Sabril 500 mg Tablets (Vigabatrin) – Anticonvulsant for Seizures & Infantile Spasms Treatment
EGP5,500
Field | Details |
---|---|
Name | Sabril 500 mg |
Brand | Sanofi Aventis |
Strength | 500 mg |
Quantity | 100 Tablets |
Form | Tablet |
Expiry Date | Varies by batch (e.g., 12/2026) |
Outer Appearance | White box, red & black branding elements |
Country of Origin | France or as indicated on packaging |
Product Code | SAB500-TAB-SANOFI |
Sabril 500 mg (vigabatrin) is a prescription anticonvulsant used as adjunctive therapy in refractory complex partial seizures in patients 2 years and older, and as monotherapy for infantile spasms in babies aged 1 month to 2 years. Due to its risk of permanent vision loss, its use is strictly regulated under the REMS Program.
Available on backorder
1. What Is Sabril (Vigabatrin)?
Sabril (generic name vigabatrin) is an anticonvulsant medication that works by inhibiting GABA‑transaminase, increasing GABA—an inhibitory neurotransmitter—to stabilize abnormal electrical activity in the brain It is available as 500 mg tablets and powder packets for oral solution.
2. Approved Uses
A. Refractory Complex Partial Seizures
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Adjunctive treatment for patients aged 2 years and older whose seizures haven’t responded to other medications.
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Not recommended as first-line therapy.
B. Infantile Spasms (West Syndrome)
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Monotherapy in babies aged 1 month to 2 years, when benefits outweigh vision risks.
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Demonstrated reduction or elimination of spasms in clinical trials.
3. How It Works
By irreversibly inhibiting GABA transaminase, vigabatrin elevates GABA levels in the brain, reducing seizure activity . It does not directly bind GABA receptors.
4. Dosage Guidelines
A. Adults (≥ 17 years) with Complex Partial Seizures
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Initial: 1,000 mg/day (500 mg twice daily).
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Target: 3,000 mg/day (1,500 mg twice daily).
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Max: Studies show no extra benefit beyond 3,000 mg; increased adverse events at 6,000 mg/day
B. Children (2–16 years) with Complex Partial Seizures
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Dosage based on body weight, adjusted weekly.
C. Infantile Spasms (1 month–2 years)
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Start: 50 mg/kg/day in two divided doses;
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Titrate: Increase by 25–50 mg/kg every 3 days;
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Max: 150 mg/kg/day.
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5. Safety & Precautions
A. Risk of Permanent Vision Loss
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The most serious concern: irreversible peripheral vision loss (“tunnel vision”).
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Available only through the REMS program with mandated baseline and quarterly eye exams during treatment and post‑therapy checkups.
B. MRI Changes & Brain Edema in Infants
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Some infants exhibited MRI signal changes and intramyelinic edema; often reversed post‑treatment
C. Neuropsychiatric Risks
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Increased risk of suicidal ideation, depression, and behavioral changes—vigilance recommended.
D. Other Risks & Lab Monitoring
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Anemia, peripheral neuropathy, drowsiness, weight gain, and interaction with certain antiepileptics (e.g., phenytoin) .
6. Side Effects
Side Effect | Adults (%) | Children (%) |
---|---|---|
Drowsiness, dizziness, headache | ~20‑30% | 10‑25% |
Weight gain | — | ~15‑47% (higher in kids) |
Blurry vision | ~13% | — |
Upper respiratory infections | — | 15‑51% (with spasms) |
Diarrhea, nausea, joint pain | ~10% | — |
Common effects include dizziness, headache, fatigue, blurred vision, infection, nausea, diarrhea, joint pain.
7. Monitoring & Discontinuation
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Eye exams at baseline, every 3 months during treatment, and 3–6 months post‑treatment.
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Gradual tapering necessary to avoid seizure recurrence; sudden withdrawal may exacerbate seizures.
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If no seizure control improvement in 3 months (adults) or 2–4 weeks (infants), discontinuation is advised.
8. REMS Program
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FDA‑mandated Vigabatrin REMS ensures informed prescribing and risk monitoring for vision.
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Providers, pharmacies, and patients must register, with distribution only through certified pharmacies.
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9. Alternatives to Sabril
Depending on seizure type, other antiepileptic drugs (AEDs) may be considered. Discuss with your neurologist to find optimal treatment.
⭐ User Reviews
★ ★ ★ ★ ★
“I started Sabril as an add‑on after several meds didn’t work. Seizure frequency dropped by 60%, and aside from some mild fatigue, I’m doing well. My ophthalmologist keeps a close eye on my vision.” – Adult patient
★ ★ ★ ★☆
“As a parent, I was worried, but Sabrilช่วย reduce my baby’s spasms in just over a week. The quarterly eye‑exam requirement is a bit tough, but worth it.” – Parent of 8‑month‑old with IS
★ ★ ★ ☆☆
“Good seizure control but I gained weight and felt sluggish at times. Vision became a concern, but results showed I’m clear so far.” – Teen patient
Frequently Asked Questions
1. How fast does Sabril start working?
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For infantile spasms: often within 5 days to 2 weeks.
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For partial seizures: may take 2 weeks to 3 months for noticeable impact .
2. Can I drive while taking Sabril?
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Avoid driving until you’ve assessed how Sabril affects you—drowsiness, vision changes, dizziness are possible.
3. What if vision changes occur?
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Immediately stop medication and inform your doctor. A vision test is required every 3 months.
4. Can breastfeeding mothers take Sabril?
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Small amounts pass into milk. Consult your healthcare provider; benefits vs. risks must be assesse.
5. What happens if I miss a dose?
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Take it as soon as remembered, but don’t double up. Missing doses may reduce seizure control—follow your provider’s plan .
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✅ Final Thoughts
Sabril (vigabatrin) 500 mg is a potent and potentially life‑changing medication for refractory seizures and infantile spasms. Its clinical benefits often outweigh risks for appropriately monitored patients. However, the potential for permanent vision loss makes rigorous REMS monitoring essential, with scheduled eye exams and cautious dosing. Taper gradually under medical supervision to avoid withdrawal seizures. Always discuss thoroughly with your neurologist.
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