APX-OLMESARTAN

What it is

APX-OLMESARTAN is available in two strengths for oral administration containing 20 mg and 40 mg olmesartan medoxomil. The 20 mg formulation is presented as white to off-white film coated tablets of round shape, whilst the 40 mg formulation is presented as white to off-white film coated tablets of oval shape.

Approved indications

— Treatment of hypertension.

Dosing overview

Dosage must be individualised, and the optimal recommended starting dose of APX-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 APX-OLMESARTAN may be increased to a maximum of 40 mg daily. APX-OLMESARTAN may be administered with or without food, and it is recommended that tablets be taken at about the same time each day. 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. No dosage adjustment is necessary in elderly patients, although if up-titration to the maximum dose of 40 mg daily is required, blood pressure should be closely monitored. No adjustment of dosage is required for patients with mild to moderate renal impairment.

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, and such conditions should be corrected before the administration of APX-OLMESARTAN. Hyperkalaemia may occur during treatment with APX-OLMESARTAN, especially in the presence of renal impairment and/or heart failure. Concomitant use of APX-OLMESARTAN with potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicinal products which may increase the potassium level may lead to an increase in serum potassium and should therefore be co-administered cautiously, with close monitoring of serum potassium levels in at risk patients 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, other etiologies should be excluded, and discontinuation of APX-OLMESARTAN should be considered 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 APX-OLMESARTAN. APX-OLMESARTAN should be immediately discontinued in patients who develop angioedema, and it should not be re-administered.

Contraindications

APX-OLMESARTAN is contraindicated in patients who are hypersensitive to olmesartan medoxomil or any component of the medication, in pregnancy, in patients with severe renal impairment (creatinine clearance less than 30 mL/min), in patients with severe hepatic impairment (Child-Pugh score 10–15) or biliary obstruction, and in patients with diabetes who are taking aliskiren.

Regulatory history

APX-OLMESARTAN olmesartan medoxomil 20 mg and 40 mg tablet formulations were first listed on the ARTG on 19 April 2021.