Favotan Use In Pregnancy & Lactation

Pregnant women: The safety of amlodipine for 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. The potential risk of losartan for fetus should not be excluded considering the mechanism of action of Angiotensin II inhibitors. Animal studies have shown that losartan has caused damage and death to fetus and newborn babies. This appears to be attributed to impacts on the renin angiotensin-aldosterone system. For human fetus, kidney perfusion due to the development of renin angiotensin-aldosterone system becomes active from the second trimester of pregnancy. So, the administration of this drug during the second and third trimester of pregnancy increases risk to fetus. The use of drugs that act directly on the renin-angiotensin system during the second and third trimesters of pregnancy may cause injury or even death to fetus. Therefore, pregnant women must not receive this drug and immediately discontinue the drug once pregnancy is confirmed.
Nursing Mother: While it is not known whether amlodipine and/or losartan are/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 this drug.