RESTORIL
TEMAZEPAM · by NOVARTIS
Composition
Cap 15 mg/30 mg: Temazepam 15 mg/ 30 mg.
Indications & Dosage
Insomnia (short-term use): Adult: 10-20 mg once daily at bed time, alternatively 30-40 mg once daily, higher dose range only to be administered in exceptional circumstances, for debilitated patients, use elderly dose. Elderly: 10 mg once daily at bedtime, alternatively 20 mg once daily, higher dose only to be administered in exceptional circumstances. Conscious sedation for dental procedures: Adult: 15-30 mg, to be administered 30-60 minutes before procedure. Premedication before surgery or investigatory procedures: Adult: 10-20 mg, to be taken 1-2 hours before procedure, alternatively 30 mg, to be taken 1-2 hours before procedure, higher alternate dose only administered in exceptional circumstances. Elderly: 10 mg, to be taken 1-2 hours before procedure, alternatively 20 mg, to be taken 1-2 hours before procedure, higher alternate dose only administered in exceptional circumstances.
Contraindications
Severe respiratory insufficiency, CNS depression, compromised airway, hyperkinesis, not recommended for use alone to treat chronic psychosis or depression (or anxiety associated with depression), obsessional state, phobic states, respiratory depression, sleep apnoea, myasthenia gravis, severe hepatic impairment.
Precautions
Chronic pulmonary insufficiency, renal impairment, mild to moderate hepatic impairment, hypoalbuminaemia, muscle weakness, organic brain changes, personality disorder (dependent, avoidant, obsessive-compulsive), may increase risk of dependence, history of drug or alcohol abuse, elderly. Avoid long term use. Withdraw gradually.
Interactions
Alcohol, CNS depressants, anticonvulsants, CYP3A4 inhibitors or inducers (e.g. cimetidine, rifampicin).
Pregnancy
Contraindicated
Lactation
Contraindicate
Side Effects
Amnesia, ataxia (especially in the elderly),confusion, dependence, drowsiness, lightheadedness, muscle weakness, paradoxical increase in aggression, dizziness, dysarthria, GI disturbances, gynaecomastia, headache, hypotension, incontinence, salivation changes, slurred speech, tremor, urinary retention, vertigo, visual disturbances. Rare: Apnoea, blood disorders, respiratory depression, jaundice, skin reactions