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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: Lorazepam tablets are recommended for short term use of approximately 2-4 weeks for adults only, as long term use may lead to dependence and withdrawal symptoms Lorazepam is indicated for: • Short-term symptomatic treatment of anxiety and insomnia caused by anxiety, where the anxiety is severe, disabling or subjecting…
Verbatim from this product's MHRA label. Tap a section to expand.
General:
For oral administration. The dosage and duration of therapy should be individualised. The lowest effective dose should be prescribed for the shortest time possible. 4). The maximum daily dose of 4mg should not be exceeded. In general the duration of treatment varies from a few days to 4 weeks, including the tapering off process.
Extension of the treatment period should not take place without re-evaluation of the need for continued therapy. If the daily dose is taken as single dose in the evening it should not be taken on a full stomach. 4).
Adults:
Anxiety: 1-4mg daily in divided doses.
Insomnia caused by anxiety:
Initial dose of 1mg before retiring to sleep. Usual Dose 1-2mg before retiring to sleep. 5mg, 1 ½-2 hours before dental treatment. Premedication before operative dentistry or surgery: 2mg – 4mg, one to two hours prior to the operation Children and adolescents: 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.
1mg/kg (max. 4mg) at least one hour before procedure.
Aged 12 – 18 years and Adults:
Premedication before operative dentistry or surgery: 1–4 mg at least one hour before procedure. Same dose may be given the night before procedure in addition to, or to replace dose before procedure. Not recommended for use in children under 5 years of age.
Elderly and debilitated patients:
The elderly and debilitated patients may respond to lower doses and half the normal adult dose or less may be adequate. The starting dose should be half of the recommended adult dose. This initial dose should be adjusted according to clinical response and tolerance.
3). In patients with moderate to mild hepatic impairment, lower doses may be adequate. The starting dose should be half the recommended adult dose. 4).
Renal impairment:
In patients with severe to mild renal impairment, lower doses may beadequate. The starting dose should be half the recommended adult dose. 4). 4). Treatment should be given for the shortest possible duration. If this medicine is being used for the treatment of epilepsy this medicine should be used for as long as the prescriber considers it necessary.
). Therefore, the drug should always be discontinued gradually. Withdrawal symptoms may consist of headaches, muscle pain, extreme anxiety, sleep disorders, tension, restlessness, confusion and irritability. In severe cases the following symptoms may occur: derealisation, depersonalisation, Hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures.
Seizures may be more common in patients with pre –existing seizure disorders, or who are taking other drugs that lower the seizure threshold such as antidepressants. The patient should also be made aware of the possibility of "rebound" phenomena to whereby the symptoms that led to treatment with a benzodiazepine recur in an enhanced form may occur on withdrawal of treatment.
It may be accompanied by other reactions including mood changes, anxiety or sleep disturbances and restlessness. Since the risk of withdrawal phenomena / rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended that the dosage is decreased gradually.
After abrupt termination of treatment withdrawal symptoms can occur even after several days of treatment and at therapeutic doses. Tolerance: • Some loss of efficacy to the hypnotic effects of short-acting benzodiazepines may develop after repeated use for a few weeks.
There is evidence that tolerance developsto the sedative effects of benzodiazepines. • Lorazepam may have abuse potential, especially in patients with a history of alcohol and / or drug abuse. Specific patients groups: • Benzodiazepines should not be given to children without careful assessment of the need to do so; the duration of treatment must be kept to a minimum.
• 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.
• 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. • Use of benzodiazepines, including lorazepam, may lead to potentially fatal respiratory depression.
Severe anaphylactic / anaphylactoid reactions have been reported with the use of benzodiazepines. Cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of benzodiazepines.
Some patients taking benzodiazepines have had additional symptoms, such as dyspnoea, throat closing, or nausea and vomiting. Some patients have required medical therapy in the emergency department. If angioedema involves the tongue, glottis or larynx, airway obstruction may occur, which may be fatal.
Patients who develop Angioedema following treatment with a benzodiazepine should not be rechallenged. Abuse of benzodiazepines has been reported, particularly in patients with a history of drug 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 either be avoided or taken in reduced dosage and alcohol should be avoided.
• 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, it is necessary to take suitable precautions and to prescribe appropriate amounts as large quantities of Lorazepam should not be prescribed to these patients. • Benzodiazepines should be used with extreme caution in patients with a history of alcohol or drug abuse.
1). • Acute pulmonary insufficiency, Respiratory depression, Chronic psychosis, phobic or obsessional states. • Myasthenia gravis, sleep apnoea syndrome, severe hepatic insufficiency and acute porphyria. 4)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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• 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 haematological and liver-function assessments are recommended where repeated courses of treatment are considered clinically necessary. • Caution should be used in the treatment of patients with acute narrow-angle glaucoma. Amnesia: • 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). Psychiatric and paradoxical reactions: • Psychiatric and Paradoxical reactions like restlessness, agitation, irritability, aggressiveness, delusion,rages, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects are known to occur when using benzodiazepines have been occasionally reported during benzodiazepine use.
Such reactions may be more likely to occur in children and the elderly. Should these occur, use of the drug should be discontinued (see Undesirable Effects). 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. Elderly patients should be warned of the risk of falls due to the myelo relaxant effect of lorazepam. Caution should be used in patients with ataxia and acute intoxication with alcohol or other CNS active agents.
Contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. 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 […]
2) depending on the indication, generally it varies from a few days up to 4 weeks, including the tapering off process. Extension beyond these periods should not take place without re – evaluation of the situation. It may be useful to inform the patient when treatment is started that it will be of limited duration and to explain precisely how the dosage will be progressively decreased.
Moreover it is important that the patient should be aware of the possibility of rebound phenomena, thereby minimising anxiety over such symptoms should they occur while the medicinal product is being discontinued. There are indications that, in the case of benzodiazepines with a short duration of action, withdrawal phenomena can become manifest within the dosage interval, especially when the dosage is high.
When benzodiazepines with a long duration of action are being used it is important to warn against changing to a benzodiazepine with a short duration of action, as withdrawal symptoms may develop. Dependence: • Pre-existing depression may emerge during benzodiazepine use.
The use of benzodiazepines may lead to physical and psychological dependence upon these products. The risk of dependence 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. • Dependence may lead to withdrawal symptoms, especially if treatment is discontinued abruptly. 8 Undesirable effects). Therefore, the drug should always be discontinued gradually.
Withdrawal symptoms may consist of headaches, muscle pain, extreme anxiety, sleep disorders, tension, restlessness, confusion and irritability. In severe cases the following symptoms may occur: derealisation, depersonalisation, Hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or epileptic seizures.
Seizures may be more common in patients with pre –existing seizure disorders, or who are taking other drugs that lower the seizure threshold such as antidepressants. The patient should also be made aware of the possibility of "rebound" phenomena to whereby the symptoms that led to treatment with a benzodiazepine recur in an enhanced form may occur on withdrawal of treatment.
It may be accompanied by other reactions including mood changes, anxiety or sleep disturbances and restlessness. Since the risk of withdrawal phenomena / rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended that the dosage is decreased gradually.
After abrupt termination of treatment withdrawal symptoms can occur even after several days of treatment and at therapeutic doses. Tolerance: • Some loss of efficacy to the hypnotic effects of short-acting benzodiazepines may develop after repeated use for a few weeks.
There is evidence that tolerance developsto the sedative effects of benzodiazepines. • Lorazepam may have abuse potential, especially in patients with a history of alcohol and / or drug abuse. Specific patients groups: • Benzodiazepines should not be given to children without careful assessment of the need to do so; the duration of treatment must be kept to a minimum.
• 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.
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