OLAMLO

What it is

OLAMLO is a film-coated tablet containing olmesartan medoxomil, amlodipine (as besilate) and hydrochlorothiazide. Five strengths are available: OLAMLO HCT 20/5/12.5 mg, OLAMLO HCT 40/5/12.5 mg, OLAMLO HCT 40/5/25 mg, OLAMLO HCT 40/10/12.5 mg, and OLAMLO HCT 40/10/25 mg.

Approved indications

— Treatment of hypertension, either as replacement for olmesartan medoxomil, amlodipine and hydrochlorothiazide being already taken as separate tablets or as add-on therapy where a patient's blood pressure is not controlled on a dual combination.

Dosing overview

The recommended dosage of OLAMLO HCT is one tablet daily, with or without food. This fixed dose combination is not indicated for initial therapy. The maximum dose is 40/10/25 mg once daily. For patients whose blood pressure is not adequately controlled on OLAMLO HCT 20/5/12.5, then titration to OLAMLO HCT 40/5/12.5 is recommended. Subsequently, if the patient's blood pressure is not adequately controlled on OLAMLO HCT 40/5/12.5, then titration to the maximum OLAMLO HCT 40/10/25 is recommended. Dosage may be increased after 2 weeks to a maximum dose of 40/10/25 mg once daily, usually by increasing one component at a time but any component can be raised to achieve more rapid control. Maximum antihypertensive effects are attained within 2 weeks after a change in dose.

Key safety warnings

Severe, chronic diarrhoea with substantial weight loss has been reported in patients taking olmesartan medoxomil months to years after drug initiation. Intestinal biopsies of patients often demonstrated villous atrophy. If a patient develops these symptoms during treatment with olmesartan medoxomil, exclude other etiologies. Consider discontinuation of OLAMLO HCT in cases where no other etiology is identified. An increased risk of non-melanoma skin cancer (NMSC) [basal cell carcinoma (BCC) and squamous cell carcinoma (SCC)] with increasing cumulative dose of hydrochlorothiazide (HCTZ) exposure has been observed in two epidemiological studies based on the Danish National Cancer Registry. Photosensitizing actions of HCTZ could act as a possible mechanism for NMSC. Patients taking HCTZ should be informed of the risk of NMSC and advised to regularly check their skin for any new lesions and promptly report any suspicious skin lesions. Possible preventive measures such as limited exposure to sunlight and UV rays and, in case of exposure, adequate protection should be advised to the patients in order to minimize the risk of skin cancer. 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; some of these patients previously experienced angioedema with other drugs including ACE inhibitors. OLAMLO HCT should be immediately discontinued in patients who develop angioedema, and OLAMLO HCT should not be re-administered. Very rare severe cases of acute respiratory toxicity, including acute respiratory distress syndrome (ARDS) have been reported after taking hydrochlorothiazide. Pulmonary oedema typically develops within minutes to hours after hydrochlorothiazide intake.

Contraindications

OLAMLO HCT is contraindicated in patients who are hypersensitive to any component of the tablet, to dihydropyridines, to thiazides or to other sulfonamide-derived drugs. OLAMLO HCT is contraindicated in pregnancy. OLAMLO HCT is contraindicated in patients with anuria or severe renal impairment (creatinine clearance < 30 mL/min). OLAMLO HCT is contraindicated in patients with severe hepatic impairment (Child-Pugh score 10-15), cholestasis or biliary obstruction. OLAMLO HCT is contraindicated in patients who are breastfeeding. OLAMLO HCT is contraindicated in patients with refractory hypokalaemia, hypercalcaemia, hyponatraemia, and symptomatic hyperuricaemia. OLAMLO HCT is contraindicated in patients with diabetes who are taking aliskiren. Due to the component amlodipine, OLAMLO HCT is also contraindicated in patients with cardiogenic shock, acute myocardial infarction (within the first 4 weeks), and unstable angina pectoris.

Regulatory history

OLAMLO HCT 20/5/12.5 mg, OLAMLO HCT 40/5/12.5 mg, OLAMLO HCT 40/5/25 mg, OLAMLO HCT 40/10/12.5 mg, and OLAMLO HCT 40/10/25 mg were first listed on the ARTG on 21 November 2019. OLAMLO 20/5 mg, OLAMLO 40/5 mg, and OLAMLO 40/10 mg (olmesartan medoxomil and amlodipine, without hydrochlorothiazide) were first listed on the ARTG on 6 December 2022.