Lexotan 3MG. 6MG TABLET

LEXOTAN is indicated for the short term (2 - 4 weeks) symptomatic treatment of anxiety that is severe, disabling and subjecting the individual to extreme distress, occurring alone or in association with insomnia, or short term psychosomatic, general medical illness or psychotic disorders. Treatment should be as short as possible. The patient should be assessed regularly and the need for continued treatment should be re-evaluated especially when the patient is symptom-free.

Standard dosage
Average dose for outpatient therapy: 1.5 - 3 mg three times daily. Severe cases, in hospital: 6 - 12 mg two or three times daily. These amounts are general recommendations, and dosage should be individually determined. Treatment of outpatients should begin with the lowest dosage, gradually increasing, if necessary, to the optimum level. The maximum dose should not be exceeded. Elderly patients and those with impaired hepatic and/or renal function require lower doses because of individual variations in sensitivity and pharmacokinetics. The patient should be checked regularly at the start of treatment in order to minimize the dosage and/or the frequency of administration, and to prevent overdose due to accumulation. Doses should not exceed half the dose normally recommended for healthy adults.

Duration of treatment
The duration of treatment should be as short as possible. The patient should be reassessed regularly and the need for continued treatment should be evaluated, especially in case the patient is symptom free. The overall duration of treatment generally should not be more than 8 - 12 weeks, including a tapering-off process. The patient should be informed when treatment is started, that it will be of limited duration, and be explained precisely how the dosage will be progressively decreased. It is important that the patient be aware of the possibility of rebound phenomena that may occur while the medicine is being discontinued. See WARNINGS AND SPECIAL PRECAUTIONS - Medicine Abuse and Dependence.

• Myasthenia gravis.
• Pregnancy and lactation.
• Hypersensitivity to bromazepam, any other ingredient of LEXOTAN, or other benzodiazepines.
• Respiratory insufficiency, respiratory depression.
• Severe hepatic insufficiency (LEXOTAN is not indicated for the treatment of patients with severe hepatic insufficiency as it may cause encephalopathy).
• Psychotic patients and in those suffering from mental depression or suicidal tendencies, unless there is a marked component of anxiety in their illness.
• Sleep apnoea syndrome.
• Safety and efficacy of LEXOTAN has not been established in children. Paradoxical reactions such as excitement and irritability may occur in children. Smaller children are more prone to these reactions.
• Phobic or obsessional states.

LEXOTAN should not be used alone to treat depression or anxiety associated with depression, suicide may be precipitated in such patients. LEXOTAN is not recommended for the primary treatment of psychotic illness.

Amnesia
It should be borne in mind that LEXOTAN may induce anterograde amnesia. Anterograde amnesia may occur using therapeutic dosages, the risk increasing at higher dosages. Amnesic effects may be associated with inappropriate behaviour. The condition usually occurs several hours after taking the product and therefore, to reduce the risk, patients should ensure that they will be able to have an uninterrupted sleep of 7 to 8 hours. In cases of loss or bereavement, psychological adjustment may be inhibited by LEXOTAN.

Duration of treatment
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. It is important that the patient should be aware of the possibility of rebound phenomena that may occur while the medicine is being discontinued. See WARNINGS AND SPECIAL PRECAUTIONS - Medicine Abuse and Dependence.

General
When LEXOTAN is used, withdrawal symptoms may develop when changing to a benzodiazepine with a considerably shorter elimination half-life, see WARNINGS AND SPECIAL PRECAUTIONS - Medicine Abuse and Dependence. Treatment should be kept to a minimum and given close medical supervision. Little is known regarding the efficacy or safety of benzodiazepines such as LEXOTAN in long term use. Patients with known or presumed dependence on alcohol, medicines or drugs should not take benzodiazepines such as LEXOTAN, except in rare situations under medical supervision. See WARNINGS AND SPECIAL PRECAUTIONS - Medicine Abuse and Dependence.

Specific patient groups
Particular care is required in patients with chronic respiratory insufficiency, due to the risk of respiratory depression. In patients with respiratory insufficiency the dose should be decreased. Particular caution should be exercised with the elderly and debilitated who are at particular risk of over sedation, respiratory depression and ataxia. (The initial oral dosage should be reduced in these patients). See DOSAGE AND DIRECTIONS FOR USE. Patients with rare hereditary problems of galactose intolerance (the Lapp lactase deficiency or glucose-galactose malabsorption) should not use LEXOTAN.

