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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.
4). Treatment should be given for the shortest possible duration. The dose 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.
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.
5 mg lorazepam on the evening before and/or 2 to 4 mg approximately 1 to 2 hours prior to the procedure. The orodispersible 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. The orodispersible tablets dissolve instantly in the mouth.
For swallowing, they can, if desired, be washed down with some liquid.
4. They may resolve spontaneously during the course of further therapy and/or upon dose reduction. 4) 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. 4 Special warnings and precautions). Symptoms reported following discontinuation of benzodiazepines include headaches, muscle pain, anxiety, tension, depression, insomnia, restlessness, confusion, irritability, sweating, and the occurrence of “rebound” phenomena whereby the symptoms that led to treatment with benzodiazepines recur in an enhanced form.
These symptoms may be difficult to distinguish from the original symptoms for which the drug was prescribed. In severe cases the following symptoms may occur: derealisation; depersonalisation; hyperacusis; tinnitus; numbness and tingling of the extremities; hypersensitivity to light, noise, and physical contact; involuntary movements; hyperreflexia, tremor, nausea, vomiting; diarrhoea, abdominal cramps, loss of appetite, agitation, palpitations, tachycardia, panic attacks, vertigo, short-term memory loss, hallucinations/delirium; catatonia; hyperthermia, convulsions.
Convulsions may be more common in patients with pre-existing seizure disorders or who are taking other drugs that lower the convulsive threshold such as antidepressants. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
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.
Other brands of Lorazepam in United Kingdom.
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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.
Drug dependence, tolerance and potential for abuse Drug addiction comprises behavioural, cognitive and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use and possible tolerance or physical dependence.
Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, which manifests as withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug.
Addiction and dependence are related but distinct presentations and in discussing these themes, terminology that apportion blame to the individual should be avoided. For all patients, prolonged use of this product may lead to drug dependence and addiction but can occur with short-term use at recommended therapeutic doses.
, major depression). Additional support and monitoring may be necessary when prescribing for patients at risk of drug misuse. A comprehensive patient history should be taken to document concomitant medications, including over-the-counter medicines and medicines obtained on-line, and past and present medical and psychiatric conditions.
Patients may find that treatment is less effective with chronic use and express a need to increase the dose to obtain the same level of symptom control as initially experienced. Patients may also supplement their treatment with additional medications to achieve the same effect.
These could be signs that the patient is developing tolerance. The risks of developing tolerance should be explained to the patient. Overuse or misuse may result in overdose and/or death. It is important that patients only use medicines that are prescribed for them at the dose they have been prescribed and do not give this medicine to anyone else.
Patients should be closely monitored for signs of misuse, abuse, or addiction. The clinical need for treatment with clonazepam should be reviewed regularly, with frequent assessments of patients being undertaken during the course of their treatment.
Drug withdrawal syndrome Prior to starting treatment with lorazepam, a discussion should be held with patients to explain the risk of dependence, addiction, and drug withdrawal syndrome. A withdrawal strategy for ending treatment with clonazepam should also be put in place with the patient […]