CLOZAPINE TABLET 25 MG [SIN11497P]

Product Info

CLOZAPINE TABLET 25 MG

[SIN11497P]

Indications
Treatment of schizophrenia in patients who are therapy resistant or intolerant to other antipsychotic agents.
Because of the possibility of the occurrence of deviations in the differential blood count it is necessary that treatment with clozapine is restricted to schizophrenic patients who have failed to respond or have not responded adequately to treatments with at least two other antipsychotic agents, administered in appropriate dosages for at least six weeks, or to patients in which treatment with classic antipsychotic agents causes severe or non-treatable neurological side effects, such as extrapyramidal symptoms or tardive dyskinesia.
Also, regular control of the differential blood count should be guaranteed, as described in the section “Special warnings and special precautions for use” – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Recommended dosage
Clozapine tablets are administered orally. The dosage should be individualised by titration, trying to maintain the patient at the lowest possible effective dose.

Adults:
The starting dose is 12.5 mg (half a tablet or 25mg) once or twice on the first day, followed by one or two tablets of 25 mg on the second day. If well tolerated, the dosage may be increased in increments of 25mg to 50mg per day, to achieve a dose of 300 mg a day after 2 to 3 weeks. If necessary, the dosage can be increased to the recommended maximum dosage of 600mg a day in increments of 50 to 100 mg per week twice or preferably, once a week.
In most patients the effective antipsychotic dosage lies between 200 and 450 mg a day, divided over several dosages.
The total daily dosage can be administered in different amounts, with the larger portion in the evening. In exceptional cases, dosages higher than 600mg per day may be necessary. Increasing the dosage carefully (by not more than 100 mg per increment) is permitted in those cases to a maximum of 900 mg a day. The possibility of increased adverse drug reactions, especially convulsions, occurring at dosages over 450 mg a day must be considered. After reaching the maximum therapeutic effect the dosage should be carefully titrated downward to the lowest possible effective dose. If the daily doses does not exceed 200 mg one dose in the evening will suffice.

Children:
Clozapine should not be used by children, because safety and efficacy of clozapine have not been studied satisfactorily in this age group.

Elderly:
For elderly patients the recommended initial dose is 12.5 mg on the first day. The dosage may be increased in increments of not more than 25 mg per day. Patients with a low body weight and those suffering from moderate hepatic, renal or cardiovascular disorders should be given low dosages to start with (a maximum of 12.5 mg on the first day). Increasing the dose should be performed slowly in those cases.

Discontinuation of therapy:
If the therapy is to be discontinued, the administration should be tapered gradually over 1 to 2 weeks.
If abrupt termination is necessary, the patient should be monitored for recurrence of psychotic symptoms.

Resumption of therapy:
If the therapy is restarted (i.e. the last dose of clozapine was taken longer than 2 days ago) the first dose should be 12.5 mg (half a tablet of 25 mg) once or twice on the first day. If this initial dose is well tolerated, the dosage may be increased to the therapeutic level faster than advised with a starting dose as described above. The increase should be performed with extreme caution when cardiac and/or respiratory problems developed previously during the initial dosing.

Switching from another antipsychotic agent to Clozapine:
The use of Clozapine in combination with other antipsychotic agents is not recommended. Therefore it is advised to taper the dosage of the other agent to zero within a week. After the therapy has been interrupted for 24 hours, the treatment with Clozapine may be started as advised in the abovementioned text on the starting dose.

Contra-indications

• Hypersensitivity to clozapine or to one of the excipients of the tablet.

• Bone marrow disorders or a history of medication-induced granulocytopenia or agranulocytosis.

• Convulsions, or epilepsy that is uncontrollable with medication.

• Alcohol psychosis or toxic psychosis, medicine intoxications, comatose conditions.

• Circulatory collapse and/or depression of the central nervous system irrespective of the causes.

• Severe liver, renal or cardiac disorders.

• Paralytic ileus.

• Uretroprostatic disorders.

• Narrow angle glaucoma.