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Lexatin

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Indications:

Bromazepam is an intermediate-acting tranquiliser, prescribed for the treatment of moderate to severe anxiety and panic disorders and for the short-term treatment of insomnia. Unlike the benzodiazepine alprazolam it does not possess any antidepressant qualities. In low doses it diminishes anxiety and tension. In higher doses the sedative and muscle-relaxant properties appear.

Contraindications:

contraindicated in patients with: • known hypersensivity to benzodiazepines • severe respiratory insufficiency, including chronic obstructive airways disease with incipient respiratory failure • severe hepatic insufficiency as it may cause encephalopathy • sleep apnoea syndrome • myasthenia gravis. may precipitate suicide or aggressive behavior, not used alone to treat depression or anxiety associated with depression

Adverse reactions:

Psychiatric Disorders: Confusional state, emotional disturbances, libido disorders, nervousness and depression have been reported. Paradoxical reactions such as restlessness, agitation, irritability, aggression, delusion, anger, nightmares, sleep disorders, hallucinations, psychosis, inappropriate behaviour and other adverse behavioural effects are known to occur with benzodiazepines or benzodiazepine-like agents. Should this occur, the use of LEXOTAN should be discontinued. Such reactions are more likely to occur in children and elderly patients than in other patients. Dependence: Chronic use (even at therapeutic doses) may lead to the development of physical and psychic drug dependence: discontinuation of therapy may result in withdrawal or rebound phenomena . Abuse of benzodiazepines has been reported. Nervous System Disorders: Drowsiness and ataxia become less common with repeated administration. Headache, dizziness, decreased alertness, seizures, tremor, speech disorders and incontinence have been reported. Anterograde amnesia may occur using therapeutic dosages with the risk increasing at higher dosages. Amnestic effects may be associated with inappropriate behaviour. Eye Disorders: Diplopia and blurred vision have been reported. Gastrointestinal Disorders: Gastrointestinal disorders, dry mouth, nausea and vomiting have been reported. Metabolic and Nutritional Disorders: Anorexia has been reported. Skin and Subcutaneous Tissue Disorders: Skin reactions including pruritis and rash have been reported. Musculoskeletal and Connective Tissue Disorders: Muscle weakness and muscle spasm have been reported. General Disorders and Administration Site Conditions: Fatigue. Injury, Poisoning and Procedural Complications: An increased risk for falls and fractures has been reported in elderly benzodiazepine users. Respiratory Disorders: Respiratory depression has been reported. Cardiac Disorders: Cardiac failure including cardiac arrest, hypotension, tachycardia and palpitations have been reported. Investigations: Instances of decreased haemoglobin and increased white cell counts have been reported.

Interactions:

LEXOTAN undergoes hepatic microsomal oxidation via the cytochrome P450 liver enzymes. Therefore, caution should be taken in patients taking medicines that inhibit the P450 liver enzymes (e.g. azole antifungals, macrolide antibiotics, HIV protease inhibitors, calcium channel blocking agents). LEXOTAN undergoes oxidative metabolism and, consequently, may interact with disulfiram or cimetidine resulting in increased plasma levels of LEXOTAN. Patients should be observed closely for evidence of enhanced benzodiazepine response during concomitant treatment with either disulfiram or cimetidine; some patients may require a reduction in benzodiazepine dosage. The benzodiazepines, including LEXOTAN, produce additive CNS depressant effects when coadministered with other medications which themselves produce CNS depression e.g. barbiturates, alcohol, sedatives, antidepressants, hypnotics, anxiolytics, phenothiazines and other antipsychotics, skeletal muscle relaxants, antihistamines, narcotic analgesics and anaesthetics. Alcohol should be avoided in patients receiving LEXOTAN. In the case of narcotic analgesics enhancement of euphoria may also occur, leading to an increase in psychic drug dependence. The anticholinergic effects of atropine and similar medicines, antihistamines and antidepressants may be potentiated. Interactions have been reported between some benzodiazepines and anticonvulsants, with changes in the serum concentration of the benzodiazepine or anticonvulsant. It is recommended that patients be observed for altered responses when benzodiazepines and anticonvulsants are prescribed together and that serum level monitoring of the anticonvulsant be performed more frequently. Interference with Clinical, Laboratory or Other Tests: Minor EEG changes, usually low voltage fast activity, of no known clinical significance, has been reported with benzodiazepine administration.

Warnings:

caution should be taken while using this medication with known hypersensitivity to benzodiazepines, acute closed-angle glaucoma, myasthenia gravis, liver or kidney disease, history of alcohol or substance abuse, chronic lung disease, epilepsy, mental illness or depression, sleep apnoea. Pregnancy: CATEGORY C . Potential risk to the foetus has been reported. Consult your doctor before use, or if you are planning to fall pregnant. Breastfeeding: Avoid. This medication is passed through breast milk and may affect your baby adversely. Consult your doctor before use. Porphyria:This medication may cause serious adverse effects. Consult your doctor before use. Infants and children: This medication is not intended for use in children. Elderly: Use with caution as side effects may be emphasised. Dosage may need adjustment. Driving and hazardous work: This medication should be avoided as it may cause extreme sedation. Alcohol: Bromazepam's effect may intensify the effect of alcohol and vice versa. Do not consume alcohol while taking this medication as side effects may be drastically pronounced.

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