Vigabatrin 500mg Tablets / Powder for Oral Solution — GABA Transaminase Inhibitor for Infantile Spasms and Refractory Epilepsy
Sabril® (Vigabatrin) — GABA Transaminase Inhibitor for Infantile Spasms and Refractory Focal Epilepsy
First-Line Treatment for Infantile Spasms and Add-On Therapy for Drug-Resistant Focal Seizures
Sabril® (Vigabatrin) is an irreversible inhibitor of gamma-aminobutyric acid transaminase (GABA-T) used to treat infantile epileptic spasms syndrome (IESS) in infants aged 1 month to 2 years and as add-on therapy for refractory complex focal seizures in adults and children aged 2 years and older. Vigabatrin works by irreversibly inhibiting GABA-T — the enzyme that breaks down GABA — increasing inhibitory neurotransmitter levels in the brain and reducing seizure activity.
A.K. Pharma is a trusted medicine distributor in Delhi supplying genuine Sabril (Vigabatrin) to hospitals, neurology centres, paediatric neurology clinics, and pharmacies across India. Manufactured by Lundbeck, a global leader in neuroscience medicines, Sabril is one of the most important anti-epileptic medicines for infantile spasms and drug-resistant focal epilepsy.
What is Sabril (Vigabatrin)?
Sabril contains Vigabatrin — a structural analogue of GABA (gamma-aminobutyric acid) with an additional vinyl group that allows it to act as a mechanism-based irreversible inhibitor of GABA transaminase. GABA is the primary inhibitory neurotransmitter in the brain — insufficient GABAergic inhibition is a key driver of seizure activity in epilepsy.
By irreversibly inhibiting GABA-T, Vigabatrin prevents the breakdown of GABA in the synaptic cleft, leading to sustained elevation of GABA levels throughout the brain. This increased inhibitory neurotransmission suppresses the abnormal electrical activity responsible for seizures — particularly infantile spasms and focal seizures.
Full prescribing information is available at the FDA label for Vigabatrin.
Clinical Studies and Evidence
ICISS Trial (Infantile Spasms — Vigabatrin + Hormonal Therapy) Published in Lancet Neurology (2017), the ICISS trial demonstrated that combination therapy of hormonal treatment (ACTH or prednisolone) plus Vigabatrin resulted in significantly higher rates of spasm cessation compared to hormonal therapy alone — 72% vs 57% at 14 days — establishing combination therapy as the preferred approach for infantile spasms.
UKISS Trial (Vigabatrin vs Hormonal Therapy) Published in The Lancet (2004), the UKISS trial compared Vigabatrin with hormonal therapy (prednisolone or tetracosactide) for infantile spasms, demonstrating clinically significant spasm cessation rates with Vigabatrin — particularly in infants with tuberous sclerosis complex (TSC) where Vigabatrin showed superior efficacy.
Vigabatrin in TSC-Associated Infantile Spasms Multiple studies have demonstrated that Vigabatrin is particularly effective for infantile spasms associated with tuberous sclerosis complex (TSC) — achieving spasm cessation rates of 95%+ in TSC patients compared to 35-54% in non-TSC patients. Vigabatrin is ranked by the International League Against Epilepsy (ILAE) as one of three first-line treatment options for infantile spasms, alongside ACTH and oral corticosteroids. NCBI
2025 Rethinking Vigabatrin Study A groundbreaking study published in Pediatric Research in 2025 by Connor, Frost, Jimenez-Mateos and colleagues offers a comprehensive reevaluation of Vigabatrin, exploring its clinical risks, underlying mechanistic actions, and potential future directions that could redefine management strategies for infantile spasms. BIOENGINEER.ORG The study advocates for more precise patient selection, genetic screening, and combination approaches to optimise outcomes while managing the visual field defect risk.
2026 Vigabatrin vs ACTH Study A study published in March 2026 evaluating Vigabatrin versus ACTH as second-line therapy after prednisolone failure demonstrated that Vigabatrin showed higher efficacy in complete control of epileptic spasms compared to ACTH, though the difference did not reach statistical significance — providing useful guidance for neurologists managing treatment-resistant infantile spasms. PubMed
Available Strengths
Sabril is available in the following formulations:
The tablet and powder formulations contain the same active ingredient — Vigabatrin 500mg. The powder sachet is dissolved in water before administration, making it suitable for infants who cannot swallow tablets.
Indications — What Sabril is Used For
Infantile Epileptic Spasms Syndrome (IESS)
Refractory Complex Focal Seizures
For detailed indication information refer to Epilepsy Foundation Vigabatrin page and MedlinePlus Vigabatrin.
Key Benefits of Sabril
First-Line for TSC-Associated Infantile Spasms Vigabatrin is the treatment of choice for infantile spasms associated with tuberous sclerosis complex — achieving spasm cessation rates of up to 95% in TSC patients, significantly higher than in non-TSC infantile spasms.
Effective Combination Partner The ICISS trial demonstrates that combining Vigabatrin with hormonal therapy (ACTH or prednisolone) achieves significantly higher spasm cessation rates than hormonal therapy alone — making it a valuable combination partner in the management of infantile spasms.
Unique Mechanism of Action Vigabatrin’s irreversible GABA-T inhibition provides a sustained increase in brain GABA levels — a fundamentally different mechanism from voltage-gated channel blockers and other antiepileptic drugs, making it effective in seizures resistant to other mechanisms.
Activity in Drug-Resistant Focal Epilepsy Sabril is approved as add-on therapy for focal seizures that have not responded to other antiepileptic medicines — providing an additional treatment option for patients with drug-resistant epilepsy.
