Clobazam
Tranquilizer, Sedative/Hypnotic · Benzodiazepine
Indications
Anxiety states, adjunctive medication in resistant epilepsy.
Dosage
Anxiety, Adults: 20-30 mg per day. Epilepsy, Adults: 5-15 mg per day initially, to be increased to 80 mg per day as max. Children: Not recommended for children under 6 yr; not recommended as monotherapy. Adjunctive therapy for epilepsy, monotherapy for catamenial (menstruation) seizures (usually for 7-10 days each mth, just before and during menstruation), cluster seizures: 1 mth-6 yr, initially 125 mcg/kg twice daily, increased if necessary every 5 days to usual maintenance dose of 250 mcg/kg twice daily; max. 500 mcg/kg twice daily, not exceeding 15 mg twice daily; 6-18 yr, initially 5 mg daily, increased if necessary every 5 days to usual maintenance dose of 0.3-1 mg/kg daily, max 60 mg daily, daily doses of up to 30 mg may be given as a single dose at bedtime, higher doses should be divided.
Adverse Effects
Occasionally tiredness, dryness of mouth, constipation, reduction of appetite, nausea, dizziness, fine tremor of the fingers. Fatigue, drowsiness, GI upset, headache, anorexia, depression, irritability, aggression, attention disturbances, agitation, insomnia, anxiety, hallucinations, nightmares, suicidal thoughts, somnolence, ataxia, confusion, speech disturbances, anterograde amnesia, respiratory depression, visual disorders, wt gain, loss of libido, restlessness, muscle weakness, tolerance, dependence.
Risk Factor (Pregnancy/Lactation)
Pregnancy: Contraindicated in pregnancy. Lactation: Contraindicated or not recommended. Contraindications: Hypersensitivity to clobazam, Myasthaenia gravis. Severe respiratory insufficiency, sleep apnoea, history of drug or alcohol dependence. Severe hepatic impairment. Precautions: Acute respiratory insufficiency. After first trimester only if strictly indicated. Nursing mothers should stop breast feeding. Spinal or cerebellar ataxia. Amnesia. Renal impairment. Mild to moderate hepatic impairment. Depression, personality disorders. Monitor for suicidal thoughts or behaviour. Monitor for serious skin reactions. Elderly. Avoid long term use. Withdraw gradually.
Interactions
Alcohol, lithium, CNS depressants, narcotic analgesics, anticonvulsants, CYP3A4 inhibitors (e.g., cimetidine), CYP2C19 inhibitors (e.g., fluconazole, fluvoxamine), CYP2D6 substrates (e.g., paroxetine, nebivolol).
Pharmacokinetics
Absorption: Well-absorbed from the GI tract. Metabolism: Hepatic. Bioavailability: 100%. Half-life elimination: 18 hrs. Active metabolite: 42 hrs. Time to peak, plasma: Oral: 1-4 hrs. Excretion: Urine (mainly). Faeces.
Brands with this active ingredient
Compiled by Healify Pharmacy from published drug references. How we compile it →
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