/Hydrochlorothiazide 100mg/12.5mg tablets USP Taj Pharma Losartan Potassium/Hydrochlorothiazide 100mg/25mg tablets USP Taj Pharma

Losartan Potassium/Hydrochlorothiazide tablets should be swallowed with a glass of water. Losartan Potassium/Hydrochlorothiazide may be administered with or without food.

2. Qualitative and quantitative composition a) Each film-coated tablet contains: Losartan potassium USP 50mg Hydrochlorothiazide USP 12.5mg Excipients q.s. Colour: Yellow Oxide of Iron & Titanium Dioxide USP. b) Each film-coated tablet contains: Losartan potassium USP 100mg Hydrochlorothiazide USP 12.5mg Excipients q.s. Colour: Yellow Oxide of Iron & Titanium Dioxide USP. c) Each film-coated tablet contains: Losartan potassium USP 100mg Hydrochlorothiazide USP 25mg Excipients q.s. Colour: Yellow Oxide of Iron & Titanium Dioxide USP. For a full list of excipients, see section 6.1

3. Pharmaceutical form Film-coated tablet.

4.1 Therapeutic indications Treatment of essential hypertension in patients whose blood pressure has not been adequately controlled by losartan or hydrochlorothiazide alone.

Hypertension Losartan and hydrochlorothiazide is not for use as initial therapy, but in patients whose blood pressure is not adequately controlled by losartan potassium or hydrochlorothiazide alone. Dose titration with the individual components (losartan and hydrochlorothiazide) is recommended. When clinically appropriate direct change from monotherapy to the fixed combination may be considered in patients whose blood pressure is not adequately controlled. The usual maintenance dose of Losartan Potassium/Hydrochlorothiazide is one tablet of Losartan Potassium/Hydrochlorothiazide 50 mg/12.5 mg (losartan 50 mg/HCTZ 12.5 mg) once daily. For patients who do not respond adequately to Losartan Potassium/Hydrochlorothiazide 50 mg/12.5 mg, the dosage may be increased to one tablet of Losartan Potassium/Hydrochlorothiazide 100 mg/25 mg (losartan 100 mg/ HCTZ 25 mg) once daily. The maximum dose is one tablet of Losartan Potassium/Hydrochlorothiazide 100 mg/25 mg once daily. In general, the antihypertensive effect is attained within three to four weeks after initiation of therapy. Losartan Potassium/Hydrochlorothiazide 100/12.5 (losartan 100 mg/ HCTZ 12.5 mg) is available


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