ALKEM

What it is

ALKEM is available in two strengths containing 20 mg and 40 mg olmesartan medoxomil. The 20 mg tablets are white to off-white, round film-coated tablets, while the 40 mg tablets are white to off-white, oval film-coated tablets. 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 ALKEM is 20 mg once daily when used as monotherapy in patients who are not volume-contracted. Dosage must be individualised. For children aged 1 to 5 years and weighing at least 5 kg, the starting dose is 0.3 mg/kg once daily with a maximum of 10 mg, with a dose range of 0.3 to 0.6 mg/kg once daily and a maximum of 20 mg once daily. For children aged 6 to 18 years weighing 20 kg to less than 35 kg, the starting dose is 10 mg once daily with a dose range of 10 to 20 mg once daily and a maximum of 20 mg once daily. For children aged 6 to 18 years weighing 35 kg or more, the starting dose is 20 mg once daily with a dose range of 20 to 40 mg once daily and a maximum of 40 mg once 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. Severe, chronic diarrhoea with substantial weight loss has been reported in patients taking olmesartan medoxomil months to years after drug initiation. Intestinal biopsies of patients often demonstrated villous atrophy. If a patient develops these symptoms during treatment with olmesartan medoxomil, exclude other etiologies. 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. Hyperkalaemia may occur during treatment with olmesartan medoxomil, especially in the presence of renal impairment and/or heart failure. Concomitant use of 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 olmesartan in patients where such coadministration is considered necessary. Close monitoring of serum potassium levels in at risk patients is recommended. NSAIDs (including acetylsalicylic acid at doses greater than 3 g/day and also COX-2 inhibitors) and angiotensin receptor antagonists may act synergistically by decreasing glomerular filtration. The risk of the concomitant use of NSAIDs and angiotensin receptor antagonists is the occurrence of acute renal failure. Monitoring of renal function at the beginning of treatment should be recommended as well as regular hydration of the patient.

Contraindications

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

PBS listing

The product is not listed on the Pharmaceutical Benefits Scheme.

Regulatory history

ALKEM OLMESARTAN olmesartan medoxomil 20 mg tablets in blister pack were first listed on the ARTG on 19 April 2021, and ALKEM OLMESARTAN olmesartan medoxomil 40 mg tablets in blister pack were first listed on the ARTG on 19 April 2021. The product received initial approval on 6 December 2022.