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Indications and Dosage
Oral
Anxiety Adult: Doses are individualised, beginning with low doses, and increasing gradually up to the optimum level. Usual dose (outpatient): 1.5-3 mg up to 3 times daily. Severe (hospitalised): 6-12 mg 2-3 times daily; up to 60 mg daily may be given. Treatment duration: Should be as short as possible; not more than 8-12 weeks, including a tapering off process.
Elderly: Max: 3 mg daily in divided doses. |
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Special Patient Group
Debilitated patients: Max: 3 mg daily in divided doses.
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Renal Impairment
Dose reduction may be required.
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Hepatic Impairment
Mild to moderate: Initiate at the lower end of the dosing range. Severe: Contraindicated.
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Administration
May be taken with or without food.
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Contraindications
Myasthenia gravis, severe respiratory insufficiency; sleep apnoea syndrome, narrow-angle glaucoma. Severe hepatic impairment.
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Special Precautions
Patients with depressive disorders or psychosis, pre-existing or chronic respiratory disease, history of alcohol or drug abuse, psychiatric or personality disorders; or those at risk of falls. Debilitated patients. Avoid abrupt withdrawal. Renal and mild to moderate hepatic impairment. Elderly. Pregnancy and lactation. Concomitant use with opioids.
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Adverse Reactions
Significant: Anterograde amnesia, psychiatric and paradoxical reactions (e.g. agitation, hallucinations, restlessness), sleep-related activities (e.g. sleep-driving, making phone calls, cooking, and eating food while asleep), respiratory depression; physical and psychological dependence.
Cardiac disorders: Cardiac failure, cardiac arrest, palpitation, tachycardia. Eye disorders: Blurred vision, diplopia, visual disturbance. Gastrointestinal disorders: Nausea, vomiting, xerostomia, salivation changes. General disorders and administration site conditions: Fatigue. Injury, poisoning and procedural complications: Falls, fractures. Injury, poisoning and procedural complications: Increased serum ALT, AST, alkaline phosphatase, and bilirubin; decreased Hg, increased WBC; changes in EEG patterns. Musculoskeletal and connective tissue disorders: Muscle weakness and spasm Nervous system disorders: Headache, drowsiness, dizziness, vertigo, ataxia, decreased alertness, seizures. Psychiatric disorders: Disorientation, confusional state, depression, emotional and mood disorder, nervousness. Renal and urinary disorders: Urinary incontinence or retention. Reproductive system and breast disorders: Rarely, changes in libido. Skin and subcutaneous tissue disorders: Pruritus, rash. Vascular disorders: Rarely, hypotension. |
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Patient Counseling Information
This drug may cause sedation, amnesia, and impaired muscular function; if affected, do not drive or operate machinery.
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Monitoring Parameters
Monitor heart rate, blood pressure; CBC (periodically), respiratory, liver and renal functions.
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Overdosage
Symptoms: Drowsiness, confusion, lethargy, ataxia, dysarthria, nystagmus, areflexia, apnoea, hypotension, hypotonia, cardiorespiratory depression, and coma. Management: Symptomatic and supportive treatment. Monitor vital signs. May administer activated charcoal within 1-2 hours of ingestion, provided that the airway is protected. May administer flumazenil cautiously for severe CNS depression.
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Drug Interactions
Prolonged elimination half-life with propranolol and cimetidine. Increased exposure and elimination half-life with fluvoxamine. Additive CNS depressant effects with centrally acting depressants (e.g. barbiturates, sedatives, anaesthetics, anxiolytics, hypnotics, phenothiazines, other antipsychotics, skeletal muscle relaxants, antihistamines). May potentiate the anticholinergic effects of atropine, antihistamines, and antidepressants.
Potentially Fatal: Concomitant use of opioids may result in profound sedation, respiratory depression, and coma. |
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Food Interaction
Food may decrease serum concentration. May enhance the CNS depressant effect of alcohol.; avoid concomitant use.
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Action
Description: Bromazepam binds to stereospecific benzodiazepine receptors on the postsynaptic GABA neuron within the CNS (including the limbic system, reticular formation) to which it increases neuronal membrane permeability to chloride ions resulting in hyperpolarisation (a less excitable state) and stabilisation.
Pharmacokinetics: Absorption: Rapidly absorbed from the gastrointestinal tract. Food may decrease absorption. Bioavailability: 60%. Time to peak plasma concentration: Within 2 hours. Distribution: Enters breast milk. Volume of distribution: Approx 50 L. Plasma protein binding: 70%, to albumin and α1-acid glycoprotein. Metabolism: Extensively metabolised in the liver via hydroxylation and glucuronidation into 3-hydroxy-bromazepam, and 2-(2-amino-5-bromo-3-hydroxybenzoyl) pyridine metabolites. Excretion: Via urine (69% as metabolites). Elimination half-life: Approx 20 hours. |
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Chemical Structure
 Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 2441, Bromazepam. https://pubchem.ncbi.nlm.nih.gov/compound/Bromazepam. Accessed Apr. 27, 2022. |
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Storage
Store between 15-30°C.
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MIMS Class
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ATC Classification
N05BA08 - bromazepam ; Belongs to the class of benzodiazepine derivatives anxiolytics. Used in the management of anxiety, agitation or tension.
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References
Anon. Bromazepam. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 02/03/2022. Buckingham R (ed). Bromazepam. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 02/03/2022. Lexotan (Cheplapharm Arsneimittel GmbH). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 02/03/2022. Lexzepam 3 (Mersifarma TM). MIMS Indonesia. http://www.mims.com/indonesia. Accessed 20/04/2022 .
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