OLMETEC

What it is

OLMETEC PLUS is a combination medicine containing olmesartan medoxomil and hydrochlorothiazide (HCTZ). OLMETEC PLUS is available as film-coated tablets for oral use containing 20/12.5 mg, 20/25 mg, 40/12.5 mg, or 40/25 mg olmesartan medoxomil/HCTZ. OLMETEC PLUS is a combination of an angiotensin II receptor antagonist, olmesartan medoxomil, and a thiazide diuretic, HCTZ, with an additive antihypertensive effect that reduces blood pressure to a greater degree than either component alone.

Approved indications

— Treatment of hypertension.

Dosing overview

OLMETEC PLUS is administered once daily, with or without food, in patients whose blood pressure is not adequately controlled by olmesartan medoxomil or HCTZ alone. Dosing should be individualised and dependent on the patient's condition, and depending on blood pressure response, the dose may be titrated after 4 weeks. Doses of OLMETEC PLUS above 40/25 mg are not recommended. No dosage adjustment is necessary for 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 necessary for patients with mild to moderate renal impairment; however, periodic monitoring of renal function is advised.

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 OLMETEC PLUS. Hyperkalaemia may occur during treatment with OLMETEC PLUS, especially in the presence of renal impairment and/or heart failure, because OLMETEC PLUS contains olmesartan medoxomil, which inhibits the renin-angiotensin system. An increased risk of non-melanoma skin cancer with increasing cumulative dose of hydrochlorothiazide exposure has been observed, with photosensitising actions of HCTZ as a possible mechanism. Patients taking HCTZ should be informed of the risk and advised to regularly check their skin for new lesions and promptly report suspicious lesions, and limited exposure to sunlight and UV rays should be advised. 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, other etiologies should be excluded and discontinuation of OLMETEC PLUS should be 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 in patients treated with olmesartan medoxomil, and OLMETEC PLUS should be immediately discontinued in patients who develop angioedema. Very rare severe cases of acute respiratory toxicity, including acute respiratory distress syndrome, have been reported after taking hydrochlorothiazide, with pulmonary oedema typically developing within minutes to hours and symptoms including dyspnoea, fever, pulmonary deterioration and hypotension; if ARDS is suspected, OLMETEC PLUS should be withdrawn and appropriate treatment given.

Contraindications

OLMETEC PLUS is contraindicated in patients who are hypersensitive to olmesartan medoxomil, sulfonamide derived drugs (e.g. thiazides), or any other component of the medication; in pregnant patients; in patients with anuria or severe renal impairment (creatinine clearance <30 mL/min); in patients with severe hepatic impairment (Child-Pugh score 10–15), cholestasis or biliary obstruction; in patients who are breastfeeding; in patients with refractory hypokalaemia, hypercalcaemia, hyponatraemia, and symptomatic hyperuricaemia; and in patients with diabetes who are taking aliskiren.

PBS listing

Information on PBS listing status and ex-manufacturer price is not available in the provided documents.

Regulatory history

OLMETEC olmesartan medoxomil monotherapy tablets (10 mg, 20 mg and 40 mg) were first registered on the ARTG on 6 September 2005. OLMETEC PLUS tablets (20/12.5 mg, 20/25 mg, 40/12.5 mg and 40/25 mg combinations of olmesartan medoxomil/hydrochlorothiazide) were first registered on the ARTG on 26 June 2006.