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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)
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
Pregnancy Category D
- section extensively revised - see PI
- 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.
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.
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
- 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
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