Lorazepam 2.5mg Aristo tablets are pale yellow, circular, flat faced, bevel edged uncoated tablets with ‘2.5’ debossed on one side and deep breakable score line on other side, diameter 8.0 mm.
Each tablet contains 116.7 mg lactose (as lactose monohydrate).
• Symptomatic short-term treatment of anxiety and insomnia caused by anxiety, where the anxiety is severe, disabling or subjecting the individual to unacceptable distress
• Premedication before diagnostic procedures, or before surgical interventions
The dose and duration of use must be adjusted to the individual response, therapeutic indication and the severity of the illness. As a basic rule, the dose should be kept as low as possible and the duration of treatment as short as possible (not exceeding 4 weeks, including the tapering off process).
Treatment of anxiety and sleep disorders caused by anxiety
The daily dose is generally 0.5 to 2.5 mg lorazepam, divided into 2 to 3 single doses or as a single evening dose. In individual cases, especially in inpatient use, the daily dose can be increased to a maximum of 7.5 mg, taking all precautions into consideration.
If the main focus involves sleep disorders requiring treatment, the daily dose (0.5 to 2.5 mg lorazepam) can be taken as a single dose approximately half an hour before bedtime.
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).
For acute illnesses, the use of lorazepam should be limited to single doses or for a few days. For chronic illnesses, the duration of use depends on progression. After 2 weeks of daily intake, the physician should clarify by gradual dose reduction whether treatment with lorazepam is still indicated.
It should be noted that, after prolonged periods of use (more than 1 week) and upon abrupt withdrawal of this medicinal product, sleep disorders, states of anxiety and tension, inner restlessness and agitation may temporarily recur in exaggerated form. Treatment should therefore not be discontinued abruptly, but rather terminated by gradual dose reduction.
Premedication before diagnostic procedures or before surgical interventions
1 to 2.5 mg lorazepam on the evening before and/or 2 to 4 mg approximately 1 to 2 hours prior to the procedure.
The tablets can be taken independently of meals.
Elderly and debilitated patients
For elderly and debilitated patients reduce the initial dose by approximately 50 % and adjust the dosage as needed and tolerated (see section 4.4).
Patients with impaired hepatic function
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 the dose should be adjusted accordingly (see section 4.4). Lorazepam is contraindicated in patients with severe hepatic insufficiency (see section 4.3).
Patients with impaired renal function
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 the dose should be adjusted accordingly (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.
Aged less than 6 years:
Lorazepam is contraindicated in children under the age of six (see section 4.3).
Aged 6 – 12 years:
Premedication before diagnostic procedures or before surgical interventions: 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.
Aged 13 – 18 years:
Premedication before diagnostic procedures or before surgical interventions: 1–4 mg one to two hours prior to the operation.
Method of administration
Lorazepam Aristo is for oral use.
The tablet should be swallowed whole with some liquid (e.g. with half to one glass of water).
• hypersensitivity to the active substance, to other benzodiazepines or to any of the excipients listed above
• myasthenia gravis
• acute intoxication with alcohol or CNS depressants (e.g. hypnotics or analgesics, neuroleptics, antidepressants and lithium)
• history of alcohol or drug dependence
• severe hepatic insufficiency (may precipitate encephalopathy)
• sleep apnoea syndrome
• severe respiratory insufficiency (e.g. chronic obstructive pulmonary disease)
• children under 6 years
At the start of therapy, the treating physician should monitor the patient’s individual response to the medicinal product, so that any relative overdose can be detected as quickly as possible. This particularly applies to children, elderly patients, as well as patients with a diminished state of health. These patients may show a more sensitive response to the effect of lorazepam and should therefore be monitored more frequently during therapy.
Depression or other psychiatric disorders
Lorazepam is not intended for the primary treatment of psychotic illness or depressive disorders. In depressive patients, the possibility of emerging or worsening of depressive symptoms is to be expected. Benzodiazepine treatment can unmask suicidal tendencies in these patients; it should not be undertaken without adequate antidepressant therapy.
Some epidemiological studies indicate an increased incidence of suicide and suicide attempts in patients with or without depression, and treated with benzodiazepines or hypnotics, including lorazepam. However, a causal association has not been demonstrated.
Renal and hepatic impairment
Although bioavailability and metabolism of lorazepam are not significantly altered by renal dysfunction and are only significantly altered by severe hepatic dysfunction, caution should be exercised due to the observed greater sensitivity to the effect of these medicinal products; this also applies to elderly patients, who are at greater risk of falls, especially when they get up at night.
Exacerbation of hepatic encephalopathy may occur with the use of lorazepam.
Some patients taking benzodiazepines have developed blood dyscrasia, and some have had elevated levels of liver enzymes. Periodic haematological and hepatic function assessments are recommended where repeated courses of treatment are considered clinically necessary.
Although hypotension has occurred only rarely, benzodiazepines should be administered with caution in those patients in whom a drop in blood pressure may lead to cardiovascular or cerebrovascular complications; this is of particular importance in elderly patients.
Although lorazepam belongs to the benzodiazepines with a medium-long half-life, hang-over effects may occur, especially at higher doses and if the duration of sleep is too short. It should therefore be ensured that sufficient sleeping time (approximately 7 to 8 hours) is available .
Transient anterograde amnesia or memory impairment has been reported in association with the use of benzodiazepines.
Patients should also be given precise instructions on how to go about their everyday life, taking their particular lifestyle into consideration (e.g. occupation).
There have been uncommon reports of paradoxical reactions occurring with the use of benzodiazepines . Such reactions are to be expected especially in children and elderly people. Treatment with lorazepam should be discontinued if paradoxical reactions occur.
Potentially fatal respiratory depression may occur with use of benzodiazepines, including lorazepam.
Lorazepam can cause muscle weakness. Therefore, in patients with pre-existing muscle weakness or spinal or cerebellar ataxia special caution is required and a dose reduction may be necessary.
Acute narrow angle glaucoma
Caution should be used in the treatment of patients with acute narrow angle glaucoma.
Lorazepam has a primary dependence potential. Even when taken daily over a few weeks, there is a risk that psychological and physical dependence may develop. This applies not only to improper use of particularly high doses, but also to the therapeutic dose range. The risk increases with the duration of use and dose and is higher in patients with a history of alcohol or medicinal product abuse, as well as in patients with massive personality disorders. In principle, benzodiazepines should be prescribed only for short periods of time (e.g. 2 to 4 weeks). Continued use should proceed only when strictly indicated after careful consideration of the therapeutic benefit versus the risk of habituation and dependence. Long-term use of lorazepam is not recommended .
Dependence may lead to withdrawal symptoms, especially if treatment is discontinued abruptly. Therefore, lorazepam should always be discontinued gradually.
It may be useful to inform the patient that treatment will be of limited duration and that it will be discontinued gradually. The patient should also be made aware of the possibility of “rebound” phenomena to minimize anxiety should they occur.
Some loss of efficacy to the sedating effects (tolerance) of benzodiazepines may develop after repeated use for a few weeks.
Abuse of benzodiazepines has been reported. At particular risk are patients with a history of medicinal product and/or alcohol abuse.
Patients should be advised that since their tolerance for alcohol and other CNS depressants will be diminished in the presence of lorazepam, CNS depressants should be avoided or taken in reduced dose and alcohol should be avoided.
Risks from concomitant use with opioids:
Concomitant use of lorazepam and opioids may result in sedation, respiratory depression, coma, and death. Because of these risks, concomitant prescribing of benzodiazepines and opioids should be reserved for patients for whom alternative treatment options are not possible.
If a decision is made to prescribe lorazepam concomitantly with opioids, the lowest effective dose should be used and the duration of treatment should be as short as possible (see also general dose recommendation). The patients should be followed closely for signs and symptoms of respiratory depression and sedation. In this respect, it is strongly recommended to inform patients and their caregivers (where applicable) to be aware of these symptoms.
Severe anaphylactic/anaphylactoid reactions have been reported with benzodiazepine use. Following ingestion of the first dose or subsequent doses of benzodiazepines, cases of angioedema involving the tongue, glottis or larynx have been reported. Some patients have experienced other symptoms while taking benzodiazepines, such as dyspnoea, swelling of the throat or nausea and vomiting. Some patients had to be treated as a medical emergency. If angioedema occurs with involvement of the tongue, glottis or larynx, airway occlusion may occur and may be fatal. In patients experiencing angioedema during treatment with a benzodiazepine, re-exposure to the medicinal product should not take place.
Lorazepam should be used with caution in elderly due to the risk of sedation and/or musculoskeletal weakness that can increase the risk of falls, with serious consequences in this population. Elderly patients should be given a reduced dose.
Elderly patients should be warned of the risk of falls.
Children and adolescents under 18 years should not be treated with lorazepam, unless strictly indicated for sedation prior to diagnostic procedures, as well as before surgical procedures. For children under 6 years, lorazepam is contraindicated.
Lorazepam Aristo contains lactose. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.