amlodipine + valsartan: clinical use

Prescribing considerations

• Licensed for adults with essential hypertension inadequately controlled by either component alone.
• Assess volume or sodium depletion because symptomatic hypotension may occur.
• Use caution in renal artery stenosis, heart failure, valve stenosis, hepatic impairment and after recent kidney transplantation.
• Safety and efficacy have not been established in people under 18 years.

Contraindications and cautions

• Hypersensitivity to either ingredient, dihydropyridines or an excipient
• Severe hepatic impairment, biliary cirrhosis or cholestasis
• Severe hypotension or shock
• High-grade left-ventricular outflow obstruction
• Haemodynamically unstable heart failure after acute myocardial infarction
• Second or third trimester of pregnancy
• Aliskiren use in patients with diabetes or qualifying renal impairment

Monitoring

• Blood pressure and symptoms of hypotension
• Renal function and serum potassium, particularly with renal impairment, volume depletion or interacting medicines
• Liver status where hepatic impairment is present
• Lithium or tacrolimus concentrations if unavoidable concurrent treatment requires monitoring

Clinical pharmacology

Amlodipine is a dihydropyridine calcium-channel blocker that relaxes vascular smooth muscle. Valsartan selectively blocks angiotensin II AT1 receptors. The fixed combination is bioequivalent to administration of the corresponding separate components.

Formulation and product differences

• The selected product is a light-yellow, oblong film-coated tablet.
• It contains sorbitol and is essentially sodium-free.
• Fixed-combination products offer less flexibility for adjusting individual components than separate preparations.

Tablet

Route: Oral

Strengths: 5 mg + 160 mg, 5 mg + 80 mg, 10 mg + 160 mg