Quetin Tablet 200 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 clinical response and drug tolerability of each patient, the dose may be adjusted within the range of 150～750 mg/day. 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 clinical response and drug tolerability of each patient, the dose may be adjusted within the range of 200～800 mg/day, and 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 pivotal 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. Increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. In patients who tolerate the medicine, clinical trials indicate 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 for acute treatment of bipolar disorder should continue on the same dose. Depending on the clinical response and each patient's tolerability, the dose may be adjusted within the range of 300～800 mg/day, administered twice daily. 3. Older adults Older patients should start with 25 mg/day and have their dose gradually increased by 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 Patients with renal or hepatic impairment should start with 25 mg/day and have their dose gradually increased by 25～50 mg per day until an effective dose is reached.

Child dose

For children and adolescents: Safety and efficacy have not been established.

This medication may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults with major depressive disorder or other psychiatric disorders; therefore, physicians should carefully assess the need for treatment and risks. Blood sugar levels may rise during the administration of this medication, so individuals with diabetes or risk factors for elevated blood sugar should routinely check blood sugar levels and monitor for abnormal symptoms. Rarely, a serious side effect known as Neuroleptic Malignant Syndrome may occur, characterized by high fever, muscle rigidity, and changes in mental status, which requires immediate medical attention. Long-term use may result in extrapyramidal symptoms or tardive dyskinesia, so adjustments to dosage or discontinuation should be considered if abnormal symptoms arise. Elderly patients with dementia may have an increased risk of death, hence the use of this medication is not recommended for them. Severe neutropenia or agranulocytosis may occur, necessitating regular blood tests to monitor white blood cell counts and immediate treatment upon the appearance of infection symptoms. There may be an increased risk of cerebrovascular disease, therefore special caution should be taken for patients with a stroke risk. There is a risk of venous thromboembolism, thus risk factors for thrombosis should be evaluated and preventive measures taken. Patients with cardiovascular disease or hypotension may experience symptoms like orthostatic hypotension and should use caution when taking this medication. Severe skin adverse reactions may occur, and if symptoms such as rash or fever develop, discontinuation of the medication and consultation with a physician is necessary. This medication should not be administered to patients with specific genetic lactose intolerance or diabetes, nor should it be combined with certain central nervous system depressants. Patients with impaired liver function should start at a lower dosage and be closely monitored, gradually increasing the dosage. Pregnant or nursing individuals should consult with a doctor before use due to the potential risks of side effects for the fetus or newborn, and it is recommended to avoid use while breastfeeding. Drowsiness and dizziness may occur while taking this medication, and caution should be exercised when driving or operating hazardous machinery. Sudden discontinuation of this medication may lead to withdrawal symptoms; therefore, dosage should be gradually reduced according to a physician's instructions when discontinuing. Co-administration with other central nervous system medications or alcohol may increase side effects, thus caution is warranted when combining them. In case of overdose, severe drowsiness, hypotension, and tachycardia may present, and since there is no specific antidote, immediate medical attention should be sought.

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

This medication should be stored in a sealed container to protect it from air and moisture, and should be kept in a cool place below 30 degrees Celsius. Proper storage will help maintain its effectiveness and prevent deterioration.

Appearance

White, round, film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle