Clozapine 100 mg Tablets (Clozapine)

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 drug may cause agranulocytosis, a serious blood condition, so patients taking this medication must undergo regular blood tests with a qualified healthcare professional. Additionally, this drug may carry a risk of seizures; therefore, patients with a history of seizures or those with factors that may provoke seizures must exercise special caution. It can affect the heart, so if myocarditis or other heart conditions are suspected, the medication should be discontinued immediately. Blood pressure-related side effects such as orthostatic hypotension and syncope may occur; thus, extra caution is needed, especially during the initial phase of treatment and when adjusting the dosage. In elderly individuals or those with dementia, the risk of death may increase; thus, careful consideration is required. There is a risk of thrombosis, so patients with risk factors for thromboembolism should consult healthcare professionals before taking this drug. Patients with hypersensitivity, bone marrow suppression, severe renal or liver diseases, severe heart diseases, and certain genetic metabolic disorders should not take this drug. Common side effects include drowsiness, dizziness, constipation, hypersalivation, increased heart rate, and others; therefore, patients should pay attention to their daily activities. Moreover, this drug may interact with other medications; if the patient is taking other medications, they must inform their healthcare provider. Women who are pregnant or may become pregnant should not take this drug and should stop breastfeeding if they are nursing. In cases of overdose, severe side effects may occur; thus, the prescribed dosage and intervals must be strictly followed, and if any abnormalities arise, a medical facility should be visited immediately. This drug has not been established as safe and effective for children and adolescents, and thus should not be used for these age groups. While taking this medication, caution is required for driving or operating machinery; sudden discontinuation may cause withdrawal symptoms, so gradual tapering according to the healthcare provider's instructions is necessary. This drug must be kept out of the reach of children and should not be transferred to other containers.

• Agranulocytosis
• agranulosis
• seizures
• myocarditis
• orthostatic hypotension
• collapse
• respiratory arrest
• cardiac arrest
• drowsiness
• sedation

This medication may be sensitive to air and moisture, so it should be stored in a sealed container. The storage temperature should be maintained at room temperature between 1 to 30 degrees Celsius.

Appearance

Yellow round tablets

Package unit

30 tablets/bottle, 100 tablets/bottle, 100 tablets (10 tablets/PTP x 10)