Use in pregnancy: When used in pregnancy during the 2nd and 3rd trimesters, drugs that act directly on the renin-angiotensin system (RAS) can cause injury and even death in the developing fetus. When pregnancy is detected, Cozaar XQ should be discontinued as soon as possible.
Although there is no experience with the use of Cozaar XQ 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 RAS. In humans, fetal renal perfusion, which is dependent upon the development of the RAS, begins in the 2nd trimester; thus, risk to the fetus increases if Cozaar XQ is administered during the 2nd or 3rd trimesters of pregnancy.
There are no adequate and well-controlled studies of amlodipine in pregnant women. The safety of amlodipine in pregnant women has not been established. Amlodipine has been shown to prolong both the gestation period and the duration of labor in rats at the dose 50 times the maximum recommended human dose.
Use in lactation: While it is not known whether losartan or amlodipine is excreted in human milk, significant levels of amlodipine and/or losartan active metabolite were shown to be present in animal milk. Therefore, nursing mothers should not receive Cozaar XQ.