Well-Established Safety and Efficacy Data Decades of clinical experience with Vigabatrin across multiple countries provide a comprehensive understanding of its efficacy and safety profile, enabling informed treatment decisions.
How Sabril Works
GABA (gamma-aminobutyric acid) is the primary inhibitory neurotransmitter in the brain. After GABA is released into the synaptic cleft and binds to its receptors, it is broken down by the enzyme GABA transaminase (GABA-T). In epilepsy insufficient GABAergic inhibition allows abnormal neuronal firing — causing seizures.
Sabril works by:
For a detailed mechanism overview refer to the Epilepsy Foundation and International League Against Epilepsy educational resources.
Sabril in Infantile Spasms — Treatment Algorithm
Current international guidelines recommend the following approach for infantile spasms:
| Step | Treatment | Notes |
|---|---|---|
| First-line | ACTH or Prednisolone + Vigabatrin (Sabril) | Combination preferred per ICISS trial |
| TSC-associated | Vigabatrin (Sabril) monotherapy | First choice — highest response rate |
| Second-line | ACTH or Vigabatrin (if one failed) | Swap to the other first-line agent |
| Refractory | Ketogenic diet, other AEDs | Specialist centre management |
Early treatment initiation is critical — prompt spasm cessation correlates strongly with improved neurodevelopmental outcomes. Contact A.K. Pharma — medicine distributor in Delhi — for immediate supply of Sabril.
Dosage and Administration
Infantile Spasms:
Refractory Focal Epilepsy (Adults):
Refractory Focal Epilepsy (Children 2-16 years):
Powder for Oral Solution:
Full dosing guidelines available at Drugs.com Vigabatrin Dosage.
Important Safety Warning — Visual Field Defects
Sabril carries an FDA Black Box Warning for permanent visual field defects. This is the most serious and clinically important safety concern with Vigabatrin:
Visual Monitoring Requirements:
This risk-benefit consideration means Sabril is recommended only when the benefits clearly outweigh the risks — particularly in TSC-associated infantile spasms where the benefit is most clearly established.
Full safety information available at FDA Vigabatrin Safety Information.
Who Should Use Sabril
Sabril is prescribed for:
Sabril is prescribed by neurologists, paediatric neurologists, and epileptologists. A.K. Pharma supplies Sabril to hospitals, neurology centres, and pharmacies across Delhi and India.
Possible Side Effects
Common side effects include somnolence, fatigue, dizziness, headache, weight gain, tremor, blurred vision, and diplopia.
In infants: hypertonia, hypotonia, hyperkinesia, agitation, insomnia, and abnormal MRI signal changes in the basal ganglia and brainstem (usually reversible and asymptomatic).
Serious side effects include:
Full side effect information available at FDA Sabril Safety Information.
Precautions
Storage and Handling
As a responsible medicine distributor in Delhi, A.K. Pharma stores all medicines including Sabril under manufacturer-recommended conditions ensuring product integrity for every supply.
Manufacturer Information
Sabril (Vigabatrin) is manufactured by Lundbeck A/S, a Danish pharmaceutical company specialising in neurological and psychiatric medicines. Vigabatrin received FDA approval in August 2009 for infantile spasms and refractory complex partial seizures. A.K. Pharma supplies only genuine Sabril sourced from authorized Lundbeck distributors.
Related Neurology and Anti-Epileptic Medicines Available at A.K. Pharma
Frequently Asked Questions
Q. What is Sabril used for? Sabril (Vigabatrin) is used to treat infantile epileptic spasms syndrome in infants aged 1 month to 2 years and as add-on therapy for refractory focal seizures in adults and children aged 2 years and older. More information available at MedlinePlus.
Q. What is the generic name of Sabril? The generic name of Sabril is Vigabatrin. It belongs to the GABA analogue class of antiepileptic medicines.
Q. Is Sabril effective for tuberous sclerosis complex (TSC)? Yes. Vigabatrin is particularly effective for infantile spasms associated with TSC — achieving spasm cessation rates of up to 95% in TSC patients, significantly higher than in non-TSC infantile spasms. It is considered the first-choice treatment for TSC-associated infantile spasms.
Q. What is the main risk of Sabril? The main risk is permanent visual field defects — bilateral concentric visual field constriction occurring in 30% or more of patients. Regular ophthalmological monitoring is mandatory during treatment. This risk-benefit consideration must be carefully evaluated before initiating therapy.
Q. How often should vision be monitored in patients taking Sabril? Ophthalmological assessment should be performed at baseline before starting treatment and every 3 months during treatment in children and every 6 months in adults. More frequent monitoring may be required in high-risk patients.
Q. Is Sabril available in India? Sabril can be supplied to hospitals, neurology centres, and pharmacies across India through licensed pharmaceutical distributors. Contact A.K. Pharma — medicine distributor in Delhi — for availability and pricing.
Q. What is the price of Sabril in India? Sabril price in India varies by formulation and pack size. Contact A.K. Pharma at 011 4172 6999 or WhatsApp +91 9810034827 for current pricing and bulk supply rates.
Q. How to order Sabril from A.K. Pharma? You can request a quote directly from this page, call us at 011 4172 6999, or WhatsApp us at +91 9810034827 with your requirements and we will respond promptly.
Q. Does A.K. Pharma supply Sabril in bulk? Yes. A.K. Pharma supplies Sabril in bulk to hospitals, neurology centres, paediatric neurology clinics, and pharmacies across Delhi and India. Contact us for bulk pricing and availability.
Why Order Sabril from A.K. Pharma?
Contact A.K. Pharma for Sabril Supply 📍 E-2/257A, 2nd Floor, Shastri Nagar, New Delhi 110052 📞 011 4172 6999 📱 WhatsApp: +91 9810034827 🌐 akpharma.in
