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Labetalol Pregnancy and Breastfeeding Warnings

Labetalol is also known as: Normodyne, Trandate

Labetalol Pregnancy Warnings

-Animal studies have failed to reveal evidence of teratogenicity, although an increased incidence of fetal resorption was demonstrated in some studies at doses approximating the maximum recommended human dose. There are no controlled data in human pregnancy. -Beta adrenergic blocking agents may cause bradycardia in the fetus and newborn infant. During the final part of pregnancy and parturition these drugs should therefore only be given after weighing the needs of the mother against the risk to the fetus. -This drug crosses the placental barrier and has been found to bind to the eyes of fetal animals. -Perinatal and neonatal distress (bradycardia, hypotension, respiratory depression, hypoglycemia, hypothermia) has been rarely reported. Response to supportive measures (e.g. intravenous fluids and glucose) is usually prompt. 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 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.

AU: Contraindicated during the first trimester of pregnancy. AU (second and third trimester), UK, US: This drug should be used during pregnancy only if the benefit outweighs the risk. AU TGA pregnancy category: C US FDA pregnancy category: C

See references

Labetalol Breastfeeding Warnings

AU: Use is contraindicated UK: Use is not recommended US: Caution is recommended Excreted into human milk: Yes Comment: -The effects in the nursing infant are unknown.

Because of the low levels of this drug in breastmilk, amounts ingested by the infant are small and would not be expected to cause any adverse effects in full-term breastfed infants. No special precautions are required in most infants; however, other agents may be preferred while nursing a preterm infant.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Labetalol Hydrochloride (labetalol)." Watson Pharmaceuticals, Parsippany, NJ.

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. Cerner Multum, Inc. "Australian Product Information." O 0
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. "Product Information. Labetalol Hydrochloride (labetalol)." Watson Pharmaceuticals, Parsippany, NJ.

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