Flumazenil
فلومازنیل
🧪 VariousBenzodiazepine antagonist (antidote)
Market / country: 🇺🇸 USA
Romazicon (US)
🧮 Dose calculator
Benzodiazepine reversal (sedation or overdose) · Regimen source: FDA Flumazenil inj. · Dosage and Administration — Adult Patients
- • If needed 0.2 mg every 60 s up to 4 more times; maximum total 1 mg. FDA Flumazenil inj. · Dosage and Administration
Enter age (weight is optional for this regimen).
🛡️ Safety & information
Contraindications
- ⛔ Hypersensitivity; benzodiazepine given for a life-threatening condition (e.g. status epilepticus, raised ICP); serious tricyclic antidepressant overdose. FDA Flumazenil inj. · Contraindications
- ⛔ Not established under 1 year. FDA Flumazenil inj. · Dosage and Administration — Pediatric Patients
Warnings
- • Boxed warning: seizures, especially after long-term benzodiazepine use or tricyclic overdose. FDA Flumazenil inj. · Boxed Warning
Formulations
- 0.1 mg/mL multiple-dose vial — injection 🇺🇸 USA FDA Flumazenil inj. · How Supplied
👥 Special populations
- 🤰 PregnancyUse with caution
Label states no clear risk or has limited data; use only if needed, under medical advice. FDA Flumazenil inj. · Pregnancy
“Pregnancy Category C: There are no adequate and well-controlled studies of the use of flumazenil in pregnant women.”
- 🤱 BreastfeedingUse with caution
Label: use with caution while breastfeeding; see the label text. FDA Flumazenil inj. · Nursing Mothers
- 👶 ChildrenUse with caution
The label has conditions, age limits or notes for children; the label sentence is quoted below. FDA Flumazenil inj. · Pediatric Use
“The safety and effectiveness of flumazenil have been established in pediatric patients 1 year of age and older.”
- 👴 Older adultsUse with caution
Label: use with caution in older adults, usually starting at the low end of the dose range. FDA Flumazenil inj. · Geriatric Use
“Several studies of flumazenil in subjects over the age of 65 and one study in subjects over the age of 80 suggest that while the doses of benzodiazepine used to induce sedation should be reduced, ordinary doses of flumazenil may be used for reversal.”
- ⚥ Females & males of reproductive potentialNo data
The source for this drug has no section for this group.
🔗 Reference links
- FDA (approval record)ANDA078527
- DailyMed (FDA label)FDA Flumazenil inj.
- MedlinePlus (NIH)❌ None
- WHO ATC/DDDV03AB25
- Darooyab (Iran)Flumazenil
🇮🇷 Registered in Iran Darooyab · G-1956/Flumazenil
Dosage forms with Iranian generic codes, per Darooyab.
- 00544 · FLUMAZENIL 0.5MG/5 ML AMP · آمپول فلومازنیل ۰٫۵ میلیگرم / ۵ میلیلیتر
📚 Reference status for this drug
Shows which sources have references recorded for this drug and which do not.
- FDA label (DailyMed)✅ PresentFDA Flumazenil inj. · How SuppliedFDA Flumazenil inj. · Dosage and Administration — Adult PatientsFDA Flumazenil inj. · Dosage and AdministrationFDA Flumazenil inj. · Dosage and Administration — Pediatric PatientsFDA Flumazenil inj. · ContraindicationsFDA Flumazenil inj. · Boxed WarningFDA Flumazenil inj. · PregnancyFDA Flumazenil inj. · Nursing MothersFDA Flumazenil inj. · Pediatric UseFDA Flumazenil inj. · Geriatric UseFDA Flumazenil inj. · SPL approval / marketing category
- 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-1956/Flumazenil
- Clinical review⚠ Unverified