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Indomethacin Pregnancy and Breastfeeding Warnings

Indomethacin is also known as: Indocin, Indocin IV, Indocin SR, Tivorbex

Medically reviewed by Drugs.com. Last updated on Apr 17, 2019.

Indomethacin 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

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned

Comments:
-Avoid use during third trimester as it may cause premature closure of the ductus arteriosus.
-Not recommended in women attempting to conceive as may impair female fertility.

Animal studies have shown prostaglandins play an important role in endometrial vascular permeability, blastocyst implantation, and decidualization; administration of prostaglandin synthesis inhibitors has resulted in increased pre-and post-implantation loss. Data from observational studies in women during the first or second trimester of pregnancy are inconclusive regarding potential embryofetal risks. Epidemiological studies suggest an increased risk of miscarriage and of cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for cardiovascular malformation increased from less than 1%, up to approximately 1.5 %; this risk is believed to increase with dose and duration of therapy. Use of nonsteroidal anti-inflammatory drugs (NSAIDs) during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. There are no controlled data in human pregnancy.

NSAIDs may impair female fertility; withdrawal of NSAID therapy should be considered in women with difficulties conceiving or who are undergoing investigation of infertility.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

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

Indomethacin Breastfeeding Warnings

Due to low levels in breastmilk and therapeutic administration directly to infants, use is considered acceptable in nursing mothers; however, according to some manufacturers, use is not recommended. In a small study where 11 out of 15 women received doses ranging from 75 mg orally to 300 mg rectally once a day, the average concentration in breast milk was estimated to be 0.27% of the maternal weight adjusted dose. One study reported a plasma level of 47 mcg/L in 1 infant 1.2 hours after the midpoint of breastfeeding in a mother receiving 2.94 mg/kg once a day.

In a single case report in which a mother was taking 200 mg from the fourth to sixth day postpartum, the infant experienced a generalized seizure when this drug was stopped in the nursing mother, followed by a second seizure the next day. No metabolic findings accounted for convulsions and no levels of this drug were measured in mother or infant. Initially it was thought that this drug was possibly responsible for causing the seizures, however, later studies and established therapeutic use in newborns makes it unlikely that this drug caused the seizures. Due to lack of published clinical experience in newborns and preterm infants, other agents may be preferred.

Benefit should outweigh risk

Excreted into human milk: Yes

Comments:
-Some authorities recommend against maternal use during breastfeeding.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug; other agents with more published information may be preferable, especially when nursing a newborn or preterm infant.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Indocin (indomethacin)." Merck & Co, Inc, West Point, PA.

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. "Product Information. Indocin (indomethacin)." Merck & Co, Inc, West Point, PA.
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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