Topamax (Topiramate) - Summary

TOPAMAX SUMMARY

TOPAMAX^®(topiramate)
Tablets
TOPAMAX^®(topiramate capsules)
Sprinkle Capsules

Topiramate is a sulfamate-substituted monosaccharide that is intended for use as an antiepileptic drug. TOPAMAX® (topiramate) Tablets are available as 25 mg, 50 mg, 100 mg, and 200 mg round tablets for oral administration. TOPAMAX® (topiramate capsules) Sprinkle Capsules are available as 15 mg and 25 mg sprinkle capsules for oral administration as whole capsules or opened and sprinkled onto soft food.

TOPAMAX® (topiramate) Tablets and TOPAMAX® (topiramate capsules) Sprinkle Capsules are indicated as adjunctive therapy for adults and pediatric patients ages 2 - 16 years with partial onset seizures, or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome.

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NEWS HIGHLIGHTS

Media Articles Related to Topamax (Topiramate)

Topamax May Raise Risk of Birth Defects
Source: MedicineNet topiramate Specialty [2008.07.22]
Title: Topamax May Raise Risk of Birth Defects
Category: Health News
Created: 7/22/2008
Last Editorial Review: 7/22/2008

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Published Studies Related to Topamax (Topiramate)

A Randomized, Double-Blind, Placebo-Controlled Study of Topiramate in the Treatment of Tourette Syndrome. [2009.09.01]
OBJECTIVE: To investigate the effects of topiramate on Tourette syndrome. BACKGROUND: Dopamine receptor blocking drugs have been traditionally used to control tics in patients with TS, but these neuroleptics are associated with potentially limiting side effects... CONCLUSION: This double-blind, placebo-controlled trial provides evidence that topiramate may have utility in the treatment of moderately severe TS.

Topiramate treatment of chronic migraine: a randomized, placebo-controlled trial of quality of life and other efficacy measures. [2009.09]
OBJECTIVE: To define yet more clearly the utility of topiramate in the treatment of chronic migraine, we evaluated prespecified secondary endpoints from a recent randomized, double-blind, placebo-controlled, multicenter clinical trial. BACKGROUND: We previously reported that topiramate 100 mg per day produced a statistically significant reduction in mean monthly migraine/migrainous and migraine headache days compared with placebo treatment and that it was safe and generally well tolerated... CONCLUSIONS: In addition to significantly reducing mean monthly migraine/migrainous and migraine headache days, treatment of chronic migraine with topiramate was effective with regard to several traditionally important and clinically relevant secondary outcomes in migraine prevention trials. Treatment with topiramate was well tolerated and not associated with serious adverse events.

A multicenter, outpatient, open-label study to evaluate the dosing, effectiveness, and safety of topiramate as monotherapy in the treatment of epilepsy in clinical practice. [2009.08]
This 24-week, multicenter, open-label trial was designed to evaluate the dosing, effectiveness, and safety of topiramate monotherapy for epilepsy and to identify patient and clinical characteristics predictive of optimally effective stabilized monotherapy doses... Most treatment-emergent adverse events (TEAEs) were mild to moderate; those occurring with cumulative incidence rates >10% in either seizure frequency group were paresthesia, fatigue, anorexia, dizziness, somnolence, headache, and hypoesthesia; 18.2% of patients discontinued topiramate because of a TEAE, 5.1% reported serious TEAEs, and no deaths were reported during the study.

A randomized, double-blind, placebo-controlled trial to assess the efficacy of topiramate in the treatment of post-traumatic stress disorder. [2009.05.29]
BACKGROUND: Topiramate might be effective in the treatment of posttraumatic stress disorder (PTSD) because of its antikindling effect and its action in both inhibitory and excitatory neurotransmitters. Open-label studies and few controlled trials have suggested that this anticonvulsant may have therapeutic potential in PTSD...

