PHENOBARBITAL injectable

Prescription under medical supervision

Therapeutic action

– Anticonvulsant, sedative and hypnotic

Indications

– Emergency treatment of convulsive status epilepticus

Forms and strengths, route of administration

– 200 mg in 1 ml ampoule (200 mg/ml) for infusion in 0.9% sodium chloride. DO NOT ADMINISTER BY DIRECT RAPID IV.

Dosage and duration

– Child 1 month to < 12 years: one dose of 15 to 20 mg/kg (max. 1 g). If necessary, a second dose of 10 mg/kg may be administered 15 to 30 minutes after the first dose.
– Child 12 years and over and adult: one dose of 10 mg/kg (max. 1 g). If necessary, a second dose of 5 to 10 mg/kg may be administered 15 to 30 minutes after the first dose.

– Each dose must be administered over at least 20 minutes. Do not exceed 1 mg/kg/minute.
For example:
Child weighing 8 kg: 120 mg (15 mg x 8 kg), i.e. 0.6 ml of phenobarbital in 20 ml of 0.9% sodium chloride over 20 minutes
Adult weighing 50 kg: 500 mg (10 mg x 50 kg), i.e. 2.5 ml of phenobarbital in a bag of 100 ml of 0.9% sodium chloride over 20 minutes

– For doses less than 1 ml, use a 1 ml syringe graduated 0.01 ml to draw phenobarbital.

Contra-indications, adverse effects, precautions

– Do not administer in patients with severe respiratory depression.
– Do not administer by SC route (risk of necrosis).
– Administer with caution in children, the elderly and patients with respiratory insufficiency.
– May cause :
• dose dependant respiratory depression (enhanced by diazepam), drowsiness; cutaneous and allergic reactions, sometimes severe;
• hypotension, apnoea, laryngospasm, shock, especially if administered too rapidly by IV route.
– Monitor closely respiration and blood pressure during and after administration. Ensure that respiratory support (Ambu bag via face mask or intubation) and IV solutions for fluid replacement are ready at hand.
– Avoid combination with central nervous system depressants (opioid analgesics, sedatives, H1 antihistamines, etc.).
– For women taking estroprogestogen, use condoms until next menstruation (decreases the efficacy of the contraceptive).
– Pregnancy and breast-feeding: risks linked to status epilepticus appear greater than risks linked to phenobarbital.

Remarks

– Do not mix with other drugs in the same infusion.
– Phenobarbital is subject to international controls: follow national regulations.
– Storage: below 25 °C -