Topiramate indications and usage: Difference between revisions

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


==Indications and Usage==
==Indications and Usage==


====Topiramate tablets USP are an antiepileptic (AED) agent indicated for:====


'''Monotherapy epilepsy''': Initial monotherapy in patients ≥10 years of age with partial onset or primary generalized tonic-clonic seizures.


'''Adjunctive therapy epilepsy''': Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) .
* Topiramate is  most frequently prescribed for, the prevention of [[migraine]]s. This drug is also widely used to treat migraines due to the effect it has on the blood vessels in the brain. It is used as a preventative for atypical migraine sufferers. It widens the blood vessels in the brain which become restricted by increased serotonin levels. It has been found to be increasingly effective for migraine sufferers with limited side effects.<ref>{{Cite journal | doi = 10.1016/j.jocn.2009.03.025| title = Effects of topiramate on neurophysiological and neuropsychological tests in migraine patients| year = 2009| last1 = Kececi| first1 = Hulusi| last2 = Atakay| first2 = Selcuk| journal = Journal of Clinical Neuroscience| volume = 16| issue = 12| pages = 1588| pmid = 19793661}}</ref>
* [[Bipolar disorder]],<ref>{{cite journal |last1=Arnone |first1=D |title=Review of the use of Topiramate for treatment of psychiatric disorders |journal=Annals of general psychiatry |volume=4 |issue=1 |page=5 |year=2005 |pmid=15845141 |pmc=1088011 |doi=10.1186/1744-859X-4-5}}</ref> and indicate that it may have mood stabilizing properties.<ref>{{cite journal |doi=10.1097/00004850-200109000-00008 |last1=Letmaier |first1=M |last2=Schreinzer |first2=D |last3=Wolf |first3=R |last4=Kasper |first4=S |title=Topiramate as a mood stabilizer |journal=International clinical psychopharmacology |volume=16 |issue=5 |pages=295–8 |year=2001 |pmid=11552774}}</ref> In 2006, a [[Cochrane review]] concluded that there is insufficient evidence on which to base any recommendations regarding the use of topiramate in any phase of bipolar illness.<ref>{{cite journal |last1=Vasudev |first1=Kamini |last2=MacRitchie |first2=Karine |last3=Geddes |first3=John |last4=Watson |first4=Stuart |last5=Young |first5=Allan H |last6=Young |first6=Allan H |editor1-last=Young |editor1-first=Allan H |title=Topiramate for acute affective episodes in bipolar disorder |year=2006 |doi=10.1002/14651858.CD003384.pub2 |pmid=16437453 |issue=1 |pages=CD003384 |journal=Cochrane database of systematic reviews (Online)}}</ref> Another meta-analysis published in the Lancet demonstrated that topiramate was of no significant benefit in the treatment of bipolar mania.<ref>{{cite pmid|21851976}}</ref>
* Sometimes use topiramate to augment psychotropics, or to counteract the weight gain associated with numerous antidepressants.
* A more recent [[Cochrane review]], published in 2010, suggested a benefit of topiramate in the treatment of symptoms of [[borderline personality disorder]], however the authors note that this was based only on one randomized controlled trial and requires replication. Also the Authors noted that the long-term effects have not been studied.<ref>{{cite journal |last1=Leib |first1=Klaus |last2=Völlm |first2=Birgit |last3=Rücker |first3=Gerta |last4=Timmer |first4=Antje |last5=Stoffers |first5=Jutta M |title=Pharmacotherapy for borderline personality disorder: Cochrane systematic review of randomised trials |year=2010 |doi=10.1192/bjp.bp.108.062984 |volume=196 |issue=1 |pages=4–12 |journal=British Journal of Psychiatry|pmid=20044651 }}</ref><ref>{{cite journal|pmid=16635055 | doi=10.1111/j.1365-2710.2006.00716.x | volume=31 | issue=2 | title=Can childhood trauma predict response to topiramate in borderline personality disorder? |date=April 2006 | author=do Prado-Lima PA, Kristensen CH, Bacaltchuck J | journal=J Clin Pharm Ther | pages=193–6}}</ref><ref>{{ClinicalTrialsGov|NCT00685178|Clinical Trial of Topiramate for Cocaine Addiction}}</ref>
