Amtrel

Amtrel Use In Pregnancy & Lactation

amlodipine + benazepril

Manufacturer:

American Taiwan Biopharm

Distributor:

American Taiwan Biopharm

Marketer:

American Taiwan Biopharm
Full Prescribing Info
Use In Pregnancy & Lactation
Use in pregnancy: Pregnancy Category C (1st Trimester) and D (2nd and 3rd Trimesters): Fetus/Newborn Disease Incidence and Death Rate: In studies from around the world, many cases have demonstrated that ACE inhibitors use in pregnant women can cause disease or death of the fetus. Hence, when a woman determines to be pregnant, the patient should immediately stop taking Amtrel. ACE inhibitors use in the 2nd or 3rd trimester can result in damage to the fetus or newborn, including hypotension, improper development of the skull, anuria, reversible or irreversible renal failure and death. Also, reduced renal function of the fetus can result in nonproduction of amniotic fluid. Oligohydramnios is related to limb contracture and deformity, facial deformity and improper lung development of a fetus. Delayed uterus growth and permanent arterial fistula have been reported, although it is unclear whether they are caused by ACE inhibitors use.
At the present, there are no clinical trials involving Amtrel in pregnant women.
Use in lactation: Only minute amounts of benazepril and benazeprilat are secreted in the breast milk of breastfeeding women. Therefore, if the newborn consumes breast milk, <0.1% of the dosage received by the mother will be absorbed by the newborn.
It is currently unclear whether amlodipine may be found in the breast milk. Thus, it is recommended that when taking Amtrel for treatment, breastfeeding should stop.
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