Colixtan Use In Pregnancy & Lactation

Pregnancy: Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. When pregnancy is detected, discontinue Fixed-dose combination of Losartan and Amlodipine as soon as possible. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Losartan and Amlodipine as soon as possible. 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.
Breastfeeding: 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 this drug.