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(generic name: Topiramate)
Brain Dev. 2005 Apr;27(3):228-32.
Clinical experience with Topiramate to counteract neuroleptic induced weight gain in 10 individuals with autistic spectrum disorders.
Canitano R.
Division of Child Neuropsychiatry, General University Hospital of Siena, Viale Bracci 1, 53100 Siena, Italy.

Children and adolescents with autistic spectrum disorders are treated with neuroleptics to limit behavioral disturbances such as aggression, hyperactivity and self-injury. They may experience substantial weight gain when undergoing treatment with atypical antipsychotics actually employed. Topiramate (TPM) is an antiepileptic medication that is being progressively demonstrating a wider spectrum of action, mainly as an agent for weight control and as a mood stabilizer. It was administered to a group of children and adolescents with autistic spectrum disorders with the aim of reversing weight gain. This is an open study over an observation period of 18 months of 10 children and adolescents, eight males and two females, mean age 13 years, SD +/-3.6, range 8-19 years with a diagnosis of autistic disorder or pervasive developmental disorder not otherwise specified according to DSM-IV. Starting dosage of TPM was 0.5mg/kg followed by titration of 0.5mg/kg on a weekly basis, up to 1-3mg/kg/day as the maintenance dosage. Eight subjects were undergoing long-term treatment with risperidone, one with pimozide and one was temporarily not on antipsychotics. Six patients took TPM on a regular basis and four dropped out. Variable degrees of weight reduction were observed in four patients, two subjects showed weight increase. Behavioral adverse effects were observed in three patients causing rapid withdrawal of the medication. TPM should be used with caution in autistic spectrum disorders because this population has a high risk of behavioral disruption.
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J Pharm Biomed Anal. 2005 Mar 9;37(3):529-34. Epub 2004 Dec 19.
Determination of topiramate and its degradation product in liquid oral solutions by high performance liquid chromatography with a chemiluminescent nitrogen detector.
Styslo-Zalasik M, Li W.
Global Analytical Development, Johnson & Johnson Pharmaceutical Research & Development, LLC, 1000 Route 202, Raritan, NJ 08869, USA.

Topiramate is a sulfamate-substituted monosaccharide that is prescribed for the treatment of epilepsy. It has been a challenge to develop analytical methods for topiramate formulations because the compounds of interest do not have chromophores that are active above 190nm and because of interference from excipients. This paper describes a simple, specific, precise, accurate, and sensitive method using a chemiluminescent nitrogen detector. The method has a validated linearity range of 32-4800ng of topiramate and excellent precision (system repeatability). The limit of quantitation was determined to be 0.1% for the degradation product w/w versus topiramate. The method has been successfully used for probe stability studies in support of early phase formulation development.

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Drug information

GENERIC NAME: topiramate

DRUG CLASS AND MECHANISM: Topiramate is an oral drug that is used to prevent the seizures of epilepsy. (It is an anti-epileptic or anti-seizure drug). It is used primarily among patients who are not controlled by other anti-epileptic drugs. About 1 in 4 Americans diagnosed with epilepsy has seizures that resist treatment with other anti-epileptic drugs. Topiramate also prevents migraine headaches.

Seizures are due to the abnormal activity ("firing") of nerves in the brain, and the abnormal activity spreads to smaller or larger portions of the brain. Although topiramate's exact mechanism of action is unknown, scientific studies suggest that it may alter neurotransmitters within the brain. Neurotransmitters are chemicals that nerves manufacture and use to communicate with other nearby nerves. By altering the production or action of the neurotransmitters, topiramate may suppress the abnormal activity of the nerves in the brain that cause the seizures or may prevent the abnormal activity from spreading to other nerves. Other studies suggest that topiramate may suppress the nerves directly (i.e., not by altering neurotransmitters) and make them less likely to fire. The FDA approved topiramate as a tablet in 1997. The Sprinkle Capsules were approved in October, 1998.

PREPARATIONS: Tablets (25, 100 and 200 mg) and Sprinkle Capsules (15 and 25 mg)

STORAGE: Topiramate tablets should be stored at room temperature, 59-86°F (15-30 ° C). Sprinkle capsules should be stored at or below 77 ° F (25 °C).

