Clzapin 50 mg (Clozapine)

Adult dose

The therapeutic dose of this medicine should be adjusted according to the patient's clinical condition, and the lowest effective dose possible should be administered. Careful dose adjustment 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, followed by 1 tablet of 25 mg once or twice on Day 2. If well tolerated, increase the dose by 25 ~ 50 mg daily; the dose may be increased to 300 mg per day by Week 2 ~ 3. Thereafter, if necessary, the daily dose may be increased by a further 50 mg to 100 mg once or twice weekly (once-weekly increases are preferred). ② Effective dose range: In most patients, an antipsychotic effect can be expected with 200 mg ~ 450 mg per day administered 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, take the largest dose at bedtime. ③ Maximum dose: In some cases, the dose may need to be increased to 900 mg per day to achieve an adequate effect; in this case, the maximum individual dose increase is 100 mg. (If the daily dose exceeds 450 mg, the possibility of adverse effects at these doses, particularly an increased risk of seizures, must be taken into account.) ④ Maintenance dose: After the maximum therapeutic effect has been achieved, most patients can continue treatment at a lower dose, which should be carefully 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, it may be administered once in the evening. ⑤ Discontinuation of treatment: If treatment with this medicine is to be discontinued, the dose should be gradually reduced over 1 ~ 2 weeks. If abrupt discontinuation is necessary (e.g., leukopenia), the patient's mental status and withdrawal symptoms (recurrence of psychotic symptoms and cholinergic rebound symptoms) should be carefully monitored. ⑥ Resumption of treatment: If 2 days or more have elapsed since the previous administration of this medicine, resume treatment 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 they have been managed continuously and successfully. ⑦ Switching from another antipsychotic medicine to this medicine In general, this medicine should not be administered concomitantly with other antipsychotic medicines. If treatment with this medicine is to be initiated in a patient currently receiving another oral antipsychotic medicine, the other antipsychotic medicine should be reduced or gradually tapered and discontinued. Depending on the clinical situation, the physician should decide whether to discontinue the other antipsychotic medicine before initiating this medicine. 2. Administration in specific populations 1) Elderly patients Treatment in elderly patients should be initiated at a particularly low dose (12.5 mg of this medicine on Day 1), and subsequent dose increases should not exceed 25 mg per day. 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: see Contraindications for patients with severe renal or cardiovascular disorders), administer an initial dose of 12.5 mg once 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

Clinical trials have not been conducted in children. The safety and efficacy of this medicine in children and adolescents under 18 years of age have not been established.

This drug can cause a serious blood disorder called agranulocytosis, which can be life-threatening, so regular blood tests should be conducted before and during use. Additionally, this drug may trigger seizures, so patients with a history of seizures or those at high risk for seizures should be particularly cautious, and they should be advised to avoid activities that may result in loss of consciousness. There is also a risk of myocarditis, which can cause inflammation of the heart, so if any cardiac symptoms arise during the initial administration, the patient must immediately stop using this medication and consult a doctor. Blood pressure-related issues such as orthostatic hypotension or fainting may occur, so special attention is needed upon initial dosing or when rapidly increasing the dose, and increased caution is required when taken with other psychiatric medications. Elderly patients or those with dementia may have an increased risk of death; therefore, this drug should not be used as a treatment for dementia-related mental disorders, and elderly patients require more careful monitoring. There is also a risk of thrombosis, so patients with thrombosis risk factors should be checked before and during treatment and appropriate preventive measures should be taken. Patients with a past allergy to this medication or its ingredients, those with damaged bone marrow function, or patients with severe kidney or heart diseases should not use this medication. Common side effects include drowsiness, dizziness, weight gain, constipation, and an increased heart rate, so it is important to inform healthcare providers if any of these symptoms occur. Additionally, it is recommended to avoid activities requiring attention, such as driving or operating machinery, for the first few weeks of treatment. Women who are pregnant or may become pregnant should not use this medication, and nursing mothers should stop breastfeeding during treatment. This drug has many interactions with other medications, and the effects or side effects may vary depending on the medications taken together, so it is essential to inform healthcare providers of any other medications being taken. When discontinuing treatment, it should not be stopped abruptly, but rather gradually reduced following healthcare provider instructions to prevent withdrawal symptoms. Lastly, this medication has not established safety and efficacy in children and adolescents, therefore, its use is not recommended for these age groups.

• Granulocytopenia
• agranulocytosis
• seizures
• myocarditis
• orthostatic hypotension
• collapse
• respiratory arrest
• cardiac arrest
• drowsiness
• sedation

This medication should be stored in a tightly sealed container to protect it from exposure to air or moisture. It is important to maintain a room temperature, specifically between 1 and 30 degrees Celsius, during storage.

Appearance

Yellow round tablet

Package unit

30 tablets/bottle, 100 tablets/bottle, 100 tablets/box [10 tablets/PTP x 10]