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Administration
May be taken with or without food.
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Contraindications
Acute or chronic severe respiratory insufficiency, respiratory depression, myasthenia gravis, sleep apnoea, severe hepatic insufficiency, acute narrow-angle glaucoma, phobic or obsessional states, chronic psychosis, hyperkinesis, acute porphyria. Infants <6 months. Concomitant use with opioids. Severe hepatic impairment.
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Special Precautions
Patient with convulsive disorder, history of alcoholism and/or drug abuse open-angle glaucoma, cardiorespiratory insufficiency, chronic respiratory insufficiency, ataxic, obese, and debilitated patient; neurologic damage (rectal). Avoid abrupt withdrawal. CYP2C19 extensive, intermediate and poor metabolisers. Renal and mild to moderate hepatic impairment. Children and elderly. Pregnancy and lactation. Not intended as monotherapy in patients with depression, anxiety as suicide may be precipitated in such patients.
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Adverse Reactions
Significant: Withdrawal symptoms (e.g. rebound insomnia and anxiety, panic, palpitations, sweating, paranoid psychosis, epileptic attacks, delirium), anterograde amnesia, paradoxical reactions (e.g. restlessness, agitation, irritability, aggressiveness, delusion, rages, nightmares, psychoses), habituation, drug dependence.
Eye disorders: Blurred vision, diplopia.
Gastrointestinal disorders: Constipation, nausea, gastrointestinal disturbances, altered salivation.
General disorders and administration site conditions: Fatigue, ataxia, local reactions at the injection site e.g. thrombophlebitis and venous thrombosis.
Investigations: Elevated transaminases and alkaline phospahatase.
Nervous system disorders: Impaired motor ability, tremor, headache, vertigo.
Psychiatric disorders: Confusion, depression, slurred speech.
Renal and urinary disorders: Urinary incontinence, urinary retention.
Reproductive system and breast disorders: Change in libido.
Vascular disorders: Hypotension.
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Drug Interactions
Potentiated effects with other centrally acting agents (e.g. antipsychotics, anxiolytics, anticonvulsants, antihistamines, MAO inhibitors, anaesthetics, barbiturates). Enhanced sedative effect with other drugs such as lofexidine, nabilone, and disulfiram. Reduce clearance and potentiate action with CYP3A4 inhibitors (e.g. cimetidine, isoniazid, erythromycin, omeprazole, ketoconazole). Increased metabolism and clearance with CYP3A4 inducers (e.g. rifampicin, carbamazepine, phenytoin). Antagonised effect with theophylline. Delayed absorption with antacids.
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CIMS Class
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ATC Classification
N05BA01 - diazepam ; Belongs to the class of benzodiazepine derivatives anxiolytics. Used in the management of anxiety, agitation or tension.
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