OLMERTAN

What it is

OLMERTAN (olmesartan medoxomil and hydrochlorothiazide) is a combination medicine containing olmesartan medoxomil and hydrochlorothiazide. OLMERTAN is available as film-coated tablets for oral use. OLMERTAN is sponsored by Pharmacor.

Approved indications

— Treatment of hypertension.

Dosing overview

OLMERTAN is administered once daily, with or without food, in patients whose blood pressure is not adequately controlled by olmesartan medoxomil or hydrochlorothiazide alone. OLMERTAN is registered in combinations of 20/12.5 mg, 20/25 mg, 40/12.5 mg and 40/25 mg. Dosing should be individualised and dependent on the patient's condition, with the dose able to be titrated after 4 weeks depending on blood pressure response. Doses above 40/25 mg are not recommended. Treatment should not be initiated with this fixed dose combination.

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. Hyperkalaemia may occur during treatment, especially in the presence of renal impairment and/or heart failure, because OLMERTAN contains olmesartan medoxomil which inhibits the renin-angiotensin system. Close monitoring of serum potassium levels in at-risk patients is recommended. An increased risk of non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma) with increasing cumulative dose of hydrochlorothiazide exposure has been observed, with photosensitising actions of hydrochlorothiazide as a possible mechanism. Patients taking hydrochlorothiazide should be informed of this risk and advised to regularly check their skin for new lesions and promptly report suspicious skin lesions, with preventive measures including limited exposure to sunlight and UV rays and adequate protection if exposed. Severe, chronic diarrhoea with substantial weight loss has been reported in patients taking olmesartan medoxomil months to years after drug initiation, often with villous atrophy on intestinal biopsy; if a patient develops these symptoms, other etiologies should be excluded and discontinuation of OLMERTAN considered if 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; OLMERTAN should be immediately discontinued in patients who develop angioedema and should not be re-administered. Very rare severe cases of acute respiratory distress syndrome have been reported after taking hydrochlorothiazide, with pulmonary oedema typically developing within minutes to hours with symptoms including dyspnoea, fever, pulmonary deterioration and hypotension; if acute respiratory distress syndrome is suspected, OLMERTAN should be withdrawn and appropriate treatment given.

Contraindications

OLMERTAN is contraindicated in patients who are hypersensitive to olmesartan medoxomil, sulfonamide-derived drugs such as thiazides, or any other component of this medication. OLMERTAN is contraindicated in pregnancy. OLMERTAN is contraindicated in patients with anuria or severe renal impairment (creatinine clearance less than 30 mL/min), patients with severe hepatic impairment (Child-Pugh score 10–15), cholestasis or biliary obstruction, patients who are breastfeeding, patients with refractory hypokalaemia, hypercalcaemia, hyponatraemia and symptomatic hyperuricaemia, and patients with diabetes who are taking aliskiren.

PBS listing

Information regarding PBS listing of OLMERTAN could not be found in the provided documents.

Regulatory history

OLMERTAN olmesartan medoxomil 20 mg and 40 mg tablets were first listed on the Australian Register of Therapeutic Goods on 25 February 2016. OLMERTAN COMBI 20/12.5 mg, 40/12.5 mg and 40/25 mg (olmesartan medoxomil and hydrochlorothiazide) tablets were first listed on 29 January 2018.