DIAZEPAM Solution for injection Ref.[6779] Active ingredients: Diazepam

Dosage depends on individual response, age and weight.

Adults

In severe anxiety or acute muscle spasm, diazepam 10mg may be given intravenously or intramuscularly and repeated after 4 hours.

In tetanus, 0.1 to 0.3mg per kg bodyweight may be given intravenously and repeated every 1-4 hours; alternatively, a continuous infusion of 3 to 10mg per kg every 24 hours may be used or similar doses may be given by nasoduodenal tube.

In status epilepticus or epileptic convulsions, 0.15-0.25mg per kg (usually 10-20mg) is given by intravenous injection. The dose can be repeated if necessary after 30 to 60 minutes. Once the patient is controlled, recurrence of seizures may be prevented by a slow infusion (maximum total dose 3mg per kg over 24 hours).

In minor surgical procedures and dentistry, 0.1-0.2mg per kg by injection (usually 10-20mg) adjusted to the patient’s requirements.

Elderly

Elderly or debilitated patients should be given not more than half of the usual dose.

Hepatic/renal impairment

Dosage reduction may also be required in patients with liver or kidney dysfunction.

Children

In status epilepticus, epileptic or febrile convulsions: 0.2-0.3mg per kg (or 1mg per year of life) is given by intravenous injection. The dose can be repeated if necessary after 30 to 60 minutes.

Sedation or muscle relaxation: up to 0.2mg per kg may be given parenterally.

Neonates

Not recommended; dosage has not been established and Diazepam Injection contains benzyl alcohol which should be avoided in injections to neonates.

Important: In order to reduce the likelihood of adverse effects during intravenous administration the injection should be given slowly (1.0ml solution per minute). It is advisable to keep the patient supine for at least an hour after administration. Except in emergencies, a second person should always be present during intravenous use and facilities for resuscitation should always be available.

It is recommended that patients should remain under medical supervision until at least one hour has elapsed from the time of injection. They should always be accompanied home by a responsible adult, with a warning not to drive or operate machinery for 24 hours.

Intravenous injection may be associated with local reactions and thrombophlebitis and venous thrombosis may occur. In order to minimise the likelihood of these effects, intravenous injections of diazepam should be given into a large vein of the antecubital fossa.

Where continuous intravenous infusion is necessary it is suggested that 2ml Diazepam Injection is mixed with at least 200ml of infusion fluid such as Sodium Chloride Injection or Dextrose Injection and that such solutions should be used immediately. There is evidence that diazepam is adsorbed onto plastic infusion bags and giving sets. It is therefore recommended that glass bottles should be used for the administration of diazepam by intravenous infusion.

Symptoms

The symptoms of mild overdose may include confusion, impairment of consciousness with somnolence or a sleep-like state, little or no respiratory depression, ataxia, dysarthria, nystagmus, hypotension, and muscular weakness. Cardiac rate and rhythm remain normal in the absence of anoxia or severe hypotension.

In severe overdose, deep coma, or other manifestations of severe depression of brainstem vital functions, particularly the respiratory centre, may occur. Coma usually lasts for only a few hours but in elderly people it may be more protracted and cyclical. Benzodiazepine respiratory depressant effects are more serious in patients with severe chronic respiratory disease.

As drug levels fall, severe agitation, insomnia and, possibly, major convulsions may develop.

Benzodiazepines potentiate the effects of other central nervous system depressants, including alcohol.

Treatment

Treatment is symptomatic. Respiration, heart rate, blood pressure and body temperature should be monitored and supportive measures taken to maintain cardiovascular and respiratory function.

Flumazenil is indicated to counteract the central depressive effect of benzodiazepines but expert advice is essential since adverse effects may occur (e.g. convulsions in patients dependent on benzodiazepines). Flumazenil should not be used in mixed overdoses or as a diagnostic test. Flumazenil is contraindicated in the presence of drugs that reduce seizure threshold (e.g. tricyclic antidepressants).

Shelf life: Three years.

For single use only. Discard any remaining contents.

Keep container in the outer carton to protect from light.

Do not store above 25°C.

Amber Type I PhEur glass ampoules (2ml or 4ml) packed in 10s in an outer printed carton.

None.