PRESCRIBED FOR: Seizures may be classified as either partial if they involve only a small portion of the brain or generalized if they involve more of the brain. Topiramate is used in combination with other anti-seizure drugs among adults and children aged 2-16 years with partial seizures or generalized tonic-clonic seizures (in which there is prolonged contraction of the muscles of the body that causes rigidity as well as jerking motions). It also is used in patients two years of age and older with seizures associated with the Lennox-Gastaut Syndrome, a severe form of epilepsy which accounts for up to 10 percent of all cases of childhood epilepsy. Children with Lennox-Gastaut Syndrome experience delays in their development and up to dozens of different, mixed types of seizures a day. The most common types of seizures in this syndrome are tonic (stiffening of the body, with the eyes rolling upwards, dilation of the pupils and shallow, irregular breathing), atonic (brief loss of muscle tone and consciousness, causing abrupt falls), myoclonic (sudden muscle jerks), and absence (staring spells).

Topiramate also is approved for the prevention of migraine headaches in adults.

DOSING: Most commonly, topiramate is started in low doses, 25 or 50 mg per day, and then increased slowly, under a doctor's orders, by 25 to 50 mg per week until an effective daily dose is reached. This slow approach to treatment reduces side effects.

In children, the starting dose is up to 25 mg (1 to 3 mg/kg/day), taken nightly for the first week. The dose is then increased at 1 or 2 week intervals by 1 to 3 mg/kg/day.

Although the usual adult dose is 200 mg twice daily, some adult patients may begin to see a clinical response at 200 mg per day. Some patients need doses higher than 200 mg daily. In children, the usual dose is 2.5 to 4.5 mg/kg twice daily.

Patients should maintain an adequate fluid intake in order to minimize the risk of kidney stones.

DRUG INTERACTIONS: The following medications, when taken with topiramate, increase the risk of kidney stones: acetazolamide (Diamox), dorzolamide (Trusopt), methazolamide (Neptazane), dichlorphenamide (Daranide).

Carbamazepine (Tegretol) and phenytoin (Dilantin) markedly decrease the amount of topiramate in the body by increasing its elimination from the body. As a result, topiramate may lose effectiveness unless doses are increased.

Topiramate may decrease the amount of estrogen in the body in women taking oral contraceptives, possibly increasing the chances of unwanted pregnancy.

Patients with seizure disorders taking anticonvulsant medications, including topiramate, may develop nerve toxicity from a chemical, 4'-O-methylpyridoxine, found as a contaminant in some ginkgo preparations.

PREGNANCY: Topiramate has been associated with abnormalities of the fetus (teratogenicity) in experimental animal studies. No data on fetal effects of topiramate exists in humans.

NURSING MOTHERS: Topiramate is excreted in the milk of lactating rats. It is not known whether topiramate is excreted in human milk or if it has important effects on nursing infants.

SIDE EFFECTS: In adults, the most common side effects of topiramate are tiredness, dizziness, coordination problems, speech problems, changes in vision or double vision, difficulty with memory, and sensory distortion.

In children, the most common side effects are drowsiness, tiredness, loss of appetite, nervousness, difficulty with concentration/attention, weight decrease, aggressive reaction and difficulty with memory.

Since topiramate was approved, there have been 23 cases reported (as of 8-17-01) of a sudden onset of vision and eye problems. Symptoms have typically occurred within the first month of therapy, with patients reporting an acute onset of decreased vision and/or eye pain. Eye examination revealed myopia (nearsightedness), redness, decreased depth of the anterior chamber of the eye and elevated ocular pressure, with or without dilation of the pupils. Fluid accumulation within the eye may displace the lens and iris anteriorly causing secondary angle closure glaucoma. If patients develop this syndrome, the treatment is to discontinue topiramate as rapidly as possible, according to the judgment of the treating physician.

Caution! Before starting to take this medicine, it is vital that you should consult your doctor! Do not use it on your own initiative, without medical advice.

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Substance: Topiramate
Manufacturer: Johnson & Johnson
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25 mg
60 tab
USD 43.00
50 mg
60 tab
USD 99.00
100 mg
60 tab
USD 145.00
200 mg
60 tab
USD 234.00

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