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Anticonvulsants
Anticonvulsants
Category:Mood stabilizers
Category:Mood stabilizers
Anti Migraine Medication


==FDA Package Insert==
==FDA Package Insert==

Revision as of 22:18, 6 February 2014

Topiramate
TOPIRAMATE® FDA Package Insert
Indications and Usage
Dosage and Administration
Dosage Forms and Strengths
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
Clinical Studies
How Supplied/Storage and Handling
Patient Counseling Information
Labels and Packages
Clinical Trials on Topiramate
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Pratik Bahekar, MBBS [2]

For patient information about topiramate, click here

Synonyms / Brand Names:

Overview

Topiramate (brand name Topamax) is an anticonvulsant drug produced by Ortho-McNeil Neurologics, a division of Johnson & Johnson. It is used to treat epilepsy in both children and adults. In children it is also indicated for treatment of Lennox-Gastaut syndrome (a disorder that causes seizures and developmental delays). It is also Food and Drug Administration (FDA) approved for, and now most frequently prescribed for, the prevention of migraines. It has been used by psychiatrists to treat bipolar disorder,[1][2][3] although it is not FDA approved for this purpose. This drug has been investigated for use in treatment of obesity,[4][5] especially to aid in the reduction of binge eating,[6][7] and also as a possible treatment for alcoholism.[8] However, these uses are not actively promoted by the manufacturer, and like its use for bipolar disorder, are off-label uses. The drug is also used in clinical trials to treat Post Traumatic Stress Disorder.[9] A pilot study suggests that Topiramate is possibly effective against infantile spasm.[10] In May 2006 the U.S. National Institutes of Health web site clinicaltrials.gov listed several studies sponsored by Ortho-McNeil which propose to examine the use of topiramate on migraine, cluster,[11] and severe headaches within various demographics. Other off-label and investigational uses of topiramate include: treatment of bulimia nervosa,[12] obsessive-compulsive disorder, treatment of alcoholism [13], smoking cessation,[14] and treatment of neuropathic pain.[15] 

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use topiramate safely and effectively. See full prescribing information for topiramate tablets USP. Topiramate Tablets USP for Oral Use Initial U.S. Approval – 1996

Category

Anticonvulsants Category:Mood stabilizers Anti Migraine Medication

FDA Package Insert

| Indications and Usage | Dosage and Administration | Dosage Forms and Strengths | Contraindications | Warnings and Precautions | Adverse Reactions | Drug Interactions | Use in Specific Populations | Overdosage | Description | Clinical Pharmacology | Nonclinical Toxicology | Clinical Studies | How Supplied/Storage and Handling | Patient Counseling Information | Labels and Packages

Mechanism of Action

Exact mechanism of action of topiramate unknown. Topiramate blocks sodium channel in a state dependent manner, of the neurons in a time-dependent manner. Topiramate augments gamma-aminobutyrate (GABA). It acts as an antagonist at the AMPA/kainate subtype of the excitatory glutamate receptor.

Sources

  • Goodman & Gilman's : The Pharmacological Basis of Therapeutics, 10th. edition, 2001. ISBN 0-07-135469-7
  • Benkert, Hippius : Kompendium der Psychiatrischen Pharmakotherapie (German), 5th. edition, 2004. ISBN 3-540-21893-9
  • E. Mutschler, G. Geisslinger, H. K. Kroemer and M. Schäfer-Korting : Arzneimittelwirkungen (German), 8th edition, 2001. ISBN 3-8047-1763-2

References

  1. ↑ Kusumakar, V.;Lakshmi, N.;Yatham, MB.;O'Donovan, CA.; Kutcher, SP. 152nd Annual Meeting of the American Psychiatric Association. Washington, DC; 1999. Topiramate in rapid cycling bipolar women.
  2. ↑ Marcotte D. Longer term treatment with topiramate for bipolar disorders. Bipolar Disord. 2001;3:46.
  3. ↑ Sachs, G.;Koslow, GC.;Orsini, C.;Cosgrove, V.;Sambur, M.;Demopulos, C.; Ghaemi, S. Topiramate shows efficacy in the treatment of refractory bipolar mood disorder. 22nd Congress of the Collegium of Internationale Psychopharmacologieum. Brussels, Belgium. 2000.
  4. ↑ Van Ameringen M, Mancini C, Pipe B, Campbell M, Oakman J. Topiramate treatment for SSRI-induced weight gain in anxiety disorders. J Clin Psychiatry. 2002;63:981-984.
  5. ↑ Wilding J, Van Gaal L, Rissanen A, Vercruysse F, Fitchet M; OBES-002 Study Group. A randomized double-blind placebo-controlled study of the long-term efficacy and safety of topiramate in the treatment of obese subjects. Int J Obes Relat Metab Disord. 2004 Nov;28(11):1399-410.
  6. ↑ Shapira NA, Goldsmith TD, McElroy S. Treatment of binge disorder with topiramate: a clinical case series. J Clin Psychiatry. 2000;61:368-372.
  7. ↑ McElroy SL, Arnold LM, Shapira NA, Keck PE, Rosenthal NR, Rezaul Karim M, Kamin M, Hudson JI. Topiramate in the treatment of binge eating disorder associated with obesity: a randomized, placebo-controlled trial. Am J Psychiatry. 2003;160:255-261.
  8. ↑ Johnson BA, Ait-Daoud , Bowden CL, DiClemente C, Roache JD, Lawson K, Javors MA, MA JZ. Oral Topiramate in the treatment of alcohol dependence: a randomised controlled trial. Lancet. 2003;361:1677-85.
  9. ↑ Berlant JL, Van Kammen DP. Open label topiramate as primary or adjunctive therapy in chronic civilian posttraumatic stress disorder: a preliminary report. J Clin Psychiatry. 2002;63:15-20.
  10. ↑ Glauser TA, Clark PO, Strawsburg R. A pilot study of topiramate in the treatment of infantile spasms. Epilepsia. 1998 Dec;39(12):1324-8.
  11. ↑ La'inez MJ, Pascual J, Pascual AM, Santonja JM, Ponz A, Salvador A. Topiramate in the prophylactic treatment of cluster headache. Headache. 2003 Jul-Aug;43(7):784-9.
  12. ↑ Hoopes SP, Reimherr FW, Hedges DW, Rosenthal NR, Kamin M, Karim R, Capece JA, Karvois D. Treatment of bulimia nervosa with topiramate in a randomized, double-blind, placebo-controlled trial, part 1: improvement in binge and purge measures. J Clin Psychiatry. 2003;64:1335-41.
  13. ↑ http://www.cnn.com/2007/HEALTH/conditions/10/09/alcoholism.pill.ap/index.html
  14. ↑ Khazaal Y, Cornuz J, Bilancioni R, Zullino DF. Topiramate for smoking cessation. Psychiatry Clin Neurosci. 2006 Jun;60(3):384-8.
  15. ↑ Chong MS, Libretto SE. The rationale and use of topiramate for treating neuropathic pain. Clin J Pain. 2003 Jan-Feb;19(1):59-68.

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