The effect of LEXOTAN may be intensified by alcohol. Concomitant intake with alcohol should be avoided. If LEXOTAN is combined with other sedatives, its central-sedative effect may be enhanced. These medicines may include antidepressants, hypnotics, narcotic analgesics, antipsychotics, anxiolytics/sedatives, antiepileptic drugs, sedative antihistamines and anaesthetics. In the case of narcotic analgesics, enhancement of the euphoria may also occur, leading to an increase in psychological dependence. Compounds which inhibit certain hepatic enzymes (particularly, cytochrome P450) may enhance the activity of LEXOTAN. Co-administration of cimetidine may prolong the elimination half-life of LEXOTAN.

There is no evidence as to LEXOTANu2019s safe use in human pregnancy, nor is there evidence from animal work that is free from hazard. Do not use during pregnancy, especially during the first and last trimesters, unless there are compelling reasons. If LEXOTAN is prescribed to a woman of childbearing potential, she should be warned to contact her physician regarding discontinuance of the product if she intends to become or suspects that she is pregnant. The administration of high doses or prolonged administration of low doses of benzodiazepines such as LEXOTAN in the last trimester of pregnancy has been reported to produce irregularities in the foetal heart rate, and hypotonia, poor sucking, hypothermia and moderate respiratory depression in the neonate. Moreover, infants born to mothers who took benzodiazepines such as LEXOTAN chronically during the latter stages of pregnancy may develop physical dependence and may be at some risk for developing withdrawal symptoms in the postnatal period. Benzodiazepines have been detected in breast milk; therefore the use of LEXOTAN should be avoided during lactation.

Sedation, amnesia and impaired muscular function may adversely affect the ability to drive or use machinery, and therefore, patients receiving LEXOTAN should be advised not to drive motor vehicles, or operate dangerous machinery, or climb dangerous heights until it is established that they do not become drowsy or dizzy while receiving LEXOTAN therapy. In these situations impaired decision making could lead to accidents. These effects are increased if the patient has taken alcohol.

Psychiatric disorders: Confusional state, emotional disorder, libido disorder. Pre-existing depression may be unmasked during LEXOTAN use. Paradoxical reactions like restlessness, agitation, irritability, aggression, delusion, anger, nightmare, hallucination, psychotic disorder and abnormal behaviour are known to occur when using benzodiazepines or benzodiazepine-like agents, see WARNINGS AND SPECIAL PRECAUTIONS - Medicine Abuse and Dependence. Should this occur, the use of LEXOTAN should be discontinued. They are more likely to occur in children and elderly patients than in other patients. Chronic use (even at therapeutic doses) may lead to the development of physical dependence: discontinuation of therapy may result in withdrawal or rebound phenomena (see WARNINGS AND SPECIAL PRECAUTIONS - Medicine Abuse and Dependence). Psychological dependence may occur. Abuse of benzodiazepines such as LEXOTAN has been reported.

Nervous system disorders: Somnolence, depressed level of consciousness, headache, dizziness, ataxia, anterograde amnesia.

Eye disorders: Diplopia.

Gastrointestinal disorders: Gastrointestinal disorder.

Skin and subcutaneous tissue disorders: Skin reaction.

Musculoskeletal, connective tissue and bone disorders: Muscular weakness. An increased risk for falls and fractures has been recorded in elderly benzodiazepine users.

General disorders and administration site conditions: Fatigue. These phenomena occur predominantly at the start of therapy and may disappear with prolonged administration.

Social circumstances: Drug abuse.

Overdose of LEXOTAN is usually manifested by central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion, and lethargy. In most cases it is sufficient to monitor the vital functions and await recovery. Higher overdoses, especially in combination with other centrally acting medicines, including alcohol, can result in ataxia, hypotonia, hypotension, respiratory depression, coma, and death. In the management of overdose with any medicinal product, it should be borne in mind that multiple agents may have been taken.

Treatment
Monitor the patientu2019s vital signs and institute supportive measures as indicated by the patientu2019s clinical state. In particular, patients may require symptomatic treatment for cardiorespiratory effects or central nervous system effects. Further absorption should be prevented using an appropriate method e.g. treatment within 1-2 hours with activated charcoal. If activated charcoal is used airway protection is imperative for drowsy patients. In case of mixed ingestion gastric lavage may be considered, however not as a routine measure. If CNS depression is severe, consider the use of flumazenil, a benzodiazepine antagonist. This should only be administered under closely monitored conditions. It has a short half-life (about an hour), therefore patients administered flumazenil will require monitoring after its effects have worn off. Flumazenil is contraindicated in the presence of medicines that reduce seizure threshold (e.g. tricyclic antidepressants). Refer to the prescribing information for flumazenil, for further information on the correct use of this drug.