====This drug has been investigated for use in:====
* Treating [[alcoholism]]<ref>{{cite journal |last1=Johnson |first1=BA |last2=Ait-Daoud |first2=N |last3=Bowden |first3=CL |last4=Diclemente |first4=CC |last5=Roache |first5=JD |last6=Lawson |first6=K |last7=Javors |first7=MA |last8=Ma |first8=JZ |title=Oral topiramate for treatment of alcohol dependence: a randomised controlled trial |journal=Lancet |volume=361 |issue=9370 |pages=1677–85 |year=2003 |pmid=12767733 |doi=10.1016/S0140-6736(03)13370-3}}</ref><ref name="Alc">{{cite journal |last1=Johnson |first1=BA |last2=Rosenthal |first2=N |last3=Capece |first3=JA |last4=Wiegand |first4=F |last5=Mao |first5=L |last6=Beyers |first6=K |last7=McKay |first7=A |last8=Ait-Daoud |first8=N |last9=Anton |first9=RF |title=Topiramate for treating alcohol dependence: a randomized controlled trial |journal=JAMA: the Journal of the American Medical Association |volume=298 |issue=14 |pages=1641–51 |year=2007 |pmid=17925516 |doi=10.1001/jama.298.14.1641|display-authors=9 }}</ref>
* [[Methamphetamine]] addiction<ref>{{cite web| title = Medication can help recovering meth addicts stay sober, study finds | url = http://corporate.uvahealth.com/news-room/archives/medication-can-help-recovering-meth-addicts-stay-sober-study-finds | accessdate = 2012-06-13}}</ref>
* [[Obesity]]<ref>{{cite journal |last1=Van Ameringen |first1=M |last2=Mancini |first2=C |last3=Pipe |first3=B |last4=Campbell |first4=M |last5=Oakman |first5=J |title=Topiramate treatment for SSRI-induced weight gain in anxiety disorders |journal=The Journal of clinical psychiatry |volume=63 |issue=11 |pages=981–4 |year=2002 |pmid=12444810 |doi=10.4088/JCP.v63n1104}}</ref><ref>{{cite journal |last1=Wilding |first1=J |last2=Van Gaal |first2=L |last3=Rissanen |first3=A |last4=Vercruysse |first4=F |last5=Fitchet |first5=M |last6=Obes-002 Study |first6=Group |title=A randomized double-blind placebo-controlled study of the long-term efficacy and safety of topiramate in the treatment of obese subjects |journal=International journal of obesity and related metabolic disorders : journal of the International Association for the Study of Obesity |volume=28 |issue=11 |pages=1399–410 |year=2004 |pmid=15486569 |doi=10.1038/sj.ijo.0802783}}</ref>
* Reduce [[binge eating]]<ref>{{cite journal |last1=Shapira |first1=NA |last2=Goldsmith |first2=TD |last3=McElroy |first3=SL |title=Treatment of binge-eating disorder with topiramate: a clinical case series |journal=The Journal of clinical psychiatry |volume=61 |issue=5 |pages=368–72 |year=2000 |pmid=10847312 |doi=10.4088/JCP.v61n0508}}</ref><ref>{{cite journal |last1=McElroy |first1=SL |last2=Arnold |first2=LM |last3=Shapira |first3=NA |last4=Keck Jr |first4=PE |last5=Rosenthal |first5=NR |last6=Karim |first6=MR |last7=Kamin |first7=M |last8=Hudson |first8=JI |title=Topiramate in the treatment of binge eating disorder associated with obesity: a randomized, placebo-controlled trial |journal=The American Journal of Psychiatry |volume=160 |issue=2 |pages=255–61 |year=2003 |pmid=12562571 |doi=10.1176/appi.ajp.160.2.255}}</ref>
* The drug is also used in clinical trials to treat [[post traumatic stress disorder]].<ref>{{cite journal |last1=Berlant |first1=J |last2=Van Kammen |first2=DP |title=Open-label topiramate as primary or adjunctive therapy in chronic civilian posttraumatic stress disorder: a preliminary report |journal=The Journal of clinical psychiatry |volume=63 |issue=1 |pages=15–20 |year=2002 |pmid=11838620 |doi=10.4088/JCP.v63n0104}}</ref>
