Land: Australia
Språk: engelsk
Kilde: Department of Health (Therapeutic Goods Administration)
valsartan, Quantity: 320 mg
Arrotex Pharmaceuticals Pty Ltd
Valsartan
Tablet
Excipient Ingredients: powdered cellulose; calcium hydrogen phosphate dihydrate; croscarmellose sodium; colloidal anhydrous silica; magnesium stearate; hypromellose; macrogol 8000; titanium dioxide; iron oxide yellow; iron oxide red; purified water; hyprolose; iron oxide black
Oral
500, 100, 28
(S4) Prescription Only Medicine
Treatment of Hypertension. Treatment of Heart failure (NYHA class II-IV) in patients receiving usual therapy (e.g. diuretics, digitalis) who are intolerant to ACE inhibitors. To improve survival following myocardial infarction in clinically stable patients with clinical or radiological evidence of left ventricular failure and/or with left ventricular systolic dysfunction (see Clinical Trials).
Visual Identification: Dark grey-violet, oval shaped, film-coated tablets, engraved 'APO' on one side and 'VA320' on the other side.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2012-04-05
1 AUSTRALIAN PRODUCT INFORMATION APO-VALSARTAN (VALSARTAN) TABLETS 1 NAME OF THE MEDICINE Valsartan 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 40, 80, 160 or 320 mg of valsartan as the active ingredient. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM VALSARTAN 40 MG TABLETS Yellow, modified, capsule shaped, film-coated tablets, engraved ‘APO’ on one side and ‘VA’ scored ‘40’ on the other side. VALSARTAN 80 MG TABLETS Pale red, round, biconvex, film-coated tablets, engraved ‘APO’ on one side and ‘VA’ over ‘80’ on the other side. VALSARTAN 160 MG TABLETS Yellow, modified, capsule shaped, film-coated tablets, engraved ‘APO’ on one side and ‘VA160’ on the other side. VALSARTAN 320 MG TABLETS Dark grey-violet, oval shaped, film-coated tablets, engraved ‘APO’ on one side and ‘VA320’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS • Treatment of hypertension • Treatment of heart failure (NYHA class II-IV) in patients receiving usual therapy (e.g. diuretics, digitalis) who are intolerant to ACE inhibitors. • To improve survival following myocardial infarction in clinically stable patients with clinical or radiological evidence of left ventricular failure and/or with left ventricular systolic dysfunction (see section 5.1 PHARMACODYNAMIC PROPERTIES - CLINICAL TRIALS). 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE DOSAGE IN ADULTS ONLY 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 2 is not adequately controlled, the daily dose may be increased to 160 mg. 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 twice daily. Titration u Les hele dokumentet