Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Genus Pharmaceuticals Holdings Limited, T/A Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK
Symptomatic relief of anxiety that is severe, disabling or subjecting the individual to unacceptable distress occurring alone or in association with insomnia or short-term psychometric, organic or psychotic illness.
Before operative dentistry and general surgery.
Not for use:
Oral.
Treatment to be given:
Doses should be individualised.
Extension of use should not take place without further clinical evaluation.
Chronic use not recommended (little is known of the long term safety and efficacy; potential for dependence–see section 4.4).
When treatment is started the patient should be informed that:
Anxiety: 1-4mg daily in divided doses.
Insomnia: 1-2mg before retiring.
Premedication before operative dentistry or general surgery: 2-3mg the night before operation 2-4mg one to two hours before the procedure.
The elderly may respond to lower doses (half normal adult dose or less).
Premedication: 0.5-2.5mg at 0.05mg/kg to the nearest 0.5mg according to weight, not less than one hour before operation.
Patients with Renal or Hepatic impairment: Lower doses may be sufficient in these patients (See section 4.4). Use in patients with severe hepatic insufficiency is contraindicated. (See section 4.6).
In the management of overdose with any drug, it should be borne in mind that multiple agents may have been taken.
Overdose of benzodiazepines is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion, and lethargy. In more serious cases, and especially when other CNS-depressant drugs or alcohol are ingested, symptoms may include ataxia, hypotension, hypotonia, respiratory depression, coma, and very rarely, death.
If ingestion was recent, induced vomiting and/or gastric lavage should be undertaken followed by general supportive care, monitoring of vital signs and close observation of the patient. If there is no advantage in emptying the stomach, activated charcoal may be effective in reducing absorption. Hypotension, though unlikely, may be controlled with noradrenaline. Lorazepam is poorly dialysable.
The benzodiazepine antagonist, flumazenil may be useful in hospitalised patients for the management of benzodiazepine overdose. Flumazenil product information should be consulted prior to use.
Shelf life: 24 months.
Store in a cool, dry place.
Blister packs of PVC backed by hard tempered aluminium foil: Pack sizes of 28, 30, 56, 60 or 100 tablets.
Opaque polypropylene Securitainers with opaque polythene caps: Pack sizes of 28, 30, 56, 60, 100, 500 or 1000 tablets.
Amber glass bottles with screw caps: Pack sizes of 28, 30, 56, 60, 100, 500 or 1000 tablets.
None stated.
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