Valforge

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Valforge Product Information Leaflets
Brand Name:
Valforge
Generic Name:
Valsartan

DESCRIPTION:

Valsartan is an angiotensin II receptor antagonist with actions similar to those of losartan.

COMPOSITION:

Valforge 40mg Tablets: Each film coated tablet contains: Valsartan U.S.P. ….......... 40 mg. Valforge 80mg Tablets Each film coated tablet contains: Valsartan U.S.P. ….......... 80 mg. Valforge 160mg Tablets Each film coated tablet contains: Valsartan U.S.P. …........ 160 mg.

INDICATIONS:

Hypertension Valforge (Valsartan) is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. Valforge (Valsartan) may be used alone or in combination with other antihypertensive agents. Heart Failure Valforge (Valsartan) is indicated for the treatment of heart failure (NYHAclass II-IV). Post - Myocardial Infarction Valforge (Valsartan) is indicated to reduce cardiovascular mortality, in clinically stable patients with left ventricular failure or left ventricular dysfunction following myocardial infarction.

DOSAGE & ADMINISTRATION:

Adult Hypertension The recommended starting dose of Valforge (Valsartan) is 80 mg or 160 mg once daily when used as mono therapy in patients who are not volume-depleted. Patients requiring greater reductions may be started at the higher dose. Valforge (Valsartan) may be used over a dose range of 80 mg to 320 mg daily, administered once a day. The antihypertensive effect is substantially present within 2 weeks and maximal reduction is generally attained after 4 weeks. If additional antihypertensive effect is required over the starting dose range, the dose may be increased to a maximum of 320 mg or a diuretic may be added. Addition of a diuretic has a greater effect than dose increases beyond 80 mg. No initial dosage adjustment is required for elderly patients, for patients with mild or moderate renal impairment, or for patients with mild or moderate liver insufficiency. Care should be exercised with dosing of Valforge in patients with hepatic or severe renal impairment. It may be administered with other antihypertensive agents. It may be administered with or without food. Pediatric Hypertension 6 to 16 Years of Age For children who can swallow tablets, the usual recommended starting dose is 1.3 mg/kg once daily (up to 40 mg total). The dosage should be adjusted according to blood pressure response. Doses higher than 2.7 mg/kg (up to 160 mg) once daily have not been studied in pediatric patients 6 to 16 years old. No data are available in pediatric patients either undergoing dialysis or with a glomerular filtration rate <30 mL/min/1.73 m2. It is not recommended for patients <6 years old. Heart Failure The recommended starting dose of Valforge (Valsartan) is 40 mg twice daily. Up titration to 80 mg and 160 mg twice daily should be done to the highest dose, as tolerated by the patient. Consideration should be given to reducing the dose of concomitant diuretics. The maximum daily dose administered in clinical trials is 320 mg in divided doses. Post-Myocardial Infarction Valforge (Valsartan) may be initiated as early as 12 hours after a myocardial infarction. The recommended starting dose of Valforge (Valsartan) is 20 mg twice daily. Patients may be up titrated within 7 days to 40 mg twice daily, with subsequent titrations to a target maintenance dose of 160 mg twice daily, as tolerated by the patient. If symptomatic hypotension or renal dysfunction occurs, consideration should be given to a dosage reduction. It may be given with other standard post-myocardial infarction treatment, including thrombolytics, aspirin, beta-blockers, and statins.

CONTRAINDICATIONS:

• Do not use in patients with known hypersensitivity to any component. • Do not co-administer aliskiren with Valforge (Valsartan) in patients with diabetes.

PRESENTATION:

1. Valforge 40mg Tablets: Alu. Alu. blister pack of 2x7’s. 2. Valforge 80mg Tablets: Alu. Alu. blister pack of 2x7’s. 3. Valforge 160mg Tablets: Alu. Alu. blister pack of 2x7’s

Patients should consult with their physician before taking any medicine.