通用名称

topiramate

儿科标签批准日期

2021/11/5 0:00:00

特定指示/秒

Monotherapy Epilepsy: initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years and older; Adjunctive Therapy Epilepsy: adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 2 years and older; Migraine: preventive treatment of migraine in patients 12 years and older

标签更改摘要

- Approved for (1) initial monotherapy for the treatment of partial-onset or primary generalized tonic-clonic seizures in patients 2 years and older, (2) adjunctive therapy for the treatment of partial-onset seizures, primary generalized tonic-clonic seizures, and seizures associated with Lennox-Gastaut syndrome in patients 2 years of age and older, and (3) preventive treatment of migraine in patients 12 years of age and older. - Safety and effectiveness in patients below the age of 2 years have not been established for the monotherapy treatment of epilepsy, the adjunctive therapy treatment of partial-onset seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut syndrome. - Safety and effectiveness in pediatric patients below the age of 12 years have not been established for the preventive treatment of migraine. The risk for cognitive adverse reaction was greater in younger patients (6 to 11 years) than in older patients (12 to 17 years). - In general, the adverse reaction profile for topiramate in this population was similar to that of older pediatric patients, although results from the controlled study and an open-label, long-term extension study in these pediatric patients 1 to 24 months old suggested some adverse reactions/toxicities that occurred with a greater frequency and/or greater severity than had been recognized previously from studies in older pediatric patients or adults for various indications. - These very young pediatric patients appeared to experience an increased risk for infections and of respiratory disorders. The following adverse reactions were observed in at least 3% of patients on topiramate and were 3% to 7% more frequent than in patients on placebo: viral infection, bronchitis, pharyngitis, rhinitis, otitis media, upper respiratory infection, cough, and bronchospasm. A generally similar profile was observed in older pediatric patients. - Information on dosing, adverse reactions, and clinical trials. - Postmarketing study.

治疗类别

Seizures

立法类型

PREA Only

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