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Alfentanil Pregnancy and Breastfeeding Warnings

Alfentanil is also known as: Alfenta

Alfentanil Pregnancy Warnings

Rats and rabbits were given doses of alfentanil 2.5 times the upper human dose for a 10 to 30 day period. Embryocidal effects were observed and maternal toxicity due to decreased food consumption was present. Alfentanil rapidly crosses the placenta. One study reported the fetal:maternal ratio of unbound alfentanil as approximately equal. In another study, 16 women undergoing vaginal delivery received alfentanil 30 mcg/kg/hr via an extradural catheter. Apgar scores, primary reflexes, and general assessment scores of the newborn infants were not significantly different than the control group. However, neurobehavioral assessment using the Amiel-Tison score at 15 to 30 minutes of life indicated a significant decrease in passive and active tone, as well as total score. At a later evaluation, no abnormal feeding habits or behavioral changes were noted in the infants. The manufacturer does not recommend the use of alfentanil during labor and delivery due to the increased risk of respiratory depression in the neonate. However, as with other narcotics, these effects can be quickly reversed with naloxone.

Alfentanil has been assigned to pregnancy category C by the FDA. Animal studies have revealed evidence of embryolethality (possibly due to maternal toxicity) but have failed to reveal evidence of teratogenicity. There are no controlled data in human pregnancy. Alfentanil should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

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Alfentanil Breastfeeding Warnings

Alfentanil (50 mcg/kg intravenously) was administered to 9 non breast-feeding women undergoing post partum tubal ligation. Colostrum was collected 4 and 28 hours after the last injection with mean levels being reported as 0.88 ng/mL and 0.05 ng/mL, respectively. Although the clinical significance of these levels is unknown, it is thought to be negligible.

Alfentanil is excreted into human milk. Adverse effects in the nursing infant are unlikely.

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References for pregnancy information

  1. Hill DA, Mccarthy G, Bali IM "Epidural infusion of alfentanil or diamorphine with bupivacaine in labour - a dose finding study." Anaesthesia 50 (1995): 415-9
  2. Zakowski MI, Ham AA, Grant GJ "Transfer and uptake of alfentanil in the human placenta during in vitro perfusion." Anesth Analg 79 (1994): 1089-93
  3. "Product Information. Alfenta (alfentanil)." Janssen Pharmaceutica, Titusville, NJ.
  4. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):

References for breastfeeding information

  1. Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 5th ed." Baltimore, MD: Williams & Wilkins (1998):
  2. "Product Information. Alfenta (alfentanil)." Janssen Pharmaceutica, Titusville, NJ.

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