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LORAZEPAM ARISTO is a brand name for Lorazepam. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: • 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
Verbatim from this product's MHRA label. Tap a section to expand.
Posology 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).
5 mg lorazepam, divided into 2 to 3 single doses or as a single evening dose. 5 mg, taking all precautions into consideration. 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.
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. 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.
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. 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. 4). Paediatric population 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.
3). 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. g. with half to one glass of water).
4. They may resolve spontaneously during the course of further therapy and/or upon dose reduction. The following categories are used for expressing the frequency of adverse reactions: Very common: ≥1/10 Common: ≥1/100 to <1/10 Uncommon: ≥1/1,000 to <1/100 Rare: ≥ /10,000 to <1/1,000 Very rare: <1/10,000 Not known: cannot be estimated from the available data Blood and lymphatic system disorders Very rare: leucopenia Not known: thrombocytopenia, agranulocytosis, pancytopenia Nervous system disorders Benzodiazepines cause dose-dependent CNS depression.
Very common: sedation, fatigue, drowsiness Common: ataxia, confusion, depression, unmasking of depression, dizziness Uncommon: changes in libido, impotence, less intense orgasm Rare: reduced alertness Not known: prolonged response times, extrapyramidal symptoms, tremor, visual disturbances (diplopia, blurred vision), dysarthria/slurred speech, headache, convulsions/seizures, amnesia, disinhibition, euphoria, coma, suicidal thoughts/attempt, impaired attentiveness/concentration, balance disorders, vertigo, paradoxical reactions, such as anxiety, states of agitation, delusion, excitability, aggressive behaviour (hostility, aggression, rage), sleep disorders/insomnia, sexual arousal, hallucinations, psychoses.
If such reactions occur, treatment with Lorazepam Aristo should be terminated. g. sleep disorders, increased dreaming) may occur upon discontinuation of therapy, especially when abrupt. Anxiety, states of tension, as well as agitation and inner restlessness may recur in exaggerated form (rebound phenomena).
Other symptoms reported after discontinuation of benzodiazepines include headache, depression, confusion, irritability, sweating, dysphoria, dizziness, loss of reality, behavioural disorders, hyperacusis, numbness and tingling in the limbs, hypersensitivity to light and touch, impaired perception, involuntary movements, nausea, vomiting, diarrhoea, loss of appetite, hallucinations/delirium, convulsions/seizures, tremor, abdominal spasms, myalgia, states of agitation, palpitations, tachycardia, panic attacks, dizziness, hyperreflexia, short-term memory loss and hyperthermia.
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.
Suicidality 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. Blood dyscrasia 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.
1. g. g. chronic obstructive pulmonary disease) • children under 6 years
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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g. antidepressants), abrupt discontinuation may trigger more frequent seizures. The risk of withdrawal phenomena increases with the duration of use and dose. These phenomena can usually be avoided by gradual dose reduction. There are indications of tolerance development with regard to the sedative effect of benzodiazepines.
Lorazepam has an abuse potential. At particular risk are patients with a history of medicinal product and/or alcohol abuse. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
Hypotension 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.
Hang-over 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. 2). Amnesia Transient anterograde amnesia or memory impairment has been reported in association with the use of benzodiazepines.
g. occupation). 8). Such reactions are to be expected especially in children and elderly people. Treatment with lorazepam should be discontinued if paradoxical reactions occur. Respiratory depression Potentially fatal respiratory depression may occur with use of benzodiazepines, including lorazepam.
Muscle weakness 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.
Dependence 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. 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.
8). 8). 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.
Tolerance Some loss of efficacy to the sedating effects (tolerance) of benzodiazepines may develop after repeated use for a few weeks. Abuse Abuse of benzodiazepines has been reported. At particular risk are patients with a history of medicinal product and/or alcohol abuse.
Alcohol 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.
2). 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 […]