Lexotan Special Precautions

General: Amnesia: Benzodiazepines may induce anterograde amnesia. Anterograde amnesia may occur using higher therapeutic dosages (documented at 6 mg), the risk increasing at higher dosages.
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 drug is being discontinued (see Drug Abuse and Dependence as follows).
General precautions: Concomitant use of alcohol/CNS depressants: The concomitant use of Bromazepam (Lexotan) with alcohol or/and CNS depressants should be avoided. Such concomitant use has the potential to increase the clinical effects of Bromazepam (Lexotan) possibly including severe sedation, clinically relevant respiratory and/or cardiovascular depression, that could result in coma or death (see Interactions and Overdosage).
Medical history of alcohol or drug abuse: Bromazepam (Lexotan) should be used with extreme caution in patients with a medical history of alcohol or drug abuse (see Drug Abuse and Dependence as follows).
Tolerance: Some loss of response to the effects of Bromazepam (Lexotan) may develop after repeated use for a prolonged time.
Benzodiazepines should not be used alone to treat depression or anxiety associated with depression (suicide may be precipitated in such patients).
Benzodiazepines are not recommended for the primary treatment of psychotic illness.
Specific patient groups: In patients with myasthenia gravis who are prescribed Bromazepam (Lexotan), care should be taken on account of pre-existing muscle weakness. Particular care is required in patients with chronic respiratory insufficiency due to the risk of respiratory depression.
If the excipients include lactose (see Description), patients with rare hereditary problems of galactose intolerance (the Lapp lactase deficiency or glucose-galactose malabsorption) should not take this medicine.
Psychiatric and 'paradoxical' reactions: Paradoxical reactions such as restlessness, agitation, irritability, aggressiveness, anxiety, delusion, anger, nightmares, hallucinations, psychoses, inappropriate behaviour and other adverse behavioural effects are known to occur when using benzodiazepines. Should this occur, the use of the drug should be discontinued. They are more likely to occur in children and in the elderly.
Drug Abuse and Dependence: Dependence: The use of benzodiazepines and benzodiazepine-like agents may lead to the development of physical and psychological dependence upon these products (see Adverse Reactions).
The risk of dependence increases with dose and duration of treatment; it is also greater in patients with a medical history of alcohol and/or drug abuse. Therefore, Bromazepam (Lexotan) should be used with extreme caution in patients with a history of alcohol or drug abuse. Abuse has been reported more commonly in poly-drug abusers.
Withdrawal: Once physical dependence has developed, termination of treatment will be accompanied by withdrawal symptoms. These may consist of headaches, diarrhea, muscle pain, extreme anxiety, tension, restlessness, confusion and irritability. In severe cases the following symptoms may occur: derealization, depersonalization, hyperacusis, numbness and tingling of the extremities, hypersensitivity to light, noise and physical contact, hallucinations or convulsions (see Adverse Reactions).
When benzodiazepines are used, withdrawal symptoms may develop when switching to a benzodiazepine with a considerably shorter elimination half-life.
Rebound anxiety: Rebound anxiety, a transient syndrome whereby the symptoms that led to treatment with Bromazepam (Lexotan) 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 and rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended that the dosage be decreased gradually.
Ability to Drive and Use Machines: Sedation, amnesia and impaired muscular function may adversely affect the ability to drive or to use machinery. This effect is increased if the patient has taken alcohol (see Interactions).
Hepatic impairment: Benzodiazepines may have a contributory role in precipitating episodes of hepatic encephalopathy in patients with severe hepatic impairment (see Contraindications). Special caution should be exercised when administering Bromazepam (Lexotan) to patients with mild to moderate hepatic impairment.
Use in Children: See Special Dosage Instructions under Dosage & Administration.
Use in the Elderly: See Special Dosage Instructions under Dosage & Administration, Adverse Reactions and Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions.
The pharmacological effects of benzodiazepines appear to be greater in elderly patients than in younger patients, even at similar plasma benzodiazepine concentrations, possibly because of age-related changes in drug-receptor interactions, post-receptor mechanisms and organ function. A reduction in dose for patients above 50 years is recommended.