amlodipine + olmesartan medoxomil: clinical use

Prescribing considerations

• Confirm inadequate control on olmesartan or amlodipine alone, or that the fixed combination matches separately established component requirements.
• Assess volume or sodium depletion, renal and hepatic function, potassium, blood pressure and interacting medicines.
• Use caution in renal impairment, heart failure, renovascular disease, valve obstruction, hypertrophic cardiomyopathy and mild-to-moderate hepatic impairment.
• Investigate severe chronic diarrhoea with weight loss for olmesartan-associated sprue-like enteropathy.
• Not recommended in severe renal impairment, recent kidney transplantation or primary aldosteronism.

Contraindications and cautions

• Hypersensitivity to either active substance, dihydropyridines or an excipient
• Second or third trimester of pregnancy
• Severe hepatic insufficiency or biliary obstruction
• Severe hypotension or shock, including cardiogenic shock
• Left-ventricular outflow obstruction, such as high-grade aortic stenosis
• Haemodynamically unstable heart failure after acute myocardial infarction
• Aliskiren co-administration in specified patients with diabetes or renal impairment

Monitoring

• Blood pressure and symptoms of hypotension
• Renal function, serum potassium and sodium
• Liver assessment if hepatic symptoms develop
• Persistent diarrhoea, weight loss or symptoms suggesting intestinal angioedema

Clinical pharmacology

Olmesartan medoxomil is converted to olmesartan, a selective AT1-receptor antagonist. Amlodipine is a long-acting, vessel-selective L-type calcium-channel blocker. Food does not materially affect exposure to either component in the fixed combination.

Formulation and product differences

• Selected products are film-coated tablets containing different fixed strengths of the two components.
• Tablet appearance and debossed markings differ by strength.
• The tablets contain no score line described for subdivision.

Tablet

Route: Oral

Strengths: 20 mg + 5 mg, 40 mg + 10 mg, 40 mg + 5 mg