DIAZEPAM emulsion

Prescription under medical supervision

For administration, equipment for ventilation must be available and ready for use.


Therapeutic action

– Anxiolytic, sedative, anticonvulsant, muscle relaxant

Indications

– Muscle spasms due to tetanus in neonates

Forms and strengths, route of administration

– 10 mg ampoule (5 mg/ml, 2 ml) emulsion for slow IV injection (3 to 5 minutes) or infusion in 10% glucose (if not available, 5%). DO NOT ADMINISTER BY IM OR RECTAL ROUTE.

Dosage and duration

– The dosage range is variable, depending on the severity of symptoms and clinical response. For information:
• 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, preferably via an electric syringe
Dilute one ampoule of diazepam emulsion (10 mg) in a syringe of 50 ml of 10% glucose to obtain a solution containing 0.2 mg of diazepam per ml.
Every 6 hours, discharge the content remaining in the electric syringe and prepare a new syringe for 6 hours.

Weight

Dose

Diluted solution 0.2 mg/ml


2.5 kg

0.1 mg/kg/hour

1.3 ml/hour

0.3 mg/kg/hour

3.8 ml/hour

0.5 mg/kg/hour

6.2 ml/hour


3 kg

0.1 mg/kg/hour

1.5 ml/hour

0.3 mg/kg/hour

4.5 ml/hour

0.5 mg/kg/hour

7.5 ml/hour


3.5 kg

0.1 mg/kg/hour

1.8 ml/hour

0.3 mg/kg/hour

5.2 ml/hour

0.5 mg/kg/hour

8.8 ml/hour

Contra-indications, adverse effects, precautions

– Do not administer to patients with severe respiratory insufficiency or severe hepatic impairment.
– Reduce the dose by one half in patients with renal or hepatic impairment.
– May cause:
• hypotension, respiratory depression, if injected too rapidly by IV route and if large doses are administered;
• drowsiness, muscle weakness;
• in the event of overdose: hypotonia, lethargy, respiratory distress, coma.
– Avoid and monitor in combination with:
• drugs containing alcohol, opioid analgesics, other anticonvulsants, etc. (increased sedation);
• enzyme inducers such as nevirapine, ritonavir, phenobarbital, phenytoin, etc. (efficacy of diazepam reduced);
• omeprazole, macrolides, ritonavir, fluconazole, etc. (effects of diazepam increased);
• phenytoin (phenytoin plasmatic concentrations modified).

Remarks

– Diazepam is subject to international controls: follow national regulations.
– Do not mix with other drugs in the same syringe or infusion.
– Storage: below 25 °C - 
Emulsion diluted in glucose can be kept 6 hours maximum.