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Amlodipine / atorvastatin Pregnancy and Breastfeeding Warnings

Amlodipine / atorvastatin is also known as: Caduet

Amlodipine / atorvastatin Pregnancy Warnings

Animal studies with amlodipine have revealed evidence of decreased litter size, increased intrauterine deaths, and prolonged gestation and labor. Animal studies with atorvastatin have revealed evidence of decreased pup survival and body weight and delayed pup development. In humans, there have been rare reports of congenital anomalies following intrauterine exposure to statins. 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 X: Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Use is contraindicated.

AU TGA pregnancy category: D
US FDA pregnancy category: X

Comments: Adequate methods of contraception should be encouraged.

See references

Amlodipine / atorvastatin Breastfeeding Warnings

Use is contraindicated.

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

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. "Product Information. Caduet (amlodipine-atorvastatin)." Pfizer U.S. Pharmaceuticals Group, New York, NY.

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  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 -]):
  3. "Product Information. Caduet (amlodipine-atorvastatin)." Pfizer U.S. Pharmaceuticals Group, New York, NY.

Further information

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

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