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Meperidine / promethazine Pregnancy and Breastfeeding Warnings

Meperidine / promethazine is also known as: Mepergan, Mepergan Fortis, Meprozine

Meperidine / promethazine Pregnancy Warnings

Meperidine has not been formally assigned to a pregnancy category by the FDA. It has been frequently used in pregnancy and during labor. Meperidine and normeperidine cross the placenta very rapidly and may cause respiratory depression and lower psychophysiologic test scores in newborns if it is administered to the mother shortly before delivery. Infants of chronic users may experience withdrawal. There are no controlled data in human pregnancy. Meperidine should only be given in pregnancy when benefit outweighs risk. Promethazine has not been formally assigned to a pregnancy category. Several retrospective studies have suggested that there is no increased risk of congenital malformations in humans with use of promethazine in pregnancy. Promethazine has been shown to impair neonatal platelet aggregation when given during labor. There are no controlled data in human pregnancy. Promethazine should only be given during pregnancy when there are no alternatives and benefit outweighs risk.

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Meperidine / promethazine Breastfeeding Warnings

Meperidine is excreted into human milk in small amounts. The concentrations achieved are probably clinically insignificant although one study has reported an increased incidence of apneic events in breast-fed infants whose mothers take opioids (including meperidine) while nursing. The American Academy of Pediatrics has no position on the use of meperidine during breast-feeding but considers morphine and other narcotics to be compatible with breast-feeding. There are no data on the excretion of promethazine into human milk. However, passage of the drug into breast milk is expected.

One study has reported that normeperidine levels are persistently elevated in breast milk. The elevation in metabolite levels has been suggested as an explanation for the fact that neonates whose mothers are treated with meperidine exhibit greater neurobehavioral depression than neonates whose mothers are treated with morphine.

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References for pregnancy information

  1. Morgan D, Moore G, Thomas J, Triggs E "Disposition of meperidine in pregnancy." Clin Pharmacol Ther 23 (1978): 288-95
  2. Kuhnert BR, Kuhnert PM, Philipson EH, Syracuse CD "Disposition of meperidine and normeperidine following multiple doses during labor II: fetus and neonate." Am J Obstet Gynecol 151 (1985): 410-5
  3. Notarianni LJ "Placental transfer of pethidine and bupivacaine." Neuropharmacology 20 (1981): 1253-8
  4. Jackson MB, Robson PJ "Preliminary clinical and pharmacokinetic experiences in the newborn when meptazinol is compared with pethidine as an obstetric analgesic." Postgrad Med J 59 (1983): 47-51
  5. "Product Information. Mepergan (meperidine-promethazine)" Wyeth Laboratories, Philadelphia, PA.
  6. Hodgkinson R, Husain FJ "The duration of effect of maternally administered meperidine on neonatal neurobehavior." Anesthesiology 56 (1982): 51-2
  7. Clark RB "Analgesia during labor: effect on the fetus and neonate." Clin Anesth 10 (1974): 139-55
  8. Edwards DJ, Svensson CK, Visco JP, Lalka D "Clinical pharmacokinetics of pethidine: 1982." Clin Pharmacokinet 7 (1982): 421-33
  9. Kuhnert BR, Kuhnert PM, Tu A-S, et al "Meperidine and normeperidine levels following meperidine administration during labor I: mother." Am J Obstet Gynecol 133 (1979): 904-8
  10. Todd EL, Stafford DT, Bucovaz ET, Morrison JC "Pharmacokinetics of meperidine in pregnancy." Int J Gynaecol Obstet 29 (1989): 143-6
  11. McDonald JS "Preanesthetic and intrapartal medications." Clin Obstet Gynecol 20 (1977): 447-59
  12. Dahlof C "Placebo-controlled clinical trials with ergotamine in the acute treatment of migraine." Cephalalgia 13 (1993): 166-71
  13. Heinonen O, Slone D, Shapiro S; Kaufman DW ed. "Birth Defects and Drugs in Pregnancy." Littleton, MA: Publishing Sciences Group, Inc. (1977): 297
  14. Kuhnert BR, Kuhnert PM, Prochaska AL, Sokol RJ "Meperidine disposition in mother, neonate, and nonpregnant females." Clin Pharmacol Ther 27 (1980): 486-91
  15. Koren G, Pastuszak A, Ito S "Drugs in pregnancy." N Engl J Med 338 (1998): 1128-37

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. Mepergan (meperidine-promethazine)" Wyeth Laboratories, Philadelphia, PA.
  3. Spigset O "Anaesthetic agents and excretion in breast milk." Acta Anaesthesiol Scand 38 (1994): 94-103
  4. Roberts RJ, Blumer JL, Gorman RL, et al "American Academy of Pediatrics Committee on Drugs: Transfer of drugs and other chemicals into human milk." Pediatrics 84 (1989): 924-36
  5. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50

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