Nicardipine Pregnancy and Breast Feeding Warnings
Nicardipine is also known as: Cardene, Cardene IV, Cardene SR
Overview
If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Nicardipine while you are pregnant. It is not known if Nicardipine is found in breast milk. Do not breast-feed while taking Nicardipine .
Nicardipine Pregnancy Warnings
Nicardipine has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence that nicardipine was embryocidal after 150 mg/kg/day (75 times the maximum recommended dose in humans on a per kg basis), but not after 50 mg/kg/day. Animal studies have revealed evidence of reduced birth weights, dystocia, and reduced neonatal survival after nicardipine 100 mg/kg/day. In vitro data reveal evidence of decreased human myometrial contractions after exposure to nicardipine. There are no controlled data in human pregnancy. Nicardipine should only be given during pregnancy when benefit outweighs risk.
At least two studies on the use of nicardipine during human pregnancy have been reported. Nicardipine was given by oral administration (20 mg TID) to 40 pregnant women with mild to moderate hypertension and by intravenous administration (no greater than 1 mcg/kg/min) to 20 pregnant women with severe preeclampsia. The drug was administered no sooner than gestation week 28 in all patients. Nicardipine effectively reduced maternal blood pressure without reducing fetal cerebral artery, umbilical artery, or maternal uterine artery blood flow. Maternal side effects were noted only after intravenous administration (headache in nine, nausea in one). Transplacental passage of nicardipine was relatively low. The mean maternal and fetal plasma drug levels were 54.6 and 4.2 ng per mL, respectively. Contrary to the data observed in animal experiments, nicardipine did not induce fetal compromise with the doses used. There were no fetal deaths, perinatal deaths, or adverse fetal effects. No adverse neonatal outcome was attributable to nicardipine. There was a 43% rate of growth-retardation, but this is comparable to the 40% rate of growth retardation that was observed in other hypertensive patients who were treated by the same investigators. In a study of 50 pregnant women with either chronic hypertension or gestational hypertension who were randomly assigned to receive nicardipine, the average umbilical artery blood flow (per Doppler velocimetry) significantly increased during therapy. There were no perinatal deaths, although significant placental infarctions were discovered in six postpartum. The average Apgar scores at 1 and 5 minutes were 7.9 and 8.9, respectively. A single case of accidental intravenous overdosage of nicardipine (20 to 25 mg/h) during the management of hypertension during pregnancy has been reported. The fetal heart rate and umbilical, cerebral and uterine arterial Doppler velocimetry were normal during the infusion. After intravenous fluid loading and discontinuation of nicardipine, the mother gave birth via Cesarean section to a normal 3080 gram newborn with an initial Apgar score of 7/10, arterial blood pressure, heart and respiratory rates of 58/31 mmol Hg, 150 beats/min, and 50 breaths/min, respectively. The newborn recovered and was discharged from intensive care in seven days.
Nicardipine Lactation Warnings
There are no data on the excretion of nicardipine into human milk. Studies in rats have shown significant concentrations in maternal milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
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