Triple fixed-dose combination: dihydropyridine CCB, angiotensin II receptor blocker, and thiazide diuretic
ATC code: C09DX01 (Valsartan, amlodipine and hydrochlorothiazide)
Three complementary classes: amlodipine dilates arterioles via L-type calcium-channel blockade, valsartan blocks AT1 receptors of angiotensin II, hydrochlorothiazide excretes sodium and water through distal tubules. The triple-combination effect exceeds any dual pairing and matches free three-drug regimens with better adherence.
Third line
Essential hypertension in patients not controlled on a dual combination of CCB + ARB or ARB + thiazide. Per ESH/ 2023 and SEH-LELHA 2023 – third-line, including for resistant hypertension. Dose: 5/160/12.5, 10/160/12.5, 5/160/25, 10/160/25, 10/320/25 mg once daily. Full effect 2-4 weeks after dose stabilization. Exclude secondary causes and verify adherence to the prior regimen before escalation.
Opens the checker prefilled with this drug. Pick the second one from your regimen.
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 + Hydrochlorothiazide 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 + Hydrochlorothiazide (≥ 1 in 100): Dizziness, Hypotension, Hyperkalemia, Hyponatremia, Hyperuricemia, Elevated creatinine. 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 + Hydrochlorothiazide is contraindicated in: Hypersensitivity to sartan, thiazides, or sulfonamides; Pregnancy (2nd-3rd trimester); Bilateral renal artery stenosis; Severe renal impairment (CrCl <30 for the thiazide component); Severe hepatic impairment, cholestasis. Full list in the Safety section.