Quetiapine 200 mg (Quetiapine fumarate)

Adult dose

1. Schizophrenia Adults: This medication is taken twice daily, regardless of meals. The total daily dose for the first 4 days is 50 mg on day 1, 100 mg on day 2, 200 mg on day 3, and 300 mg on day 4. From day 4 onward, the dose should be adjusted to the usual effective daily dose of 300～400 mg. The dose may be adjusted within 150～750 mg/day according to each patient's clinical response and drug tolerability. Maintenance therapy has not been evaluated in adult patients with schizophrenia. Patients should be reassessed regularly to determine whether maintenance therapy is needed. 2. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: Adults: This medication is taken twice daily, regardless of meals. As monotherapy or as adjunctive therapy to a mood stabilizer (lithium or valproate), the total daily dose for the first 4 days is 100 mg on day 1, 200 mg on day 2, 300 mg on day 3, and 400 mg on day 4. The total daily dose may be increased to 800 mg by day 6, with increases of no more than 200mg per day. The dose may be adjusted within 200～800 mg/day according to each patient's clinical response and drug tolerability; the usual effective daily dose is 400～800 mg. (2) Treatment of depression associated with bipolar disorder: Adults: This medication is taken once daily at bedtime, regardless of meals. The total daily dose for the first 4 days should reach 50 mg on day 1, 100 mg on day 2, 200 mg on day 3, and 300 mg on day 4. In the pivotal clinical trials of this medication, doses of 50 mg on day 1, 100 mg on day 2, 200 mg on day 3, 300 mg on day 4, 400 mg on day 5, and up to 600 mg on day 8 were administered. The recommended daily dose is 300 mg. Antidepressant effects were observed with both 300 mg and 600 mg, but there was no additional benefit at 600 mg. Increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. In patients who tolerate the medication, reduction to as low as 200 mg has been shown to be possible in clinical trials. (3) Prevention of recurrence of bipolar disorder: Adults: To prevent recurrence of manic, mixed, or depressive episodes associated with bipolar disorder, patients who responded to quetiapine during acute treatment of bipolar disorder should continue on the same dose. Depending on clinical response and each patient's tolerability, the dose may be adjusted within 300～800 mg/day, given twice daily. It is important to use the minimum effective dose for maintenance therapy. 3. Older adults As with other antipsychotics, this medication should be administered with caution to older adults, particularly when starting treatment. Older patients should start this medication at 25 mg/day, with gradual increases of 25～50 mg per day; the effective dose in older adults may be lower than that in younger patients. 5. Patients with renal or hepatic impairment Clearance after oral administration of quetiapine is reduced by approximately 25% in patients with renal or hepatic impairment. Because quetiapine is primarily metabolized in the liver, it should be administered cautiously to patients with known hepatic impairment. Patients with renal or hepatic impairment should start this medication at 25 mg/day, with gradual increases of 25～50 mg per day until an effective dose is reached.

Child dose

Children and adolescents: The safety and efficacy of this medication have not been established in children and adolescents.

This medication may increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults, so prescribers should carefully evaluate the risks and benefits before administration. During the use of this medication, blood sugar may increase, so diabetic patients or those with risk factors for diabetes should regularly monitor their blood sugar levels. A serious side effect known as neuroleptic malignant syndrome may occur, so if symptoms such as high fever, muscle rigidity, or changes in consciousness occur, medical personnel should be notified immediately. Long-term use of this drug may lead to tardive dyskinesia, an involuntary movement disorder, so patients should consult their doctor if any abnormal symptoms arise. Elderly patients with dementia may experience an increased risk of death when taking this drug, requiring special caution. Severe neutropenia or agranulocytosis may occur due to a rapid decrease in neutrophil count in the blood, so blood leukocyte counts should be monitored regularly, and immediate treatment should be sought if signs of infection arise. When administered to patients at risk for cerebrovascular disease, care should be taken considering the potential for stroke and other vascular conditions. There is a risk of venous thrombosis, so patients with risk factors for thrombosis should confirm this and take preventive measures. Patients with cardiovascular diseases or hypotension may be particularly vulnerable to dizziness or fainting related to orthostatic hypotension during initial dosage adjustments, and caution is warranted. Severe skin adverse reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS syndrome may occur; therefore, if symptoms such as widespread skin rashes, fever, or lymphadenopathy arise, medication should be discontinued immediately, and medical personnel notified. This drug should not be administered to patients with hypersensitivity to it, those in coma, those taking specific central nervous system depressants, those undergoing treatment with epinephrine, diabetic patients, and patients with lactose intolerance. Patients with impaired liver function, cardiovascular disease, cerebrovascular disease, a history of seizures, the elderly, patients at risk for suicide, pregnant or lactating women should take special caution when administered this drug. Common side effects include sedation, dizziness, dry mouth, weight gain, abnormal blood lipid levels, extrapyramidal symptoms, etc., so patients should discuss symptoms with their doctor when they occur. This medication affects the central nervous system and may lead to drowsiness and decreased attention, so caution should be observed when driving or operating dangerous machinery. In case of overdose, there is no specific antidote, and immediate medical attention and intensive care are required. Epinephrine and dopamine should not be used, as they can worsen hypotension in overdose situations. If a pregnant woman takes this medication, the newborn may exhibit withdrawal symptoms or extrapyramidal disorders; therefore, administration during pregnancy should be decided cautiously, and nursing during treatment is not recommended.

• Drowsiness
• dizziness
• dry mouth
• withdrawal symptoms
• increased triglyceride levels
• increased total cholesterol
• decreased HDL cholesterol
• weight gain
• decreased hemoglobin
• extrapyramidal symptoms

Store this medication in a tightly sealed container to protect it from air and moisture, and keep it in a cool place below 30 degrees Celsius. Proper storage helps maintain the drug's effectiveness for a longer duration.

Appearance

White, round film-coated tablet

Package unit

[For domestic use] 30 tablets/bottle, 100 tablets/bottle [For export] 30 tablets (10 tablets/PTP x3), 60 tablets (10 tablets/PTP x6), 100 tablets (10 tablets/PTP x10)