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Methotrimeprazine Pregnancy and Breastfeeding Warnings

Methotrimeprazine is also known as: Levoprome

Methotrimeprazine Pregnancy Warnings

Animal studies using other phenothiazines have revealed contradictory evidence of fetal harm when given during the first trimester. Animal studies using this drug have not been reported. There are no controlled data in human pregnancy.

There have been reports of agitation, bradycardia, feeding disorder, hyper/hypotonia, respiratory distress, somnolence, tachypnea, and tremor in neonates exposed to antipsychotic drugs during the third trimester of pregnancy. Complications occurred more frequently when patients were given antimuscarinic or psychotropic drugs concomitantly; however, the events have occurred with antipsychotic use alone. Phenothiazine-specific neonatal adverse events (e.g., abdominal bloating, delayed meconium passage, feeding disorder, meconium ileus, tachycardia) have been reported. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization.

Hyperprolactinemia may be associated with impaired fertility in men and women. There are no controlled data in human females or males.

This drug is only recommended for use in women of childbearing potential or during pregnancy when there are no alternatives and the benefit outweighs the risk.

AU TGA pregnancy category: Not formally assigned to a pregnancy category.

Comments:
-Some authorities state that safety has not been established in pregnancy, and use is not recommended in pregnancy or in women of childbearing potential not using contraception.
-Use of adequate methods of contraception should be encouraged.
-Neonates exposed to antipsychotic drugs during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery.
-Exposed neonates should be monitored and treated for the signs/symptoms of extrapyramidal syndrome and/or withdrawal symptoms.

See references

Methotrimeprazine 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: Yes

Comments:
-The effects in the nursing infant are unknown.
-Breastfed infants exposed to this drug should be monitored for sedation and developmental milestones.

This drug is known to cause hyperprolactinemia. Galactorrhea has been reported in non-lactating female patients.

See references

References for pregnancy information

  1. "Product Information. Methoprazine (methotrimeprazine)." AA Pharma Inc, Vaughan , ON.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Cerner Multum, Inc. "Canadian Product Information." O 0 (2015):
  4. New Zealand Medicines and Medical Devices Safety Authority "MEDSAFE. Available from: URL: http://www.medsafe.govt.nz/Profs/Datasheet/DSForm.asp." ([2018, Aug 1]):

References for breastfeeding information

  1. "Product Information. Methoprazine (methotrimeprazine)." AA Pharma Inc, Vaughan , ON.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. New Zealand Medicines and Medical Devices Safety Authority "MEDSAFE. Available from: URL: http://www.medsafe.govt.nz/Profs/Datasheet/DSForm.asp." ([2018, Aug 1]):
  4. Cerner Multum, Inc. "Canadian Product Information." O 0 (2015):

Further information

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