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Hydrocodone / ibuprofen Pregnancy and Breastfeeding Warnings

Hydrocodone / ibuprofen is also known as: Ibudone, Reprexain, Vicoprofen, Xylon 10

Hydrocodone / ibuprofen Pregnancy Warnings

Not recommended during last trimester of pregnancy Prior to 30 weeks gestation: Use only if potential benefit justifies the potential risk to the fetus US FDA pregnancy category: Not assigned Risk Summary: Opioids and NSAIDs are both associated with risks during pregnancy. Comments: -Avoid use during third trimester as NSAID use may cause premature closure of the ductus arteriosus. -Prolonged use of opioids during pregnancy can result in physical dependence in the neonate; women should be advised of the risk of neonatal abstinence syndrome and ensure that appropriate treatment will be available.

Animal studies have revealed evidence of increased risk of miscarriage, cardiac malformation, and gastroschisis following use of prostaglandin synthesis inhibitors in early pregnancy. Administration of nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen during the third trimester of pregnancy may cause significant adverse effects, including premature closure of the fetal ductus arteriosus, oligohydramnios, fetal renal impairment, pulmonary hypertension, and prolongation of bleeding time. Prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome. There are no controlled data in human pregnancy. NSAIDs may impair female fertility as animal studies have shown a reversible decrease in ovulation. Chronic opioid use may cause reduced fertility in males and females; it is unknown whether these effects on fertility are reversible. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Hydrocodone / ibuprofen Breastfeeding Warnings

Maternal use of narcotics during breastfeeding can cause infant drowsiness, CNS system depression, and even death; newborn infants are particularly sensitive. Withdrawal symptoms can occur in infants if hydrocodone is discontinued after a prolonged period (i.e., if the mother stops the drug or stops breastfeeding). Ibuprofen is excreted in low levels in the breastmilk and its use is generally considered acceptable.

Benefit should outweigh risk Excreted into human milk: Yes (hydrocodone); Yes (ibuprofen) Comments: -Once a mother's milk is in, it is best to provide pain control with nonnarcotic analgesics; if hydrocodone is used, consider limiting maternal intake to a few days with a maximum dose of 30 mg/day. -Breastfed infants should be closely monitored for increased sedation, difficulty breastfeeding, breathing difficulties, or limpness; mothers should be counseled to seek medical assistance promptly if these develop.

See references

References for pregnancy information

  1. "Product Information. Hydrocodone-Ibuprofen (hydrocodone-ibuprofen)." Par Pharmaceutical Inc (formerly Qualitest Pharmaceuticals Inc), Huntsville, AL.

References for breastfeeding information

  1. "Product Information. Hydrocodone-Ibuprofen (hydrocodone-ibuprofen)." Par Pharmaceutical Inc (formerly Qualitest Pharmaceuticals Inc), Huntsville, AL.
  2. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL:" ([cited 2013 -]):

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