Description:

Flumazenil is a benzodiazepine antagonist used to reverse the sedative effects of benzodiazepines in cases of overdose or during medical procedures. It is typically administered in a hospital or clinical setting under the supervision of a healthcare professional.

Prescription:

• Prescription only medication.

Dosage:

• Adults:
  • Initial dose: 0.2 mg intravenously over 15 seconds.
  • If desired consciousness is not achieved, additional doses of 0.2 mg can be administered at 60-second intervals, up to a maximum total dose of 1 mg.
• Children (above 1 year):
  • Initial dose: 0.01 mg/kg intravenously (up to 0.2 mg).
  • Additional doses may be given at intervals of 60 seconds if required, up to a maximum of 0.05 mg/kg or 1 mg.
• Dosage adjustments may be needed for specific conditions or populations.

Therapeutic Category:

• Antidote and benzodiazepine antagonist.

Active Ingredients/Composition:

• Flumazenil 0.1 mg/ml or 0.5 mg/ml, depending on the formulation.

Variant:

• Injection solution in vials or ampoules.

Consume Type:

• Injectable form; administered intravenously.

Directions/Usage:

1. Administered by a trained healthcare professional.
2. Monitor the patient for re-sedation or withdrawal symptoms.
3. Used only in controlled settings, such as hospitals.

Common Side Effects:

• Mild effects:
  • Nausea.
  • Dizziness.
  • Sweating.
  • Headache.
• Serious effects (rare):
  • Seizures (especially in long-term benzodiazepine users).
  • Increased anxiety or agitation.
  • Arrhythmia.

Package Type:

• Typically available in ampoules or vials for single-use administration.

Storage Advice:

• Store at controlled room temperature (20°C to 25°C or 68°F to 77°F).
• Protect from light and keep in the original packaging.
• Keep out of reach of children.

Safety Advice:

1. Supervised use: Must be used under medical supervision due to the risk of withdrawal seizures and other complications.
2. Pregnancy and breastfeeding: Use only if clearly needed and prescribed by a doctor.
3. Allergies: Avoid if allergic to flumazenil or any other ingredients in the formulation.
4. Drug interactions: Inform the doctor about all other medications, especially benzodiazepines, to avoid adverse reactions.
5. Medical history: Use with caution in patients with a history of seizures, panic disorders, or long-term benzodiazepine use.

Product Substitutes:

• Anexate Injection (Roche).
• Lanexat Injection.

Manufacturer/Marketer:

• Roche

Country of Origin:

• Switzerland