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Hydrocodone / ibuprofen Pregnancy and Breastfeeding Warnings

Hydrocodone / ibuprofen is also known as: Ibudone, Reprexain, Vicoprofen, Xylon

Hydrocodone / ibuprofen Pregnancy Warnings

Hydrocodone-ibuprofen has been assigned to pregnancy category C by the FDA. Animal testing (at a maternally toxic dose) resulted in an increase in the percentage of litters and fetuses with a major abnormality and an increase in the number of litters and fetuses with one or more nonossified metacarpals. There are no controlled data on this combination product in human pregnancy. Hydrocodone-ibuprofen should only be given during pregnancy when benefit outweighs risk. Hydrocodone-ibuprofen should be avoided near term.

Babies born to mothers who have been taking opioids regularly prior to delivery may be physically dependent. The withdrawal signs include irritability and excessive crying, tremors, hyperactive reflexes, increased respiratory rate, increased stools, sneezing, yawning, vomiting, and fever. The intensity of the syndrome does not always correlate with the duration of maternal opioid use or dose. There is no consensus on the best method of managing withdrawal. Because of the known effects of nonsteroidal anti-inflammatory drugs on the fetal cardiovascular system (closure of the ductus arteriosus), use during pregnancy (particularly late pregnancy) should be avoided.

See references

Hydrocodone / ibuprofen Breastfeeding Warnings

In one woman treated with ibuprofen 400 mg twice a day for two weeks, ibuprofen concentrations in milk were below the level of detection (< 0.5 mcg/mL) at all times tested. The hydroxy and carboxy metabolites were also undetectable. In another study, ibuprofen concentrations in milk were below the level of detection (nine below 1.0 mcg/mL) in all samples taken from 12 postpartum women receiving ibuprofen 400 mg every six hours for 24 hours. The authors conclude that a breast-feeding infant would ingest less than 1 mg ibuprofen per day.

There are no data on the excretion of hydrocodone into human milk. Other narcotic analgesics are excreted into human milk in small amounts. Ibuprofen has not been detected in human milk. Ibuprofen is considered compatible with breast-feeding by the American Academy of Pediatrics. The manufacturer of hydrocodone-ibuprofen recommends that a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

See references

References for pregnancy information

  1. Rudolph AM "Effects of aspirin and acetaminophen in pregnancy and in the newborn." Arch Intern Med 141 (1981): 358-63
  2. "Product Information. Vicoprofen (hydrocodone-ibuprofen)." Knoll Pharmaceutical Company, Whippany, NJ.
  3. Koren G, Pastuszak A, Ito S "Drugs in pregnancy." N Engl J Med 338 (1998): 1128-37
  4. "Product Information. Motrin (ibuprofen)." Pharmacia and Upjohn, Kalamazoo, MI.
  5. Rementeria JL, Nunag NN "Narcotic withdrawal in pregnancy: stillbirth incidence with a case report." Am J Obstet Gynecol 116 (1973): 1152-6
  6. Ostensen M "Optimisation of antirheumatic drug treatment in pregnancy." Clin Pharmacokinet 27 (1994): 486-503
  7. Zelson C, Lee SJ, Casalino M "Neonatal narcotic addiction: comparative effects of maternal intake of heroin and methadone." N Engl J Med 289 (1973): 1216-20
  8. Barry WS, Meinzinger MM, Howse CR "Ibuprofen overdose and exposure in Utero: results from a postmarketing voluntary reporting system." Am J Med 77 (1984): 35-9
  9. Levy G, Garrettson LK, Soda DM "Evidence of placental transfer of acetaminophen." Pediatrics 55 (1975): 895

References for breastfeeding information

  1. Weibert RT, Townsend RJ, Kaiser DG, Naylor AJ "Lack of ibuprofen secretion into human milk." Clin Pharm 1 (1982): 457-8
  2. "Product Information. Motrin (ibuprofen)." Pharmacia and Upjohn, Kalamazoo, MI.
  3. Anderson PO "Drug use during breast-feeding." Clin Pharm 10 (1991): 594-623
  4. Committee on Drugs, 1992 to 1993 "The transfer of drugs and other chemicals into human milk." Pediatrics 93 (1994): 137-50
  5. "Product Information. Vicoprofen (hydrocodone-ibuprofen)." Knoll Pharmaceutical Company, Whippany, NJ.
  6. Findlay JW, DeAngelis RL, Kearney MF, et al "Analgesic drugs in breast milk and plasma." Clin Pharmacol Ther 29 (1981): 625-33
  7. Townsend RJ, Benedetti TJ, Erickson SH, Cengiz C, Gillespie Wr, Gschwend J, Albert KS "Excretion of ibuprofen into breast milk." Am J Obstet Gynecol 149 (1984): 184-6

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