APX-OLMESARTAN/HCTZ

What it is

APX-OLMESARTAN/HCTZ is a tablet consisting of olmesartan medoxomil and hydrochlorothiazide (HCTZ). The medicine is available in three strengths: 20/12.5 mg, 40/12.5 mg, and 40/25 mg.

Approved indications

— Treatment of hypertension.

Dosing overview

APX-OLMESARTAN/HCTZ 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 the dose may be titrated after 4 weeks depending on blood pressure response. If blood pressure is not adequately controlled on olmesartan medoxomil alone, HCTZ may be added with a starting dose of 12.5 mg, with possible up-titration of HCTZ to 25 mg or olmesartan medoxomil to 40 mg if control remains inadequate. If blood pressure is not adequately controlled on HCTZ alone, olmesartan may be added with a starting dose of 20 mg with up-titration to 40 mg if control remains inadequate. Doses above 40/25 mg are 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. Hyperkalaemia may occur during treatment with olmesartan medoxomil and hydrochlorothiazide, especially in the presence of renal impairment and/or heart failure, as olmesartan medoxomil inhibits the renin-angiotensin system which can cause hyperkalaemia. An increased risk of non-melanoma skin cancer with increasing cumulative dose of hydrochlorothiazide has been observed, with photosensitising actions of HCTZ as a possible mechanism; patients should be informed of this risk, advised to check their skin regularly for new lesions, and given advice about limiting sun exposure and UV protection. 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 causes should be excluded and discontinuation should be considered if no other etiology is identified. Angioedema, including swelling of the larynx and glottis, has been reported in patients treated with olmesartan medoxomil, and the medicine should be immediately discontinued if angioedema develops and not re-administered.

Contraindications

APX-OLMESARTAN/HCTZ is contraindicated in patients who are hypersensitive to olmesartan medoxomil, sulfonamide derived drugs (such as thiazides), or any other component of the medication. It is contraindicated in pregnancy and in patients who are breastfeeding. APX-OLMESARTAN/HCTZ is contraindicated in patients with severe renal impairment (creatinine clearance less than 30 mL/min). It should not be used in patients with severe hepatic impairment, cholestasis and biliary obstruction. APX-OLMESARTAN/HCTZ is contraindicated in patients with refractory hypokalaemia, hypercalcaemia, hyponatraemia, and symptomatic hyperuricaemia, and in patients with diabetes who are taking aliskiren.

Regulatory history

APX-OLMESARTAN/HCTZ was first listed on the ARTG on 29 January 2018, with three strengths registered: 20/12.5 mg, 40/12.5 mg, and 40/25 mg.