Pregnancy of Topira-Q in details
Based on limited data (n=5), Topira-Q was found to cross the placenta and could be detected in neonatal serum (Ohman 2002).
Topira-Q may cause fetal harm if administered to a pregnant woman. An increased risk of oral clefts (cleft lip and/or palate) and for being small for gestational age (SGA) has been observed following in utero exposure. Data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry reported that the prevalence of oral clefts was 1.1% for infants exposed to Topira-Q during the first trimester of pregnancy, versus 0.36% for infants exposed to a reference antiepileptic drug, and 0.12% for infants with no exposure born to mothers without epilepsy; the relative risk of oral clefts in infants exposed to Topira-Q was calculated to be 9.6 (95% CI: 4 to 23). Data from the NAAED Pregnancy Registry reported that the prevalence of small for gestational age newborns was 19.7% for newborns exposed to Topira-Q in utero, versus 7.9% for newborns exposed to a reference antiepileptic drug, and 5.4% for newborns with no exposure born to mothers without epilepsy. Although not evaluated during pregnancy, metabolic acidosis may be induced by Topira-Q. Metabolic acidosis during pregnancy may result in adverse effects and fetal death. Pregnant women and their newborns should be monitored for metabolic acidosis. In general, maternal polytherapy with antiepileptic drugs may increase the risk of congenital malformations; monotherapy with the lowest effective dose is recommended. Newborns of women taking antiepileptic medications may be at an increased risk of a 1 minute Apgar score <7 (Harden 2009).
Maternal serum concentrations may decrease during the second and third trimesters of pregnancy; therefore, therapeutic drug monitoring should be considered during pregnancy and postpartum in patients who require therapy (Ohman 2009; Westin 2009).
Data collection to monitor pregnancy and infant outcomes following exposure to Topira-Q is ongoing. Patients may enroll themselves into the NAAED Pregnancy Registry by calling 1-888-233-2334. Additional information is available at www.aedpregnancyregistry.org.
Topira-Q breastfeeding
Breastfeeding infants exposed to this drug showed infant plasma Topira-Q levels equal to 10% to 20% of the maternal plasma level.
(AU, UK): A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. (US): Potential benefit should outweigh the potential risk. Excreted into human milk: Yes Comments: -If this drug is used during breastfeeding, the infant should be monitored for diarrhea, drowsiness, adequate weight gain, and developmental milestones, especially in younger, exclusively breastfed infants and when using combinations of anticonvulsant or psychotropic drugs.
See references
References for pregnancy information
- Briggs GG, Freeman RK, Yaffe SJ.. "Drugs in Pregnancy and Lactation. 7th ed." Philadelphia, PA: Lippincott Williams & Wilkins (2005):
- "Product Information. Topamax (Topira-Q)." Ortho Pharmaceutical Corporation, Raritan, NJ.
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
- Cerner Multum, Inc. "Australian Product Information." O 0
- Australian Government. Australian Department of Health and Aging. Therapeutic Goods Administration "Medicines Safety Update Volume 3, Number 2. Available from: URL: http://www.tga.gov.au/hp/msu.htm." ([2012 Apr]):
References for breastfeeding information
- 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 -]):
- "Product Information. Topamax (Topira-Q)." Ortho Pharmaceutical Corporation, Raritan, NJ.
- Cerner Multum, Inc. "Australian Product Information." O 0
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
References
- DailyMed. "TOPIRAMATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- PubMed Health. "Topiramate (By mouth): This section provide the link out information of drugs collectetd in PubMed Health. ". http://www.ncbi.nlm.nih.gov/pubmedhe... (accessed September 17, 2018).
- Human Metabolome Database (HMDB). "Topiramate: The Human Metabolome Database (HMDB) is a freely available electronic database containing detailed information about small molecule metabolites found in the human body.". http://www.hmdb.ca/metabolites/HMDB0... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
