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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.
- Child 1 month and over:
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