Is there an amlodipine (AML) and hydrochlorothiazide (HCTZ) combination pill available?

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Amlodipine and Hydrochlorothiazide Combination Availability

No, there is no FDA-approved fixed-dose combination pill containing amlodipine and hydrochlorothiazide as a two-drug formulation. However, these two agents are available together in triple-combination pills that also include a renin-angiotensin system blocker.

Available Triple Combinations Containing Both Drugs

The following FDA-approved single-pill triple combinations include both amlodipine and hydrochlorothiazide:

  • Amlodipine/valsartan/hydrochlorothiazide (Exforge HCT) is the first fixed-dose triple combination containing these agents along with an ARB, available in multiple dose strengths 1, 2

  • Amlodipine/aliskiren/hydrochlorothiazide (Amturnide) combines these agents with a direct renin inhibitor in five different formulations with escalating dosages 3, 4

Why This Combination Pattern Exists

The pharmaceutical industry has developed triple combinations rather than the amlodipine/HCTZ dual combination because guidelines recommend combining agents from complementary drug classes. The standard approach pairs a calcium channel blocker (amlodipine) and thiazide diuretic (HCTZ) with a renin-angiotensin system blocker to maximize blood pressure reduction through synergistic mechanisms 5, 6.

  • The 2013 ESH/ESC Guidelines explicitly favor combinations that have been tested in clinical trials, and the triple combination of ARB + calcium antagonist + diuretic represents a preferred, well-validated approach 5

  • The 2003 JNC 7 Guidelines list multiple ACE inhibitor/diuretic and ARB/diuretic combinations, as well as ACE inhibitor/calcium channel blocker combinations, but notably do not include a calcium channel blocker/diuretic-only fixed-dose combination 5

Clinical Implications for Prescribing

If you need both amlodipine and hydrochlorothiazide for a patient, you must either prescribe them as separate pills or use a triple combination that includes an ARB or ACE inhibitor:

  • Prescribe amlodipine and hydrochlorothiazide as separate tablets if the patient does not require or cannot tolerate a renin-angiotensin system blocker 5

  • Consider a triple combination pill (amlodipine/valsartan/HCTZ or amlodipine/aliskiren/HCTZ) if the patient requires all three drug classes, which improves adherence by reducing pill burden 1, 2

  • Despite amlodipine being the #2 and hydrochlorothiazide being among the most commonly prescribed antihypertensives in the US, pharmaceutical companies have not developed a two-drug fixed-dose combination of these specific agents 7

Evidence for Triple Combination Efficacy

Triple therapy with amlodipine/valsartan/HCTZ produces significantly greater blood pressure reductions than any dual combination of these agents:

  • In an 8-week randomized trial, the triple combination achieved superior reductions in systolic and diastolic blood pressure compared to valsartan/HCTZ, amlodipine/HCTZ, or amlodipine/valsartan dual therapy 2

  • The proportion of patients achieving blood pressure control was significantly greater with triple therapy regardless of age, sex, race, ethnicity, or baseline blood pressure severity 2

  • The triple combination attenuates diuretic-induced hypokalemia, a common adverse effect of HCTZ monotherapy 1

References

Research

Amlodipine/valsartan/hydrochlorothiazide: fixed-dose combination in hypertension.

American journal of cardiovascular drugs : drugs, devices, and other interventions, 2009

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Guideline

Combination Therapy for Hypertension

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Guideline

Availability of Losartan and Amlodipine Combination Pill in the US

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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