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Trimethadione Pregnancy and Breastfeeding Warnings

Trimethadione is also known as: Tridione

Trimethadione Pregnancy Warnings

Use is not recommended unless this drug is clearly shown to be essential.

US FDA pregnancy category: Not assigned

Comments:
-This drug can harm a developing fetus.
-Women of childbearing potential should use adequate contraception while taking this drug.

-There are multiple reports in the clinical literature which indicate that the use of anticonvulsant drugs during pregnancy results in an increased incidence of birth defects in the offspring. Data are more extensive with respect to trimethadione, paramethadione, phenytoin, and phenobarbital than with other anticonvulsant drugs.
-Anticonvulsant drugs such as this drug should be administered to women of childbearing potential only if they are clearly shown to be essential in the management of their seizures. Effective means of contraception should accompany the use of this drug in such patients. If a patient becomes pregnant while taking this drug, termination of the pregnancy should be considered. A patient who requires therapy with this drug and who wishes to become pregnant should be advised of the risks.
-Maternal ingestion of anticonvulsant drugs, particularly barbiturates, is associated with a neonatal coagulation defect that may cause bleeding during the early (usually within 24 hours of birth) neonatal period. The possibility of the occurrence of this defect with the use of this drug should be kept in mind. The defect is characterized by decreased levels of vitamin k-dependent clotting factors, and prolongation of either the prothrombin time or the partial thromboplastin time, or both. It has been suggested that prophylactic vitamin k be given to the mother one month prior to, and during delivery, and to the infant, IV, immediately after birth.

To provide information regarding the effects of in utero exposure to this drug, physicians are advised to recommend that pregnant patients taking this drug enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/.

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

Trimethadione Breastfeeding Warnings

Safety has not been established.

Excreted into human milk: Data not available
Excreted into animal milk: Data not available

See references

References for pregnancy information

  1. "Product Information. Tridione (trimethadione)" Abbott Pharmaceutical, Abbott Part, IL.

References for breastfeeding information

  1. "Product Information. Tridione (trimethadione)" Abbott Pharmaceutical, Abbott Part, IL.

Further information

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

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