LORAZEPAM MACURE is a brand name for Lorazepam. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: As pre-operative medication or premedication for uncomfortable or prolonged investigations, e.g. bronchoscopy, arteriography, endoscopy. For the treatment of acute anxiety states, acute excitement or acute mania. Lorazepam Macure is indicated in adults, adolescents, children and infants from 1 month of age: for the…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Dosage and duration of therapy should be individualised. The lowest effective dose should be prescribed for the shortest time possible. 4). 5 mg for an average 70 kg man). By the intravenous route the injection should be given 30-45 minutes before surgery when sedation will be evident after 5-10 minutes and maximal loss of recall will occur after 30-45 minutes.
By the intramuscular route the injection should be given 1-1½ hours before surgery when sedation will be evident after 30-45 minutes and maximal loss of recall will occur after 60-90 minutes.
Paediatric population:
Lorazepam Macure 4 mg/ml solution for injection is not recommended in children under 12. 1 mg for an average 70 kg man). Repeat 6 hourly.
Paediatric population:
Lorazepam Macure 4 mg/ml solution for injection is not recommended in children under 12. Status epilepticus Adults: 4 mg intravenously. Paediatric population: 2 mg intravenously. 4).
Elderly:
The elderly may respond to lower doses and half the normal adult dose may be sufficient. 4). 4). Use in patients with severe hepatic insufficiency is contraindicated. 4). 6. Lorazepam Macure 4 mg/ml solution for injection can be given intravenously or intramuscularly.
However, the intravenous route is to be preferred. Care should be taken to avoid injection into small veins and intra-arterial injection. Absorption from the injection site is considerably slower if the intramuscular route is used and as rapid an effect may be obtained by oral administration of lorazepam.
Lorazepam Macure should not be used for long-term chronic treatment.
4 Special warnings and precautions). Investigations Increase in bilirubin, increase in liver transaminases, increase in alkaline phosphatase ± Benzodiazepine effects on the CNS are dose-dependent, with more severe CNS depression occurring with high doses.
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. β The extent of respiratory depression with benzodiazepines is dose-dependent, with more severe depression occurring with high doses.
Tolerance at the injection site is generally good although, rarely, pain and redness have been reported after lorazepam. 4). 4). 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.
2). Intravenous injection should be administered slowly except in the control of status epilepticus where rapid injection is required. After use It is recommended that patients receiving lorazepam should remain under observation for at least eight hours and preferably overnight.
When lorazepam is used for short procedures on an outpatient basis, the patient should be accompanied when discharged. Respiratory distress The possibility that respiratory arrest may occur or that the patient may have partial airway obstruction should be considered.
Therefore, equipment necessary to maintain a patent airway and to support respiration/ventilation should be available and used where necessary. Use of benzodiazepines, including lorazepam, may lead to potentially fatal respiratory depression.
g. chronic obstructive pulmonary disease [COPD]), because of the possibility that apnoea and/or cardiac arrest may occur. Care should also be exercised when administering lorazepam to a patient with status epilepticus, especially when the patient has received other central nervous system depressants.
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 and be fatal.
Patients who develop angioedema after treatment with a benzodiazepine should not be rechallenged with the drug. 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.
1. Acute pulmonary insufficiency. Sleep apnoea syndrome. Myasthenia gravis. Severe hepatic insufficiency. Lorazepam Macure 4 mg/ml solution for injection is not recommended for out-patient use unless the patient is accompanied. Lorazepam Macure is contraindicated in children under 12 years of age, except for the indication status epilepticus where it is contraindicated in neonates.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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 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.
Psychiatric illness 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.
Pre-existing depression may emerge during […]