Calcium-Channel Blocker + ARB (Fixed-Dose Combination Antihypertensive) Pregnancy: Contraindicated in the second and third trimesters of pregnancy. Angiotensin II receptor antagonists should not be initiated during pregnancy and are not recommended in the first trimester; patients planning pregnancy should be changed to alternative antihypertensives, and treatment stopped immediately when pregnancy is diagnosed. The safety of amlodipine in human pregnancy has not been established — use only when there is no safer alternative and the disease itself carries greater risk for mother and foetus. Breast-feeding: not recommended (amlodipine is excreted in human milk; no information on the combination).

Amlodipine with Valsartan

Brand names: Exforge

A fixed-dose combination tablet of amlodipine (a dihydropyridine calcium-channel blocker) and valsartan (an angiotensin receptor blocker), used for essential hypertension in patients suited to combination therapy.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: One tablet per day (fetched SPC is the amlodipine 10 mg / valsartan 160 mg strength)

Route: Oral — take with some water, with or without food

Frequency: Once daily

Source is the fixed-combination SPC 'Amlodipine / Valsartan 10 mg / 160 mg film-coated tablets'; the recommended dose is one tablet per day. The 10 mg/160 mg strength may be administered in patients whose blood pressure is not adequately controlled with amlodipine 10 mg or valsartan 160 mg alone, or with amlodipine/valsartan 5 mg/160 mg. Individual dose titration with the components is recommended before changing to the fixed dose combination; when clinically appropriate a direct change from monotherapy may be considered. Patients receiving valsartan and amlodipine as separate tablets/capsules may be switched to the combination containing the same component doses. Hepatic impairment: contraindicated in severe hepatic impairment; caution in hepatic impairment or biliary obstructive disorders; in mild to moderate hepatic impairment without cholestasis the maximum recommended dose is 80 mg valsartan (amlodipine dosage recommendations have not been established in mild to moderate hepatic impairment) — when switching such patients, use the lowest available dose of the amlodipine component. Elderly (≥65 years): caution required when increasing the dosage; use the lowest available dose of the amlodipine component when switching. Paediatric: safety and efficacy in children under 18 years have not been established and no data are available.

Dose adjustments

Renal

No dosage adjustment is required for patients with mild to moderate renal impairment; monitoring of potassium levels and creatinine is advised in moderate renal impairment. There are no available clinical data in severely renally impaired patients. (Comparator symbol for the GFR threshold quoted in §4.4 was stripped in the fetched source text — verify against the full SPC.)

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

Hypersensitivity to the active substances, to dihydropyridine derivatives, or to any of the excipients
Severe hepatic impairment, biliary cirrhosis or cholestasis
Concomitant use with aliskiren-containing products in patients with diabetes mellitus or renal impairment
Second and third trimesters of pregnancy
Severe hypotension
Shock (including cardiogenic shock)
Obstruction of the outflow tract of the left ventricle (e.g. hypertrophic obstructive cardiomyopathy and high grade aortic stenosis)
Haemodynamically unstable heart failure after acute myocardial infarction

Side effects

Common: nasopharyngitis, influenza
Common: headache
Uncommon: oedema, pitting oedema, facial oedema, peripheral oedema (listed among the most frequent or significant reactions)
Uncommon: orthostatic hypotension, dizziness, postural dizziness, somnolence, palpitations, tachycardia
Uncommon: hyponatraemia; abdominal discomfort, nausea, diarrhoea, constipation, dry mouth
Rare: hypersensitivity, syncope, hypotension; also reported — fatigue, asthenia, flushing and hot flush

Interactions

Aliskiren-containing products — contraindicated in diabetes mellitus or renal impairment (§4.3)
Potassium supplements, potassium-sparing diuretics, potassium-containing salt substitutes or other products that may increase potassium (e.g. heparin) — use with caution and monitor potassium levels frequently (§4.4)
High-dose diuretics / volume- or salt-depleting therapy — symptomatic hypotension may occur; correct depletion before administration or start under close medical supervision (§4.4)
NOTE: SPC §4.5 was not captured in the fetched extract — clinician to review the full interactions section

Clinical monograph

How it works

Amlodipine relaxes vascular smooth muscle by blocking L-type calcium channels to cause arterial vasodilatation, while valsartan blocks the angiotensin II type 1 receptor to reduce vasoconstriction and aldosterone-driven sodium retention; the two actions lower blood pressure through complementary pathways.

Prescribing in practice

The valsartan component is contraindicated in pregnancy and can cause hyperkalaemia and renal deterioration, so avoid in women who are or may become pregnant and use caution with renal impairment or other renin-angiotensin agents.
Amlodipine commonly causes dose-related ankle oedema that does not respond to diuretics, which can limit tolerability.
Combination products are intended for patients already needing both classes or not controlled on one, rather than as initial therapy in everyone.

Monitoring

Monitor blood pressure, renal function and serum potassium, particularly after initiation or dose changes of the valsartan component.

Counselling the patient

Stop the tablet and contact your prescriber promptly if you become pregnant.
Report significant ankle swelling, dizziness or fainting.
Rise slowly from sitting or lying, especially when starting treatment.

Evidence & guidelines

Calcium-channel blocker plus angiotensin receptor blocker combinations align with NICE hypertension guidance, which supports step-wise combination of these classes.

Reference: NICE NG133 (Hypertension in adults, 2019 updated 2023); ESC/ESH Hypertension Guidelines (2023); Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Curated clinical cross-links plus same-class fallbacks.

Calculators

Pathways