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Mometasone Pregnancy and Breastfeeding Warnings

Mometasone is also known as: Asmanex HFA, Asmanex Twisthaler

Mometasone Pregnancy Warnings

Animal reproduction studies in mice, rats, and rabbits revealed evidence of teratogenicity, such as increased fetal malformations and decreased fetal growth (measured by lower fetal weights and/or delayed ossification). Dystocia and related complications were also observed when administered in late gestation. In mice, subcutaneous administration produced cleft palate at approximately one-third of the maximum recommended daily human dose (MRHD). In rats, topical administration produced umbilical hernia at doses approximately 6 times the MRHD. Subcutaneous administration in rats, throughout pregnancy or late in gestation, had caused prolonged and difficult labor, fewer live births, lower birth weight, and reduced early pup survival at doses approximately 8 times the MRHD. In rabbits, topical administration caused multiple malformations (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at doses approximately 3 times the MRHD. 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.

This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

US FDA pregnancy category: C

Comments:
-Hypoadrenalism may occur in infants born to women receiving corticosteroids during pregnancy.
-Monitor signs of hypoadrenalism in infants born to mothers taking substantial corticosteroid doses during pregnancy.

See references

Mometasone Breastfeeding Warnings

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Asmanex HFA (mometasone)." Merck & Company Inc, Whitehouse Station, NJ.
  3. "Product Information. Asmanex Twisthaler (mometasone)." Schering-Plough Corporation, Kenilworth, NJ.

References for breastfeeding information

  1. "Product Information. Asmanex Twisthaler (mometasone)." Schering-Plough Corporation, Kenilworth, NJ.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Asmanex HFA (mometasone)." Merck & Company Inc, Whitehouse Station, NJ.

Further information

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

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