Clobazam
کلوبازام
🧠 Nervous SystemBenzodiazepine anticonvulsant
Market / country: 🇺🇸 USA
Onfi (US)
🧮 Dose calculator
Lennox-Gastaut syndrome · Regimen source: FDA Onfi · 2.1, Table 1
- • ≤30 kg: 5 mg/day, day 7 → 10 mg, day 14 → 20 mg. >30 kg: 10 mg/day, day 7 → 20 mg, day 14 → 40 mg. Above 5 mg/day give in 2 doses. No faster than weekly; taper to stop. FDA Onfi · 2.1, Table 1FDA Onfi · 2.2
Enter age and weight.
🛡️ Safety & information
Contraindications
- ⛔ History of hypersensitivity to clobazam. FDA Onfi · 4
Warnings
- • Boxed warning: concomitant opioids (profound sedation, respiratory depression, death), abuse and dependence, withdrawal reactions. FDA Onfi · Boxed Warning
Formulations
- 10 mg tablet (scored) — tablet 🇺🇸 USA FDA Onfi · 3
- 20 mg tablet (scored) — tablet 🇺🇸 USA FDA Onfi · 3
- 2.5 mg/mL oral suspension — suspension 🇺🇸 USA FDA Onfi · 3
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Onfi · 8.1
“Risk Summary Neonates born to mothers using benzodiazepines late in pregnancy have been reported to experience symptoms of sedation and/or neonatal withdrawal [see Warnings and Precautions ( 5.9) and Clinical Considerations] .”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Onfi · 8.2
“Risk Summary ONFI is excreted in human milk ( see Data) .”
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Onfi · 8.4
“Safety and effectiveness in patients less than 2 years of age 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 Onfi · 8.5
“Clinical studies of ONFI did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.”
- ⚥ Females & males of reproductive potentialUse with caution
Label has advice on pregnancy testing, contraception or fertility for females and males. FDA Onfi · 8.3
“Administration of clobazam to rats prior to and during mating and early gestation resulted in adverse effects on fertility and early embryonic development at plasma exposures for clobazam and its major active metabolite, N-desmethylclobazam, below those in humans at the MRHD [see Nonclinical Toxicology ( 13.1 )] .”
🔗 Reference links
- FDA (approval record)NDA202067
- DailyMed (FDA label)FDA Onfi
- MedlinePlus (NIH)Clobazam
- WHO ATC/DDDN05BA09
- Darooyab (Iran)Clobazam
🇮🇷 Registered in Iran Darooyab · G-660/Clobazam
Dosage forms with Iranian generic codes, per Darooyab.
- 00312 · CLOBAZAM 10MG TAB · قرص کلوبازام ۱۰ میلیگرم
- 53342 · CLOBAZAM 2.5 mg/1mL 120ML SUSPENSION ORAL · سوسپانسیون خوراکی کلوبازام ۲٫۵ میلیگرم / ۱ میلیلیتر ۱۲۰ میلیلیتر
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Onfi · 3FDA Onfi · 2.1, Table 1FDA Onfi · 2.2FDA Onfi · 4FDA Onfi · Boxed WarningFDA Onfi · SPL approval / marketing categoryFDA Onfi · 8.1FDA Onfi · 8.2FDA Onfi · 8.4FDA Onfi · 8.5FDA Onfi · 8.3
- 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-660/Clobazam
- Clinical review⚠ Unverified