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Topiramate

This section is designed to inform professionals

(Consumers, see Topiramate Fact Sheet)

Available as,Topamax
Topiramate is a carbonic anhydrase inhibitor

Uses:

  • Anticonvulsant used to treat refractory partial seizures.
  • Mood stabiliser, although its efficacy as a mood stabiliser lacks good evidence.
  • To treat migraine.

Use in Pregnancy

Category C

  • Some animal studies have found Topiramate to be teratogenic but its possible effects on the human fetus has not yet been determined.
  • There is limited information about the use of topiramate as the number of outcomes of human pregnancies exposed to topiramate is low, but the major congenital malformation rate for topiramate used in combination with other anticonvulsants, raises some concerns. In a study of 203 women who used topiramate during pregnancy the rate of oral cleft defects was 11 times the background rate. Although this study provides some new information about use of topiramate in pregnancy, the sample size is quite small and in most of the cases reported topiramate was being used in combination with other anticonvulsants that are also known to increase the risk of congenital birth defects. In a study of the outcome of 52 pregnancies in which topiramate alone was used, it appears that topiramate reduces birth weight without decreasing gestational age at delivery, but does not seem to increase the risk for structural defects.
  • There is a case report of two siblings with neonatal hypocalcemic seizures whose mother took topiramate during both pregnancies.
  • Long-term follow up of children exposed to antiepileptic drugs in utero has been limited, so that more subtle effects on the subsequent neurological and cognitive development of children have been poorly studied.

Use in Breast Feeding


Category L3

  • Topiramate is excreted in the milk of lactating rats.
  • The excretion of topiramate in human milk has not been evaluated in controlled studies. Limited observations in patients suggest an extensive secretion of topiramate into breast milk.
  • In view of the sparse data and the potential adverse effects of the drug,breast feeding while taking topiramate cannot be recommended
  • Because the potential for serious adverse reactions in nursing infants to Topiramate is unknown, the potential benefit to the mother should be weighed against the potential risk to the infant when considering recommendations regarding nursing.


References

1. MEDSAFE: Information for Health Professionals

2. Medline Plus: Trusted Health Information for you.

3. Hunt S, Russell A, Smithson W.H, Parsons L, Robertson I, Waddell R, Irwin B, Morrison P. J, Morrow J, and Craig J: Topiramate in pregnancy Preliminary experience from the UK Epilepsy and Pregnancy Register. Neurology (2008);71:272-276.

4. Ornoy A, Zvi N, Arnon J, Wajnberg R, Shechtman S, Diav-Citrin O : The outcome of pregnancy following topiramate treatment: A study on 52 pregnancies, Reproductive Toxicology (2008); 25:3 : 388-389.

5. Battino D, Tomson T: Management of Epilepsy during Pregnancy. Preview. Drugs (2007) 68:18: 727-2746.

6. Gorman M, Soul J: Neonatal Hypocalcemic Seizures in Siblings Exposed to Topiramate In Utero. Pediatric Neurology (2007); 36:4: 274-276.

7. Bar-Oz, B, Nulman, I, Koren, G, Ito S : Anticonvulsants and Breast Feeding: A Critical Review. Pediatric Drugs (2000): 2:2: 113-126.

8. Öhman I, Vitols S, Luef G, Söderfeldt Bi, Tomson T: Topiramate Kinetics during Delivery, Lactation, and in the Neonate: Preliminary Observations. Epilepsia (2002); 43:10; 1157-1160.

 

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