Vigabatrin

VIGADRONE is indicated for the treatment of: Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments; VIGADRONE is not indicated as a first line agent ( 1.1 ) Infantile Spasms – monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss ( 1.2 ) 1.1 Refractory Complex Partial Seizures (CPS) VIGADRONE is indicated as adjunctive therapy for adults and pediatric patients 2 years of age and older with refractory complex partial seizures who have inadequately responded to several alternative treatments and for whom the potential b …

• Refractory Complex Partial Seizures
• Adults (17 years of age and older): Initiate at 1,000 mg/day (500 mg twice daily); increase total daily dose weekly in 500 mg/day increments, to the recommended dose of 3,000 mg/day (1,500 mg twice daily) Pediatric (2 to 16 years of age): The recommended dosage is based on body weight and administered as two divided doses The dosage may be increased in weekly intervals, depending on response Dose patients weighing more than 60 kg according to adult recommendations Infantile Spasms Initiate at a daily dose of 50 mg/kg (25 mg/kg twice daily); increase total daily dose every 3 days, in increments of 25 mg/kg/day to 50 mg/kg/day, up to a maximum daily dose of 150 mg/kg (75 mg/kg twice daily) Renal Impairment : Dose adjustment recommended Important Dosing and Administration Instructions Dosing Use the lowest dosage and shortest exposure to VIGADRONE consistent with clinical objectives [see Warnings and Precautions ]
• The VIGADRONE dosing regimen depends on the indication, age group, weight, and dosage form (tablets or powder for oral solution) [see Dosage and Administration ]
• Patients with impaired renal function require dose adjustment [see Dosage and Administration ]
• Monitoring of VIGADRONE plasma concentrations to optimize therapy is not helpful
• Administration VIGADRONE tablets are given orally with or without food. …

VIGADRONE tablets, 500 mg for oral use are white to off-white, oval, film-coated, biconvex tablets, debossed with "ZNV" on one side and scored on the other side. Tablets: 500 mg ( 3 )

• The safety and effectiveness of vigabatrin as adjunctive treatment of refractory complex partial seizures
• In pediatric patients 2 to 16 years of age have been established and is supported by three double-blind, placebo-controlled studies in patients 3 to 16 years of age, adequate and well-controlled studies in adult patients, pharmacokinetic data from patients 2 years of age and older, and additional safety information in patients 2 years of age [ s ee Clinical Pharmacology , Clinical Studies ]. …

Clinical studies of vigabatrin did not include sufficient numbers of patients aged 65 and over to determine whether they responded differently from younger patients. Vigabatrin is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. …

• Advise patients and caregivers to read the FDA-approved patient labeling (Medication Guide)
• Permanent Vision Loss Inform patients and caregivers of the risk of permanent vision loss, particularly loss of peripheral vision, from VIGADRONE, and the need for monitoring vision [see Warnings and Precautions ]
• Monitoring of vision, including assessment of visual fields and visual acuity, is recommended at baseline (no later than 4 weeks after starting VIGADRONE), at least every 3 months while on therapy, and about 3 to 6 months after discontinuation of therapy. …

• None
• None

Decreased phenytoin plasma levels: dosage adjustment may be needed ( 7.1 ) 7.1 Antiepileptic Drugs Phenytoin Although phenytoin dose adjustments are not routinely required, dose adjustment of phenytoin should be considered if clinically indicated, since VIGADRONE may cause a moderate reduction in total phenytoin plasma levels [see Clinical Pharmacology (12.3) ]. Clonazepam VIGADRONE may moderately increase the C max of clonazepam resulting in an increase of clonazepam-associated adverse reactions [see Clinical Pharmacology (12.3) ]. Other AEDs There are no clinically significant pharmacokinetic interactions between vigabatrin and either phenobarbital or sodium valproate. …

Abnormal MRI signal changes and intramyelinic edema have been reported in some infants with Infantile Spasms receiving vigabatrin ( 5.3 , 5.4 ) Suicidal behavior and ideation: Antiepileptic drugs, including VIGADRONE, increase the risk of suicidal thoughts and behavior ( 5.5 ) Withdrawal of AEDs: Taper dose to avoid withdrawal seizures ( 5.6 ) Anemia: Monitor for symptoms of anemia ( 5.7 ) Somnolence and fatigue: Advise patients not to drive or operate machinery until they have gained sufficient experience on VIGADRONE ( 5.8 ) 5.1 Permanent Vision Loss VIGADRONE can cause permanent vision loss. …

The following serious and otherwise important adverse reactions are described elsewhere in labeling: Permanent Vision Loss [see BOXED WARNING , Warnings and Precautions (5.1) ] Magnetic Resonance Imaging (MRI) Abnormalities in Infants [see Warnings and Precautions (5.3) ] Neurotoxicity [see Warnings and Precautions (5.4) ] Suicidal Behavior and Ideation [see Warnings and Precautions (5.5) ] Withdrawal of Antiepileptic Drugs (AEDs) [see Warnings and Precautions (5.6) ] Anemia [see Warnings and Precautions (5.7) ] Somnolence and Fatigue [see Warnings and Precautions (5.8) ] Peripheral Neuropathy [see Warnings and Precautions (5.9) ] Weight Gain [see Warnings and Precautions (5.10) ] Edema [see …

8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to AEDs, including VIGADRONE, during pregnancy. Encourage women who are taking VIGADRONE during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll-free number 1-888-233-2334 or visiting the website, http://www.aedpregnancyregistry.org/. …

10.1 Signs, Symptoms, and Laboratory Findings of Overdosage Confirmed and/or suspected vigabatrin overdoses have been reported during clinical trials and in post marketing surveillance. No vigabatrin overdoses resulted in death. When reported, the vigabatrin dose ingested ranged from 3 g to 90 g, but most were between 7.5 g and 30 g. Nearly half the cases involved multiple drug ingestions including carbamazepine, barbiturates, benzodiazepines, lamotrigine, valproic acid, acetaminophen, and/or chlorpheniramine. …

9.1 Controlled Substance Vigabatrin is not a controlled substance. 9.2 Abuse Vigabatrin did not produce adverse events or overt behaviors associated with abuse when administered to humans or animals. It is not possible to predict the extent to which a CNS active drug will be misused, diverted, and/or abused once marketed. …

Store at 20° to 25°C (68 to 77°F). [See USP Controlled Room Temperature].

تناولها عندما تتذكر، إلا إذا اقترب موعد الجرعة التالية. عندها تخطَّ الجرعة المنسية. لا تتناول جرعتين معًا أبدًا للتعويض. راجع النشرة، فبعض الأدوية مختلفة.