* A pilot study suggested that topiramate is effective against infantile spasms.<ref>{{cite journal |last1=Glauser |first1=TA |last2=Clark |first2=PO |last3=Strawsburg |first3=R |title=A pilot study of topiramate in the treatment of infantile spasms |journal=Epilepsia |volume=39 |issue=12 |pages=1324–8 |year=1998 |pmid=9860068 |doi=10.1111/j.1528-1157.1998.tb01331.x}}</ref> 
* Topiramate as an effective treatment in the prevention of [[periventricular leukomalacia]] in preterm infants after an [[Hypoxia (medical)|hypoxic]]-[[ischemic]] injury.<ref>{{cite journal |last1=Follett |first1=PL |last2=Deng |first2=W |last3=Dai |first3=W |last4=Talos |first4=DM |last5=Massillon |first5=LJ |last6=Rosenberg |first6=PA |last7=Volpe |first7=JJ |last8=Jensen |first8=FE |title=Glutamate receptor-mediated oligodendrocyte toxicity in periventricular leukomalacia: a protective role for topiramate |journal=Journal of Neuroscience |volume=24 |issue=18 |pages=4412–20 |year=2004 |pmid=15128855 |doi=10.1523/JNEUROSCI.0477-04.2004}}</ref>
====Off-label and investigational uses====
* [[Essential tremor]]
* [[Bulimia nervosa]]<ref>{{cite journal |last1=Hoopes |first1=SP |last2=Reimherr |first2=FW |last3=Hedges |first3=DW |last4=Rosenthal |first4=NR |last5=Kamin |first5=M |last6=Karim |first6=R |last7=Capece |first7=JA |last8=Karvois |first8=D |title=Treatment of bulimia nervosa with topiramate in a randomized, double-blind, placebo-controlled trial, part 1: improvement in binge and purge measures |journal=The Journal of clinical psychiatry |volume=64 |issue=11 |pages=1335–41 |year=2003 |pmid=14658948 |doi=10.4088/JCP.v64n1109}}</ref>
* [[Obsessive-compulsive disorder]]
* [[Alcoholism]]<ref name="Alc"/>
* [[Smoking cessation]]<ref>{{cite journal |last1=Khazaal |first1=Y |last2=Cornuz |first2=J |last3=Bilancioni |first3=R |last4=Zullino |first4=DF |title=Topiramate for smoking cessation |journal=Psychiatry and clinical neurosciences |volume=60 |issue=3 |pages=384–8 |year=2006 |pmid=16732758 |doi=10.1111/j.1440-1819.2006.01518.x}}</ref>
* [[Idiopathic intracranial hypertension]]<ref>{{cite journal |last1=Celebisoy |first1=N |last2=Gökçay |first2=F |last3=Sirin |first3=H |last4=Akyürekli |first4=O |title=Treatment of idiopathic intracranial hypertension: topiramate vs acetazolamide, an open-label study |journal=Acta neurologica Scandinavica |volume=116 |issue=5 |pages=322–7 |year=2007 |pmid=17922725 |doi=10.1111/j.1600-0404.2007.00905.x}}</ref>
* [[Cluster headache]]<ref>{{cite journal |last1=Láinez |first1=MJ |last2=Pascual |first2=J |last3=Pascual |first3=AM |last4=Santonja |first4=JM |last5=Ponz |first5=A |last6=Salvador |first6=A |title=Topiramate in the prophylactic treatment of cluster headache |journal=Headache |volume=43 |issue=7 |pages=784–9 |year=2003 |pmid=12890134 |doi=10.1046/j.1526-4610.2003.03137.x}}</ref>
* [[Treatment-resistant depression]]
* [[Cocaine]] dependence
* Topiramate is also being studied with a mixture of [[phentermine]] to form a drug called [[Qsymia]] for the treatment of [[obesity]].
On May 21, 2010, Ortho-McNeil pled guilty and was fined $6.14 million by the FDA for promoting Topamax to treat psychiatric disorders without applying for any Federal government approval. Also, there were no data from any well-controlled clinical trial to demonstrate that Topamax was safe and/or effective to treat any psychiatric conditions at all.<ref>{{cite web|date=2010-05-21|accessdate=2010-05-25|title=Ortho-McNeil Pharmaceutical, LLC Pleads Guilty to Illegal Promotion of Topamax|work=FDA website|url=http://www.fda.gov/ICECI/CriminalInvestigations/ucm213163}}</ref><ref name="dailymed.nlm.nih.gov">{{Cite web  | last =  | first =  | title = TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | url = http//dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=32b48ea0-a215-43b8-83b4-a5435a686d68 | publisher =  | date =  | accessdate = 6 February 2014 }}</ref>


<ref name="dailymed.nlm.nih.gov">{{Cite web  | last =  | first =  | title = TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=32b48ea0-a215-43b8-83b4-a5435a686d68 | publisher =  | date =  | accessdate = 6 February 2014 }}</ref>
==References==
==References==


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{{Antimigraine preparations}}
{{Antimigraine preparations}}


[[Category:Antimigraine drugs]]
[[Category:Drugs]]
[[Category:Drugs]]

Latest revision as of 01:51, 9 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.

Indications and Usage

Topiramate tablets USP are an antiepileptic (AED) agent indicated for:

Monotherapy epilepsy: Initial monotherapy in patients ≥10 years of age with partial onset or primary generalized tonic-clonic seizures.

Adjunctive therapy epilepsy: Adjunctive therapy for adults and pediatric patients (2 to 16 years of age) with partial onset seizures or primary generalized tonic-clonic seizures, and in patients ≥2 years of age with seizures associated with Lennox-Gastaut syndrome (LGS) .

  • Topiramate is most frequently prescribed for, the prevention of migraines. This drug is also widely used to treat migraines due to the effect it has on the blood vessels in the brain. It is used as a preventative for atypical migraine sufferers. It widens the blood vessels in the brain which become restricted by increased serotonin levels. It has been found to be increasingly effective for migraine sufferers with limited side effects.[1]
  • Bipolar disorder,[2] and indicate that it may have mood stabilizing properties.[3] In 2006, a Cochrane review concluded that there is insufficient evidence on which to base any recommendations regarding the use of topiramate in any phase of bipolar illness.[4] Another meta-analysis published in the Lancet demonstrated that topiramate was of no significant benefit in the treatment of bipolar mania.[5]
  • Sometimes use topiramate to augment psychotropics, or to counteract the weight gain associated with numerous antidepressants.
  • A more recent Cochrane review, published in 2010, suggested a benefit of topiramate in the treatment of symptoms of borderline personality disorder, however the authors note that this was based only on one randomized controlled trial and requires replication. Also the Authors noted that the long-term effects have not been studied.[6][7][8]

This drug has been investigated for use in:

  • A pilot study suggested that topiramate is effective against infantile spasms.[17]

Off-label and investigational uses

  • Topiramate is also being studied with a mixture of phentermine to form a drug called Qsymia for the treatment of obesity.

