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Bisoprolol Pregnancy and Breastfeeding Warnings

Bisoprolol is also known as: Zebeta

Bisoprolol Pregnancy Warnings

Use is recommended only if clearly needed and the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: C
US FDA pregnancy category: C

Comments:
-If used during pregnancy, monitor placental blood flow and fetal growth.
-After birth, monitor the newborn for the signs and symptoms of beta blockade, generally present in the first 3 days.

Animal models have shown embryofetal toxicity, resorptions, and abortions at doses of 50 mg/kg/day and 12.5 mg/kg/day, or greater in rats and rabbits, respectively. Beta-adrenergic blocking agents have been shown to decrease placental perfusion which has been associated with growth retardation, premature and immature deliveries and fetal death. Due to limited data with this drug, if a beta-blocking agent is required, may consider a beta -1 adrenoreceptor blocker. There are no controlled data in human pregnancy.

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 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.

See references

Bisoprolol Breastfeeding Warnings

This drug is expected to have a moderately high risk of accumulation in nursing infants due to its low protein binding, moderate renal excretion, and a long half-life. Beta-blocking agents with similar breastmilk excretion have caused adverse events in breastfed newborns.

AU and UK: Use not recommended
US: Use caution; other agents may be preferred

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
Monitor breastfed infants for the signs and symptoms of beta blockade, for example, bradycardia, respiratory depression, and hypoglycemia.

See references

References for pregnancy information

  1. "Product Information. Zebeta (bisoprolol)." Lederle Laboratories, Wayne, NJ.
  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. Cerner Multum, Inc. "Australian Product Information." O 0
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Zebeta (bisoprolol)." Lederle Laboratories, Wayne, NJ.
  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. Cerner Multum, Inc. "Australian Product Information." O 0
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." 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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