罕见病药物氨己烯酸片的说明书

On August 21, 2009, the US FDA approved monotherapy for pediatric patients 1 month to 2 years old, whose potential benefits for infantile spasms outweigh the potential risk of vision loss, and as an adjunctive (additional) treatment (CPS) for adult patients with refractory complex partial epilepsy. CPS, also known as temporal lobe seizures and psychomotor seizures, manifests as partial seizures accompanied by varying degrees of disturbance of consciousness. Vigabatrin tablets work by irreversibly inhibiting GABA aminotransferase (GABA-T) and increasing GABA concentration in the brain.

Instructions for the rare disease drug Vigabatrin Tablets

Generic name: Vigabatrin tablets

Product name: Sabril

Full names: Vigabatrin, Vigabatrin, Sabril, Vigabatrin, Sabrilex, Vigadrone

Indications: Treatment of epilepsy in which other anti-epileptic drugs are ineffective, especially partial seizures. and the treatment of infantile spasms (West syndrome, West syndrome).

Usage and dosage: The starting dose for adults is 2g per day, divided into 2 times or taken as a single dose. If necessary, increase by 0.5 to 1g, with a maximum dose of 4g per day. Children should start taking 40 mg/kg orally per day, 2 times in divided doses, and gradually increase to 80 to 100 mg/kg per day if necessary. Adult doses can be given to those weighing more than 50kg.

Adverse reactions: Common ones include fatigue, drowsiness, headache, dizziness, confusion and depression. Occasional aggressive behavior and psychosis (more common in patients with a history of psychosis and behavioral problems), memory loss, diplopia, weight gain, gastrointestinal disturbances, edema, and hair loss. Nystagmus, nervousness, agitation, ataxia, paresthesia, and tremor may also occur. Some patients develop irreversible visual field defects, retinal lesions such as peripheral retinal atrophy, and more rarely, optic neuritis and atrophy.

Drug interactions: There are complex interactions between anti-epileptic drugs, and the toxicity may increase, but the anti-epileptic effect does not increase accordingly. This type of interaction changes a lot and is unpredictable. During combined use, blood drug concentrations must be closely monitored to prevent poisoning. Patients should inform their doctor in advance if they use other drugs while taking this product.

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