amlodipine + valsartan: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
amlodipine + valsartan: clinical details
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.
amlodipine + valsartan preparations and strengths
Tablet
Route: Oral
Strengths: 5 mg + 160 mg, 5 mg + 80 mg, 10 mg + 160 mg
amlodipine + valsartan interactions
Check all prescribed, non-prescribed and herbal products. Important examples include:
ACE inhibitors, other ARBs or aliskiren
Combining renin–angiotensin system blockers increases the risk of hypotension, high potassium and kidney impairment; some combinations are contraindicated.
Potassium supplements, potassium-containing salt substitutes and potassium-sparing diuretics
These can raise blood potassium and may require closer monitoring.
NSAIDs, including ibuprofen, naproxen and diclofenac
They may reduce the blood-pressure effect and increase the risk of kidney impairment and high potassium.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.