Lucius LuciViga Vigabatrin 500mg

Product Information

• Product name: LuciViga Vigabatrin 500mg
• Manufacturer / brand: Laos Lucius Pharma
• Active ingredient: Vigabatrin
• Current strength: 500mg
• SKU: LU-ITEM-127
• Site category: other cancer

Product Summary

LuciViga Vigabatrin 500mg is an AISTIKA-listed product supplied by Laos Lucius Pharma. This page summarizes the product identity, strength, SKU, site category, and public medical reference information. Product name, manufacturer, packaging, and strength follow this AISTIKA product page.

Active Ingredient and Reference Data

Vigabatrin is the active ingredient used for this product page. Public prescribing information for Vigabatrin was used for the medical reference sections. Medical details are provided for reference and must be interpreted by a qualified healthcare professional.

Mechanism of Action

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.

Reference Indications

Vigabatrin 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; Vigabatrin is not indicated as a first line agent Infantile Spasms – monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss 1.1 Refractory Complex Partial Seizures (CPS) Vigabatrin 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 benefits outweigh the risk of vision loss . Vigabatrin is not indicated as a first line agent for complex partial seizures.

Reference Dosage and Administration

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

With this 500mg product, that corresponds to 1 x 500mg tablet when that reference dose is clinically appropriate.

This reference dosage is not an individualized prescription. Dose changes, treatment interruptions, or discontinuation must be directed by a physician.

Important Safety Information

WARNING: PERMANENT VISION LOSS Vigabatrin can cause permanent bilateral concentric visual field constriction, including tunnel vision that can result in disability. The onset of vision loss from Vigabatrin is unpredictable and can occur within weeks of starting treatment or sooner, or at any time after starting treatment, even after months or years. Symptoms of vision loss from Vigabatrin 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. 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.

Common Adverse Reactions and Monitoring

Adjunctive clinical studies of refractory CPS in adults. The median vigabatrin dose was 49.4 mg/kg (range of 8 to 105.9 mg/kg). Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Drug Interactions and Special Populations

Decreased phenytoin plasma levels: dosage adjustment may be needed 7.1 Antiepileptic Drugs Phenytoin Although phenytoin dose adjustments are not routinely required, dose adjustment of phenytoin should be considered if clinically indicated, since Vigabatrin may cause a moderate reduction in total phenytoin plasma levels . Other AEDs There are no clinically significant pharmacokinetic interactions between vigabatrin and either phenobarbital or sodium valproate. Based on population pharmacokinetics, carbamazepine, clorazepate, primidone, and sodium valproate appear to have no effect on plasma concentrations of vigabatrin . The suppression of ALT and AST activity by Vigabatrin may preclude the use of these markers, especially ALT, to detect early hepatic injury.

Storage and Purchase Notes

Store according to the package or pharmacist instructions and keep out of reach of children. Before ordering, confirm product name, strength, quantity, price, shipping details, and payment method. After receipt, check packaging, batch number, expiration date, and storage conditions.

Sources

Sources: VIGADRONE public prescribing information; openFDA/DailyMed public label data. These sources are used for public medical reference. Product information follows this AISTIKA product page.

DisclaimerThis page is for product information and public-label reference only. It does not provide diagnosis, prescription, or individualized medical advice. Consult a physician for treatment decisions.