DIAZEPAM solution

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    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 (a) Citation a. 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.

    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

    • 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 
    • (a)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.