DILART

What it is

DILART is a valsartan film-coated tablet available in strengths of 40 mg, 80 mg, 160 mg or 320 mg. Valsartan is an orally active, potent and specific angiotensin II receptor antagonist that acts selectively on the AT1 receptor subtype, which is responsible for the known actions of angiotensin II.

Approved indications

— Treatment of hypertension. — Treatment of heart failure (NYHA class II-IV) in patients receiving usual therapy (such as diuretics or 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.

Dosing overview

For patients with severe renal impairment, a maximum daily dose of 80 mg per day is recommended. In patients with mild to moderate hepatic impairment without cholestasis, valsartan should be used with caution and a daily dose of 80 mg should not be exceeded.

Key safety warnings

In severely sodium-depleted and/or volume-depleted patients, such as those receiving high doses of diuretics, symptomatic hypotension may occur in rare cases after initiation of therapy with valsartan. Sodium and/or volume depletion should be corrected before starting treatment, for example, by reducing the diuretic dose or treatment should be commenced under close medical supervision. Angioedema, including swelling of the larynx and glottis, causing airway obstruction and/or swelling of the face, lips, pharynx and/or tongue has been reported in patients treated with valsartan. Valsartan should be immediately discontinued in patients who develop angioedema, and should not be re-administered. An increase in the mortality rate among patients who received a combination of valsartan, ACE inhibitors and beta blockers has been observed in clinical trials. Concurrent administration of ACE inhibitors, beta blockers and valsartan is not recommended. Concomitant use of potassium-sparing diuretics (such as spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels may lead to increases in serum potassium.

Contraindications

DILART is contraindicated in patients with hypersensitivity to any of the components and in pregnancy. It is also contraindicated in patients with severe hepatic impairment, biliary cirrhosis and cholestasis, and in concomitant use with aliskiren in patients with Type 2 diabetes mellitus.

PBS listing

DILART valsartan is listed on the PBS in four strengths. The 40 mg tablet has one PBS item with unrestricted access at an ex-manufacturer price of A$4.56. The 80 mg tablet has two PBS items with restricted and unrestricted access at an ex-manufacturer price of A$4.98. The 160 mg tablet has two PBS items with restricted and unrestricted access at an ex-manufacturer price of A$6.39. The 320 mg tablet has two PBS items with unrestricted and restricted access at an ex-manufacturer price of A$8.19.

Regulatory history

DILART valsartan tablets in strengths of 40 mg, 80 mg, 160 mg and 320 mg were first registered on the ARTG on 26 August 2014 as sponsor Alphapharm.