Valsar Plus Use In Pregnancy & Lactation

Fetal/Neonatal Morbidity and Mortality: Valsar Plus can cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
Drugs that act on the renin angiotensin system can cause fetal and neonatal morbidity and mortality when used in pregnancy. In several dozen published cases, ACE inhibitor use during the second and third trimesters of pregnancy was associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death.
Pregnancy: Pregnancy Category D.
Valsar Plus, like other drugs that act on the renin angiotensin system, can cause fetal and neonatal morbidity and death when used during the second or third trimester of pregnancy. Valsar Plus can cause fetal harm when administered to a pregnant woman. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. When pregnancy occurs in a patient using Valsar Plus, the physician should discontinue Valsar Plus treatment as soon as possible. The physician should inform the patient about potential risks to the fetus based on the time of gestational exposure to Valsar Plus (first trimester only or later).
Nursing Mothers: It is not known whether amlodipine is excreted in human milk. In the absence of this information, it is recommended that nursing be discontinued while amlodipine is administered. It is not known whether valsartan is excreted in human milk. Valsartan was excreted into the milk of lactating rats; however, animal breast milk drug levels may not accurately reflect human breast milk levels. Because many drugs are excreted into human milk and because of the potential for adverse reactions in nursing infants from Valsar Plus, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.