DIAZEPAM Rectal solution Ref.[6780] Active ingredients: Diazepam

Posology

Sensitivity to diazepam varies with age.

Children above 1 year of age: 0.5 mg/kg body weight.

Adults: 0.5 mg/kg body weight.

Elderly patients: 0.25 mg/kg body weight.

A maximum dose of 30 mg diazepam is recommended, unless adequate medical supervision and monitoring are available.

If convulsions are not controlled other anticonvulsive measures should be instituted.

The dose can be repeated every 12 hours.

Method of administration

The solution is administered rectally. Adults should be in the lateral position; children should be in the prone or lateral position.

1. Tear open the foil pack. Remove the cap.
2. Insert the tube nozzle completely into the rectum. For children under 15kg, insert only half way. Hold the tube with the spout downwards. The contents of the tube should be completely emptied by using firm pressure with the index finger and thumb.
3. To avoid suction, maintain pressure on the tube until it is withdrawn from the rectum. Press together the patient’s buttocks for a short time.

In anxiety, the duration of treatment should be as short as possible and generally not more than 8-12 weeks, including a tapering off process (see 4.4 Special Warnings and Special Precautions for Use).

Patients requiring chronic dosing should be checked regularly at the start of treatment in order to decrease, if necessary, the dose or frequency of administration, to prevent overdose due to accumulation.

Features

The symptoms of diazepam overdose are mainly an intensification of the therapeutic effects (ataxia, drowsiness, dysarthria, sedation, muscle weakness, profound sleep, hypotension, bradycardia, nystagmus) or paradoxical excitation. In most cases only observation of vital functions is required.

Extreme overdosage may lead to coma, areflexia, cardiorespiratory depression and apnoea, requiring appropriate countermeasures (ventilation, cardiovascular support). Benzodiazepine respiratory depressant effects are more serious in patients with severe chronic obstructive airways disease. Severe effects in overdose also include rhabdomyolysis and hypothermia.

Management

Maintain a clear airway and adequate ventilation.

Monitoring level of consciousness, respiratory rate, pulse oximetry and blood pressure in symptomatic patients.

Consider arterial blood gas analysis in patients who have a reduced level of consciousness (GCS<8; AVPU scale P or U) or have reduced oxygen saturations on pulse oximetry.

Correct hypotension by raising the foot of the bed and by giving an appropriate fluid challenge. Where hypotension is thought mainly due to decreased systemic vascular resistance, drugs with alpha-adrenergic activity such as noradrenaline or high dose dopamine (10-30 micrograms/kg/min) may be beneficial. The dose of inotrope should be titrated against blood pressure.

If severe hypotension persists despite the above measures, then central venous pressure monitoring should be considered.

Supportive measures are indicated depending on the patient’s clinical state.

Benzodiazepines are not significantly removed from the body by dialysis.

Flumazenil, a benzodiazepine antagonist, is not advised as a routine diagnostic test in patients with reduced conscious level. It may sometimes be used as an alternative to ventilation in children who are naive to benzodiazepines, or in patients with COPD to avoid the need for ventilation. It is not necessary or appropriate in cases of poisoning to fully reverse the benzodiazepine effect. Flumazenil has a short half-life (about an hour) and in this situation an infusion may therefore be required. Flumazenil is contraindicated when patients have ingested multiple medicines, especially after co-ingestion of a benzodiazepine and a tricyclic antidepressant or any other drug that causes seizures. This is because the benzodiazepine may be suppressing seizures induced by the second drug; its antagonism by flumazenil can reveal severe status epilepticus that is very difficult to control.

Contraindications to the use of flumazenil include features suggestive of a tricyclic antidepressant ingestion including a wide QRS, or large pupils. Use in patients postcardiac arrest is also contraindicated.

It should be used with caution in patients with a history of seizures, head injury, or chronic benzodiazepine use.

Occasionally a respirator may be required but generally few problems are encountered, although behavioral changes are likely in children.

If excitation occurs, barbiturates should not be used.

Effects of overdose are more severe when taken with centrally-acting drugs, especially alcohol, and in the absence of supportive measures, may prove fatal.

Shelf life: Three years.

Once foil is opened, use immediately.

Do not store above 25°C.

Store in the original package in order to protect from light.

Packs of 2 or 5 rectal tubes each containing 2.5ml of solution

The tubes are made of low-density polyethylene. The tubes have a nozzle attached for application. Each tube is individually presented in a foil wrap and placed in an outer carton.

Not all pack sizes may be marketed.

For single use only.