Fixed-dose combination: dihydropyridine calcium channel blocker plus angiotensin II receptor blocker
ATC code: C09DB01 (Valsartan and amlodipine)
Amlodipine relaxes arteriolar smooth muscle by blocking L-type calcium channels; valsartan blocks AT1 receptors of angiotensin II. The combined action gives sustained BP reduction and dampens the reflex tachycardia seen with amlodipine monotherapy. Used for essential hypertension uncontrolled on either component alone.
Second line
Essential hypertension in patients uncontrolled on amlodipine or valsartan monotherapy. Per ESH/ 2023 and SEH-LELHA 2023, CCB plus ARB is a preferred second-line pair (or first-line in stage 2-3 hypertension). Dose: 5/80, 5/160, 10/160 mg once daily. Full effect at 2-4 weeks. Less ankle edema than amlodipine 10 mg monotherapy.
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Contraindicated from the 2nd trimester. ARBs and ACE inhibitors cause fetopathy: oligohydramnios, fetal renal failure, skull hypoplasia, limb contractures. In women of reproductive age planning pregnancy, switch in advance to methyldopa, labetalol, or slow-release nifedipine (ACOG 222 (2020), SEGO 2023).
Milk excretion data for the fixed combination are limited. For breastfeeding ESH 2023 and ACOG 2020 recommend switching to enalapril (RID 0.2%), captopril (RID 0.02%), methyldopa, or labetalol.
Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.
Amlodipine + Valsartan is evaluated for the following indications with varying evidence strength: Hypertension (evidence tier A). See the full indication matrix with dosing and citations above on this page.
Common side effects of Amlodipine + Valsartan (≥ 1 in 100): Headache, Dizziness, Peripheral edema, Fatigue, Palpitations. See the Safety section for uncommon and serious reactions.
FDA category D. Contraindicated from the 2nd trimester. ARBs and ACE inhibitors cause fetopathy: oligohydramnios, fetal renal failure, skull hypoplasia, limb contractures. In women of reproductive age planning pregnancy, switch in advance to methyldopa, labetalol, or slow-release nifedipine (ACOG 222 (2020), SEGO 2023).
Milk excretion data for the fixed combination are limited. For breastfeeding ESH 2023 and ACOG 2020 recommend switching to enalapril (RID 0.2%), captopril (RID 0.02%), methyldopa, or labetalol.
Amlodipine + Valsartan is contraindicated in: Hypersensitivity; Pregnancy (2nd-3rd trimester); Severe hepatic impairment, biliary cirrhosis, cholestasis; Shock, severe aortic stenosis; Concomitant aliskiren in diabetes or CrCl <60. Full list in the Safety section.