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Temazepam Pregnancy and Breastfeeding Warnings

Brand names: Restoril

Temazepam Pregnancy Warnings

Use is not recommended.
-Some experts recommend: Use is contraindicated.

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

Comments:
-The child born to a mother taking benzodiazepines may be at risk for withdrawal symptoms.
-Benzodiazepines may cause fetal harm when administered during pregnancy.
-The patient should be warned of the potential risks to the fetus and instructed to discontinue the drug prior to becoming pregnant.

Several studies have suggested an increased risk of congenital malformations associated with the use of benzodiazepines during the first trimester of pregnancy. There are no controlled data in human pregnancy.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. 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.

See references

Temazepam Breastfeeding Warnings

Caution is recommended.
-Some experts recommend: Use is contraindicated.

Excreted into human milk: Yes

Comments:
-The American Academy of Pediatrics considers this agent a drug for which the effect on nursing infants is unknown but may be of concern.
-This drug may cause drowsiness and feeding difficulties in the infant.

See references

See also

References for pregnancy information

  1. Product Information. Restoril (temazepam). Sandoz Pharmaceuticals Corporation. 2001;PROD.
  2. Cerner Multum, Inc. UK Summary of Product Characteristics.
  3. Cerner Multum, Inc. Australian Product Information.

References for breastfeeding information

  1. Product Information. Restoril (temazepam). Sandoz Pharmaceuticals Corporation. 2001;PROD.
  2. Cerner Multum, Inc. UK Summary of Product Characteristics.
  3. Cerner Multum, Inc. Australian Product Information.
  4. Briggs GG, Freeman RK. Drugs in Pregnancy and Lactation. Philadelphia, PA: Wolters Kluwer Health. 2015.

Further information

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

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