Quetiapine 100 mg Tablets (Quetiapine Fumarate)

Adult dose

1. Schizophrenia - Adults: This drug 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 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 adults with schizophrenia. Patients should be regularly reassessed to determine the need for maintenance therapy. 2. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: - Adults: This drug 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 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 drug 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 confirmatory clinical trials of this drug, 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. Dose increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. In patients who tolerate the drug, clinical trials indicate 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, and depressive episodes associated with bipolar disorder, patients who responded to quetiapine for acute treatment of bipolar disorder should be maintained on the same dose. Depending on clinical response and each patient's tolerability, the dose administered twice daily may be adjusted within the range of 300～800 mg/day. It is important to use the minimum effective dose for maintenance therapy. 3. Older adults : As with other antipsychotic drugs, this drug should be administered with caution to older adults, particularly at the start of treatment. Treatment in older patients should be initiated at 25 mg/day, with gradual increases of 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 : 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. Treatment in patients with renal or hepatic impairment should be initiated at 25 mg/day, with gradual increases of 25～50 mg per day until the effective dose is reached.

Child dose

Pediatric patients and adolescents: The safety and efficacy of this drug have not been established.

This drug may increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults with major depressive disorder or psychiatric disorders, thus physicians should carefully assess the need and risks before prescribing. During treatment with this drug, blood sugar levels may rise and severe complications related to diabetes or hyperglycemia may occur, therefore patients with diabetes or risk factors should regularly monitor their blood sugar and observe symptoms. Rare but serious side effects known as neuroleptic malignant syndrome may occur, presenting with high fever, muscle rigidity, and changes in mental status; if these occur, treatment should be stopped immediately and medical attention sought. Prolonged use may lead to tardive dyskinesia, an involuntary movement disorder, so if abnormal symptoms appear, dose adjustment or discontinuation should be considered. In elderly patients with dementia, there may be an increased risk of death, so it is advisable not to prescribe this drug to them. Serious blood dyscrasias such as agranulocytosis and neutropenia may occur, necessitating regular monitoring of white blood cell counts and immediate consultation with a physician if symptoms of infection arise. In patients at risk for cerebrovascular diseases, caution is necessary due to the possibility of stroke. Due to the risk of venous thromboembolism, patients with risk factors for thrombosis should be evaluated and preventive measures taken. For patients with cardiovascular diseases or hypotension, postural hypotension may occur when taking this drug, thus careful observation of symptoms is required. Severe skin adverse reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS syndrome may occur; if skin rashes or fever develop, medication should be discontinued immediately and a physician consulted. This drug should not be administered to patients with specific allergies, patients in a comatose state, patients taking central nervous system depressants, patients undergoing epinephrine treatment, patients with diabetes, or lactose intolerance. Patients with liver impairment may experience increased blood concentrations, thus starting at a low dose and closely monitoring their condition while increasing the dose is recommended. Pregnant or breastfeeding women should only use this drug if necessary as it may affect the fetus or newborn, and breastfeeding should be avoided during treatment. This drug may cause CNS side effects such as drowsiness and dizziness, so caution is needed when driving or operating machinery. In case of overdose, there is no specific antidote; immediate medical treatment and intensive management are required. During treatment, metabolic side effects such as weight gain, lipid abnormalities, and elevated blood sugar levels may occur, thus regular health checks are essential. When discontinuing this medication, do not stop abruptly; taper off gradually to prevent acute withdrawal symptoms or worsening of symptoms.

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

Store this medication in a tightly closed container to prevent exposure to air or moisture. It is advisable to keep it at a cool temperature below 30 degrees Celsius.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle