Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
TABLET, FILM COATED
**DOSAGE REGIMEN AND ADMINISTRATION** **Dosage regimen** **Hypertension** The recommended dose of Diovan 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. Diovan may also be administered with other antihypertensive agents. **Heart failure** The recommended starting dose of Diovan is 40 mg twice daily. Up-titration to 80 mg 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 in clinical trials 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 20 mg twice daily, valsartan therapy should be titrated to 40 mg, 80 mg, and 160 mg 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 occur, consideration should be given to 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 impairment of non-biliary origin and without cholestasis. **Use in children and adolescents** The safety and efficacy of Diovan have not been established in children and adolescents (below the age of 18 years). **Method of administration** **Film-coated tablets:** Diovan may be taken independently of a meal and should be administered with water.
ORAL
Medical Information
**INDICATIONS** **Hypertension** Treatment of hypertension. **Heart failure** Treatment of heart failure (NYHA class II–IV) in patients receiving standard therapy such as diuretics, digitalis and either angiotensin-converting enzyme (ACE) inhibitors or beta- blockers but not both; presence of all these standard therapies is not mandatory. Diovan improves morbidity in these patients, primarily via reduction in hospitalization for heart failure. Diovan 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 (see section CLINICAL PHARMACOLOGY – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). **Post-myocardial infarction** Diovan is indicated to improve survival following recent myocardial infarction in clinically stable patients with signs, symptoms or radiological evidence of left ventricular failure and/or with left ventricular systolic dysfunction (see section CLINICAL PHARMACOLOGY – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
**CONTRAINDICATIONS** Severe hepatic impairment, cirrhosis, biliary obstruction Severe renal impairment (creatinine clearance < 10mL/min) and patients undergoing dialysis. Known hypersensitivity to valsartan or to any of the excipients of Diovan Pregnancy (see section PREGNANCY, LACTATION, FEMALES AND MALES OF REPRODUCTIVE POTENTIAL – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) Concomitant use of angiotensin receptor antagonists (ARBs) - including Diovan - or of angiotensin-converting-enzyme inhibitors (ACEIs) with aliskiren in patients with Type 2 diabetes (see section INTERACTIONS, subsection Dual blockade of the RAS – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) The concomitant use of Diovan with aliskiren-containing products is contraindicated in patients with renal impairment (GFR <60 mL/min/1.73m2) (see INTERACTIONS – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).
C09CA03
valsartan
Manufacturer Information
NOVARTIS (SINGAPORE) PTE LTD
Siegfried Barbera S.L
Novartis Farma S.p.A
Active Ingredients
Documents
Package Inserts
Diovan Film-Coated Tablets PI.pdf
Approved: May 24, 2021