Vigabatrin
ویگاباترین
🧠 Nervous SystemGABA transaminase inhibitor
Market / country: 🇺🇸 USA
Sabril (US)
🧮 Dose calculator
Infantile spasms (West syndrome) · Regimen source: FDA Vigabatrin · 2.3
- • Increase by 25–50 mg/kg/day every 3 days. FDA Vigabatrin · 2.3
Enter age and weight.
🛡️ Safety & information
Warnings
- • Boxed warning: permanent bilateral visual field loss (tunnel vision) — baseline and 3-monthly vision assessment; available only through REMS. FDA Vigabatrin · Boxed Warning
Formulations
- 500 mg packet dissolved in 10 mL water = 50 mg/mL — solution 🇺🇸 USA FDA Vigabatrin · 3FDA Vigabatrin · 2.3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Vigabatrin · 8.1
“Risk Summary There are no adequate data on the developmental risk associated with the use of vigabatrin in pregnant women.”
- 🤱 BreastfeedingDangerous / avoid
Label: breastfeeding not recommended, or choose between the drug and breastfeeding. FDA Vigabatrin · 8.2
“Because of the potential for serious adverse reactions from vigabatrin in nursing infants, breastfeeding is not recommended.”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Vigabatrin · 8.4
“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 …”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Vigabatrin · 8.5
“Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)ANDA208218
- DailyMed (FDA label)FDA Vigabatrin
- MedlinePlus (NIH)Vigabatrin
- WHO ATC/DDDN03AG04
- Darooyab (Iran)Vigabatrin
🇮🇷 Registered in Iran Darooyab · G-691/Vigabatrin
Dosage forms with Iranian generic codes, per Darooyab.
- 01282 · VIGABATRIN 500MG FC TAB · قرص روکشدار ویگاباترین ۵۰۰ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Vigabatrin · 3FDA Vigabatrin · 2.3FDA Vigabatrin · 2.2FDA Vigabatrin · 2.4FDA Vigabatrin · Boxed WarningFDA Vigabatrin · SPL approval / marketing categoryFDA Vigabatrin · 8.1FDA Vigabatrin · 8.2FDA Vigabatrin · 8.4FDA Vigabatrin · 8.5
- UK SmPC (eMC / MHRA)❌ Not present
- Published guideline❌ Not present
- Licensed reference (medical school)❌ Not present
- Iranian leaflet (IFDA)❌ Not present
- Pharmacy website (secondary, unreliable)✅ PresentDarooyab · G-691/Vigabatrin
- Clinical review⚠ Unverified