Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Genus Pharmaceuticals Holding Limited, T/A Genus Pharmaceuticals, Linthwaite, Huddersfield, HD7 5QH, UK
Lormetazepam is indicated for the short term treatment of insomnia when it is disabling or subjecting the individual to extreme distress.
Dosage and duration of therapy should be individualised. The lowest effective dose should be prescribed for the shortest time possible. Generally, the duration of treatment varies from a few days to 2 weeks, with a maximum of 4 weeks including the tapering off process. Extension of the treatment period should not take place without re-evaluation of the need for continued therapy.
For patients with mild to moderate chronic respiratory insufficiency or hepatic insufficiency a dose reduction should be considered.
Since insomnia is often transient and intermittent, the prolonged administration of lormetazepam is generally unnecessary and is not recommended.
Treatment in all patients should be withdrawn gradually to minimise possible withdrawal symptoms (see Special Warnings and Precautions for Use).
0.5mg to 1.5mg before retiring.
Subsequently the initial dosage may be increased in individual cases if this proves necessary.
The lower adult dose is preferable for elderly patients.
Lormetazepam has not been evaluated for the treatment of children.
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. Special attention should be paid to respiratory and cardiovascular functions in intensive care. Hypotension, though unlikely, may be controlled with noradrenaline. Lormetazepam 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: 60 months.
Store in a cool dry place.
PVC/aluminium foil blister packs: Pack sizes of 28, 30 or 100 tablets.
Opaque polypropylene Securitainers: Pack sizes of 28, 30 or 100 tablets.
Amber glass bottles: Pack sizes of 28, 30 or 100 tablets.
None stated.
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