Revision Year: 2022 Publisher: Medochemie Ltd., 1-10 Constantinoupoleos Street, 3011 Limassol, Cyprus
Temelor is indicated for:
The dosage and duration of therapy should be individualised. The lowest effective dose should be prescribed for the shortest time possible. Since the risk of withdrawal and rebound phenomena is greater after abrupt withdrawal, the drug should be discontinued gradually for all patients (see section 4.4). The maximum daily dose of 4mg should not be exceeded.
In general 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 re-evaluation of the need for continued therapy. If the daily dose is taken as single dose in the evening it should not be taken on a full stomach. Due to a delayed onset of effect and depending on the length of the sleeping period a hang-over effect might be possible during the following day (see Section 4.4).
Initial dose 0.5 mg, 2-3 times a day, maintenance dose is up to 2.5mg per day. The daily dose can be divided in 2-3 separate doses given during the day or it can be taken as a single dose in the evening, half hour before retiring.
Initial dose 1mg before going to sleep, usual dose 1-2 mg before going to sleep.
2 mg – 4 mg, one to two hours prior to the operation.
For elderly and debilitated patients reduce the initial dose by approximately 50% and adjust the dosage as needed and tolerated (see section 4.4).
Lorazepam should not be used in children and adolescents under 18 years of age, as safety and efficacy have not been established in this population, except as indicated below.
Children under the age of six should not be treated with lorazepam.
Premedication before operative dentistry or surgery: 0.5 mg – 1 mg, or 0.05 mg/kg body weight should not be exceeded. The dose should be taken one to two hours prior to the operation.
Premedication before operative dentistry or surgery: 1–4 mg one to two hours prior to the operation.
Use in patients with severe hepatic impairment is contraindicated (see section 4.3).
In patients with moderate to mild hepatic impairment, lower doses may be adequate. The starting dose should be half the recommended adult dose. Such patients should be carefully monitored for clinical response and tolerability, and dosage adjusted accordingly (see section 4.4).
In patients with severe to mild renal impairment, lower doses may be adequate. The starting dose should be half the recommended adult dose. Such patients should be carefully monitored for clinical response and tolerability, and dosage adjusted accordingly (see section 4.4).
For oral administration.
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. In postmarketing experience, overdose with lorazepam has occurred predominantly in combination with alcohol and/or other medicinal products.
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 where alcohol or other CNS depressant medicinal products are ingested, symptoms may include dysarthria, ataxia, paradoxical reactions, CNS depression, hypotension, hypotonia, respiratory and cardiovascular depression, rarely coma, and very rarely death.
Following overdose with oral benzodiazepines, vomiting should be induced (within one hour) if the patient is conscious or gastric lavage undertaken with the airway protected if the patient is unconscious. If there is no advantage in emptying the stomach, activated charcoal should be given to reduce absorption. Thereafter treatment should be symptomatic and supportive. The patient should be maintained under close observation, with monitoring of vital signs. Special attention should be paid to respiratory and cardiovascular functions in intensive care.
Hypotension, although 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. See flumazenil product information before use. The doctor should be aware of a risk of seizure in association with flumazenil therapy, especially in long term benzodiazepine users and in cyclic antidepressant overdose.
15 months in opaque PVC/PE/PVDC – Aluminium blisters
24 months in Aluminium – Aluminium blisters
Store below 25°C. Store in original packaging to protect from light.
Lorazepam 1 and 2.5 mg: Blisters of opaque PVC/PE/PVDC – Aluminium or blisters of Aluminium – Aluminium.
Lorazepam 0.5 mg: Blisters of Aluminium – Aluminium.
Packs containing: 10, 14, 15, 20, 28, 30, 50, 60, 90, 100 and (hospital/pharmacy only) 500 tablets are available.
Not all pack sizes may be marketed.
No special requirements.
Any unused product or waste material should be disposed of in accordance with local requirements.
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