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vigabatrin
Overview
What is SABRIL?
SABRIL (vigabatrin) is an oral antiepileptic drug and is available as white film-coated 500 mg tablets and as a white to off-white granular powder for oral solution in packets of 500 mg.
The chemical name of vigabatrin, a racemate consisting of two enantiomers, is (±) 4-amino-5-hexenoic acid. The molecular formula is CHNO and the molecular weight is 129.16. It has the following structural formula:
Vigabatrin is a white to off-white powder which is freely soluble in water, slightly soluble in methyl alcohol, very slightly soluble in ethyl alcohol and chloroform, and insoluble in toluene and hexane. The pH of a 1% aqueous solution is about 6.9. The n-octanol/water partition coefficient of vigabatrin is about 0.011 (log 1.96) at physiologic pH. Vigabatrin melts with decomposition in a 3-degree range within the temperature interval of 171ºC to 176ºC. The dissociation constants (pK) of vigabatrin are 4 and 9.7 at room temperature (25ºC).
Each SABRIL tablet contains 500 mg of vigabatrin. The inactive ingredients are hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycols, povidone, sodium starch glycolate, and titanium dioxide.
SABRIL powder for oral solution is available as white to off-white granular powder for oral administration. Each packet contains 500 mg of vigabatrin. The inactive ingredient is povidone.
What does SABRIL look like?
What are the available doses of SABRIL?
Tablet: 500 mg: white, oval, film-coated, biconvex, scored on one side, and debossed with OV 111 on the other.
Powder for Oral Solution: 500 mg packets of a white to off-white granular powder.
What should I talk to my health care provider before I take SABRIL?
How should I use SABRIL?
SABRIL is indicated as adjunctive therapy for adults and pediatric patients 10 years of age and older with refractory complex partial seizures who have inadequately responded to several alternative treatments and for whom the potential benefits outweigh the risk of vision loss . SABRIL is not indicated as a first line agent for complex partial seizures.
Dosing
Use the lowest dosage and shortest exposure to SABRIL consistent with clinical objectives
The SABRIL dosing regimen depends on the indication, age group, weight, and dosage form (tablets or powder for oral solution) Patients with impaired renal function require dose adjustment
SABRIL tablets and powder for oral solution are bioequivalent. Either tablet or powder can be used for CPS. Powder for oral solution should be used for IS; tablets should not be used for IS because of difficulty in the administration of tablets to infants and young children.
Monitoring of SABRIL plasma concentrations to optimize therapy is not helpful.
Administration
SABRIL is given orally with or without food.
SABRIL powder for oral solution should be mixed with water prior to administration
If a decision is made to discontinue SABRIL, the dose should be gradually reduced
What interacts with SABRIL?
Sorry No Records found
What are the warnings of SABRIL?
Sorry No Records found
What are the precautions of SABRIL?
Sorry No Records found
What are the side effects of SABRIL?
Sorry No records found
What should I look out for while using SABRIL?
None.
Because of the risk of permanent vision loss, SABRIL is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Vigabatrin REMS Program . Further information is available at www.vigabatrinREMS.com or 1-866-244-8175.
What might happen if I take too much SABRIL?
How should I store and handle SABRIL?
Sorry No Records found
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
The precise mechanism of vigabatrin’s anti-seizure effect is unknown, but it is believed to be the result of its action as an irreversible inhibitor of γ-aminobutyric acid transaminase (GABA-T), the enzyme responsible for the metabolism of the inhibitory neurotransmitter GABA. This action results in increased levels of GABA in the central nervous system.
No direct correlation between plasma concentration and efficacy has been established. The duration of drug effect is presumed to be dependent on the rate of enzyme re-synthesis rather than on the rate of elimination of the drug from the systemic circulation.
Non-Clinical Toxicology
None.Because of the risk of permanent vision loss, SABRIL is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the Vigabatrin REMS Program . Further information is available at www.vigabatrinREMS.com or 1-866-244-8175.
See Table 1 for clinically significant drug interactions with naproxen.
