Description
Clobazam 10 Mg 60 Tablet
1. Clinical information
1.1 Therapeutic indications
Clobazam is 1,5-benzodiazepine, which is prescribed for short-term relief (2-4 weeks), alone or insomnia or short-term psychosomatic, organically occurring, exposing the individual to non-serious, disabling or unacceptable distress. or psychotic illness. It is not appropriate to use clobazam to treat short-term “mild” anxiety.
Before the treatment of anxiety states associated with emotional imbalance, it should be determined whether the patient suffers from a depressive disorder that requires additional or different treatment. Indeed, in patients with anxiety associated with depression, clobazam should only be used in combination with adequate concurrent therapy. Using only benzodiazepine (such as clobazam) can speed up suicide in these patients.
In patients with schizophrenic or other psychotic diseases, the use of benzodiazepines is not recommended only for auxiliary, that is, for primary therapy.
Clobazam can be used as an adjunctive therapy in epilepsy.
1.2 Posology and method of administration
Anxiety treatment
The usual anxiolytic dose for adults is 20-30 mg per day in divided doses or as a single dose given at night. Doses up to 60 mg per day were used in the treatment of adult inpatients with severe anxiety.
The lowest dose that can control symptoms should be used. The dose can be reduced after the symptoms have improved.
It should not be used for more than 4 weeks. Long-term chronic use is not recommended as anxiolytics. In some cases, it may be necessary to extend beyond the maximum treatment period; Treatment should not be extended without reassessing the patient’s condition using special expertise. It is highly recommended to avoid long-term uninterrupted treatment, as it can lead to addiction. Treatment should always be withdrawn gradually. Patients taking Clobazam for a long time may require a longer period of time when the doses are reduced.
Anxiolytic therapy should be limited to the lowest possible dose in the shortest possible time (see CSM recommendation). Addiction is especially possible in patients with a history of alcohol or drug addiction and in patients with significant personality disorders.
CSM advice:
1. Benzodiazepines are indicated for short-term anxiety (only two to four weeks), alone or in association with insomnia or short-term psychosomatic, organic or psychotic disease, subject to severe disabling or unacceptable distress.
2. Benzodiazepines should only be used to treat insomnia when it is severe, disabling, or exposing the individual to extreme distress.
Withdrawal of a benzodiazepine should be gradual because sudden withdrawal can create a condition similar to confusion, toxic psychosis, convulsions, or delirium tremen. Benzodiazepine withdrawal syndrome can develop at any time up to 3 weeks after stopping a long-acting benzodiazepine, but it can occur within a few hours in a short-acting state. It is characterized by insomnia, anxiety, anorexia and body weight, tremors, sweating, tinnitus and perceptual disorders. These symptoms are similar to the original complaint and may encourage more prescribing; some symptoms can last weeks or months after stopping benzodiazepines.
A benzodiazepine can be withdrawn every two weeks in about the eighth (tenth to one-quarter) steps of the daily dose. A recommended withdrawal protocol for patients with difficulties is as follows:
1. Transfer the patient to the equivalent daily dose of diazepam, preferably at night.
2. Decrease the dose of diazepam every 2 weeks in steps of 2 or 2.5 mg; If withdrawal symptoms occur, keep this dose until your symptoms improve.
3. Reduce the dose further, if necessary, in smaller steps every two weeks; it is better to reduce it very slowly, not too fast
4. Stop completely; the time required for withdrawals can range from about 4 weeks to a year or more
Counseling can help; beta-blockers should only be attempted if other measures fail; antidepressants should only be used for clinical depression or panic disorder; avoid antipsychotics (may exacerbate withdrawal symptoms).
Elderly: In elderly people who are more sensitive to the effects of psychoactive agents, 10-20mg anxiety doses can be used daily. Treatment requires low initial doses and gradual dose increases under careful observation.
Treatment of epilepsy with one or more other anticonvulsants
mouth
Adults: An initial dose of 20-30 mg per day is recommended in epilepsy and, when necessary, increases to a maximum of 60 mg per day.
Auxiliary therapy for epilepsy
Monotherapy for cataract seizures under specialist supervision (usually for 7-10 days immediately before and during menstruation)
Cluster attacks
Pediatric patients 6 years and older:
When prescribed for child treatment, it requires low initial doses and gradual dose increases under careful observation.
Normally, it is recommended to start treatment at 5 mg per day. A maintenance dose of 0.3 to 1 mg / kg body weight per day is usually sufficient.
Since there is no age-appropriate formulation that will provide safe and accurate dosing, dosage recommendations cannot be made in children under 6 years of age.
Tablets should be swallowed with a sufficient amount of liquid (1/2 cup) without chewing. Tablets can be applied whole or crushed and mixed in apple sauce (see Section 5.2). Clobazam can be given with or without food.
To evaluate the need for continuous treatment, the patient should be re-evaluated regularly after and after a period not exceeding 4 weeks. If drug depletion develops, a break in treatment may be beneficial by recommending treatment at a low dose. At the end of treatment (including patients with poor responses), it is recommended to gradually reduce the dosage, since the withdrawal phenomena / recoil phenomena are greater after abrupt withdrawal of treatment.
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