OLSETAN

What it is

OLSETAN is available in 2 strengths for oral administration containing 20 mg and 40 mg olmesartan medoxomil. The 20 mg strength contains olmesartan medoxomil 20 mg, whilst the 40 mg strength contains olmesartan medoxomil 40 mg. OLSETAN 20 mg is a white to off-white coloured round film coated tablet debossed with OLM on one side and 20 on the other side, whilst the 40 mg strength is an oval shape film coated tablet debossed with OLM on one side and 40 on the other side.

Approved indications

— Treatment of hypertension.

Dosing overview

Dosage must be individualised in adults, with an optimal recommended starting dose of OLSETAN of 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 OLSETAN may be increased to a maximum of 40 mg daily. Twice-daily dosing offers no advantage over the same total dose given once 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. No dosage adjustment is necessary in elderly patients. No adjustment of dosage is required for patients with mild to moderate renal impairment. No adjustment of dosage is required for patients with mild to moderate hepatic 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. Such conditions should be corrected before the administration of olmesartan medoxomil. Hyperkalaemia may occur during treatment with OLSETAN, 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 be co-administered cautiously. 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 OLSETAN, other etiologies should be excluded and discontinuation of olmesartan medoxomil 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 olmesartan medoxomil. OLSETAN should be immediately discontinued in patients who develop angioedema, and should not be re-administered.

Contraindications

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

PBS listing

No source document contains information regarding PBS listing for OLSETAN.

Regulatory history

OLSETAN olmesartan medoxomil 20 mg and 40 mg tablets were first listed on the ARTG on 2022-05-19.