Clozapine 200 mg Tablets

Adult dose

The therapeutic dose of this medicine should be adjusted according to the patient's clinical condition, and the lowest possible effective dose should be administered. 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, followed by 1 25 mg tablet once or twice on Day 2. If well tolerated, the dose may be increased by 25 ~ 50 mg daily, up to 300 mg per day by Week 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: In most patients, an antipsychotic effect can be expected with 200 mg ~ 450 mg per day in 2 ~ 4 divided doses, although some patients may require a daily dose of up to 600 mg. If the total daily dose is not divided evenly, the largest dose should be taken 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 such cases, the maximum individual increase should be 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 considered.) ④ Maintenance dose: After achieving the maximum therapeutic effect, most patients can continue treatment at a lower dose, and the dose should be reduced carefully to a daily dose of 150 mg ~ 300 mg. Treatment should be continued for at least 6 months. If the daily dose does not exceed 200 mg, a single dose in the evening may also be appropriate. ⑤ End of treatment: When ending treatment with this medicine, the dose should be reduced gradually over 1 ~ 2 weeks. If treatment must be stopped abruptly (e.g., leukopenia), the patient's mental state and withdrawal symptoms (recurrence of psychotic symptoms and cholinergic rebound symptoms) should be monitored carefully. ⑥ Resumption of treatment: If 2 days or more have elapsed since the patient last received this medicine, 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 arrest or cardiac arrest during their first use, even if these events were managed successfully and continuously. ⑦ Switching from an existing antipsychotic agent to this medicine In general, this medicine should not be administered concomitantly with existing antipsychotic agents. If treatment with this medicine is to be initiated in a patient currently receiving another oral antipsychotic agent, the other antipsychotic agent should be reduced or gradually tapered and discontinued. Depending on the clinical situation, the physician should decide whether to discontinue the other antipsychotic agent before initiating treatment with this medicine. 2. Administration in special populations 1) Older adults Treatment in older adults should be initiated at a particularly low dose (12.5 mg of this medicine on Day 1), and the dose should not exceed 25 mg per day thereafter. 2) Patients with a history of seizures or renal or cardiovascular disorders In patients with a history of seizures or renal or cardiovascular disorders (Note: severe renal or cardiovascular disorders are contraindicated; see Contraindications), 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

Children and adolescents under 18 years of age: No clinical trials have been conducted in children. The safety and efficacy of this medicine have not been established.

This medication can cause a serious side effect known as agranulocytosis, which can be life-threatening, so both patients and healthcare providers must register in a special monitoring system. This medication should only be used restrictively in patients with schizophrenia who have not responded to other treatments or are at high risk for suicide. Regular blood tests must be conducted to check white blood cell and neutrophil counts before and during treatment, and the doctor should be informed immediately if any symptoms of infection occur. Care should be taken in patients with a history of seizures or those with factors that could trigger seizures, and they should be instructed to avoid dangerous activities if they lose consciousness. There is a risk of potentially fatal myocarditis, so if any heart-related symptoms appear, especially in the first month, the medication should be stopped immediately. Orthostatic hypotension and syncope, as well as abnormal heart and respiratory functions, may occur, so doses should be adjusted slowly at the beginning of treatment, and more caution should be exercised when combined with other psychiatric drugs such as benzodiazepines. This medication should be avoided in patients with dementia as the risk of death may increase. There is a risk of thrombosis, so risk factors for thrombosis should be assessed and preventive measures taken. Patients with a history of allergy to this medication or its components, those with compromised bone marrow function, and patients with severe heart, liver, or kidney disease should not use this medication. Patients with a history of seizures, elderly patients, and those with prostate enlargement or glaucoma should be administered cautiously, and monitoring for adverse reactions during treatment is essential. This medication can cause various side effects such as drowsiness, dizziness, constipation, weight gain, increased heart rate, among others, and in severe cases, may result in blood abnormalities, heart issues, liver dysfunctions, and neurological problems. Regular blood tests to monitor white blood cell counts are essential, and if abnormalities are found, administration should be stopped immediately. This medication may interact with other drugs, so patients should consult with healthcare providers regarding any concurrent medications. Pregnant women or those who may become pregnant, as well as breastfeeding women, should not take this medication, and appropriate contraceptive measures should be taken if pregnancy is planned. Severe overdose symptoms may occur, so caution is needed, and it is advisable to avoid driving or operating machinery during treatment. If discontinuation is necessary, withdrawal symptoms may occur, so the medication should be tapered off gradually according to the physician's instructions. The safety and effectiveness of this medication have not been established in children, and elderly patients should begin at especially low doses and be monitored for side effects.

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

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance

Yellow rectangular tablets

Package unit

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