Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Actavis UK Limited (Trading style: Actavis), Whiddon Valley, BARNSTAPLE, N Devon EX32 8NS
As an anxiolytic, the lowest effective dose should be employed; dosage regimes should not exceed beyond 4 weeks and treatment should be gradually withdrawn. Patients who have received benzodiazepines for a long time may require an extended withdrawal period. Long-term chronic use is not recommended.
Anxiety states, obsessive-compulsive neuroses, and other psychiatric disorders: 5-30mg daily in divided doses.
Insomnia associated with anxiety: 5-15mg before retiring.
Cerebral palsy: 5-60mg daily in divided doses.
Upper motor neuronic spasticity: 5-60mg daily in divided doses.
Muscle spasm of varied aetiology, fibrositis, cervical spondylosis: 5-15mg daily in divided doses.
Adjunct to the management of some types of epilepsy: 2-60 mg daily in divided doses.
Alcohol withdrawal: 5-20mg, repeated if necessary in 2 to 4 hours.
Oral premedication in dental patients: 5mg the night before, 5mg on waking and 5mg two hours before the appointment.
Oral Premedication before surgery: 5mg-20mg.
Alternative presentations of diazepam are recommended for paediatric usage in order to obtain suitable doses of less than 5mg.
Spastic children with minimal brain damage: 5-40mg daily in divided doses.
Oral Premedication before surgery (see section 4.4): 2mg-10mg.
Doses should be half the above recommended doses.
The use of diazepam in hepatic impairment may precipitate coma, therefore the dose should be reduced or an alternative drug considered. In severe renal impairment the dose should be reduced.
For oral administration.
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 over-dosage may lead to coma, areflexia, cardio-respiratory 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.
Maintain a clear airway and adequate ventilation.
Consider activated charcoal (50g for an adult, 1g/kg for a child) in adults who have taken more than 100mg or children who have taken more than 1mg/kg within one hour, provided they are not too drowsy.
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 post-cardiac 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 behavioural 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 from the date of manufacture.
Shelf-life after dilution/reconstitution: Not applicable.
Shelf-life after first opening: Not applicable.
Do not store above 25°C.
The product containers are rigid injection moulded polypropylene or injection blow-moulded polyethylene containers and press fit polyethylene lids; in case any supply difficulties should arise the alternative is amber glass containers with screw caps.
The product may also be supplied in blister packs in cartons:
Pack size: 7, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 168, 180, 250, 500, 1000.
Not applicable.
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