OLMESARTAN-WGR

What it is

OLMESARTAN-WGR is available in 2 strengths for oral administration containing 20 mg and 40 mg olmesartan medoxomil. The 20 mg strength comprises white to off-white coloured, round film coated tablets, while the 40 mg strength comprises white to off-white coloured, oval film coated tablets.

Approved indications

— Treatment of hypertension

Dosing overview

The optimal recommended starting dose of OLMESARTAN-WGR 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 may be increased to a maximum of 40 mg daily. OLMESARTAN-WGR 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 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. The use of olmesartan medoxomil in patients with severe renal impairment is not recommended.

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 administration of OLMESARTAN-WGR. Hyperkalaemia may occur during treatment with OLMESARTAN-WGR, especially in the presence of renal impairment and/or heart failure; concomitant use with potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium or other medicines which may increase potassium level should be co-administered cautiously, and 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, other etiologies should be excluded, and discontinuation of OLMESARTAN-WGR 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; OLMESARTAN-WGR should be immediately discontinued in patients who develop angioedema, and should not be re-administered.

Contraindications

OLMESARTAN-WGR is contraindicated in patients who are hypersensitive to olmesartan medoxomil or any component of the medication, in pregnancy, in patients with severe renal impairment, in patients with severe hepatic impairment or biliary obstruction, and in patients with diabetes who are taking aliskiren.

PBS listing

No information regarding PBS listing is available in the provided documents.

Regulatory history

OLMESARTAN-WGR olmesartan medoxomil 20 mg film coated tablets and 40 mg film coated tablets were first listed on the ARTG on 30 May 2024.