Clozapine 25 mg Tablet

Adult dose

The therapeutic dose of this drug should be adjusted according to the patient's clinical condition, and the lowest effective dose possible should be used. Careful dose titration and divided dosing are necessary to minimize the risk of hypotension, seizures, or sedation. The recommended doses are as follows: 1. Adults ① Initial dose: On Day 1, administer 12.5 mg (1/2 of a 25 mg tablet) once or twice, then on Day 2 administer one 25 mg tablet once or twice. If well tolerated, the dose may be increased by 25 ~ 50 mg daily, up to 300 mg daily by weeks 2 ~ 3. Thereafter, if necessary, the daily dose may be increased further by 50 mg to 100 mg once or twice weekly (once-weekly increases are preferable). ② Effective dose range: Most patients can be expected to achieve an antipsychotic effect with 200 mg ~ 450 mg daily in 2 ~ 4 divided doses, although some patients may require a daily dose of up to 600 mg. If the total daily dose cannot be divided equally, the largest dose should be taken at bedtime. ③ Maximum dose: In some cases, the dose may need to be increased to 900 mg daily to achieve an adequate effect; the maximum individual dose increase is 100 mg. (When the daily dose exceeds 450 mg, the possibility of adverse effects at these doses, particularly an increased risk of seizures, must be considered.) ④ Maintenance dose: After achieving the maximum therapeutic effect, most patients can continue treatment at a lower dose, and the dose should be cautiously reduced to a daily dose of 150 mg ~ 300 mg. Treatment should continue for at least 6 months. If the daily dose does not exceed 200 mg, a single dose in the evening may also be used. ⑤ Discontinuation of treatment: If treatment with this drug is to be stopped, the dose should be gradually reduced over 1 ~ 2 weeks. If treatment must be discontinued abruptly (e.g., leukopenia), the patient's mental status and withdrawal symptoms (recurrence of psychotic symptoms and cholinergic rebound symptoms) should be closely monitored. ⑥ Resumption of treatment: If 2 days or more have elapsed since the previous administration of this drug, treatment should be resumed with 12.5 mg (1/2 of a 25 mg tablet) once or twice on Day 1. If this dose is well tolerated, the dose may be adjusted to the therapeutic dose more rapidly than recommended for initial treatment. However, considerable caution is required in patients who experienced respiratory or cardiac arrest during initial use, even if these events have been managed continuously and successfully. ⑦ Switching from an existing antipsychotic drug to this drug In general, this drug should not be administered concomitantly with existing antipsychotic drugs. If treatment with this drug is to be initiated in a patient currently receiving another oral antipsychotic drug, the other antipsychotic drug should be reduced or gradually tapered and discontinued. Depending on the clinical situation, the physician should decide whether or not to discontinue the other antipsychotic drug before initiating this drug. 2. Administration in special populations 1) Older adults Treatment in older adults should be initiated particularly at a low dose (12.5 mg of this drug on Day 1), and the dose thereafter should not exceed 25 mg daily. 2) Patients with a history of seizures or renal or cardiovascular disorders In patients with a history of seizures or renal or cardiovascular disorders (caution: refer to contraindications for patients with severe renal or cardiovascular disorders), administer a single initial dose of 12.5 mg on Day 1 and increase the dose slowly in small increments. 3) Patients with hepatic impairment A low initial dose and slow dose adjustment are recommended for patients with hepatic impairment.

Child dose

The safety and efficacy of this drug have not been established in children and adolescents under 18 years of age.

This medication can cause a serious blood disorder called agranulocytosis, which can be life-threatening, therefore all healthcare providers and patients must be registered in a special patient management system. This medication is to be used restrictively only for schizophrenia patients who do not respond to standard treatments or have severe side effects, and for patients at risk of suicide. Regular checks of white blood cell and neutrophil counts are required before and during treatment, and any signs of infection should be reported to a doctor immediately. This medication may increase the risk of seizures, thus patients with a history of seizures or risk factors must be monitored closely. Myocarditis and other heart inflammations may occur, so special attention should be paid to cardiac symptoms during the first month of treatment. Orthostatic hypotension or fainting, as well as cardiac and respiratory issues, may rarely occur, necessitating careful dosage adjustments. Caution should be exercised when prescribing to elderly or dementia patients as there may be an increased risk of death. Due to the risk of thrombosis, patients at risk should take preventive measures. This medication should not be administered to those with allergies to this medication or its components, those with bone marrow suppression, or severe renal or cardiac diseases. Patients with seizures, renal and cardiovascular disorders, glaucoma, and prostatic hypertrophy should be administered the medication cautiously. This medication can cause various side effects such as drowsiness, dizziness, constipation, weight gain, and cardiovascular irregularities, so symptoms should be monitored closely. In particular, if there are symptoms of fever or infection during the initial treatment period, immediate medical attention must be sought. This medication may interact with other drugs, so any other medications being taken must be reported. Women who are pregnant or may become pregnant should avoid using this medication, and lactating women should discontinue nursing. In case of overdose, there is a risk of serious side effects and death, thus the dosage must be strictly adhered to, and in the case of an overdose, immediate medical attention should be sought. Regular blood tests and cardiac function tests should be conducted to confirm safety during administration, and abrupt discontinuation of therapy should be avoided; it should be tapered off gradually. Safety and efficacy for children and adolescents have not been established, and they should not be given this medication. This medication should be kept out of the reach of children and must not be transferred to other containers.

• Granulocytopenia
• Agranulocytosis
• Seizures
• Myocarditis
• Orthostatic hypotension
• Collapse
• Respiratory arrest
• Cardiac arrest
• Drowsiness
• Sedation

This medication is sensitive to air and moisture, so it should be stored in a tightly closed container. It is also recommended to keep it at room temperature, avoiding extremes of temperature, ideally between 1°C to 30°C.

Appearance

Yellow round tablets

Package unit

30 tablets/bottle, 30 tablets (10 tablets/PTP x 3)