Omexta Use In Pregnancy & Lactation

Pregnancy: Drugs that act on the renin-angiotensin system can reduce fetal renal function and increase fetal and neonatal morbidity and mortality when used in pregnancy during the second and third trimesters. The use of drugs that act on the renin-angiotensin system are associated with oligohydramnios. Oligohydramnios, due to decreased fetal renal function, may lead to fetal lung hypoplasia and skeletal malformations. Use is also associated with anuria, hypotension, renal failure, skull hypoplasia, and death in the fetus/neonate. ACE inhibitors also may increase the risk of major congenital malformations when administered during the first trimester of pregnancy. Olmesartan medoxomil should be discontinued as soon as possible when pregnancy is detected.
Lactation: Olmesartan medoxomil is distributed into milk in rats. It is not known whether the drug is distributed into milk in humans. Because of the potential for serious adverse reactions to Olmesartan medoxomil in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the mother.