Capsin Tablet 100 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 each patient's clinical response and tolerability, the dose may be adjusted within 150～750 mg/day. Maintenance treatment has not been evaluated in adults with schizophrenia. Patients should be reassessed regularly to determine whether maintenance treatment is needed. 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. Whether used 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 200 mg per day. Depending on each patient's clinical response and tolerability, the dose may be adjusted within 200～800 mg/day; 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 should reach 300 mg by day 4, with doses of 50 mg on day 1, 100 mg on day 2, and 200 mg on day 3. 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 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, 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 a range of 300～800 mg/day, administered twice daily. It is important to use the minimum effective dose for maintenance treatment. 3. Elderly patients As with other antipsychotics, this medicine should be administered with caution to elderly patients, particularly at the start of treatment. Elderly patients should start at 25 mg/day and the dose should be increased gradually 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 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. Patients with renal or hepatic impairment should start at 25 mg/day and the dose should be increased gradually by 25～50 mg per day until an effective dose is reached.

Child dose

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, careful judgment by a doctor is required when administering to patients in this age group. This medication can elevate blood sugar levels, and patients with diabetes or at risk should monitor their blood sugar regularly. Neuroleptic Malignant Syndrome, a serious side effect, may occur rarely, so if symptoms such as high fever, muscle rigidity, and changes in mental status appear, immediate medical attention should be sought. Long-term use may result in extrapyramidal symptoms or tardive dyskinesia, and dosage adjustment or cessation should be considered if abnormal symptoms are observed. It is not recommended for elderly patients with dementia as it may increase the risk of mortality. Hematological abnormalities such as agranulocytosis or neutropenia may occur, so immediate medical consultation is necessary in case of signs of infection or fever. Patients with a history of cerebrovascular disease should exercise caution when using this medication, and the risk of thrombosis may increase; thus, risk factors for venous thrombosis should be assessed and preventive measures taken. Caution is required for patients with cardiovascular disease or hypotension as symptoms of orthostatic hypotension may occur upon administration of this medication. Severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS syndrome may occur rarely; if symptoms such as skin rashes, fever, or lymph node swelling arise, immediate discontinuation of the medication and consultation with a doctor is necessary. This medication should not be used in patients with hypersensitivity to specific components, in coma, in overdose of central nervous system depressants such as barbiturates, in patients receiving epinephrine, in diabetic patients, or in those with lactose intolerance. Hepatic impairment patients may experience increased plasma concentrations, thus starting with a lower dosage and close monitoring and adjustment of the dose is required. Pregnant or nursing women should carefully consider the use of this medication as it may affect the fetus or newborn; use during breastfeeding is recommended to be avoided. This medication commonly causes side effects such as drowsiness, dizziness, and dry mouth, and caution is needed when driving or operating hazardous machinery. When discontinuing the medication, do not stop abruptly; tapering the dosage gradually is essential to prevent acute withdrawal symptoms or the recurrence of psychotic symptoms. Taking this medication with other central nervous system depressants or alcohol may enhance its effects; thus, caution is warranted when co-administering. In cases of overdose, as there are no specific antidotes, immediate medical treatment and intensive observation are required, especially in patients with cardiovascular disease.

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

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, it is best to keep it in a cool place below 30 degrees Celsius to maintain its efficacy.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle