Tetrabenazine
تترابنازین
🧠 Nervous SystemVMAT2 inhibitor
Market / country: 🇺🇸 USA
Xenazine (US)
🧮 Dose calculator
Huntington disease chorea · Regimen source: FDA Tetrabenazine · 2.2
- • 37.5–50 mg in three doses; max single dose 25 mg. Above 50 mg only after CYP2D6 genotyping (EM/IM: max 100 mg/day, single 37.5 mg). With strong CYP2D6 inhibitors max 50 mg. FDA Tetrabenazine · 2.2FDA Tetrabenazine · 2.3
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Active suicidality or untreated/inadequately treated depression; hepatic impairment; MAOIs (or within 14 days); reserpine (20 days apart); deutetrabenazine or valbenazine. FDA Tetrabenazine · 4
Warnings
- • Boxed warning: depression and suicidality in Huntington’s disease; contraindicated with untreated depression or suicidality. FDA Tetrabenazine · Boxed Warning
- • Neuroleptic malignant syndrome; akathisia and parkinsonism; sedation; QTc prolongation. FDA Tetrabenazine · 5
Formulations
- 12.5 mg tablet (unscored) — tablet 🇺🇸 USA FDA Tetrabenazine · 3
- 25 mg tablet (scored) — tablet 🇺🇸 USA FDA Tetrabenazine · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Tetrabenazine · 8.1
“Risk Summary There are no adequate data on the developmental risk associated with the use of tetrabenazine in pregnant women.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Tetrabenazine · 8.2
“Risk Summary There are no data on the presence of tetrabenazine or its metabolites in human milk, the effects on the breastfed infant, or the effects of the drug on milk production.”
- 👶 ChildrenSafety not established
Label: safety and effectiveness in children have not been established. FDA Tetrabenazine · 8.4
“Safety and effectiveness in pediatric patients have not been established.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Tetrabenazine · 8.5
“The pharmacokinetics of tetrabenazine and its primary metabolites have not been formally studied in geriatric subjects.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)ANDA206093
- DailyMed (FDA label)FDA Tetrabenazine
- MedlinePlus (NIH)Tetrabenazine
- WHO ATC/DDDN07XX06
- Darooyab (Iran)Tetrabenazine
🇮🇷 Registered in Iran Darooyab · G-4282/Tetrabenazine
Dosage forms with Iranian generic codes, per Darooyab.
- 01203 · TETRABENAZINE 25MG TAB · قرص تترابنازین ۲۵ میلیگرم
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Tetrabenazine · 3FDA Tetrabenazine · 2.2FDA Tetrabenazine · 2.3FDA Tetrabenazine · 4FDA Tetrabenazine · Boxed WarningFDA Tetrabenazine · 5FDA Tetrabenazine · SPL approval / marketing categoryFDA Tetrabenazine · 8.1FDA Tetrabenazine · 8.2FDA Tetrabenazine · 8.4FDA Tetrabenazine · 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-4282/Tetrabenazine
- Clinical review⚠ Unverified