VYTAN FILM-COATED TABLET 160 MG [SIN16404P]

Product Info

VYTAN FILM-COATED TABLET 160 MG

[SIN16404P]

IV. INDICATIONS
Hypertension
Treatment of hypertension.

Heart failure
Treatment of heart failure (NYHA class II–IV) in patients receiving usual therapy (such as diuretics, digitalis) who are intolerant to ACE inhibitors. Valsartan improves morbidity in these patients, primarily via reduction in hospitalization for heart failure. Valsartan also slows the progression of heart failure, improves NYHA functional class, ejection fraction and signs and symptoms of heart failure and improves quality of life versus placebo.

Post-myocardial infarction
Valsartan is indicated to improve survival following myocardial infarction in clinically stable patients with signs, symptoms or radiological evidence of left ventricular failure and/or with left ventricular systolic dysfunction.

X. DOSAGE AND ADMINISTRATION
Hypertension
The recommended dose of valsartan is 80 mg once daily, irrespective of race, age, or gender. The maximum antihypertensive effect is seen after 4 weeks. In patients whose blood pressure is not adequately controlled, the daily dose may be increased to 160mg. If additional blood pressure reduction is required, a diuretic may be added or the dose can be increased further to a maximum of 320 mg.
Valsartan may also be administered with other antihypertensive agents.

Heart failure
The recommended starting dose of Valsartan is 40 mg film-coated tablet twice daily. Up-titration to 80mg and 160 mg twice daily should be done to the highest dose tolerated by the patient. Consideration should be given to reducing the dose of concomitant diuretics. The maximum daily dose administered is 320 mg in divided doses.
Evaluation of patients with heart failure should always include assessment of renal function.

Post-myocardial infarction
Therapy may be initiated as early as 12 hours after a myocardial infarction. After an initial dose of 20mg twice daily, valsartan therapy should be titrated to 40 mg, 80 mg, and 160 mg film-coated tablet twice daily over the next few weeks. The starting dose is provided by the 40 mg divisible tablet.
Achievement of the target dose of 160mg twice daily should be based on the patient’s tolerability to valsartan during titration. If symptomatic hypotension or renal dysfunction occurs, consideration should be given to a dosage reduction.
Valsartan may be used in patients treated with other post-myocardial infarction therapies, e.g. thrombolytics, acetylsalicylic acid, beta blockers or statins.
Evaluation of post-myocardial infarction patients should always include assessment of renal function.
NOTE for all indications: No dosage adjustment is required for patients with renal impairment or for patients with hepatic insufficiency of non-biliary origin and without cholestasis.

Use in children and adolescents
The safety and efficacy of Valsartan have not been established in children and adolescents (below the age of 18 years).

Method of administration
Film-coated tablets: Valsartan may be taken independently of a meal and should be administered with water.
Route of Administration: Oral
Tablet can be divided into equal halves.

V. CONTRAINDICATIONS

• Hypersensitivity to any of the components of Vytan;

• Pregnancy (see "Use in Pregnancy" – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information);

• Severe hepatic impairment, cirrhosis, biliary obstruction;

• Severe renal impairment (creatinine clearance < 10mL/min) and patients undergoing dialysis.

• Concomitant use of angiotensin receptor antagonists (ARBs) - including valsartan - or of angiotensin-converting-enzyme inhibitors (ACEIs) with aliskiren in patients with Type 2 diabetes.

• The concomitant use of valsartan with aliskiren-containing products is contraindicated in patients with renal impairment (GFR <60 mL/min/1.73m²).