Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2021 Publisher: Martindale Pharmaceuticals Ltd, Bampton Road, Harold Hill, Essex, RM3 8UG
Clobazam is a 1,5-benzodiazepine indicated for the short-term relief (2-4 weeks) only of anxiety that is severe, disabling or subjecting the individual to unacceptable distress, occurring alone or in association with insomnia or short term psychosomatic, organic or psychotic illness. The use of clobazam to treat short-term “mild” anxiety is inappropriate and unsuitable.
Before treatment of anxiety states associated with emotional instability, it must first be determined whether the patient suffers from a depressive disorder requiring adjunctive or different treatment. Indeed, in patients with anxiety associated with depression, clobazam must be used only in conjunction with adequate concomitant treatment. Use of benzodiazepine (such as clobazam) alone, can precipitate suicide in such patients.
In patients with schizophrenic or other psychotic illnesses, use of benzodiazepines is recommended only for adjunctive, i.e. not for primary treatment.
Clobazam may be used as adjunctive therapy in epilepsy in adults or children over 2 years of age, if standard treatment with one or more anticonvulsants has failed.
Clobazam oral suspension should only be used in children from 6 months to 2 years old, under exceptional situations, where there is a clear epilepsy indication.
If low doses are required, the 5mg/5ml strength product is the most suitable presentation. If high doses are required, the 10mg/5ml strength product is the most suitable presentation.
For patients who require only small doses of less than 1ml, the 150ml pack size of the 5mg/5ml strength should be used, which is provided with a 1ml oral syringe.
The usual anxiolytic dose for adults is 20-30 mg daily in divided doses or as a single dose given at night. Doses up to 60mg daily have been used in the treatment of adult in-patients with severe anxiety.
The lowest dose that can control symptoms should be used. After improvement of the symptoms, the dose may be reduced.
It should not be used for longer than 4 weeks. Long term chronic use as an anxiolytic is not recommended. In certain cases, extension beyond the maximum treatment period may be necessary; treatment must not be extended without re-evaluation of the patient’s status using special expertise. It is strongly recommended that prolonged periods of uninterrupted treatment be avoided, since they may lead to dependence. Treatment should always be withdrawn gradually. Patients who have taken clobazam for a long time may require a longer period during which doses are reduced.
Doses of 10-20 mg daily in anxiety may be used in the elderly, who are more sensitive to the effects of psychoactive agents. Treatment requires low initial doses and gradual dose increments under careful observation.
The oral suspension is suitable for any epilepsy patient in whom the clinician feels an oral suspension is preferable to clobazam tablets.
In all cases, treatment should be initiated at the lowest effective dose with gradual dose increments under careful observation.
In epilepsy a starting dose of 20-30 mg/day is recommended, increasing as necessary up to a maximum of 60 mg daily.
Treatment requires low initial doses and gradual dose increments under careful observation.
When prescribed for children treatment requires low initial doses and gradual dose increments under careful observation. It is recommended that normally treatment should be started at 5mg daily. A maintenance dose of 0.3 to 1mg/kg body weight daily is usually sufficient.
Initial: 5 mg/day (aged 6 years and above) or 0.1 mg/kg/day for younger patients. The dose may be increased slowly by steps of 0.1 to 0.2 mg/kg/day at 7 days intervals, until the required clinical effect is achieved or side effects occur.
Maintenance dose: usually 0.3 to 1 mg/kg/day. The daily dose can be taken in divided doses or as single dose at night.
Clobazam oral suspension should only be used in children from 6 months to 2 years old, under exceptional situations, when there is a clear epilepsy indication. Use 0.1mg/kg/day and titrate upwards very slowly (increasing not more often than every 5 days) to achieve required clinical effect, in divided doses twice daily.
The patient must be re-assessed after a period not exceeding 4 weeks and regularly thereafter in order to evaluate the need for continued treatment. A break in therapy may be beneficial if drug exhaustion develops, recommencing therapy at a low dose. At the end of treatment (including in poor-responding patients), since the risk of withdrawal phenomena/rebound phenomena is greater after abrupt discontinuation of treatment, it is recommended to gradually decrease the dosage.
For oral use only.
Once titrated to an effective dose of clobazam, patients should remain on their treatment and care should be exercised when changing between different formulations.
Overdose of benzodiazepines is usually manifested by degrees of central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion and lethargy, in more serious cases, symptoms may include ataxia, hypotonia, hypotension, respiratory depression, rarely coma and very rarely death. As with other benzodiazepines, overdose should not present a threat to life unless combined with other CNS depressants (including alcohol).
In the management of overdose, it is recommended that the possible involvement of multiple agents be taken into consideration.
Following overdose with oral benzodiazepines, vomiting should be induced (within one hour) if the patient is conscious, or gastric lavage undertaken with the airway protected if the patient is unconscious. If there is no advantage in emptying the stomach, activated charcoal should be given to reduce absorption. Special attention should be paid to respiratory and cardiovascular functions in intensive care.
Secondary elimination of clobazam (by forced diuresis or haemodialysis) is ineffective.
Consideration should be given to the use of flumazenil as a benzodiazepine antagonist.
2 years.
28 days after first opening.
Do not store above 25°C.
Amber glass bottles sealed with tamper evident, child-proof plastic screw caps. The bottle is packed in a cardboard carton containing a 1 ml and a 5ml syringe with an adaptor and a 30ml measuring cup along with the patient information leaflet.
Pack sizes: 100 ml, 150 ml and 250 ml.
Not all pack sizes may be marketed.
No special requirements for disposal.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
This product may settle during storage. Please shake the bottle thoroughly before use.
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