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BROMAZEPAM is a brand name for Bromazepam, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 3 WARNINGS AND…
Verbatim from this product's HC label. Tap a section to expand.
Dosing Considerations BROMAZEPAM should always be prescribed at the lowest effective dose for the shortest duration possible. BROMAZEPAM can produce withdrawal symptoms or rebound phenomena following abrupt discontinuation or rapid dose reduction (see SERIOUS WARNINGS AND PRECAUTIONS BOX, Withdrawal; WARNINGS AND PRECAUTIONS, Dependence/Tolerance).
Abrupt discontinuation should be avoided and treatment - even if only of short duration - should be terminated by gradually tapering the dosage schedule underclose monitoring. Tapering should be tailored to the specific patient. Special attention should be given to patients with a history of seizure.
If a patient experiences withdrawal symptoms, consider postponing the taper or raising the benzodiazepine to the previous dosage prior to proceeding with a gradual taper. Geriatric patients in particular may be more sensitive to benzodiazepines (see WARNINGS AND PRECAUTIONS, Falls and Fractures).
Long-term use of BROMAZEPAM should be avoided in elderly patients. Enhanced monitoring is recommended. Patients should be evaluated carefully at the start of treatment in order to minimize the dosage and/or the frequency of administration and to prevent overdose due to accumulation.
The dosage of BROMAZEPAM (bromazepam) must be individualized and carefully titrated in order to avoid excessive sedation or mental and motor impairment. Short course of treatment should usually be the rule for the symptomatic relief of excessive anxiety and the initial course of treatment should not last longer than one week without reassessment of the need for a limited extension.
If necessary, drug dosage can be adjusted after one week of treatment. Initially, not more than one week’s supply of BROMAZEPAM should be provided and automatic prescription renewals should not be allowed. Subsequent prescriptions, when required, should be limited to a short course of BROMAZEPAM.
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 BROMAZEPAM is being discontinued.
Recommended Dose and Dosage Adjustment Usual Adult Dosage:
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Bromazepam in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
The recommended initial adult daily dosage is 6 to 18 mg in equally divided doses, depending on the severity of symptoms and response of the patient. Treatment should be initiated by lower doses and adjusted as necessary. The optimal dosage may range from 6 to 30 mg daily in individual patients, in divided doses.
There is limited experience with higher doses up to 60 mg daily.
Geriatrics Elderly and Debilitated Patients:
Elderly and debilitated patients, or those with organic brain syndrome, have been found to be Page 13 of 25 prone to CNS depression after even low doses of benzodiazepines. Therefore, medication should be initiated in these patients with very low initial doses, and increments should be made gradually, depending on the response of the patient, in order to avoid over sedation or neurological impairment.
A reduction in dose for patients above 50 years is recommended. The initial daily dose in these patients should not exceed 3 mg in divided doses. This dosage can be carefully adjusted, depending on tolerance and response of the patient (see WARNINGS AND PRECAUTIONS, Special Populations, Geriatrics; ACTION AND CLINICAL PHARMACOLOGY, Special Populations and Conditions).
OVERDOSAGE For management of a suspected drug overdose, contact your regional poison control centre. Symptoms Benzodiazepines commonly cause drowsiness, ataxia, dysarthria and nystagmus. Overdose is seldom life-threatening if BROMAZEPAM is taken alone, but may lead to areflexia, apnea, hypotension, cardiorespiratory depression and coma.
Coma, if it occurs, usually lasts a few hours but it may be more protracted and cyclical, particularly in elderly patients. Benzodiazepine respiratory depressant effects are more serious in patients with respiratory disease. Benzodiazepines increase the effects of other central nervous system depressants, including alcohol.
Treatment In managing overdosage, consider the possibility of multiple drug involvement. Monitor the patient’s vital signs and institute supportive measures as indicated by the patient’s clinical state. In particular, patients may require symptomatic treatment for cardiorespiratory effects or central nervous system effects.
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. Induction of vomiting is not generally recommended.
As in overdosage with other benzodiazepines, dialysis is of no known value in bromazepam overdosage. If CNS depression is severe consider the use of flumazenil, a benzodiazepine receptor antagonist. The following should be kept in mind when flumazenil is used in the treatment of benzodiazepine overdosage: Flumazenil should only be administered under closely monitored conditions.
, resedation) have subsided. Particular caution is necessary when using flumazenil in cases of multiple drug overdosage, since the toxic effects (cardiac arrhythmias and/or convulsions) of other psychotropic drugs, especially cyclic antidepressants, may increase as the effects of benzodiazepines subside.
Flumazenil is contraindicated in patients who are showing signs of serious cyclic antidepressant overdose.
Page 14 of 25 Warning:
The benzodiazepine receptor antagonist flumazenil is not indicated in patients with epilepsy who have […]