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Tedizolid Pregnancy and Breastfeeding Warnings

Tedizolid is also known as: Sivextro

Medically reviewed by Drugs.com. Last updated on May 1, 2019.

Tedizolid Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.
-According to some authorities: Use should be avoided.

US FDA pregnancy category: C

Animal studies have revealed evidence of fetal developmental toxicity; such toxicity included reduced fetal weights, increased incidence of costal cartilage anomalies, and increased skeletal variations (including reduced ossification of the sternebrae, vertebrae, and skull) at exposures of 4- to 6-fold the estimated human exposure. The no observed adverse effect levels for fetal toxicity in mice, maternal and fetal toxicity in rats, and rabbits were associated with drug plasma AUC values about equivalent to (mice and rats) or 0.04-fold (rabbits) the drug AUC value associated with the oral human therapeutic dose. 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.

See references

Tedizolid Breastfeeding Warnings

An alternate agent may be preferred, particularly while breastfeeding newborn or preterm infants.
-According to some authorities: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother and the benefit of breastfeeding for the infant.
-According to some authorities: Caution is recommended.

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

Comments:
-No published data available on use of this drug during breastfeeding.
-The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Sivextro (tedizolid)." Cubist Pharmaceuticals Inc, Lexington, MA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Sivextro (tedizolid)." Cubist Pharmaceuticals Inc, Lexington, MA.
  3. 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 -]):

Further information

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

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