Quetiapine 25 mg Tablets (Quetiapine Fumarate)

Adult dose

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. 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. 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. 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. 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. Patients with renal or hepatic impairment: Treatment should be initiated at 25 mg/day, with gradual increases of 25～50 mg per day until the effective dose is reached.

Child dose

4. Pediatrics: The safety and efficacy of this medication in children and adolescents have not been established.

This medication should be used with caution in patients with suicidal tendencies, especially those aged 18 to 24 years, including children, adolescents, and young adults. During treatment, close observation of the patient's suicidal impulses or changes in behavior is necessary, and families or guardians should also be attentive. This medication may raise blood sugar levels; hence, patients with diabetes or those at risk of diabetes should monitor their blood sugar regularly. Rarely, a serious side effect known as neuroleptic malignant syndrome may occur; if symptoms such as high fever, muscle rigidity, or changes in mental status appear, immediate consultation with health professionals is necessary. Long-term use may lead to extrapyramidal symptoms or tardive dyskinesia; if abnormal movements occur, consultation with a physician is advised. Elderly patients with dementia should use this medication cautiously as it may increase the risk of death. Blood abnormalities such as neutropenia and agranulocytosis may occur, so regular monitoring of white blood cell counts is required, and immediate treatment is necessary if infection symptoms appear. Special caution is needed when using this medication in patients at risk for cerebrovascular disease, and there may be an increased risk of venous thromboembolism; therefore, risk factors should be identified and preventive measures taken. Patients with cardiovascular diseases or hypotension may experience orthostatic hypotension upon initial administration, so gradual dose adjustment and monitoring of conditions are necessary. If severe skin reactions occur, the medication should be discontinued immediately and the healthcare provider notified. This medication should not be used in certain patients, such as those with lactose intolerance, those in a coma, or those concurrently using specific central nervous system depressants. For patients with liver dysfunction, it should be started at a low dose and gradually increased while monitoring their condition closely. Women who are pregnant or of childbearing potential, and nursing mothers should consider that this medication can affect the fetus and newborn if taken. Common side effects when administering this medication include sedation, dizziness, dry mouth, withdrawal symptoms, increased triglycerides, increased total cholesterol, decreased HDL cholesterol, weight gain, decreased hemoglobin, extrapyramidal symptoms, speech difficulties, seizures, restless legs syndrome, tardive dyskinesia, syncope, nightmares, symptoms related to sleepwalking, constipation, dyspepsia, vomiting, dysphagia, intestinal obstruction, rhinitis, tachycardia, palpitations, bradycardia, blurred vision, pain in various areas, and muscle pain. Special attention should be given to the potential for increased side effects when taken along with other central nervous system medications or alcohol. An overdose of this medication has no specific antidote, so one should visit a medical institution immediately for appropriate treatment. Abrupt discontinuation of the medication may lead to withdrawal symptoms, so the dosage should be gradually reduced per the physician's instructions.

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

This medication should be stored in a tightly closed container to protect it from air and moisture. Additionally, it is important to store it in a cool place below 30 degrees Celsius to maintain its efficacy.

Appearance

Pink round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle