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LORAZEPAM is a brand name for Lorazepam. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: FOR SHORT TERM (2-4 weeks only) USE (adults only) • Symptomatic relief of anxiety that is severe, disabling or subjecting the individual to unacceptable distress occurring alone or in association with insomnia or short- term psychometric, organic or psychotic illness. AS PREMEDICATION (adults and children 5 years and…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Treatment to be given: • under close medical supervision • at the lowest effective dose • for the shortest possible duration (not exceeding 4 weeks) Doses should be individualised. Extension of use should not take place without further clinical evaluation.
4). When treatment is started the patient should be informed that: • treatment will be of limited duration • the dosage will be progressively decreased • there is a possibility of rebound phenomena.
Dosage:
Adults Anxiety: 1-4mg daily in divided doses. Insomnia: 1-2mg before retiring Pre-medication before operative dentistry or general surgery: 2-3 mg the night before operation, 2-4 mg one to two hours before the procedure. 4). 5mg according to weight, not less than one hour before operation.
4). 6). Method of administration For oral use.
Adverse reactions, when they occur, are usually observed at the beginning of therapy and generally decrease in severity or disappear with continued use or upon decreasing the dose. Most frequently reported adverse reactions associated with benzodiazepines include daytime drowsiness, dizziness, muscle weakness, and ataxia.
Adverse reactions are listed by frequency:
Very common (≥1/10) Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 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: Thrombocytopenia, leucopenia, agranulocytosis, pancytopenia.
Immune system disorders Very rare:
Hypersensitivity including anaphylaxis/anaphylactoid reactions.
Endocrine disorders Very rare:
Inappropriate antidiuretic hormone secretion, hyponatraemia.
Psychiatric disorders Rare:
Confusion, depression and unmasking of depression, numbed emotions, disinhibition, euphoria, appetite changes, sleep disturbance, change in libido, decreased orgasm.
Unknown:
Dependence, Suicidal ideation/attempt. Paradoxical reactions such as restlessness, agitation, irritability, aggressiveness, delusion, rage, insomnia, nightmares, hallucinations, psychoses, sexual arousal, and inappropriate behaviour have been occasionally reported during use.
Nervous system Very common:
Daytime drowsiness, sedation.
Common:
Patients should be advised that since their tolerance for alcohol and other CNS depressants will be diminished in the presence of lorazepam, these substances should either be avoided or taken in reduced dosage. Lorazepam is not intended for the primary treatment of psychotic illness or depressive disorders and should not be used alone to treat depressed patients.
The use of benzodiazepines may have a disinhibiting effect and may release suicidal tendencies in depressed patients. Therefore, large quantities of lorazepam should not be prescribed to these patients. Pre-existing depression may emerge during benzodiazepine use.
The use of benzodiazepines may lead to physical and psychological dependence. The risk of dependence on lorazepam is low when used at the recommended dose and duration, but increases with higher doses and longer- term use. The risk of dependence is further increased in patients with a history of alcoholism or drug abuse, or in patients with significant personality disorders.
Therefore, use in individuals with a history of alcoholism or drug abuse should be avoided. 8). Therefore, the drug 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 minimise anxiety should they occur. Abuse of benzodiazepines has been reported. Some loss of efficacy to the hypnotic effects of short-acting benzodiazepines may develop after repeated use for a few weeks.
Anxiety or insomnia may be a symptom of several other disorders. The possibility should be considered that the complaint may be related to an underlying physical or psychiatric disorder for which there is more specific treatment. Caution should be used in the treatment of patients with acute narrow-angle glaucoma.
6)) • Myasthenia gravis • Benzodiazepines should not be used alone in depression or anxiety with depression (may precipitate suicide).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Dizziness, ataxia. Rare: headache, reduced alertness, dysarthria/slurred speech, transient anterograde amnesia or memory impairment. 9).
Eye disorders Rare:
Visual disturbances (diplopia, blurred vision). 4).
Respiratory, thoracic and mediastinal disorders Rare:
Apnoea, worsening of sleep apnoea, worsening of obstructive pulmonary disease. 9).
Gastrointestinal disorders Rare:
Nausea, constipation, salivation changes.
Hepatobiliary disorders Rare:
Abnormal liver function test values (increases in bilirubin, transaminases, alkaline phosphatise), jaundice.
Skin and subcutaneous tissue disorders Rare:
Rash, allergic dermatitis.
Musculoskeletal disorders Common:
Muscle weakness.
Reproductive system and breast disorders Rare:
Impotence.
General disorders Common:
Asthenia, fatigue.
Very rare:
Hypothermia. 4) 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.
Injury, poisoning and procedural complications Not known:
Fall 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.
Patients with impaired renal or hepatic function should be monitored frequently and have their dosage adjusted carefully according to patient response. Lower doses may be sufficient in these patients. The same precautions apply to elderly or debilitated patients and patients with chronic respiratory insufficiency.
As with all CNS-depressants, the use of benzodiazepines may precipitate encephalopathy in patients with severe hepatic insufficiency. Therefore, use in these patients is contraindicated. Some patients taking benzodiazepines have developed a blood dyscrasia, and some have had elevations in liver enzymes.
Periodic haematologic and liver- function assessments are recommended where repeated courses of treatment are considered clinically necessary. Transient anterograde amnesia or memory impairment has been reported in association with the use of benzodiazepines.
This effect may be advantageous when lorazepam is used as a premedicant. , 7-8 hours). Paradoxical reactions have been occasionally reported during benzodiazepine use. Such reactions may be more likely to occur in children and the elderly.
8). Although hypotension has occurred only rarely, benzodiazepines should be administered with caution to patients in whom a drop in blood pressure might lead to cardiovascular or cerebrovascular complications. This is particularly important in elderly patients.
Risk from concomitant use of opioids:
Concomitant use of lorazepam and opioids may result in sedation, respiratory depression, coma and death. Because of these risks, concomitant prescribing of sedative medicines such as benzodiazepines or related drugs such as lorazepam with opioids should be reserved for patients for whom alternative treatment options are not possible.
2). The patient should be followed closely for signs and symptoms of respiratory depression and sedation. 5). This medicine contains lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Elderly patients Lorazepam should be used with caution in the elderly due to the risk of sedation and/or musculoskeletal weakness that can increase the risk of falls, with serious consequences in this population. 2).