国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
TOPIRAMATE (UNII: 0H73WJJ391) (TOPIRAMATE - UNII:0H73WJJ391)
Proficient Rx LP
TOPIRAMATE
TOPIRAMATE 25 mg
ORAL
PRESCRIPTION DRUG
Topiramate tablets are indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures. Effectiveness was demonstrated in a controlled trial in patients with epilepsy who had no more than 2 seizures in the 3 months prior to enrollment. Safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials. Topiramate tablets are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 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. Topiramate tablets are contraindicated in patients with a history of hypersensitivity to any component of this product. The abuse and dependence potential of topiramate has not been evaluated in human studies.
Topiramate tablets are available as debossed, film-coated, circular tablets in the following strengths and colors: 25 mg white (coded "S" on one side; "707" on the other) 50 mg yellow (coded "S" on one side; "710" on the other) 100 mg yellow (coded "S" on one side; "711" on the other) They are supplied as follows: 25 mg tablets Bottles of 30's with Child Resistant Cap… …………NDC 63187-077-30 Bottles of 60's with Child Resistant Cap… …………NDC 63187-077-60 50 mg tablets Bottles of 30's with Child Resistant Cap… …………NDC 63187-059-30 Bottles of 90's with Child Resistant Cap… …………NDC 63187-059-90 100 mg tablets Bottles of 30's with Child Resistant Cap… …………NDC 63187-060-30 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight container.
Abbreviated New Drug Application
TOPIRAMATE- TOPIRAMATE TABLET, FILM COATED Proficient Rx LP ---------- MEDICATION GUIDE TOPIRAMATE TABLETS Read this Medication Guide before you start taking topiramate tablets and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. If you have any questions about topiramate tablets, talk to your healthcare provider or pharmacist. What is the most important information I should know about topiramate tablets? • Topiramate tablets may cause eye problems. Serious eye problems include: o any sudden decrease in vision with or without eye pain and redness o a blockage of fluid in the eye causing increased pressure in the eye (secondary angle closure glaucoma). o These eye problems can lead to permanent loss of vision if not treated. You should call your healthcare provider right away if you have any new eye symptoms. • Topiramate tablets may cause decreased sweating and increased body temperature (fever). People, especially children, should be watched for signs of decreased sweating and fever, especially in hot temperatures. Some people may need to be hospitalized for this condition. • Like other antiepileptic drugs, topiramate tablets may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: • thoughts about suicide or dying • attempts to commit suicide • new or worse depression • new or worse anxiety • feeling agitated or restless • panic attacks • trouble sleeping (insomnia) • new or worse irritability • acting aggressive, being angry, or violent • acting on dangerous impulses • an extreme increase in activity and talking (mania) • other unusual changes in behavior or mood Do not stop topiramate tablets without first talking to a healthcare provider. • Stopping topiramate tablets suddenly can cause serious p 完全なドキュメントを読む
TOPIRAMATE- TOPIRAMATE TABLET, FILM COATED PROFICIENT RX LP ---------- TOPIRAMATE TABLETS DESCRIPTION Topiramate is a sulfamate-substituted monosaccharide. Topiramate tablets are available as 25 mg, 50 mg, and 100 mg circular tablets for oral administration. Topiramate is a white crystalline powder with a bitter taste. Topiramate USP is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3. Topiramate has the molecular formula C H NO S and a molecular weight of 339.37. Topiramate is designated chemically as 2,3:4,5-Di-_O_-isopropylidene-β-D-fructopyranose sulfamate and has the following structural formula: Topiramate tablets contain the following inactive ingredients: anhydrous lactose, microcrystalline cellulose, pregelatinized starch, sodium starch glycolate, magnesium stearate, purified water, polyvinyl alcohol, titanium dioxide, polyethylene glycol and talc. In addition, individual tablets contain: 50 mg tablets: iron oxide yellow 100 mg tablets: iron oxide yellow, and D&C Yellow # 10 Aluminum Lake CLINICAL PHARMACOLOGY MECHANISM OF ACTION: The precise mechanisms by which topiramate exerts its anticonvulsant effects are unknown; however, preclinical studies have revealed four properties that may contribute to topiramate's efficacy for epilepsy. Electrophysiological and biochemical evidence suggests that topiramate, at pharmacologically relevant concentrations, blocks voltage- dependent sodium channels, augments the activity of the neurotransmitter gamma- 12 21 8 aminobutyrate at some subtypes of the GABA-A receptor, antagonizes the AMPA/kainate subtype of the glutamate receptor, and inhibits the carbonic anhydrase enzyme, particularly isozymes II and IV. PHARMACODYNAMICS: Topiramate has anticonvulsant activity in rat and mouse maximal electroshock seizure (MES) tests. Topiramate is only weakly effecti 完全なドキュメントを読む