Quetiapine Tablets 100 mg (Quetiapine Fumarate)

Adult dose

1. Schizophrenia - Adults: Take this medicine 2 times daily, with or without food. 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, adjust the dose 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 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: Take this medicine 2 times daily, with or without food. Whether used 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, in increments 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 tolerability; the usual effective daily dose is 400～800 mg. (2) Treatment of depression associated with bipolar disorder: - Adults: Take this medicine once daily at bedtime, with or without food. 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 confirmatory clinical trials of this medicine, 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 seen 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 medicine, clinical trials have shown that the dose may be reduced to as low as 200 mg. (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 a range of 300～800 mg/day, administered 2 times daily. It is important to use the minimum effective dose for maintenance therapy. 3. Elderly patients : As with other antipsychotics, this medicine should be administered with caution to elderly patients, particularly when initiating treatment. Start elderly patients on 25 mg/day of this medicine and increase gradually by 25～50 mg per day. The effective dose in elderly patients 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. Since quetiapine is primarily metabolized in the liver, administer with caution to patients with known hepatic impairment. Start patients with renal or hepatic impairment on 25 mg/day of this medicine and increase gradually by 25～50 mg per day to the effective dose.

Child dose

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

This medication requires careful observation when administered to patients with suicidal tendencies, particularly in children, adolescents, and young adults aged 18 to 24. This medication may increase blood glucose levels, so diabetic patients or those at risk of diabetes should regularly check their blood glucose and cautiously observe for abnormal symptoms. During the course of treatment, there is a rare but serious side effect known as neuroleptic malignant syndrome, which can occur; therefore, if symptoms such as high fever, muscle rigidity, and altered mental state occur, immediate consultation with a physician is necessary. Long-term use may lead to extrapyramidal symptoms or tardive dyskinesia, so patients should inform healthcare providers if they notice abnormal movements or discomfort. Special caution is required for elderly patients with dementia, as the risk of death may be increased with this medication. This medication may decrease the number of neutrophils in the blood, so if infection symptoms or fever occur, inform healthcare providers immediately, and periodic blood testing may be necessary. Patients at risk for cerebrovascular disease should be cautious as this medication may increase the risk of stroke. There is a risk of venous thromboembolism, so patients with risk factors for thrombosis should be carefully managed, including preventive measures. Patients with cardiovascular diseases or low blood pressure may experience orthostatic hypotension or heart-related abnormal symptoms when taking this medication, requiring symptom monitoring. This medication can cause severe skin adverse reactions, so if symptoms such as skin rashes, fever, or lymph node swelling occur, discontinue use immediately and seek medical attention. This medication should not be administered to certain patient groups, such as those with hypersensitivity reactions, coma, those receiving epinephrine, diabetic patients, and those with lactose intolerance. Patients with impaired liver function, cardiovascular diseases, cerebrovascular diseases, a history of seizures, the elderly, pregnant women, and lactating women should carefully receive this medication, adjusting the dosage and closely monitoring their conditions. This medication may cause side effects such as drowsiness, dizziness, dry mouth, weight gain, changes in blood lipids and blood glucose levels, so patients should consult with healthcare providers if these symptoms occur. When taken with other central nervous system depressants or alcohol, side effects may be exacerbated, requiring caution when used in combination. Women who are pregnant or may become pregnant should carefully consider the risks to the fetus when taking this medication, and breastfeeding women are advised to avoid breastfeeding while taking it. In cases of overdose, severe drowsiness, hypotension, and tachycardia may occur, necessitating immediate emergency care; however, since there is no specific antidote, supportive care according to symptoms will be provided. When storing this medication, keep it out of reach of children and avoid transferring it to other containers to prevent misuse. Patients should be cautious about driving or operating hazardous machinery while taking this medication due to the risk of accidents from drowsiness or decreased concentration.

• Suicidal impulses
• suicidal tendencies
• hyperglycemia
• diabetic ketoacidosis
• diabetic coma
• abnormal high fever
• changes in mental state
• muscle rigidity
• autonomic dysregulation
• increased creatine phosphokinase

This medication should be stored in a tightly closed container to protect it from exposure to air and moisture, kept in a cool place below 30 degrees Celsius. This will help maintain the medication’s effectiveness and prevent degradation.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle