PHENOBARBITAL = PB injectable

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    Last updated : October 2024

     

    Prescription under medical supervision

     

     
    During and after administration, have ventilation equipment (Ambu and mask) and solutions for fluid replacement ready for use.

     

    Therapeutic action

    • Antiseizure (anticonvulsant), sedative

    Indications

    • Second-line treatment of convulsive status epilepticus

    Forms and strengths, route of administration

    • 200 mg in 1 ml ampoule (200 mg/ml) for IV infusion in 0.9% sodium chloride
    • DO NOT ADMINISTER BY DIRECT IV INJECTION. DO NOT ADMINISTER THE SOLUTION UNDILUTED.
    • DO NOT ADMINISTER BY SC INJECTION (risk of necrosis).

    Dosage and duration

    • Loading dose:
      • Child 1 month and over:
        • Use diluted solution: add 1 ml (200 mg) of PB to 9 ml of 0.9% NaCl to obtain 10 ml of solution containing 20 mg of PB per ml.
        • Administer 20 mg/kg (max. 1 g) over 20 minutes by IV infusion using a syringe pump (or only if not available, using a pediatric infusion set).
        • If seizures do not stop after the end of the first dose, readminister half dose: 10 mg/kg as above.
      • Adult: 
        • 15 mg/kg (max. 1 g) single dose over 15 minutes 
        • Use diluted solution as above (20 mg/ml) if administered by IV infusion using a syringe pump.
        • Use undiluted solution if administered by IV infusion in a bag of 100 ml of 0.9% NaCl. 

     

    Do not exceed an infusion rate of 1 mg/kg/minute in children and 100 mg/minute in adults.

     

    • If maintenance treatment is indicated after the loading dose: change to oral route as soon as possible.

    Contra-indications, adverse effects, precautions

    • Do not administer to patients with severe impairment of respiratory, renal or hepatic function (risk of accumulation).
    • Administer with caution in children, older patients and patients with mild to moderate impairment of respiratory, renal or hepatic function.
    • May cause :
      • drowsiness, dizziness, headache, behavioural disturbances;
      • dose-dependant respiratory depression;
      • hypotension, apnoea, laryngospasm, shock, especially if administered rapidly by IV route and if large doses are administered;
      • haematologic disorders, gastrointestinal disturbances;
      • hypersensitivity reactions sometimes severe;
      • coma in the event of overdose.
    • Monitor closely respiratory rate and blood pressure during and after administration.
    • Avoid or monitor the combination with:
      • mefloquine (reduced effect of PB);
      • benzodiazepines, opioid analgesics, antipsychotics, first-generation antihistamines (hydroxyzine, promethazine), antidepressants, other antiseizure medications, etc. (increased sedation).
    • Use with extreme caution with benzodiazepines and opioids analgesics (increased risk of respiratory depression).
    • PB may reduce the effect of many drugs:
      • diazepam, midazolam, antimicrobials, some antiretrovirals, corticosteroids, tricyclic antidepressants, itraconazole, direct-acting antivirals for chronic hepatitis C, warfarin, etc. Adjust dosage if necessary.
      • implants and oral contraceptives: use condoms until next menstruation.
    • Pregnancy and breast-feeding: prefer a safer drug (levetiracetam). If PB is the only option, the risks linked to status epilepticus appear greater than risks linked to PB.

    Remarks

    • PB is subject to international controls: follow national regulations.
    • Do not mix with other drugs in the same syringe or infusion.

    Storage

     
    – Below 25 °C