Quetiapine Tablets 100 mg (Quetiapine Fumarate)

Adult dose

1. Schizophrenia Adults: This medicine is taken twice 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, the dose should be adjusted to the usual effective daily dose of 300～400 mg. Depending on the individual patient's clinical response and tolerability, the dose may be adjusted within the range of 150～750 mg/day. Maintenance therapy has not been evaluated in adults 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 medicine is taken twice daily, with or without food. 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. Depending on the individual patient's clinical response and tolerability, the dose may be adjusted within the range of 200～800 mg/day; the usual effective daily dose is 400～800 mg. (2) Treatment of depression associated with bipolar disorder: Adults: This medicine is taken 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 the 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 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. Clinical trials indicate that the dose may be reduced to a minimum of 200 mg in patients who tolerate the medicine. (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 for acute treatment of bipolar disorder should continue on the same dose. Depending on the clinical response and tolerability of each patient, the dose may be adjusted within the range of 300～800 mg/day, given twice daily. It is important to use the minimum effective dose for maintenance therapy. 3. Elderly patients As with other antipsychotic drugs, this medicine should be administered with caution to elderly patients, particularly at the start of treatment. Elderly patients should start with 25 mg/day, with gradual increases of 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, it should be administered with caution to patients with known hepatic impairment. Patients with renal or hepatic impairment should start with 25 mg/day, with gradual increases of 25～50 mg per day until the effective dose is reached.

Child dose

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

This medication is primarily used to treat psychiatric disorders and is not approved for use in children and adolescents, so it is recommended not to administer it to them. The risk of suicidal thoughts or behaviors may increase in certain age groups during treatment, thus young adults and adolescents should be closely monitored by a physician. Patients at risk for diabetes or hyperglycemia should regularly check their blood glucose levels while taking this medication, and closely monitor for symptoms of hyperglycemia such as thirst, frequent urination, and weight change. If symptoms of severe neuroleptic malignant syndrome such as muscle rigidity, high fever, or changes in mental status occur, the medication should be immediately discontinued, and consultation with healthcare professionals is necessary. Long-term use may result in extrapyramidal symptoms and tardive dyskinesia, such as involuntary movements of the face, tongue, and lips, so consult a physician if these symptoms occur. In elderly patients with dementia, the use of this medication may increase the risk of mortality, so careful administration is necessary. Severe neutropenia or agranulocytosis may occur with decreased white blood cell count, so medical personnel should be notified immediately if symptoms of infection or fever occur. Patients with cardiovascular disorders or hypotension may experience dizziness or orthostatic hypotension during initial dosing, so caution is needed. Rarely, severe skin adverse reactions such as severe rash, fever, lymph node swelling may occur; if these symptoms occur, stop taking the medication and consult healthcare professionals immediately. This medication may cause increased drowsiness or decreased concentration when taken with other central nervous system depressants or alcohol, so caution is advised. Pregnant or breastfeeding women should consult a physician before use, as it may affect the fetus or newborn; it is recommended to avoid taking this medication while breastfeeding. In case of overdose, symptoms such as severe drowsiness, hypotension, and increased heart rate may occur, so the prescribed dose must be strictly followed, and emergency treatment should be sought if overdose is suspected. Activities requiring attention, such as driving or operating machinery, should be performed with caution during treatment due to potential drowsiness or dizziness. Sudden discontinuation of this medication may cause withdrawal symptoms or worsen symptoms; therefore, the dosage should be gradually reduced according to a physician's instructions.

• Suicidal ideation
• suicidal tendencies
• hyperglycemia
• diabetic ketoacidosis
• diabetic coma
• hyperpyrexia
• changes in mental state
• muscle rigidity
• autonomic dysregulation
• increased creatine phosphokinase

This medication should be stored in a tightly sealed container to avoid exposure to air and moisture, and it is important to maintain a temperature below 30 degrees Celsius. Proper storage will help preserve the effectiveness of the medication over time.

Appearance

Yellow circular film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle