Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2020 Publisher: Tillomed Laboratories Limited, 220 Butterfield, Great Marlings, Luton, LU2 8DL, UK
Oxazepam is recommended for short term use of approximately 2-4 weeks. As with all benzodiazepines, doctors should be aware that long term use may lead to dependence and withdrawal symptoms in certain patients.
Oxazepam is indicated for the short-term treatment of anxiety that is disabling or subjecting the individual to unacceptable distress, occurring alone or in association with psychosomatic, organic or psychotic illness.
Dosage and duration of therapy should be individualised and all patients receiving oxazepam should be carefully monitored and re-evaluated before any extension of the treatment period.
Long-term chronic use is not recommended.
As an anxiolytic, the lowest effective dose should be employed, for the shortest time possible; dosage regimes should not exceed beyond 4 weeks and treatment should always be withdrawn gradually to minimise possible withdrawal symptoms (see section 4.4).
Please note that in patients with renal or hepatic impairment, lower doses may be sufficient (see section 4.4).
Anxiety: 15-30mg three or four times daily.
Insomnia associated with anxiety: Generally 15-25mg one hour before retiring. This may be increased to a maximum of 50mg when necessary.
10-20mg three or four times a day.
Not recommended for children.
For oral administration.
Overdose of benzodiazepines, induced vomiting and/or gastric lavage should be undertaken (if ingestion was recent). Alternatively (if there is no advantage in emptying the stomach), is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion, ataxia, dysarthia, nystagmus and lethargy, in more serious cases, symptoms may include hypotension, respiratory depression and rarely coma.
As with other benzodiazepines, overdose should not present a threat to life unless combined with other CNS depressants (including alcohol).
In the management of overdose with any medicinal product, it should be borne in mind that multiple agents may have been taken.
Following overdose with oral benzodiazepines, activated charcoal should be considered to reduce absorption. 50g for adults and 10-15g for children if they have taken more than 1mg/kg within 1 hour, provided they are not too drowsy. Special attention should be paid to respiratory and cardiovascular functions in intensive care. Supportive measures are indicated depending on the patient’s clinical state. The patient is likely to sleep and therefore a clear airway should be maintained.
Hypotension, though unlikely, may be controlled with noradrenaline. The dialysability of oxazepam is minimal.
Flumazenil (Anexate), a benzodiazepine antagonist, is available but should rarely be required. It has a short half-life (about an hour). Flumazenil is NOT TO BE USED IN MIXED OVERDOSE OR AS A “DIAGNOSTIC” TEST.
3 years.
Store in a cool dry place. Store in the original container in order to protect from light.
A polypropylene tubular container with a tamper-evident tear strip in pack sizes of: 7, 14, 21, 28, 30, 50, 56, 60, 84, 90, 100, 112, 120, 250, 500 and 1000 tablets or PVdC coated PVC/Aluminium blisters (40g/m2 PVdC on 250µm PVC/25µm A1) in pack sizes of: 7, 14, 21, 28, 30, 50, 56, 60, 84, 90, 100, 112 and 120 tablets.
Not all pack sizes may be marketed.
No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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