LORAZEPAM MACURE

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.