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Budesonide Pregnancy and Breastfeeding Warnings

Budesonide is also known as: Entocort EC, Pulmicort Flexhaler, Pulmicort Nebuamp, Pulmicort Respules, Pulmicort Turbuhaler, Uceris

Budesonide Pregnancy Warnings

Benefit should outweigh risk AU TGA pregnancy category: A (inhalation); B3 (oral) US FDA pregnancy category: B (inhalation); C (oral) Comments: -The possibility of fetal ham with inhaled corticosteroids appears remote; but data are insufficient with oral and rectal administration to inform a drug-associated risk for major birth defects and miscarriage. -Hypoadrenalism may occur in neonates exposed to glucocorticosteroids in utero; carefully observe neonates for signs and symptoms of hypoadrenalism.

Teratogenicity and embryocidal effects have been observed in rabbits and rats administered subcutaneous doses that represent 0.05 and 0.5 times the maximum recommended human doses, respectively. These effects have been reported as increased fetal loss, decreased pup weights, and skeletal abnormalities. Higher doses administered by inhalation to rats have not shown to be teratogenic. Experience with oral corticosteroids at pharmacologic doses suggests rodents are more prone to teratogenic effect than humans. Results from a large population-based prospective cohort epidemiological study reviewing data from 3 Swedish registries covering approximately 99% of the pregnancies from 1995-1997 indicate no increased risk for congenital malformations from the use of inhaled drug during early pregnancy. These same data were used in a second study bringing the total to 2,534 infants whose mothers were exposed to inhaled budesonide. In this study, the rate of congenital malformations among infants whose mother were exposed to inhaled budesonide during early pregnancy was not different from the rate for all newborn babies during the same period (3.6%). There are few data on pregnancy outcomes after oral or rectal administration in humans. The maximal concentration of budesonide in plasma is expected to be higher with oral compared to inhaled use. Prolonged or repeated exposure may increase the risk of intra-uterine growth retardation. When considering use, risk benefit analysis should take into consideration disease-associated maternal and/or embryo/fetal risks. Inhaled glucocorticosteroids offer lower systemic effects compared to oral glucocorticosteroids and achieve similar pulmonary responses. There are no adequate and well controlled studies in pregnant women. AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

See references

Budesonide Breastfeeding Warnings

Most experts consider inhaled corticosteroids acceptable during breastfeeding as the presence in breast milk is expected to be low and infant exposure negligible. A fully breastfed infant is expected to receive a maximum 0.3% to 1% of the weight-adjusted maternal dosage; a milk to plasma ratio between 0.4 and 0.5. Drug levels have not been detected in breastfed infants following maternal use of the inhaled drug. Oral drug at the recommended daily dose is expected to produce plasma concentrations up to 10 times higher than the inhaled drug. Due to lack of specific data with the oral or rectal formulations, some manufacturers recommend therapy be avoided.

Inhalation: Use is considered acceptable Oral/Rectal: Use with cation Excreted into human milk: Yes Comment: The effects in the nursing infant are unknown; at therapeutic doses minimal effects are expected.

See references

References for pregnancy information

  1. "Product Information. Pulmicort Respules (budesonide)." Astra-Zeneca Pharmaceuticals, Wayne, PA.
  2. "Product Information. Entocort EC (budesonide)." Perrigo, L. Company, Allegan, MI.
  3. "Product Information. Uceris (budesonide)." Santarus Inc, San Diego, CA.
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  5. Cerner Multum, Inc. "Australian Product Information." O 0
  6. "Product Information. Pulmicort Flexhaler (budesonide)." A-S Medication Solutions, Chicago, IL.

References for breastfeeding information

  1. "Product Information. Pulmicort Respules (budesonide)." Astra-Zeneca Pharmaceuticals, Wayne, PA.
  2. 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 -]):
  3. "Product Information. Pulmicort Flexhaler (budesonide)." A-S Medication Solutions, Chicago, IL.
  4. "Product Information. Uceris (budesonide)." Santarus Inc, San Diego, CA.
  5. "Product Information. Entocort EC (budesonide)." Perrigo, L. Company, Allegan, MI.
  6. Cerner Multum, Inc. "Australian Product Information." O 0
  7. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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