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U.S. Department of Health and Human Services

Safety

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Cozaar (losartan potassium) 25 mg, 50 mg, and 100 mg Tablets

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) 

 

September 2014

Summary View

PRECAUTIONS

Drug Interactions

Dual Blockade of the Renin-Angiotensin System (RAS)

  • .....The Veterans Affairs Nephropathy in Diabetes (VA NEPHRON-D) trial enrolled 1448 patients with type 2 diabetes, elevated urinary-albumin-to-creatinine ratio, and decreased estimated glomerular filtration rate (GFR 30 to 89.9 ml/min), randomized them to lisinopril or placebo on a background of losartan therapy and followed them for a median of 2.2 years. Patients receiving the combination of losartan and lisinopril did not obtain any additional benefit compared to monotherapy for the combined endpoint of decline in GFR, end stage renal disease, or death, but experienced an increased incidence of hyperkalemia and acute kidney injury compared with the monotherapy group.
  • Closely monitor blood pressure, renal .....

Lithium

  • ..... Increases in serum lithium concentrations and lithium toxicity have been reported during concomitant administration of lithium with angiotensin II receptor agonists or hydrochlorothiazide. Monitor serum lithium levels during concomitant use......

PATIENT INFORMATION LEAFLET

What should I tell my doctor before taking Cozaar?:

  • added bullet: lithium (a medicine used to treat a certain kind of depression)

 

January 2014

Summary View

BOXED WARNING

Warning: fetal toxicity
  • When pregnancy is detected, discontinue COZAAR as soon as possible.
  • Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. See WARNINGS, Fetal Toxicity

WARNINGS

Fetal Toxicity

Pregnancy Category D

  • section extensively revised - see PI

PRECAUTIONS

Pregnancy:

  • Female patients of childbearing age should be told about the consequences of exposure to COZAAR during pregnancy. Discuss treatment options with women planning to become pregnant. Patients should be asked to report pregnancies to their physicians as soon as possible.

Neonates with a history of in utero exposure to COZAAR:

  • If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing  hypotension and/or substituting for disordered renal function.

PPI

What is the most important information I should know about COZAAR?

  • COZAAR can cause harm or death to an unborn baby
  • Talk to your doctor about other ways to lower your blood pressure if you plan to become pregnant.
  • If you get pregnant while taking COZAAR, tell your doctor right away.

 

 

March 2013

Summary View

PATIENT INFORMATION/Who should not take COZAAR?

  • Do not take COZAAR if you have diabetes and are taking a medicine called aliskiren to reduce blood pressure

 

November 2011

Summary View

PRECAUTIONS

  • Dual blockade of the renin-angiotensin-aldosterone system: Dual blockade of the renin-angiotensin-aldosterone system is associated with increased risk of hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure). Closely monitor blood pressure, renal function and electrolytes in patients.

PATIENT PACKAGE INSERT

What should I tell my doctor before taking?

Especially tell your doctor if you are taking:

  • other medicines to reduce blood pressure

 

June 2009

Summary View

 

ADVERSE REACTIONS

Post Marketing Experience
  • General Disorders and Administration Site Conditions: Malaise