Topiramate versus amitriptyline in migraine prevention: a 26-week, multicenter, randomized, double-blind, double-dummy, parallel-group noninferiority trial in adult migraineurs. [2009.03]
OBJECTIVE: The primary objective of this study was to compare the efficacy and tolerability of topiramate and amitriptyline in the prophylaxis of episodic migraine headache... CONCLUSIONS: In this noninferiority study, topiramate was at least as effective as amitriptyline in terms of reducing the rate of mean monthly migraine episodes and all prespecified secondary efficacy end points. Topiramate was associated with improvement in some quality-of-life indicators compared with amitriptyline and was associated with weight loss and improved weight satisfaction.

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Clinical Trials Related to Topamax (Topiramate)

Topiramate in the Treatment of Post Traumatic Stress Disorder (PTSD) [Completed]

Fed Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's topiramate sprinkle 25 mg capsules to Ortho-McNeil's Topamax® Sprinkle 25 mg capsules following a single, oral 25 mg (1 x 25 mg) dose administered under fed conditions.

Fasting Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's topiramate sprinkle 25 mg capsule to Ortho-McNeil's Topamax® Sprinkle 25 mg capsule following a single, oral 25 mg (1 x 25 mg) dose administered under fasting conditions.

Applesauce Study of Topiramate Sprinkle Capsules 25 mg and Topamax® Sprinkle Capsules 25 mg [Completed]
The objective of this study was to investigate the bioequivalence of Mylan's topiramate sprinkle 25 mg capsule to Ortho-McNeil's Topamax® Sprinkle 25 mg capsule following a single, oral 25 mg (1 x 25 mg) dose sprinkled on one teaspoon of applesauce under fasting conditions.

Safety and Efficacy of Topamax Versus Carbamazepine in Benign Rolandic Epilepsy [Completed]

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PATIENT REVIEWS / RATINGS / COMMENTS

Topamax review by 43 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Migraine prevention
Dosage & duration:		Five 25 mg tablets Twice a Day taken daily for the period of 3 Years
Other conditions:		Allergies
Other drugs taken:		Benadryl, Aleve. birth control pills
		Reported Results
Benefits:		Topamax helped decrease the frequency and intensity of my migraines.
Side effects:		Treatment side effects include paresthesia of my hands and mild drowsiness.
Comments:		Topamax was taken in order to prevent migraines. I also monitored my diet to avoid migraine triggers such as caffeine, aged cheeses, preserved meats, bananas, avocados, beans, dairy products, beer, wine, etc. In addition, I took birth control pills to control hormonal fluctuations. This helped prevent menstrual migraines.

Topamax review by 45 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Moderate Side Effects
		Treatment Info
Condition / reason:		bipolar II
Dosage & duration:		150mg taken once a day for the period of 2 years
Other conditions:		alcoholism
Other drugs taken:		celexa
		Reported Results
Benefits:		treated hypomanic systems, reduced impulsivity; reduced cravings for alcohol; reduced irratibility; loss of weight (15 lbs); more stable moods;
Side effects:		cognitive impairments; difficulty remembering names; memory problems; loss of weight
Comments:		was identified with Bipolar II two years ago presenting with mixed states. Hospitalized one week for high anxiety and depression. Relapsed into alcoholism which exacerbated symptoms. Doctor diagnosed BPII and prescribed Topomax to help diminish alcohol cravings in addition to BP symptoms. Initially became depressed and lethargic. These feelings subsided after three weeks. Weight loss was dramatic and quick. Cravings dimished, felt more balanced, less irritable and impulsive.

Topamax review by 50 year old female patient
		Rating
Overall rating:
Effectiveness:		Considerably Effective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		severe headaches
Dosage & duration:		25mg taken 4 times per day for the period of 1 month
Other conditions:		anxiety and depression
Other drugs taken:		propranalol and citalopram
		Reported Results
Benefits:		they helped to reduce headaches that I had been sufferein over a period of over 2 years
Side effects:		I noticed, after only a couple of weeks that my anxiety and depression had to an almost unbearable level, I looked at the tablets side effects and realised that they must be the contributing factor as my condition had remained stable for a few years, before i started taking them. the side effects still remain, months after stopping the medication.
Comments:		I took 1 x 25mg per day which built up to 4 x 25mg per day over 4 weeks