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Droperidol Pregnancy and Breastfeeding Warnings

Droperidol is also known as: Inapsine

Droperidol Pregnancy Warnings

Droperidol should be used during pregnancy only if the benefit outweighs the risk. AU TGA pregnancy category: C US FDA pregnancy category: C

Animal studies have failed to reveal evidence of teratogenicity. There are no controlled data in human pregnancy; however, neonates exposed to droperidol during the third trimester are at risk of extrapyramidal neurological disturbances and/or withdrawal symptoms following delivery. During postmarketing surveillance, agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorders have been reported in these neonates. The severity of these reactions varied from self-limited to those requiring treatment or monitoring. 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. 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

Droperidol Breastfeeding Warnings

Single-dose or short-term use during breastfeeding (such as during surgery), is not likely to adversely affect the breastfed infant, especially if the infant is older than 2 months. If multiple doses are given to the mother, the infant should be monitored for drowsiness, especially in younger, exclusively breastfed infants and when using combinations of psychotropic drugs. UK manufacturer information states that administration of droperidol during lactation should be limited to a single administration and repeat use is not recommended.

AU: Use of droperidol is contraindicated. UK: Treatment with droperidol should be limited to a single administration. US: Caution is recommended. Excreted into human milk: Unknown (droperidol); Yes (butyrophenones) Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Inapsine (droperidol)." Janssen Pharmaceutica, Titusville, NJ.
  3. Aberg H, Frithz G, Morlin C "Comparison of captopril (SQ 14225) with hydrochlorothiazide in the treatment of essential hypertension." Int J Clin Pharmacol Ther Toxicol 19 (1981): 368-71
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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. Inapsine (droperidol)." Janssen Pharmaceutica, Titusville, NJ.
  3. "Product Information. Droperidol (droperidol)." Abbott Pharmaceutical, Abbott Park, IL.

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