AKM-OLMESARTAN HCTZ

What it is

AKM-OLMESARTAN HCTZ is a combination of olmesartan medoxomil and hydrochlorothiazide (HCTZ). It is available for oral use as film-coated tablets. The medicine is registered in strengths of 20/12.5 mg, 20/25 mg, 40/12.5 mg, and 40/25 mg.

Approved indications

— Treatment of hypertension.

Dosing overview

AKM-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, with the dose potentially titrated after 4 weeks based on blood pressure response. Doses above 40/25 mg are not recommended. No dosage adjustment is necessary for elderly patients. No adjustment of dosage is necessary for patients with mild to moderate renal 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, and such conditions should be corrected before administration of AKM-OLMESARTAN HCTZ. Hyperkalaemia may occur during treatment with AKM-OLMESARTAN HCTZ, especially in the presence of renal impairment and/or heart failure, because it 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 HCTZ has been observed, with photosensitising actions of HCTZ potentially acting as a mechanism for this risk. Patients taking HCTZ should be informed of this risk and advised to regularly check their skin for any new lesions and promptly report any suspicious skin lesions. 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 olmesartan medoxomil, other etiologies should be excluded, and discontinuation of AKM-OLMESARTAN HCTZ 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; AKM-OLMESARTAN HCTZ should be immediately discontinued in patients who develop angioedema and should not be re-administered.

Contraindications

AKM-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, and in pregnant patients. It 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. It is contraindicated in patients who are breastfeeding, those with refractory hypokalaemia, hypercalcaemia, hyponatraemia, and symptomatic hyperuricaemia, and in patients with diabetes who are taking aliskiren.

PBS listing

Information regarding PBS listing is not available in the provided sources.

Regulatory history

AKM-OLMESARTAN HCTZ was first registered on the ARTG on 29 January 2018, with three strengths listed: 20/12.5 mg, 40/12.5 mg, and 40/25 mg, all under licence category RE.