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| Calmepam |
PRECAUTIONS: Calmepam
In patients with chronic pulmonary insufficiency and in patients with chronic renal or hepatic disease, dosage may need to be reduced.
Calmepam should not be used alone to treat depression and anxiety associated with depression, since suicide may be precipitated in such patients.
Amnesia may occur. If Calmepam is combined with centrally-acting drugs such as neuroleptics, tranquilisers, antidepressants, hypnotics, analgesics and anaesthetics, the sedative effects are likely to be intensified. The elderly require special supervision.
Patients should be advised that, like all medicaments of this type, Calmepam may modify patients, performance at skilled tasks (driving, operating machiner etc) to a varying degree depending upon dosage, administration and individual susceptibility. Patients should further be advised that alcohol may intensify any impairment and should therefore be avoided during treatment.
The dependence potential of the benzodiazepines is low, particularly when limited to short- term use, but this increases when high doses are used, especially when given overlong periods. This is particularly so in patients with a history of alcoholism or drug abuse or inpatients with marked personality disorders. Regular monitoring in such patients is essential, routine repeat prescriptions should be withdrawn gradually. Symptoms such as depression, nervousness, rebound insomnia, irritability, sweating, and diarrhoea have been reported following abrupt cessation of treatment in patients receiving even normal therapeutic doses for short periods of time. In rare instances, withdrawal following excessive dosages may produce confusional states, psychotic manifestations and convulsions.
Abnormal psychological reactions to benzodiazepines have been reported. Rare behavioral effects include paradoxical aggressive outbursts, excitement, confusion and the uncovering of depression with suicidal tendencies. Extreme caution should therefore be used in prescribing benzodiazepines to patients with personality disorders.
When Calmepam is used in conjunction with antiepileptic drugs, side effects and toxicity may be more evident, particularly with hJantoins or barbiturates or combinations including them. This requires extra care in adjusting dosage in the initial stages of treatment.
Known inhibitors of hepatic enzymes, e.g. cimetidine, have been shown to reduce the clearance of benzodiazepines and maypotentiate their action and known inducers of hepatic enzymes, e.g. rifampicin, may increase the clearance of benzodiazepines.
SIDE EFFECTS AND A[WERSE REACTIONS:
Common adverse effects include drowsiness, sedation, unsteadiness and ataxia; these are dose- related and may persist into the following day, even after a single dose. Drowsiness may be iarticutar probTerww1iwCatmepam isusedin higherttosagein 5orn patients, especially if they are unused to this form of therapy The elderlyare particularly sensitive to the effects of centrally depressant drugs and may experience confusion, especially if organic brain changes are present; dosage of Calmepam should not exceed one-half that recommended for other adults.
Other adverse effects are rare and include headache, vertigo, hypotension, gastro-intestinal upsets, skin rashes, casual disturbances, changes in libido, and urinary retention. Isolated cases of blood dyscrasias and jaundice have also been reported.
TREATMENT OF YJERDOSAGE:
When taken alone in overdosage, Calmepam presents few problems in management. Signs may include drowsiness, ataxia and dysarthria, with coma in severe cases. Treatment is symptomatic. Gastric lavage is useful only if performed soon after ingestion.
The value of dialysis has not been determined. Anexate is a specific IV antidote for use in emergency situations. Patients requiring such intervention should be monitored closely in hospital.
If excitation occurs, barbiturates should not be used. When taken with centrally-acting drugs, especially alcohol, the effects of overdosage likely to be more severe and, in the absence of supportive measures, may prove fatal.
In patients with chronic pulmonary insufficiency and in patients with chronic renal or hepatic disease, dosage may need to be reduced.
Calmepam should not be used alone to treat depression and anxiety associated with depression, since suicide may be precipitated in such patients.
Amnesia may occur. If Calmepam is combined with centrally-acting drugs such as neuroleptics, tranquilisers, antidepressants, hypnotics, analgesics and anaesthetics, the sedative effects are likely to be intensified. The elderly require special supervision.
Patients should be advised that, like all medicaments of this type, Calmepam may modify patients, performance at skilled tasks (driving, operating machiner etc) to a varying degree depending upon dosage, administration and individual susceptibility. Patients should further be advised that alcohol may intensify any impairment and should therefore be avoided during treatment.
The dependence potential of the benzodiazepines is low, particularly when limited to short- term use, but this increases when high doses are used, especially when given overlong periods. This is particularly so in patients with a history of alcoholism or drug abuse or inpatients with marked personality disorders. Regular monitoring in such patients is essential, routine repeat prescriptions should be withdrawn gradually. Symptoms such as depression, nervousness, rebound insomnia, irritability, sweating, and diarrhoea have been reported following abrupt cessation of treatment in patients receiving even normal therapeutic doses for short periods of time. In rare instances, withdrawal following excessive dosages may produce confusional states, psychotic manifestations and convulsions.
Abnormal psychological reactions to benzodiazepines have been reported. Rare behavioral effects include paradoxical aggressive outbursts, excitement, confusion and the uncovering of depression with suicidal tendencies. Extreme caution should therefore be used in prescribing benzodiazepines to patients with personality disorders.
When Calmepam is used in conjunction with antiepileptic drugs, side effects and toxicity may be more evident, particularly with hJantoins or barbiturates or combinations including them. This requires extra care in adjusting dosage in the initial stages of treatment.
Known inhibitors of hepatic enzymes, e.g. cimetidine, have been shown to reduce the clearance of benzodiazepines and maypotentiate their action and known inducers of hepatic enzymes, e.g. rifampicin, may increase the clearance of benzodiazepines.
SIDE EFFECTS AND A[WERSE REACTIONS:
Common adverse effects include drowsiness, sedation, unsteadiness and ataxia; these are dose- related and may persist into the following day, even after a single dose. Drowsiness may be iarticutar probTerww1iwCatmepam isusedin higherttosagein 5orn patients, especially if they are unused to this form of therapy The elderlyare particularly sensitive to the effects of centrally depressant drugs and may experience confusion, especially if organic brain changes are present; dosage of Calmepam should not exceed one-half that recommended for other adults.
Other adverse effects are rare and include headache, vertigo, hypotension, gastro-intestinal upsets, skin rashes, casual disturbances, changes in libido, and urinary retention. Isolated cases of blood dyscrasias and jaundice have also been reported.
TREATMENT OF YJERDOSAGE:
When taken alone in overdosage, Calmepam presents few problems in management. Signs may include drowsiness, ataxia and dysarthria, with coma in severe cases. Treatment is symptomatic. Gastric lavage is useful only if performed soon after ingestion.
The value of dialysis has not been determined. Anexate is a specific IV antidote for use in emergency situations. Patients requiring such intervention should be monitored closely in hospital.
If excitation occurs, barbiturates should not be used. When taken with centrally-acting drugs, especially alcohol, the effects of overdosage likely to be more severe and, in the absence of supportive measures, may prove fatal.
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[ KEEP ALL MEDICAMENTS OUT OF REACH OF
CHILDREN I
Manufactured by
Glaxb SmithKline S.A.E.
El Salam City, Cairo, A.R.E.
GlaxoSmith Kline
Glaxb SmithKline S.A.E.
El Salam City, Cairo, A.R.E.
GlaxoSmith Kline
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