Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
Pre-operative medication or premedication for uncomfortable or prolonged investigations, e.g. bronchoscopy, arteriography, endoscopy.
The treatment of acute anxiety states, acute excitement or acute mania.
The control of status epilepticus.
Dosage and duration of therapy should be individualised. The lowest effective dose should be prescribed for the shortest time possible.
Treatment in all patients should be withdrawn gradually to minimise possible withdrawal symptoms (See section 4.4).
Ativan Injection can be given intravenously or intramuscularly. However, the intravenous route is to be preferred. Care should be taken to avoid injection into small veins and intra-arterial injection.
Absorption from the injection site is considerably slower if the intramuscular route is used and as rapid an effect may be obtained by oral administration of lorazepam.
Ativan should not be used for long-term chronic treatment.
Ativan Injection is slightly viscid when cool.
Intramuscular administration: A 1:1 dilution of Ativan Injection with normal saline or Sterile Water for Injection BP is recommended in order to facilitate intramuscular administration.
Intravenous administration: For intravenous administration, Ativan Injection should always be diluted with saline or Sterile Water for Injection BP as a 1:1 dilution.
Ativan Injection is presented as a 1ml solution in a 2ml ampoule to facilitate dilution.
Ativan Injection should not be mixed with other drugs in the same syringe.
Adults: 0.05mg/kg (3.5mg for an average 70kg man). By the intravenous route the injection should be given 30-45 minutes before surgery when sedation will be evident after 5-10 minutes and maximal loss of recall will occur after 30-45 minutes.
By the intramuscular route the injection should be given 1-11/2 hours before surgery when sedation will be evident after 30-45 minutes and maximal loss of recall will occur after 60-90 minutes.
Paediatric population: Ativan Injection is not recommended in children under 12.
Adults: 0.025-0.03mg/kg (1.75-2.1mg for an average 70kg man). Repeat 6 hourly.
Paediatric population: Ativan Injection is not recommended in children under 12.
Adults: 4mg intravenously.
Paediatric population: 2mg intravenously.
Elderly: The elderly may respond to lower doses and half the normal adult dose may be sufficient.
Lower doses may be sufficient in these patients (See section 4.4). Use in patients with severe hepatic insufficiency is contraindicated.
For elderly and debilitated patients reduce the initial dose by approximately 50% and adjust the dosage as needed and tolerated (see section 4.4 Special warnings and precautions for use).
In the management of overdosage with any drug, it should be borne in mind that multiple agents may have been taken.
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 ataxia, hypotension, hypotonia, respiratory depression, cardiovascular depression, coma and, very rarely, death.
Propylene glycol toxicity and polyethylene glycol toxicity have been reported following higher than recommended doses of Ativan Injection (see section 4.4).
Treatment of overdosage is mainly supportive including monitoring of vital signs and close observation of the patient. An adequate airway should be maintained and assisted respiration used as needed. 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 overdosage. 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 tricyclic antidepressant overdose.
1 year.
Store and transport refrigerated (2°C to 8°C).
Keep ampoule in the outer carton to protect from light.
1ml solution in 2ml ampoules (Type I glass) with a one-point-cut opening, position marked by red spot in pack sizes of 10.
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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