Temazepam Pregnancy and Breastfeeding Warnings

Brand names: Restoril

Temazepam Pregnancy Warnings

Use is not recommended.
-According to some authorities: Use is contraindicated.

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

Risk summary: Use of benzodiazepines, including this drug, late in pregnancy may cause neonatal sedation and/or withdrawal symptoms.

Comments:
-A pregnancy exposure registry is available.
-Patients should inform their healthcare provider if they are pregnant.
-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.
-Monitor neonates exposed to this drug during pregnancy or labor for signs of sedation, respiratory depression, hypotonia, feeding problems and withdrawal.

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.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-866-961-2388.

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 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

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

Further information

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

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