Table 1: Clinically Significant Drug Interactions with naproxen
Drug/Laboratory Test Interactions
SABRIL can cause permanent vision loss. Because of this risk and because, when it is effective, SABRIL provides an observable symptomatic benefit; patient response and continued need for treatment should be periodically assessed.
Based upon adult studies, 30 percent or more of patients can be affected with bilateral concentric visual field constriction ranging in severity from mild to severe. Severe cases may be characterized by tunnel vision to within 10 degrees of visual fixation, which can result in disability. In some cases, SABRIL also can damage the central retina and may decrease visual acuity. Symptoms of vision loss from SABRIL are unlikely to be recognized by patients or caregivers before vision loss is severe. Vision loss of milder severity, while often unrecognized by the patient or caregiver, can still adversely affect function.
Because assessing vision may be difficult in infants and children, the frequency and extent of vision loss is poorly characterized in these patients. For this reason, the understanding of the risk is primarily based on the adult experience. The possibility that vision loss from SABRIL may be more common, more severe, or have more severe functional consequences in infants and children than in adults cannot be excluded.
The onset of vision loss from SABRIL is unpredictable, and can occur within weeks of starting treatment or sooner, or at any time after starting treatment, even after months or years.
The risk of vision loss increases with increasing dose and cumulative exposure, but there is no dose or exposure known to be free of risk of vision loss.
In patients with refractory complex partial seizures, SABRIL should be withdrawn if a substantial clinical benefit is not observed within 3 months of initiating treatment. If, in the clinical judgment of the prescriber, evidence of treatment failure becomes obvious earlier than 3 months, treatment should be discontinued at that time .
In patients with infantile spasms, SABRIL should be withdrawn if a substantial clinical benefit is not observed within 2 to 4 weeks. If, in the clinical judgment of the prescriber, evidence of treatment failure becomes obvious earlier than 2 to 4 weeks, treatment should be discontinued at that time
SABRIL should not be used in patients with, or at high risk of, other types of irreversible vision loss unless the benefits of treatment clearly outweigh the risks. The interaction of other types of irreversible vision damage with vision damage from SABRIL has not been well-characterized, but is likely adverse.
SABRIL should not be used with other drugs associated with serious adverse ophthalmic effects such as retinopathy or glaucoma unless the benefits clearly outweigh the risks.
Monitoring of Vision
Monitoring of vision by an ophthalmic professional with expertise in visual field interpretation and the ability to perform dilated indirect ophthalmoscopy of the retina is recommended Because vision testing in infants is difficult, vision loss may not be detected until it is severe. For patients receiving SABRIL, vision assessment is recommended at baseline (no later than 4 weeks after starting SABRIL), at least every 3 months while on therapy, and about 3-6 months after the discontinuation of therapy. The diagnostic approach should be individualized for the patient and clinical situation.
In adults and cooperative pediatric patients, perimetry is recommended, preferably by automated threshold visual field testing. Additional testing may also include electrophysiology (e.g., electroretinography [ERG]), retinal imaging (e.g., optical coherence tomography [OCT]), and/or other methods appropriate for the patient. In patients who cannot be tested, treatment may continue according to clinical judgment, with appropriate patient counseling. Because of variability, results from ophthalmic monitoring must be interpreted with caution, and repeat assessment is recommended if results are abnormal or uninterpretable. Repeat assessment in the first few weeks of treatment is recommended to establish if, and to what degree, reproducible results can be obtained, and to guide selection of appropriate ongoing monitoring for the patient.
The onset and progression of vision loss from SABRIL is unpredictable, and it may occur or worsen precipitously between assessments. Once detected, vision loss due to SABRIL is not reversible. It is expected that even with frequent monitoring, some SABRIL patients will develop severe vision loss. Consider drug discontinuation, balancing benefit and risk, if vision loss is documented. It is possible that vision loss can worsen despite discontinuation of SABRIL.
The following serious and otherwise important adverse reactions are described elsewhere in labeling:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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