Valsaram Use In Pregnancy & Lactation

Due to the mechanism of action of angiotensin II blocker, risk on fetus can't be ruled out. Fetal morbidity and death have been reported in the second and third trimesters of pregnant women who took angiotensin converting enzyme inhibitor (special drug group act on the renin-angiotensin-aldosterone system (RAAS)). And use of ACE inhibitor at the first trimester of pregnancy is associated with potential risk of fetal anomaly. Spontaneous abortion, oligohydramnios and neonatal renal function abnormality have been reported in pregnant women who accidentally took valsartan. Just like other drugs directly action on RAAS, this drug should not be used in case of pregnancy or planning to be pregnant. A medical doctor should explain female with pregnancy potential about potential risk of these drugs during pregnancy when prescribing a drug acting on RAAS. If pregnancy is detected during treatment with this drug, discontinue as soon as possible.
Although human milk secretion of valsartan and/or amlodipine in human has not been known, Valsartan was secreted in rat. Therefore, it is not recommended to use this drug in female in lactation. No clinical study was made on breeding ability in this drug and each single component preparation. Although there is no non-clinical information on breeding ability available, in non-clinical study performed with each Valsartan and Amlodipine separately, no influence on breeding ability was shown.
Others: In embryonic and fetal toxicity study of rat and animal test performed with rat and marmoset for 13 weeks, there was no toxicological finding which may be considered meaningful in human. As a result of oral administration in rat for 13 weeks, proventricular inflammation was observed in male administered with over 3/48mg/kg/day but not observed in female rat. These results were not found in any doses of marmoset but colitis was observed upon high dose administration (No influence was found in less than 5/80mg/kg/day). Occurrence of gastrointestinal system adverse reaction observed on drug administration was similar with that observed on single administration in clinical studies.