On May 21, 2010, Ortho-McNeil pled guilty and was fined $6.14 million by the FDA for promoting Topamax to treat psychiatric disorders without applying for any Federal government approval. Also, there were no data from any well-controlled clinical trial to demonstrate that Topamax was safe and/or effective to treat any psychiatric conditions at all.[23][24]

References

  1. ↑ Kececi, Hulusi; Atakay, Selcuk (2009). "Effects of topiramate on neurophysiological and neuropsychological tests in migraine patients". Journal of Clinical Neuroscience. 16 (12): 1588. doi:10.1016/j.jocn.2009.03.025. PMID 19793661.
  2. ↑ Arnone, D (2005). "Review of the use of Topiramate for treatment of psychiatric disorders". Annals of general psychiatry. 4 (1): 5. doi:10.1186/1744-859X-4-5. PMC 1088011. PMID 15845141.
  3. ↑ Letmaier, M; Schreinzer, D; Wolf, R; Kasper, S (2001). "Topiramate as a mood stabilizer". International clinical psychopharmacology. 16 (5): 295–8. doi:10.1097/00004850-200109000-00008. PMID 11552774.
  4. ↑ Vasudev, Kamini; MacRitchie, Karine; Geddes, John; Watson, Stuart; Young, Allan H; Young, Allan H (2006). Young, Allan H, ed. "Topiramate for acute affective episodes in bipolar disorder". Cochrane database of systematic reviews (Online) (1): CD003384. doi:10.1002/14651858.CD003384.pub2. PMID 16437453.
  5. ↑ PMID 21851976 (PMID 21851976)
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  6. ↑ Leib, Klaus; Völlm, Birgit; Rücker, Gerta; Timmer, Antje; Stoffers, Jutta M (2010). "Pharmacotherapy for borderline personality disorder: Cochrane systematic review of randomised trials". British Journal of Psychiatry. 196 (1): 4–12. doi:10.1192/bjp.bp.108.062984. PMID 20044651.
  7. ↑ do Prado-Lima PA, Kristensen CH, Bacaltchuck J (April 2006). "Can childhood trauma predict response to topiramate in borderline personality disorder?". J Clin Pharm Ther. 31 (2): 193–6. doi:10.1111/j.1365-2710.2006.00716.x. PMID 16635055.
  8. ↑ Clinical trial number NCT00685178 for "Clinical Trial of Topiramate for Cocaine Addiction" at ClinicalTrials.gov
  9. ↑ Johnson, BA; Ait-Daoud, N; Bowden, CL; Diclemente, CC; Roache, JD; Lawson, K; Javors, MA; Ma, JZ (2003). "Oral topiramate for treatment of alcohol dependence: a randomised controlled trial". Lancet. 361 (9370): 1677–85. doi:10.1016/S0140-6736(03)13370-3. PMID 12767733.
  10. ↑ 10.0 10.1 Johnson, BA; Rosenthal, N; Capece, JA; Wiegand, F; Mao, L; Beyers, K; McKay, A; Ait-Daoud, N; Anton, RF (2007). "Topiramate for treating alcohol dependence: a randomized controlled trial". JAMA: the Journal of the American Medical Association. 298 (14): 1641–51. doi:10.1001/jama.298.14.1641. PMID 17925516.
  11. ↑ "Medication can help recovering meth addicts stay sober, study finds". Retrieved 2012-06-13.
  12. ↑ Van Ameringen, M; Mancini, C; Pipe, B; Campbell, M; Oakman, J (2002). "Topiramate treatment for SSRI-induced weight gain in anxiety disorders". The Journal of clinical psychiatry. 63 (11): 981–4. doi:10.4088/JCP.v63n1104. PMID 12444810.
