TRANXENE
CLORAZEPATE · by SANOFI-AVENTIS
Composition
Cap 5 mg/10 mg/15 mg: Clorazepate potassium 5 mg/10 mg/15 mg.
Indications & Dosage
Short-term treatment of anxiety occurring alone or with insomnia, Acute alcohol withdrawal, Night terrors: Adults & Children above 16 yr: 5 mg-25 mg daily in single or divided doses; max: 60 mg/day. Elderly, 5 mg daily
Contraindications
Respiratory depression, sleep apnoea, acute pulmonary insufficiency, phobic or obsessional state, chronic psychosis, unstable myasthenia gravis, severe he-patic impairment. Not recommended as monotherapy to treat depression or anxiety associated with depression.
Precautions
Chronic pulmonary insufficiency, myasthenia gravis, renal impairment, mild to moderate hepatic impair-ment, history of drugs or alcohol abuse, personality disorders, elderly, avoid long-term use. Withdraw gradually.
Interactions
Alcohol, CNS depressants, anticonvulsants, CYP3A4 inhibitors or inducers (e.g. cimetidine, rifampicin).
Pregnancy
Positive evidence of riUse only when no safer alternative exists for a serious problem.
Lactation
Caution advised or effect undetermined.
Side Effects
Amnesia, ataxia, headache, confusion, dependence, drowsiness, lightheadedness, muscle weakness, paradoxical increase inaggression, changes in libido,dizziness, dysarthria, GI disturbances, impaired alertness and dexterity, gynaecomastia, hypotension, incontinence, salivation changes, slurred speech, tremor, urinary retention, vertigo, visual disturbances. Rare: Apnoea, blood disorders, respiratory depression, skin reactions