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Amlodipine / telmisartan Pregnancy and Breastfeeding Warnings

Amlodipine / telmisartan is also known as: Twynsta

Medically reviewed on May 8, 2018

Amlodipine / telmisartan Pregnancy Warnings

This drug should not be used during pregnancy unless there are no alternatives and the benefit outweighs the risk to the fetus; contraindicated per some authorities.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned

Risk Summary: Discontinue this drug as soon as possible upon detection of pregnancy.

Comments: Adequate methods of contraception should be encouraged.

Animal studies with amlodipine have revealed increased intrauterine deaths. Animal studies with telmisartan have revealed evidence of fetotolethality. 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. 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 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

Amlodipine / telmisartan Breastfeeding Warnings

Use should be avoided; contraindicated per some authorities.

Excreted into human milk: Yes (amlodipine); Unknown (telmisartan)
Excreted into animal milk: Yes (telmisartan)

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Twynsta (amlodipine-telmisartan)." Boehringer-Ingelheim, Ridgefield, CT.

References for breastfeeding information

  1. 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 -]):
  2. "Product Information. Twynsta (amlodipine-telmisartan)." Boehringer-Ingelheim, Ridgefield, CT.
  3. Cerner Multum, Inc. "Australian Product Information." O 0

Further information

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

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