Trandolapril / verapamil Pregnancy and Breastfeeding Warnings
Brand names: Tarka
Medically reviewed by Drugs.com. Last updated on Jun 1, 2023.
Trandolapril / verapamil Pregnancy Warnings
AU: Use is contraindicated.
UK: Use is not recommended during the first trimester of pregnancy and is contraindicated during the second and third trimesters.
US: This drug should not be used during pregnancy unless there are no alternatives and the benefit outweighs the risk to the fetus.
AU TGA pregnancy category: D
US FDA pregnancy category: D
Comments:
-Adequate methods of contraception should be encouraged.
-Female patients of childbearing age should be told about the consequences of exposure to this drug during pregnancy. Patients should be asked to report pregnancies as soon as possible.
Animal studies with trandolapril have failed to reveal evidence of teratogenicity. Animal studies with verapamil have revealed evidence of embryolethality at doses that produced maternal toxicity. In humans, use of drugs that act on the renin angiotensin system (RAS) during the second and third trimesters increases fetal and neonatal morbidity and death. Verapamil may inhibit contractions if used at the end of pregnancy. There are no controlled data in human pregnancy.
AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.
US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Trandolapril / verapamil Breastfeeding Warnings
AU: Use is contraindicated.
UK and US: Use is not recommended.
Excreted into human milk: Data not available (trandolapril); Yes (verapamil)
Excreted into animal milk: Yes (trandolapril)
See also
References for pregnancy information
- (2001) "Product Information. Tarka (trandolapril-verapamil)." Knoll Pharmaceutical Company
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- Cerner Multum, Inc. "Australian Product Information."
References for breastfeeding information
- (2001) "Product Information. Tarka (trandolapril-verapamil)." Knoll Pharmaceutical Company
- Cerner Multum, Inc. "UK Summary of Product Characteristics."
- Cerner Multum, Inc. "Australian Product Information."
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
