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LORAZIUM is a brand name for Lorazepam. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Anxiety Benzodiazepines are only indicated for the short term relief (2 – 4 weeks only) of anxiety that is severe, disabling or subjecting the individual to extreme distress, occurring alone or in association with insomnia or short-term psychosomatic, organic or psychotic illness. Insomnia Benzodiazepines are only…
Verbatim from this product's MHRA label. Tap a section to expand.
4). Treatment should be given for the shortest possible duration. Anxiety Treatment should be as short as possible. The patient should be reassessed regularly and the need for continued treatment should be evaluated, especially in the case the patient is symptom free.
The overall duration of treatment generally should not be more than 2 - 4 weeks, including a tapering off process. In certain cases, extension beyond the maximum treatment period may be necessary; if so, it should not take place without re-evaluation of the patient’s status with special expertise.
Insomnia Treatment should be as short as possible. Generally, the duration of treatment varies from a few days to two weeks with a maximum, including tapering off process of four weeks. In certain cases, extension beyond the maximum treatment period may be necessary; if so, it should not take place without the re-evaluation of the patient’s status.
For all products: treatment should be started with the lowest recommended dose. The maximum dose should not be exceeded. The method of administration is by the oral route.
Adults dosage:
Anxiety: 1-4 mg daily in divided doses. Start with a low dose and increase gradually to achieve symptom control. Insomnia associated with anxiety: 1-2 mg at bedtime, for administration when required rather than regular use. Phobic and Obsessional/Compulsive State: 1-4 mg daily in divided doses.
Start with a low dose and increase gradually to achieve symptom control.
Premedication:
Preferably to be given the night before surgical or dental procedures, 2-3 mg. This dosage may be repeated one or two hours before operation and increased, if necessary, to 4 mg. 5 mg one-and- a-half hours to two hours before the treatment.
Elderly and patients with impaired liver and/or renal function:
Half the normal adult dose may be sufficient for a therapeutic response in the elderly.
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
Drowsiness, numbed emotions, reduced alertness, confusion, fatigue, headache, dizziness, muscle weakness, ataxia or double vision. These phenomena occur predominantly at the start of therapy and usually disappear with repeated administration.
Other adverse reactions like gastrointestinal disturbances, changes in libido or skin reactions have been reported occasionally. Amnesia Anterograde amnesia may occur using therapeutic dosages, the risk increasing at higher dosages.
Amnestic effects may be associated with inappropriate behaviour. (See Warnings and Precautions). Depression Pre-existing depression may be unmasked during benzodiazepine use. Psychiatric and paradoxical reactions 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 or benzodiazepinelike agents.
They may be quite severe with this product. They are more likely to occur in children and the elderly. 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.
).
Children:
Not recommended for children. 3 Contraindications Myasthenia gravis. Hypersensitivity to benzodiazepines. Severe respiratory insufficiency. Sleep apnoea syndrome. Severe hepatic insuffiency. LORAZIUM should not be given to patients with a sensitivity to the benzodiazepine group of drugs.
4 Special warnings and precautions for use Tolerance Some loss of efficacy to the hypnotic effects of benzodiazepines may develop after repeated use for a few weeks. Drug dependence, tolerance and potential for abuse Use of benzodiazepines may lead to the development of physical and psychic dependence upon these products.
The risk of dependence increases with dose and duration of treatment; it is also greater in patients with a history of alcohol or drug 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.
Myasthenia gravis. Hypersensitivity to benzodiazepines. Severe respiratory insufficiency. Sleep apnoea syndrome. Severe hepatic insuffiency. LORAZIUM should not be given to patients with a sensitivity to the benzodiazepine group of drugs.
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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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. Use (even at therapeutic doses) may lead to the development of physical dependence: discontinuation of the therapy may result in withdrawal or rebound phenomena (see Warnings and precautions).
Psychic dependence may occur. Abuse of benzodiazepines has been reported. 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.
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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 Lorazepam 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 Lorazepam should also be put in place with the patient before starting treatment (there may be exceptions to this in specific clinical situations such as symptom management in end of life palliative care).
Drug withdrawal syndrome may occur upon abrupt cessation of therapy or dose reduction. When a patient no longer requires therapy, it is advisable to taper the dose gradually to minimise symptoms of withdrawal. Tapering from a high dose may take in excess of weeks or months.
Patients should be informed of this when the medication is first prescribed. The reduction schedule for a patient should be tailored to the individual and should be modified to allow intolerable withdrawal symptoms to improve before making the next reduction.
If using a published withdrawal schedule, apply it flexibly to accommodate the person’s preferences, changes to their circumstances and the response to dose reductions. Suggest a slow stepwise rate of reduction proportionate to the existing dose, so that decrements become smaller as the dose is lowered, unless clinical risk is such that rapid withdrawal is needed.
If a patient develops withdrawal reactions, consider pausing the taper or increasing the dosage to the previous tapered dosage level. If women take this drug during pregnancy, there is a risk that their newborn infants will experience neonatal withdrawal syndrome.
Once physical dependence has developed, abrupt termination of treatment will be accompanied by withdrawal symptoms. These may consist of headaches, muscle pain, extreme anxiety, 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.
Rebound insomnia and anxiety: a transient syndrome 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. Duration of treatment The duration of treatment should be as short as possible (see Posology) depending on the indication, but should not exceed 4 weeks, including a tapering off process.
Extension beyond these periods should not take place without re-evaluation of the situation. Withdrawal phenomena can become manifest within the dosage interval, especially when the dosage is high. Amnesia Benzodiazepines may induce anterograde amnesia.
The condition occurs most often after several hours after ingesting the product and therefore to reduce the […]