LORANS Tablet Ref.[28191] Active ingredients: Lorazepam

Posology

Dosage and duration of therapy should be individualised. The lowest effective dose should be prescribed for the shortest time possible. The risk of withdrawal and rebound phenomena is greater after abrupt discontinuation; therefore, the drug should be discontinued gradually for all patients (see section 4.4). Generally, the duration of treatment varies from a few days to 4 weeks including the tapering off process. Extension of the treatment period should not take place without reevaluation of the need for continued therapy.

Increases in the dosage of lorazepam should be made gradually to help avoid adverse effects. The evening dose should be increased before the daytime doses.

Dosage

Adults

Moderate and severe anxiety:

• 1-4 mg daily in divided doses.

Insomnia:

• 1-2 mg before going to bed.

Premedication before operative dentistry or general surgery:

• 2-3mg the night prior to the operation;
• 2-4mg one to two hours prior to the operation.

Elderly and debilitated patients

Elderly and debilitated patients usually may respond to lower doses and half the normal adult dose or less may be sufficient.

This initial dose should be adjusted as needed and tolerated.

Paediatric population (aged 5-13 years)

Lorans is not recommended for the treatment of anxiety or insomnia in children.

Premedication:

• 0.5 to 2.5 mg, based on a dosage of 0.05 mg/kg, to the nearest 0.5mg according to bodyweight, not less than one hour prior to the surgery.

Hepatic or renal impairment

Lower doses may be sufficient in patients with impaired renal function or mild to moderate hepatic insufficiency (see section 4.4). Use in patients with severe hepatic insufficiency is contraindicated (see section 4.3).

Method of administration

The tablets are for oral administration.

Symptoms

In the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken. In postmarketing experience, overdose with lorazepam has occurred predominantly in combination with alcohol and/or other drugs.

Overdosage 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 dysarthia, ataxia, paradoxical reactions, CNS depression, hypotension, hypotonia, respiratory depression, cardiovascular depression, coma, and very rarely, death.

Treatment

When there is a risk of aspiration, induction of emesis is not recommended. 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. Lorazepam glucuronide, the inactive metabolite, may be highly dialysable.

The benzodiazepine antagonist, flumazenil may be useful in hospitalised patients as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. Flumazenil product information should be consulted prior to use. The physician should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose.

5 years.

Store below 25°C, in the original package.

Lorans tablets (1mg and 2mg) are packed in aluminium foil-PVC film blisters. Packs containing 50 tablets, 100, 500 or 1000 tablets are available.

Not all pack sizes may be marketed.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.