Quetiapine Tablet 300 mg (Quetiapine Fumarate)

Adult dose

Schizophrenia Adults: This medicine should be 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 each 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 adult patients with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance therapy. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: Adults: This medicine should be 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, with increases of no more than 200mg per day. Depending on each 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 should be taken once daily at bedtime, with or without food. The total daily dose should reach 300 mg by Day 4, with 50 mg on Day 1, 100 mg on Day 2, and 200 mg on Day 3. In the confirmatory clinical trials of this medicine, doses were administered as follows: 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. 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. For 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 clinical response and each patient's tolerability, the dose may be adjusted within the range of 300～800 mg/day, administered twice daily. It is important to use the minimum effective dose for maintenance therapy. Older adults As with other antipsychotics, this medicine should be administered with caution to older adults, particularly when initiating treatment. Older patients should start with 25 mg/day and the dose should be gradually increased by 25～50 mg per day. The effective dose in older adults may be lower than that in younger patients. Patients with renal or hepatic impairment After oral administration of quetiapine, clearance 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 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 and behaviors in children, adolescents, and young adults with major depressive disorder or other psychiatric conditions, hence careful assessment by a physician and close observation by the patient and family is necessary when administering to these age groups. In some patients taking this medication, blood sugar levels may rise leading to worsened diabetes or serious hyperglycemia-related side effects, therefore patients with diabetes or at risk for hyperglycemia need to regularly monitor blood sugar levels, and should consult a doctor immediately if hyperglycemia symptoms develop. This medication may rarely cause a serious side effect known as neuroleptic malignant syndrome, which is characterized by high fever, muscle rigidity, and altered mental state; if such symptoms appear, the medication should be stopped immediately and medical attention sought. Long-term use can lead to abnormal movement symptoms such as extrapyramidal symptoms or tardive dyskinesia, and if these symptoms occur, dosage adjustment or discontinuation should be considered. For elderly patients with dementia, the use of this medication is not recommended due to an increased risk of death. Severe neutropenia or agranulocytosis may occur resulting in decreased white blood cell counts; hence, patients with low white blood cell counts should discontinue this medication and be vigilant for symptoms of infection. There may be an increased risk of stroke in patients with a high risk of cerebrovascular disease when using this medication, so particular caution is warranted. There is a risk of venous thromboembolism; thus, patients with risk factors for thrombosis should confirm these risk factors before and during treatment. Patients with cardiovascular diseases or hypotension may experience orthostatic hypotension while taking this medication, so careful monitoring is needed. This medication can cause severe skin adverse reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, or DRESS syndrome; if symptoms like skin rash, fever, or lymphadenopathy occur, the medication should be stopped immediately and the patient should seek medical attention. This medication should not be given to patients with certain conditions or diseases, and should be used with caution in patients with liver impairment, elderly patients, pregnant women, and nursing mothers according to a physician's advice. Common side effects such as drowsiness, dizziness, and dry mouth may occur during treatment, so caution is advised when driving or operating machinery. Abrupt discontinuation of this medication may result in withdrawal symptoms or worsening of symptoms; therefore, the dosage should be gradually reduced according to the physician's instructions. Additionally, this medication may have increased side effects when taken in conjunction with other central nervous system depressants or alcohol, so caution is needed when co-administered.

This medication should be stored in a tightly sealed container to prevent air and moisture from entering. It is also important to store it in a cool place below 30 degrees Celsius to maintain the drug's efficacy.

Appearance

White rectangular film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle