Cozaar Special Precautions

General: Although Cozaar is antihypertensive in all races, as with other drugs that affect the renin-angiotensin-aldosterone system, black hypertensive patients have a smaller average response to losartan monotherapy. If Cozaar is given together with thiazide-type diuretics, the blood pressure-lowering effects are approximately additive. Losartan potassium administered in doses of up to 150 mg once daily did not cause clinically important changes in fasting triglycerides, total cholesterol or HDL cholesterol in patients with hypertension. The same dose of losartan had no effect on fasting glucose levels. Cozaar should not be used with potassium-sparing diuretics.
In patients who are intravascularly volume-depleted (eg, those treated with high-dose diuretics), symptomatic hypotension may occur. These conditions should be corrected prior to administration of Cozaar, or a lower starting dose should be used (see Dosage & Administration).
Based on pharmacokinetic data which demonstrates significantly increased plasma concentrations of losartan in cirrhotic patients, a lower dose should be considered for patients with a history of hepatic impairment (see Dosage & Administration).
Other drugs that affect the renin-angiotensin system may increase blood urea and serum creatinine in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney. While not confirmed, this potentially may occur with angiotensin II receptor antagonists.
Use in pregnancy: When used in pregnancy during the 2nd and 3rd trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death in the developing fetus. When pregnancy is detected, Cozaar should be discontinued as soon as possible.
Although there is no experience with the use of Cozaar in pregnant women, animal studies with losartan potassium have demonstrated fetal and neonatal injury and death, the mechanism of which is believed to be pharmacologically mediated through effects on the renin-angiotensin system. In humans, fetal renal perfusion, which is dependent upon the development of the renin-angiotensin system, begins in the 2nd trimester; thus, risk to the fetus increases if Cozaar is administered during the 2nd or 3rd trimesters of pregnancy.
Use in lactation: It is not known whether losartan is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue Cozaar, taking into account the importance of Cozaar to the mother.
Use in children: Safety and effectiveness in children have not been established.
Use in the elderly: In clinical studies, there was no age-related difference in the efficacy or safety profile of losartan.