DIAZEPAM solution

Prescription under medical supervision

– Do not use this solution in neonates, use diazepam emulsion only.
– For IV administration, equipment for ventilation must be available and ready for use.


Therapeutic action

– Anxiolytic, sedative, anticonvulsant, muscle relaxant

Indications

– Seizures
– Muscle spasms due to tetanus in children over 1 month and adults
– Severe agitation in adults

Forms and strengths, route of administration

– 10 mg ampoule (5 mg/ml, 2 ml) for IM or slow IV injection (3 to 5 minutes) or infusion in 0.9% sodium chloride or 5% glucose
– The injectable solution may be used rectally.

Dosage and duration

– Seizures

   Child:
    • Rectal route: 0.5 mg/kg/dose (= 0.1 ml/kg/dose); max. 10 mg/dose

Age

Weight

10 mg/2 ml solution*

6 to < 12 months

7 to < 10 kg

1 ml

1 to < 3 years

10 to < 14 kg

1.25 ml

3 to < 5 years

14 to < 19 kg

1.5 ml

≥ 5 years and adult

≥ 19 kg

2 ml

 * Use a 1 ml syringe without needle and insert it 2 to 3 cm into the rectum, or attach a nasogastric tube n°8 cut to a length of 2 to 3 cm to the tip of a 2 ml syringe. Hold the buttocks together for a few minutes.

    • Slow IV injection: 0.3 mg/kg/dose (= 0.06 ml/kg/dose); max. 10 mg/dose

   Adult:
   Slow IV injection or rectal route: 10 mg/dose (= 2 ml/dose)

   In children and adults, if seizures do not stop within 10 minutes after the first dose, repeat the same dose once, whatever the route of administration.

– Muscle spasms due to tetanus
The dosage range is variable, depending on the severity of symptoms and clinical response. For information:
Child and adult:
• 0.1 to 0.3 mg/kg by slow IV injection every 1 to 4 hours
or
• 0.1 to 0.5 mg/kg/hour by continuous perfusion over 24 hours

– Severe agitation
Adult: 10 mg by IM injection, to be repeated once after 30 to 60 minutes if necessary

Contra-indications, adverse effects, precautions

– Do not administer to neonates (contains benzyl alcohol) and to patients with severe respiratory insufficiency or severe hepatic impairment.
– Reduce the dose by one half in elderly patients and patients with renal or hepatic impairment.
– May cause:
• pain at injection site, drowsiness, muscle weakness;
• hypotension, respiratory depression, if injected too rapidly by IV route and if large doses are administered (tetanus);
• in the event of overdose: hypotonia, lethargy, respiratory distress, coma.
– Avoid and monitor in combination with:
• drugs containing alcohol, opioid analgesics, antipsychotics, antihistamines, antidepressants, other anticonvulsants, etc. (increased sedation);
• enzyme inducers such as rifampicin, rifabutin, nevirapine, ritonavir, phenobarbital, phenytoin, carbamazepine, griseofulvin, etc. (efficacy of diazepam reduced);
• omeprazole, macrolides, ritonavir, isoniazid, fluconazole, itraconazole, etc. (effects of diazepam increased);
• phenytoin (phenytoin plasmatic concentrations modified).
– Pregnancy and breast-feeding: avoid if possible, except if vital (passage through the placenta and breast milk)

Remarks

– Diazepam is subject to international controls: follow national regulations.
– For administration by infusion, the concentration of diazepam in the solution should not exceed 0.25 mg/ml (e.g. 1 mg in at least 4 ml).
– Do not mix with other drugs in the same syringe or infusion.
– Storage: below 25 °C -