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Molindone Pregnancy and Breastfeeding Warnings

Molindone is also known as: Moban

Molindone Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

US FDA pregnancy category: Not formally assigned to a pregnancy category.

Risk Summary: There are no data available on use of this drug in pregnant women to inform of a drug-related risk.

Comment:
-Neonates exposed during the third trimester should be closely monitored, as they are at risk of extrapyramidal/withdrawal symptoms after delivery (e.g., agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, feeding disorder).

Animal study data have revealed evidence of a slight increase in resorptions at doses of at least 20 mg/kg/day given for 10 days. There are no controlled data in human pregnancy.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Molindone Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

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

Comments: The effects in the nursing infant are unknown.

See references

References for pregnancy information

  1. "Product Information. Moban (molindone)." Gate Pharmaceuticals, Sellersville, PA.

References for breastfeeding information

  1. "Product Information. Moban (molindone)." Gate Pharmaceuticals, Sellersville, PA.
  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 -]):

Further information

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

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