APO-OLMESARTAN

What it is

APO-OLMESARTAN contains the active ingredient olmesartan medoxomil. It is available for oral use as film-coated tablets containing 20 mg or 40 mg olmesartan medoxomil. Olmesartan medoxomil is an orally active angiotensin II receptor (type AT1) antagonist.

Approved indications

— Treatment of hypertension.

Dosing overview

The optimal recommended starting dose of APO-OLMESARTAN is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. If additional blood pressure reduction is required, the dose of APO-OLMESARTAN may be increased to a maximum of 40 mg daily. The antihypertensive effect of olmesartan medoxomil is substantially present within 2 weeks of initiating therapy and is maximal by about 8 weeks after initiating therapy. Hydrochlorothiazide therapy should be considered in those patients requiring additional blood pressure control beyond 40 mg daily.

Key safety warnings

Symptomatic hypotension, especially after the first dose, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea or vomiting. Such conditions should be corrected before the administration of olmesartan medoxomil. Hyperkalaemia may occur during treatment with APO-OLMESARTAN, especially in the presence of renal impairment and/or heart failure, because the tablet contains olmesartan medoxomil, a drug which inhibits the renin-angiotensin system and drugs that inhibit the renin-angiotensin system can cause hyperkalaemia. Close monitoring of serum potassium levels in at risk patients is recommended. Severe, chronic diarrhoea with substantial weight loss has been reported in patients taking olmesartan medoxomil months to years after drug initiation, with intestinal biopsies often demonstrating villous atrophy. If a patient develops these symptoms during treatment with olmesartan medoxomil, exclude other etiologies and consider discontinuation of olmesartan medoxomil in cases where no other etiology is identified. 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 olmesartan medoxomil. Olmesartan medoxomil should be immediately discontinued in patients who develop angioedema, and olmesartan medoxomil should not be re-administered.

Contraindications

APO-OLMESARTAN is contraindicated in patients who are hypersensitive to either olmesartan medoxomil or any component of this medication. It is contraindicated in pregnancy. APO-OLMESARTAN is contraindicated in patients with severe renal impairment (creatinine clearance < 30 mL/min). APO-OLMESARTAN is contraindicated in patients with severe hepatic impairment (Child-Pugh score 10–15) or biliary obstruction. APO-OLMESARTAN is contraindicated in patients with diabetes who are taking aliskiren.

PBS listing

No source document contains information about PBS listing status.

Regulatory history

APO-OLMESARTAN 20 mg and 40 mg film-coated tablets were first listed on the ARTG on 5 February 2015.