Clobazam is indicated in anxiety, tension, irritability, restlessness, epilepsy and response in the treatment of fear, depressive mood, sleep disturbances.
Clobazam binds to one or more specific GABA receptors at several sites within the CNS including the limbic system and reticular formation. Increased permeability of neuronal membrane to chloride ions results in GABA’s inhibitory effect leading to hyperpolarisation and stabilisation.
20-30 mg daily in divided dosage or as a single dosage at bed time, may increase up to 60 mg daily in divided dosage in severe anxiety and dosage of 20 mg daily for elderly, debilitated patients.
: Over 3 years up to ½ of the adult dose. Clobazam is not recommended for children under 3 years of age.
Elderly: Doses of 20 mg daily may be used in the elderly patients with anxiety.
The administration of alcohol results in significantly higher serum concentrations of clobazam. The concurrent administration of hypnotic or antidepressants with sedative activity may cause an increase in side effects, particularly tiredness or drowsiness.
Clobazam should not be used in patients known to be hypersensitive to benzodiazepines.
The most frequently observed adverse reactions, particularly during the initial phase of therapy include drowsiness, ataxia, fatigue, confusion, vertigo and these may diminish with continued therapy. Occasionally dry mouth, headache, hypersensitivity reactions and respiratory depression may occur.
: There is little information on the use of Clobazam in early pregnancy but no untoward effects have been found in animal studies. However, there are reports of a possible malformations in infants due to the administration of other benzodiazepines in early pregnancy.
Lactation: Clobazam has been detected in the breast milk of nursing mothers, but the effect on the neonate is not known.
Clobazam should be administered with caution to patients with hepatic or renal disease. The ability to operate machinery or drive a car may be impaired for patients taking high doses.
: Drowsiness, mental confusion, lethargy, ataxia, hypotonia, hypotension, respiratory depression, coma and very rarely death.
Management: Treatment includes emptying stomach by inducing vomiting (if within 1 hr) or gastric lavage. Activated charcoal may be used to reduce absorption. Monitor respiratory and CV functions. Flumazenil may be given if necessary. Forced diuresis or haemodialysis unlikely to be effective.
Store at 15-30° C.