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Therapeutic action
- Antiseizure (anticonvulsant), muscle relaxant, sedative, anxiolytic
Indications
- First-line treatment of convulsive status epilepticus
- Muscle spasms due to tetanus
- Severe agitation in adults
Forms and strengths, route of administration
- 10 mg in 2 ml ampoule (5 mg/ml) for IM injection, slow IV injection (3 to 5 minutes) or IV infusion in 0.9% sodium chloride or 5% glucose
- The injectable solution may be used rectally.
Dosage and duration
Convulsive status epilepticus
- Child 1 month to 11 years:
- Rectal route: one dose of 0.5 mg/kg (0.1 ml/kg); max. 10 mg (2 ml)
- Slow IV injection: one dose of 0.2 to 0.3 mg/kg (0.04 to 0.06 ml/kg); max. 10 mg (2 ml)
Age |
Weight |
10 mg/2 ml solution |
|
---|---|---|---|
Rectal route | IV injection | ||
1 to < 4 months | 3 to < 6 kg | 0.4 ml | 0.25 ml |
4 to < 12 months |
6 to < 10 kg |
0.7 ml |
0.4 ml |
1 to < 3 years |
10 to < 15 kg |
1.2 ml |
0.6 ml |
3 to < 5 years |
15 to < 20 kg |
1.5 ml |
1 ml |
5 to < 9 years |
20 to < 30 kg |
2 ml |
1.2 ml |
9 to < 12 years | 30 to < 40 kg | 2 ml | 2 ml |
- Child 12 years and over and adult:
- Rectal route: one dose of 10 to 20 mg (2 to 4 ml); one dose of 10 mg (2 ml) in older patients
- Slow IV injection: one dose of 10 mg (2 ml); one dose of 5 mg (1 ml) in older patients
In children and adults, if seizures do not stop 5 minutes after the first dose, readminister the same dose, regardless of the route of administration. Do not administer more than 2 doses in total.
Muscle spasms due to tetanus
The dosage range is variable, depending on the severity of symptoms and clinical response. For information:
- Child 1 month and over 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 IV infusion over 24 hours
Severe agitation
- Adult: 10 mg (2 ml) by IM injection, to be repeated once after 30 to 60 minutes if necessary
Rectal administration technique
- Lay the patient on their side.
- For volumes up to 1 ml, use a 1 ml syringe. Withdraw the required dose. Remove the needle. Insert the syringe into the rectum for a length of 1 to 3 cm (depending on age) to administer the dose. For volumes greater than 1 ml, use a 2 ml syringe and attach to the tip of the syringe a nasogastric tube n°8 cut to a length of 2 to 3 cm to administer the dose.
- After administration, hold the buttocks together for at least one minute.
Contra-indications, adverse effects, precautions
- Do not administer to neonates (contains benzyl alcohol) and to patients with severe respiratory insufficiency or severe hepatic impairment.
- Administer with caution:
- to older patients and patients with renal or hepatic impairment (reduce the dose by half);
- to patients with history of substance abuse or mental disorders.
- May cause:
- pain at injection site;
- hypotension, muscle weakness, ataxia, hypotonia, drowsiness, lethargy, confusional state;
- respiratory depression, especially if injected rapidly by IV route and if large doses are administered;
- coma in the event of overdose.
- Avoid or monitor in combination with:
- opioid analgesics, antipsychotics, first-generation antihistamines (hydroxyzine, promethazine), antidepressants, other antiseizure medications, etc. (increased sedation);
- enzyme inducers such as rifampicin, rifabutin, nevirapine, phenobarbital, phenytoin, carbamazepine, etc. (reduced effect of diazepam);
- omeprazole, macrolides, ritonavir, isoniazid, fluconazole, itraconazole, etc. (increased diazepam toxicity);
- phenytoin (increased phenytoin toxicity).
- Pregnancy and breast-feeding: avoid, except if vital (passage through the placenta and breast milk)
Remarks
- Diazepam is subject to international controls: follow national regulations.
- For administration by IV infusion, the concentration of diazepam in the solution should not exceed 0.25 mg/ml (e.g. 1 mg in at least 4 ml).
- Diazepam slow IV is also used in delirium tremens (alcohol withdrawal) in adults: 10 to 20 mg every 4 to 6 hours under close supervision in intensive care unit.
- Do not mix with other drugs in the same syringe or infusion.
Storage
– Below 25 °C