What is the maximum recommended dose of Cozaar (Losartan)?

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Maximum Recommended Dose of Losartan (Cozaar)

The maximum recommended dose of losartan (Cozaar) is 100 mg once daily according to FDA-approved labeling. 1

Dosing Guidelines by Indication

Hypertension

  • Initial dose: 50 mg once daily
  • Maximum dose: 100 mg once daily
  • Special populations:
    • Patients with possible intravascular depletion (e.g., on diuretic therapy): Start with 25 mg once daily
    • Patients with mild-to-moderate hepatic impairment: Start with 25 mg once daily 1

Hypertensive Patients with Left Ventricular Hypertrophy

  • Initial dose: 50 mg once daily
  • Maximum dose: 100 mg once daily (with possible addition of hydrochlorothiazide) 1

Nephropathy in Type 2 Diabetic Patients

  • Initial dose: 50 mg once daily
  • Maximum dose: 100 mg once daily 1

Dosing Considerations in Heart Failure

While the FDA label doesn't specifically address heart failure dosing, the American College of Cardiology/American Heart Association guidelines provide important context:

  • Target dose for losartan in heart failure with reduced ejection fraction (HFrEF): 100 mg once daily 2
  • Note: Although ACC/AHA guidelines historically recommended losartan 150 mg as target dose, the current FDA-approved maximum dose of 100 mg is used in performance measures 2

Clinical Efficacy and Dose-Response Relationship

Research suggests that higher doses of losartan may provide greater clinical benefits:

  • In diabetic nephropathy, losartan 100 mg daily was significantly more effective than 50 mg daily in reducing albuminuria (48% vs 30% reduction) 3
  • The HEAAL trial demonstrated that 150 mg daily of losartan was superior to 50 mg daily, with a 10% relative risk reduction in death or heart failure hospitalization 4

Important Monitoring Considerations

  • Blood pressure, renal function, and electrolytes should be checked 1-2 weeks after initiation and after each dose increase 4
  • Losartan is contraindicated in pregnancy and should be used with caution in patients with severe bilateral renal artery stenosis or elevated potassium levels 4

Pharmacokinetic Considerations

  • Losartan is rapidly absorbed, reaching maximum concentrations 1-2 hours after administration
  • Approximately 14% of losartan is converted to its active metabolite E3174, which is 10-40 times more potent than the parent compound 5
  • The pharmacokinetics are linear and dose-proportional with repetitive administration 5

Clinical Pearl

While the maximum FDA-approved dose is 100 mg daily, some experts suggest that higher doses (up to 150 mg) may provide additional clinical benefits in certain conditions like heart failure and diabetic nephropathy 6. However, clinicians should adhere to the FDA-approved maximum dose of 100 mg daily unless participating in research protocols.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Optimal dose of losartan for renoprotection in diabetic nephropathy.

Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association, 2002

Guideline

Cardiovascular Disease Management

Praxis Medical Insights: Practical Summaries of Clinical Guidelines, 2025

Research

Clinical pharmacokinetics of losartan.

Clinical pharmacokinetics, 2005

Research

Pharmacokinetic evaluation of losartan.

Expert opinion on drug metabolism & toxicology, 2011

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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