Serapine 12.5 mg (quetiapine fumarate)

Adult dose

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 to the usual effective daily dose of 300～400 mg. Depending on the individual patient's clinical response and tolerability, the dose may be adjusted within the range of 150～750 mg/day. Maintenance treatment has not been evaluated in adults with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance treatment. 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 individual 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: 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 pivotal 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 no additional benefit was observed with 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 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 individual 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 treatment. Older adults As with other antipsychotics, this medicine should be used with caution in older adults, particularly at the start of treatment. Initiate treatment in older patients at 25 mg/day and increase gradually 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. In patients with renal or hepatic impairment, initiate treatment with this medicine at 25 mg/day and increase gradually by 25～50 mg per day to the effective dose.

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 disorders or other psychiatric illnesses; therefore, physicians should exercise caution in prescribing this medication and closely monitor the symptoms of patients and their guardians. Some patients taking this medication may experience elevated blood sugar levels, worsening diabetes, or hyperglycemia-related complications; thus, diabetic patients or those with risk factors for diabetes should regularly monitor their blood sugar and ensure that the patient and their family are adequately educated about hyperglycemic symptoms. This medication can occasionally cause a serious side effect known as neuroleptic malignant syndrome, which may include high fever, muscle stiffness, and altered consciousness; if these symptoms occur, the treatment should be discontinued immediately and appropriate medical care sought. Prolonged use may lead to movement disorders such as extrapyramidal symptoms or tardive dyskinesia; if such symptoms appear, dose adjustment or cessation of the medication may be considered. In elderly patients with dementia, the use of this medication can increase the risk of death; thus, it is generally contraindicated in patients with dementia-related psychosis. This medication can rarely cause serious blood dyscrasias such as agranulocytosis or severe neutropenia; therefore, patients with low white blood cell counts should avoid taking it, or their blood should be carefully monitored during treatment. In patients at risk of cerebrovascular disease, there may be an increased risk of stroke associated with this medication, warranting additional caution. There is also a risk of venous thromboembolism; hence, patients with risk factors for thrombosis should assess risk factors before and during treatment and take preventative measures. Patients with cardiovascular disease or hypotension may experience orthostatic hypotension or heart-related side effects; careful monitoring and caution in administration are advised. Serious skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis can occur; thus, if symptoms like skin rash or fever develop, the medication should be stopped immediately. This medication should not be administered to specific patient groups and should be used with caution in patients with liver impairment, cardiovascular disease, a history of epilepsy, the elderly, those at risk of suicide, and during pregnancy and lactation. This medication can cause various side effects such as drowsiness, dizziness, dry mouth, weight gain, and blood lipid anomalies; if such symptoms occur, patients should consult a doctor. During administration, patients should avoid driving or operating dangerous machinery, exercise caution when taking alcohol or central nervous system depressants, and avoid sudden discontinuation, gradually reducing the dose instead. Use during pregnancy may pose risks to the fetus, and it is recommended to avoid breastfeeding while on this medication. In cases of overdose, it is important to visit a medical facility immediately for appropriate treatment as there is no antidote for this medication, and supportive treatment according to symptoms may be necessary.

• Drowsiness
• dizziness
• dry mouth
• withdrawal symptoms
• increased triglyceride levels
• increased 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 sealed container. The storage temperature should ideally be maintained between 1 to 30 degrees Celsius. Storing it this way helps to preserve the medication's effectiveness for longer.

Appearance

white round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle