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Administration
May be taken with or without food.
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Contraindications
History of drug or alcohol dependence, myasthenia gravis, severe respiratory insufficiency, sleep apnoea syndrome. Severe hepatic impairment. Pregnancy (1st trimester) and lactation.
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Special Precautions
Patients with spinal or cerebellar ataxia, pre-existing muscle weakness, personality disorders (e.g. depression), at risk of falls. Avoid abrupt discontinuation and prolonged use. Renal and mild to moderate hepatic impairment. Children and elderly. Pregnancy (2nd-3rd trimester). CYP2C19 poor metabolisers. Concomitant use with opioids. Patient Counselling This drug may cause sedation, amnesia, impaired concentration and impaired muscular function, if affected, do not drive or operate machinery. Monitoring Parameters Monitor respiratory, renal and hepatic function; signs and symptoms of dermatological toxicities, depression or suicidal thoughts. Assess seizure control and ensure adequate tolerance of the medications.
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Adverse Reactions
Significant: Withdrawal syndrome (e.g. insomnia, hallucination, behavioural disorder, convulsions, psychosis, tremor), anterograde amnesia, CNS depression, muscle weakness, suicidal thoughts or behaviour, physical and psychological dependence, paradoxical reactions (e.g. restlessness, irritability, anxiety, frequent muscle spasms), respiratory depression.
Eye disorders: Double vision.
Gastrointestinal disorders: Dry mouth, constipation, nausea.
General disorders and administration site conditions: Ataxia, fall, fatigue, lethargy.
Investigations: Weight gain.
Metabolism and nutrition disorders: Decreased appetite.
Musculoskeletal and connective tissue disorders: Muscle spasm.
Nervous system disorders: Somnolence, drowsiness, dizziness, headache, tremor.
Psychiatric disorders: Confusion, dysarthria, agitation, aggression.
Skin and subcutaneous tissue disorders: Rash, urticaria.
Potentially Fatal: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN). |
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Drug Interactions
Concomitant use with opioids may result in sedation, respiratory depression, and coma. Enhanced CNS depressive effect with antipsychotics (neuroleptics), hypnotics, anxiolytics/sedatives, antidepressant agents, anticonvulsants, anaesthetics and sedative antihistamines. Increased serum concentration of phenytoin. Increased plasma concentrations with CYP2C19 and CYP3A inhibitors (e.g. stiripentol) or moderate to strong CYP2C19 inhibitors (e.g. fluconazole, fluvoxamine, ticlopidine, omeprazole). Enhanced effects of muscle relaxants, analgesics, and nitrous oxide. Decreased serum concentration of hormonal contraceptives (e.g. oestrogen).
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CIMS Class
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ATC Classification
N05BA09 - clobazam ; Belongs to the class of benzodiazepine derivatives anxiolytics. Used in the management of anxiety, agitation or tension.
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