  13. ↑ Wilding, J; Van Gaal, L; Rissanen, A; Vercruysse, F; Fitchet, M; Obes-002 Study, Group (2004). "A randomized double-blind placebo-controlled study of the long-term efficacy and safety of topiramate in the treatment of obese subjects". International journal of obesity and related metabolic disorders : journal of the International Association for the Study of Obesity. 28 (11): 1399–410. doi:10.1038/sj.ijo.0802783. PMID 15486569.
  14. ↑ Shapira, NA; Goldsmith, TD; McElroy, SL (2000). "Treatment of binge-eating disorder with topiramate: a clinical case series". The Journal of clinical psychiatry. 61 (5): 368–72. doi:10.4088/JCP.v61n0508. PMID 10847312.
  15. ↑ McElroy, SL; Arnold, LM; Shapira, NA; Keck Jr, PE; Rosenthal, NR; Karim, MR; Kamin, M; Hudson, JI (2003). "Topiramate in the treatment of binge eating disorder associated with obesity: a randomized, placebo-controlled trial". The American Journal of Psychiatry. 160 (2): 255–61. doi:10.1176/appi.ajp.160.2.255. PMID 12562571.
  16. ↑ Berlant, J; Van Kammen, DP (2002). "Open-label topiramate as primary or adjunctive therapy in chronic civilian posttraumatic stress disorder: a preliminary report". The Journal of clinical psychiatry. 63 (1): 15–20. doi:10.4088/JCP.v63n0104. PMID 11838620.
  17. ↑ Glauser, TA; Clark, PO; Strawsburg, R (1998). "A pilot study of topiramate in the treatment of infantile spasms". Epilepsia. 39 (12): 1324–8. doi:10.1111/j.1528-1157.1998.tb01331.x. PMID 9860068.
  18. ↑ Follett, PL; Deng, W; Dai, W; Talos, DM; Massillon, LJ; Rosenberg, PA; Volpe, JJ; Jensen, FE (2004). "Glutamate receptor-mediated oligodendrocyte toxicity in periventricular leukomalacia: a protective role for topiramate". Journal of Neuroscience. 24 (18): 4412–20. doi:10.1523/JNEUROSCI.0477-04.2004. PMID 15128855.
  19. ↑ Hoopes, SP; Reimherr, FW; Hedges, DW; Rosenthal, NR; Kamin, M; Karim, R; Capece, JA; Karvois, D (2003). "Treatment of bulimia nervosa with topiramate in a randomized, double-blind, placebo-controlled trial, part 1: improvement in binge and purge measures". The Journal of clinical psychiatry. 64 (11): 1335–41. doi:10.4088/JCP.v64n1109. PMID 14658948.
  20. ↑ Khazaal, Y; Cornuz, J; Bilancioni, R; Zullino, DF (2006). "Topiramate for smoking cessation". Psychiatry and clinical neurosciences. 60 (3): 384–8. doi:10.1111/j.1440-1819.2006.01518.x. PMID 16732758.
  21. ↑ Celebisoy, N; Gökçay, F; Sirin, H; Akyürekli, O (2007). "Treatment of idiopathic intracranial hypertension: topiramate vs acetazolamide, an open-label study". Acta neurologica Scandinavica. 116 (5): 322–7. doi:10.1111/j.1600-0404.2007.00905.x. PMID 17922725.
  22. ↑ Láinez, MJ; Pascual, J; Pascual, AM; Santonja, JM; Ponz, A; Salvador, A (2003). "Topiramate in the prophylactic treatment of cluster headache". Headache. 43 (7): 784–9. doi:10.1046/j.1526-4610.2003.03137.x. PMID 12890134.
  23. ↑ "Ortho-McNeil Pharmaceutical, LLC Pleads Guilty to Illegal Promotion of Topamax". FDA website. 2010-05-21. Retrieved 2010-05-25.
  24. ↑ [http//dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=32b48ea0-a215-43b8-83b4-a5435a686d68 "TOPIRAMATE (TOPIRAMATE ) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]"] Check |url= value (help). Retrieved 6 February 2014.

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