Expiration date: 02/2025
Structure and Composition:
Tablets. 1 tablet contains 25 or 100 mg clozapine
Excipients: lactose monohydrate, corn starch PVP colloidal silicon dioxide magnesium stearate, talc purified water
in blister 10 pcs. a stack of cardboard 5, 10, 12 or 25 blisters.
Dosage and administration:
Inside. Doses must be individualized. Every patient should maintain an effective minimum dose.
In patients receiving drugs that interact with clozapine (such as benzodiazepines or SSRIs), adequate correction is required dose.
For oral dosage recommended for the following:
Schizophrenia, resistant to therapy. The initial phase of treatment: 1 day administered 12.5 mg (1/2 tab 25 mg.) 1 or 2 times a day during Day 2 - Table 1-2. 25 mg. Further, provided good tolerability, the dose can slowly increase of 25-50 mg, so that for 2-3 weeks to achieve a daily dose of 300 mg. Then, if necessary, the daily dose can be increased and further, 50-100 mg every 3-4 days or better seven days.
The therapeutic dose range. In most patients, the onset of antipsychotic drug action can be expected when using a daily dose of 300-450 mg leponeks (in divided doses). Some patients may be effective in smaller doses, others may require doses up to 600 mg / day. The daily dose can be distributed unevenly in the individual techniques, assigning it a large part of the bedtime.
The maximum dose. To achieve the full therapeutic effect requires some patients assignment higher doses. In this case, it is expedient to gradually increase the dose (in each case not more than 100 mg) until the 900 mg / day. It should take into account the possibility of more frequent side effects (in particular the appearance of convulsions) using doses exceeding 450 mg / day.
The maintenance dose. After reaching the maximum therapeutic effect in many patients it is possible to switch to the lower maintenance doses. Reduce the dose should be slowly and carefully. Maintenance treatment should be continued for at least 6 months. If the daily dose does not exceed 200 mg, it is possible to switch to a single drug evening reception.
Cessation of therapy. In the event of planned termination of treatment leponeks recommended gradually over 1-2 weeks, a dose reduction. If necessary, the sudden withdrawal of the drug (for example in the case of leukopenia) should establish a careful observation of the patient in connection with a possible worsening of psychotic symptoms and the development of the syndrome, which manifests itself in the form of profuse sweating, headache, nausea, vomiting and diarrhea, and associated with the termination of the anticholinergic effect of the drug .
The resumption of treatment. If more than two days after the last dose leponeks drug treatment should be resumed, starting with 12.5 mg doses (Table 2.1. 25 mg) was applied 1 or 2 times during the first day. If this dose is well tolerated, the subsequent increase in dose to achieve a therapeutic effect can be carried out more quickly than is recommended for initial treatment. However, if a patient in the initial treatment period was observed respiratory arrest or cardiac activity, but then the dose of the drug was able to successfully bring to therapy, increasing the dose during the second appointment of the drug should be carried out with extreme caution.
The transition from the previous antipsychotic treatment on therapy with leponeks. Apply leponeks drug in combination with other neuroleptics is not recommended. In the case when treatment with leponeks need to start a patient already receiving antipsychotic inside, dose reduction or cancellation of prior preparation should be done gradually. Based on the clinical data the treating physician should determine the need for stopping the other antipsychotic therapy before drug leponeks.
Reducing the risk of recurrent suicidal behavior in schizophrenia and schizoaffective psychosis. In the treatment of patients with schizophrenia and schizoaffective psychosis, with risk of recurrence of suicidal behavior, you should follow the same recommendations for the application and dosing, which are given to patients with schizophrenia resistant to medication.
To reduce the risk of suicidal behavior is recommended to take the drug leponeks, at least for 2 years. After a 2-year course of treatment is recommended to re-evaluate the risk of suicidal behavior in patients. Further, the need for continued therapy with leponeks determined on the basis of a thorough evaluation of the regular recurrence of suicidal behavior risk.
Psychosis in Parkinson's disease (in the case of standard therapy inefficiency). The initial dose should not exceed clozapine 12.5 mg / day (Table 1.2. 25 mg), should be taken in the evening. Further, the dosage should be increased by 12.5 mg, no more than two times per week to a maximum dose - 50 mg. The dose of 50 mg may be administered no earlier than the end of the 2 weeks after the start of treatment. All daily dose preferably taken in 1 reception in the evening.
The average effective dose - an average of 25-37,5 mg / day. If the treatment is at least 1 week 50 mg daily dose does not provide a satisfactory therapeutic effect may further increase careful daily dose of not more than 12.5 mg per week.
The dose of 50 mg / day may be greater than in exceptional cases. Do not exceed the dose of 100 mg / day.
Dose escalation should be limited or deferred in the case of orthostatic hypotension, pronounced sedation or confusion. During the first weeks of treatment requires monitoring of blood pressure. Increasing the dose of anti-Parkinsonian drugs (levodopa), if it is shown on the basis of the assessment of the status of the motor, it is possible not earlier than 2 weeks after complete relief of psychotic symptoms. According to the 2-year study in patients with Parkinson's disease on the background of therapy with leponeks with knocking psychotic symptoms in order to improve motor function may increase the dose of levodopa to 17-68% of the initial dosage (15 months improved by 11-22% on the motor scale).
If this increase causes reoccurrence of psychotic symptoms leponeks drug dose may be increased to 12.5 mg per week to a maximum dose of 100 mg / day, received a 1 or 2 divided doses (see. Above).
At the end of therapy it is recommended to gradually decrease the daily dose of 12.5 mg, not more than 1 time per week (preferably 2 weeks).
Treatment should be discontinued immediately in the event of neutropenia or agranulocytosis. In this situation, careful psychiatric monitoring, as symptoms may recur quickly.
Use in patients aged 65 years and older. It is recommended to begin treatment with very low doses (12.5 mg 1 time per day on day 1) and subsequently increasing the dose no more than 25 mg per day.
Experience with leponeks drug in patients aged 65 years and older did not allow to conclude that there are differences between age groups in their response to treatment with leponeks.
