PMS Quetiapine 200 mg Tablet (Quetiapine Fumarate)

Adult dose

1. Schizophrenia Adults: Take this medicine 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, adjust the dose to the usual effective daily dose of 300～400 mg. Depending on the clinical response and tolerability of each patient, the dose may be adjusted within the range of 150～750 mg/day. Maintenance therapy has not been evaluated in adult patients with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance therapy. 2. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: Adults: Take this medicine 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 tolerability of each patient, 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: 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 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 medicine, clinical trials have shown that the dose may be reduced to a minimum of 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 clinical response and each patient's tolerability, 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 treatment with 25 mg/day and have the dose gradually increased 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: Following oral administration of quetiapine, clearance is reduced by approximately 25% in patients with renal or hepatic impairment. Because 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 treatment with 25 mg/day and have the dose gradually increased by 25～50 mg per day until an 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 may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults with major depressive disorder or psychiatric illness; therefore, when prescribing this age group, the physician should carefully evaluate the risks and benefits. This medication can elevate blood sugar levels; patients with diabetes or risk factors for diabetes should regularly monitor and manage their blood sugar levels. There can be rare but serious symptoms of neuroleptic malignant syndrome, so if high fever, muscle rigidity, or changes in mental state occur, prompt medical attention is required. Long-term use of this medication may lead to extrapyramidal symptoms or tardive dyskinesia; thus, if any abnormal symptoms appear, consideration should be given to dose adjustment or discontinuation of treatment. It is generally advisable not to use this medication in elderly patients with dementia due to an increased risk of death; extreme caution is recommended if prescribed. This medication can rarely lead to serious neutropenia or agranulocytosis; thus, regular blood tests to monitor white blood cell counts are necessary. Caution is warranted when administering this medication to patients at risk of cerebrovascular disease, as it may increase the risk of stroke. Since there is a risk of venous thromboembolism, patients with risk factors for thrombosis should be carefully monitored before and during treatment. Patients with cardiovascular diseases or hypotension may experience side effects such as orthostatic hypotension; special caution is needed during the initial dose adjustment. This medication may rarely cause serious skin reactions; if extensive skin rashes, fever, or lymphadenopathy occur, immediate discontinuation and medical evaluation are required. This medication is not indicated for certain patient groups, such as those with hypersensitivity, comatose patients, those taking strong central nervous system depressants, patients receiving epinephrine, diabetic patients, and those with specific genetic lactose intolerance. Patients with liver impairment, cardiovascular diseases, a history of epilepsy, elderly patients, those at risk of suicide, pregnant women, and breastfeeding mothers should use this medication with caution. While taking this medication, side effects such as drowsiness, dizziness, dry mouth, weight gain, changes in blood glucose and lipid levels may occur; if these symptoms persist or worsen, consult with healthcare professionals. Abruptly discontinuing this medication may lead to withdrawal symptoms; therefore, dosage should be gradually reduced under medical supervision when discontinuing treatment. When taken in conjunction with other central nervous system depressants or alcohol, drowsiness or confusion may be exacerbated; caution is advised. If taken by pregnant women, withdrawal symptoms or extrapyramidal symptoms may occur in the newborn; thus, the risks and benefits of use during pregnancy should be carefully weighed. Breastfeeding women are advised to avoid breastfeeding while taking this medication. In case of an overdose, symptoms such as drowsiness, sedation, hypotension may occur; as there is no specific antidote, immediate hospital care and appropriate treatment are required. This medication should be kept out of reach of children; re-packaging may affect quality, so caution is advised.

• 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 tightly sealed container to protect it from air and moisture. Additionally, it is important to keep it in a cool place below 30 degrees Celsius to maintain its effectiveness.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle