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'''''For patient information about XXXXX, click [[XXXXX (patient information)|here]]'''''
'''''For patient information about topiramate, click [[topiramate (patient information)|here]]'''''


{{SB}}
{{SB}}


==Overview==
==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 [[migraine]]s.  It has been used by psychiatrists to treat [[bipolar disorder]],<ref>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.</ref><ref>Marcotte D. Longer term treatment with topiramate for bipolar disorders. Bipolar Disord. 2001;3:46.</ref><ref>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.</ref> although it is not FDA approved for this purpose. This drug has been investigated for use in treatment of obesity,<ref>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.</ref><ref>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.</ref> especially to aid in the reduction of binge eating,<ref>Shapira NA, Goldsmith TD, McElroy S. Treatment of binge disorder with topiramate: a clinical case series. J Clin Psychiatry. 2000;61:368-372.</ref><ref>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.</ref> and also as a possible treatment for alcoholism.<ref>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.</ref>  However, these uses are not actively promoted by the manufacturer, and like its use for bipolar disorder, are [[Off-label use|off-label]] uses. The drug is also used in clinical trials to treat [[Post Traumatic Stress Disorder]].<ref>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.</ref> A pilot study suggests that Topiramate is possibly effective against infantile spasm.<ref>Glauser TA, Clark PO, Strawsburg R. A pilot study of topiramate in the treatment of infantile spasms. Epilepsia. 1998 Dec;39(12):1324-8.</ref>  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 headache|cluster]],<ref>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.</ref> and severe headaches within various demographics. Other off-label and investigational uses of topiramate include: treatment of [[bulimia nervosa]],<ref>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.</ref> [[obsessive-compulsive disorder]], treatment of alcoholism <ref>http://www.cnn.com/2007/HEALTH/conditions/10/09/alcoholism.pill.ap/index.html</ref>, smoking cessation,<ref>Khazaal Y, Cornuz J, Bilancioni R, Zullino DF. Topiramate for smoking cessation. Psychiatry Clin Neurosci. 2006 Jun;60(3):384-8.</ref> and treatment of [[neuropathic pain]].<ref>Chong MS, Libretto SE. The rationale and use of topiramate for treating neuropathic pain. Clin J Pain. 2003 Jan-Feb;19(1):59-68.</ref>
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==
==Category==
Anticonvulsants
Category:Mood stabilizers


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


'''| [[XXXXX indications and usage|Indications and Usage]]'''
'''| [[topiramate indications and usage|Indications and Usage]]'''
'''| [[XXXXX dosage and administration|Dosage and Administration]]'''
'''| [[topiramate dosage and administration|Dosage and Administration]]'''
'''| [[XXXXX dosage forms and strengths|Dosage Forms and Strengths]]'''
'''| [[topiramate dosage forms and strengths|Dosage Forms and Strengths]]'''
'''| [[XXXXX contraindications|Contraindications]]'''
'''| [[topiramate contraindications|Contraindications]]'''
'''| [[XXXXX warnings and precautions|Warnings and Precautions]]'''
'''| [[topiramate warnings and precautions|Warnings and Precautions]]'''
'''| [[XXXXX adverse reactions|Adverse Reactions]]'''
'''| [[topiramate adverse reactions|Adverse Reactions]]'''
'''| [[XXXXX drug interactions|Drug Interactions]]'''
'''| [[topiramate drug interactions|Drug Interactions]]'''
'''| [[XXXXX use in specific populations|Use in Specific Populations]]'''
'''| [[topiramate use in specific populations|Use in Specific Populations]]'''
'''| [[XXXXX overdosage|Overdosage]]'''
'''| [[topiramate overdosage|Overdosage]]'''
'''| [[XXXXX description|Description]]'''
'''| [[topiramate description|Description]]'''
'''| [[XXXXX clinical pharmacology|Clinical Pharmacology]]'''
'''| [[topiramate clinical pharmacology|Clinical Pharmacology]]'''
'''| [[XXXXX nonclinical toxicology|Nonclinical Toxicology]]'''
'''| [[topiramate nonclinical toxicology|Nonclinical Toxicology]]'''
'''| [[XXXXX clinical studies|Clinical Studies]]'''
'''| [[topiramate clinical studies|Clinical Studies]]'''
'''| [[XXXXX how supplied storage and handling|How Supplied/Storage and Handling]]'''
'''| [[topiramate how supplied storage and handling|How Supplied/Storage and Handling]]'''
'''| [[XXXXX patient counseling information|Patient Counseling Information]]'''
'''| [[topiramate patient counseling information|Patient Counseling Information]]'''
'''| [[XXXXX labels and packages|Labels and Packages]]'''
'''| [[topiramate labels and packages|Labels and Packages]]'''


==Mechanism of Action==
==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.


==References==
{{Reflist|2}}
[[Category:Cardiovascular Drugs]]
[[Category:Drugs]]
'''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 [[migraine]]s.  It has been used by psychiatrists to treat [[bipolar disorder]],<ref>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.</ref><ref>Marcotte D. Longer term treatment with topiramate for bipolar disorders. Bipolar Disord. 2001;3:46.</ref><ref>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.</ref> although it is not FDA approved for this purpose. This drug has been investigated for use in treatment of obesity,<ref>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.</ref><ref>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.</ref> especially to aid in the reduction of binge eating,<ref>Shapira NA, Goldsmith TD, McElroy S. Treatment of binge disorder with topiramate: a clinical case series. J Clin Psychiatry. 2000;61:368-372.</ref><ref>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.</ref> and also as a possible treatment for alcoholism.<ref>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.</ref>  However, these uses are not actively promoted by the manufacturer, and like its use for bipolar disorder, are [[Off-label use|off-label]] uses. The drug is also used in clinical trials to treat [[Post Traumatic Stress Disorder]].<ref>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.</ref> A pilot study suggests that Topiramate is possibly effective against infantile spasm.<ref>Glauser TA, Clark PO, Strawsburg R. A pilot study of topiramate in the treatment of infantile spasms. Epilepsia. 1998 Dec;39(12):1324-8.</ref>  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 headache|cluster]],<ref>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.</ref> and severe headaches within various demographics. Other off-label and investigational uses of topiramate include: treatment of [[bulimia nervosa]],<ref>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.</ref> [[obsessive-compulsive disorder]], treatment of alcoholism <ref>http://www.cnn.com/2007/HEALTH/conditions/10/09/alcoholism.pill.ap/index.html</ref>, smoking cessation,<ref>Khazaal Y, Cornuz J, Bilancioni R, Zullino DF. Topiramate for smoking cessation. Psychiatry Clin Neurosci. 2006 Jun;60(3):384-8.</ref> and treatment of [[neuropathic pain]].<ref>Chong MS, Libretto SE. The rationale and use of topiramate for treating neuropathic pain. Clin J Pain. 2003 Jan-Feb;19(1):59-68.</ref>
==Pharmacodynamics==
Chemically, topiramate is a [[sulfamic acid|sulfamate]]-substituted [[monosaccharide]], related to [[fructose]], a rather unusual chemical structure for an anticonvulsant. Topiramate is quickly absorbed after oral use. Most of the drug (70%) is excreted in the urine as unchanged drug. The remainder is extensively metabolized by [[hydroxylation]], [[hydrolysis]], and [[glucuronidation]]. Six [[metabolite]]s have been identified in humans, none of which constitutes more than 5% of an administered dose. Topiramate enhances [[GABA]]-activated chloride channels. In addition, topiramate inhibits excitatory neurotransmission, through actions on [[kainic acid|kainate]] and [[AMPA receptor]]s. There is evidence that topiramate has a specific effect on GluR5 kainate receptors. It is also an inhibitor of [[carbonic anhydrase]], particularly subtypes II and IV, but this action is weak and unlikely to be related to its anticonvulsant actions, but may account for the bad taste and the development of [[Kidney stone|renal stones]] seen during treatment. Its possible effect as a [[mood stabilizer]] seems to occur before anticonvulsant qualities at lower dosages. Topiramate inhibits maximal electroshock and pentylenetetrazol-induced seizures as well as partial and secondarily generalized tonic-clonic seizures in the kindling model, findings predictive of a broad spectrum of activities clinically.
==Side effects==
A [[GlaxoSmithKline]]-sponsored Phase IV (post-marketing) study suggested that cognitive side effects may be more common with topiramate than with [[lamotrigine]].<ref>{{cite journal
|author=Blum D, Meador K, Biton V, ''et al''
|title=Cognitive effects of lamotrigine compared with topiramate in patients with epilepsy
|journal=Neurology
|volume=67
|issue=3
|pages=400–6
|year=2006
|pmid=16894098
|doi=10.1212/01.wnl.0000232737.72555.06
}}
</ref> In studies of healthy volunteers, comparing the two medications, therapeutic doses of topiramate for bipolar disorder produced greater cognitive deficits than lamotrigine, including short term memory loss and word-finding difficulty. This effect has led to the occasional use of the name "dopamax" by some dissatisfied customers.  A flat affect was reported in > 75% patients (n=60).
The most common side effects include a change in taste (carbonated beverages, especially diet sodas and beer, taste particularly bad) and feelings of pins and needles in the head and extremities.  Less common side effects include cognitive deficiency (particularly word-finding difficulty); grogginess; lethargy; [[renal]] (kidney) stones, impairment of fine motor skills; vision abnormality and transient or permanent vision loss (see below for FDA warning); weight loss; breast pain; abdominal pain; intense sweating; menstrual disorder; taste changes; [[pharyngitis]]; [[sinusitis]]; [[diplopia]]; rash; [[leukopenia]]; fatigue; dizziness; insomnia; anxiety; depression; [[paresthesia]]; diarrhea; nausea; [[dyspepsia]]; constipation; dry-mouth; [[dysmenorrhea]].
Rarely, the inhibition of [[carbonic anhydrase]] may be strong enough to cause [[metabolic acidosis]] of clinical importance.
The side-effects most frequently leading to discontinuation of therapy with topiramate were :
* Psychomotor slowing (4.1%)
* Memory problems (3.3%)
* Fatigue (3.3%)
* Confusion (3.2%)
* [[Somnolence]] (3.2%)
The side-effects reported by > 10% of subjects in at least 1 clinical study<ref>{{cite journal
  | last = Chengappa
  | first = K. N. Roy
  | authorlink =
  | coauthors = LK Schwarzman, JF Hulihan, J Xiang, NR Rosenthal
  | title = Adjunctive Topiramate Therapy in Patients Receiving a Mood Stabilizer fo Bipolar I Disorder: A Randomized Placebo-Controlled Trial
  | journal = J Clin Psychiatry
  | volume = 67
  | issue = 11
  | pages = 1703
  | publisher = Physicians Postgraduate Press
  | date = November 2006
  | url =
  | doi =
  | id = ISSN 0160-6689
  | accessdate =  }} </ref>
Listed by prevalence:
(*indicates placebo rate [%] is the same or higher than side-effect rate) 
* headache (23.8%) *[25.9%]
* paresthesia (numbness & tingling) (23.1%)
* upper respiratory tract infection (17.5%)
* diarrhea (16.8%)
* nausea (15.4%)
* somnolence (15.4%) *[16.1%]
* anorexia (loss of appetite) (13.3%) *[5.6%]
* insomnia (11.9%) *[11.2%]
* memory problems (11.2%)
* dizziness (10.5%) *[10.5]
The Food and Drug Administration (FDA) has issued a notification alerting physicians who prescribe topiramate, and their patients, to the risk of vision loss (blindness). Acute [[myopia]] and secondary angle closure [[glaucoma]], in a small subset of patients who take topiramate regularly, may cause transient (reversible), or permanent, loss of vision. The symptoms, which typically begin in the first month of use, include blurred vision and eye pain. If addressed early in its course, discontinuation of topiramate, along with other measures deemed prudent by the prescribing physician and/or ophthalmologist, may halt the progression of the ocular damage, and may reverse the visual impairment. Patients who take topiramate and who feel pain in or around their eyes, or notice a loss of vision, visual [[acuity]], or blurred vision, are advised to seek consultation with their physician as soon as reasonably possible. According to the FDA: "in more than 825,000 patients...As of August 17, 2001 there have been 23 reported cases: 22 in adults and 1 in pediatric patients. It is generally recognized that postmarketing data are subject to substantial under-reporting."
Another serious side-effect is the development of osteoporosis in adults and children (bones affected break more easily) and rickets (abnormal, deformed growth of bones) in children. Topiramate may also slow the growth of children. All of these conditions should be detected early by performing regular clinical examinations of the patients.
In other postmarketing research, a risk of decreased sweating and [[hyperthermia]] was  discovered. Pediatric patients (children) are especially prone to this side-effect. It is recommended that children treated with topiramate should be monitored closely for evidence of decreased sweating and increased body temperature, especially in hot weather. All patients, particularly those with other predisposing factors, should be instructed to maintain an adequate fluid intake in order to minimize the risk of [[kidney stone]] formation.
==Interactions==
* As topiramate inhibits [[carbonic anhydrase]], the concomitant use of other inhibitors of carbonic anhydrase (e.g. [[acetazolamide]]) may lead to an increased risk of renal stones.
* Enzyme inductors (e.g. carbamazepine) : The elimination of topiramate may be increased, possibly requiring dose escalations of topiramate.
* [[Phenytoin]] : Topiramate may increase the plasma-levels of phenytoin.
* Topiramate itself is a weak inhibitor of CYP 2C19 and induces CYP 3A4. Under topiramate a decrease of plasma-levels of estrogens (e.g. 'the pill') and [[digoxin]] have been noted.
* Alcohol may cause increased sedation or drowsiness, and increase the risk of having a seizure.
* As listed in the 06/29/2005 label posted at the Drugs@FDA website page 14,'conditions or therapies that predispose to acidosis may be additive to the bicarbonate lowering effects of Topiramate'. Absent from this label is any direct discussion of narcotic (drugs known to promote respiratory acidosis) interactions. This discussion on page 14 is under the topic of Metabolic Acidosis, and is not repeated under the topic of interactions.<ref>[Shttp://www.fda.gov/cder/foi/label/2005/020505s018lbl.pdf FDA.gov]</ref>
==Doses==
In order to avoid early side-effects (e.g. cognitive dysfunction) the initial dose normally is low and increased in slow steps. The usual initial dose is 25 to 50 mg daily in 2 single doses. Recommended increments are 25 to 50mg every 1 or 2 weeks. Common doses for maintenance treatment are 100 to 200 mg daily. The highest dose possible is 1,000 mg daily in divided doses.
==Overdose==
Symptoms of overdose may include but are not limited to:
* Seizures
* Dizziness, drowsiness, tiredness
* Agitation
* Depression
* Speech problems
* Blurred vision, double vision
* Troubled thinking
* Loss of coordination
* Inability to respond to things around you
* Loss of consciousness
* Confusion and coma
* Fainting
* Upset stomach and stomach pain
* Loss of appetite and vomiting
* Excessive hunger
* Shortness of breath; fast, shallow breathing 
* Pounding or irregular heartbeat
* Muscle weakness
* Bone pain
A specific antidote is not available. Treatment is entirely symptomatic.
==References==
===Notes===
{{reflist|2}}
===Sources===
===Sources===
* Goodman & Gilman's : The Pharmacological Basis of Therapeutics, 10th. edition, 2001. ISBN 0-07-135469-7
* 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
* 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
* E. Mutschler, G. Geisslinger, H. K. Kroemer and M. Schäfer-Korting : Arzneimittelwirkungen (German), 8th edition, 2001. ISBN 3-8047-1763-2
==References==


==External links==
{{Reflist|2}}
 
* [http://migrainecycle.org/topiramate.php?kw=419942 Topamax® (topiramate): Break the Migraine Cycle; the FDA and Topamax® (topiramate) as a psychotherapeutic agent in Bipolar Disorder.]
* [http://migrainecycle.org/topiramate.php?kw=419942 Topamax® (topiramate): Break the Migraine Cycle; the FDA and Topamax® (topiramate) as a psychotherapeutic agent in Bipolar Disorder.]
* [http://www.topamax.com Topamax (topiramate): Treatment for Migraine Prevention]
* [http://www.topamax.com Topamax (topiramate): Treatment for Migraine Prevention]
Line 163: Line 61:
* Green, Ben [http://www.priory.com/focus7.htm Focus on Topiramate - a new anti-epileptic] Priory Lodge Education Ltd., 1997-99. Focus on Topiramate First published May 1997. Version 1.1
* Green, Ben [http://www.priory.com/focus7.htm Focus on Topiramate - a new anti-epileptic] Priory Lodge Education Ltd., 1997-99. Focus on Topiramate First published May 1997. Version 1.1
* [http://www.topamax.com/html/ptop/about-topamax-what-to-expect.jsp Topamax: Side Effects]
* [http://www.topamax.com/html/ptop/about-topamax-what-to-expect.jsp Topamax: Side Effects]
 
[[Category:Cardiovascular Drugs]]
[[Category:Drugs]]


{{Anticonvulsants}}
{{Anticonvulsants}}

Revision as of 22:17, 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

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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