Soomdipin Tablet 200 mg (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, adjust to the usual effective daily dose of 300～400 mg. The dose may be adjusted within 150～750 mg/day according to each patient's clinical response and tolerability. Maintenance therapy has not been evaluated in adults with schizophrenia. Patients should be reassessed regularly 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 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. The dose may be adjusted within 200～800 mg/day according to each patient's clinical response and tolerability; 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 at 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 drug, reduction to a minimum of 200 mg has been shown to be possible in clinical trials. (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 in acute treatment of bipolar disorder should continue on the same dose. Depending on clinical response and individual tolerability, the twice-daily dose 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 antipsychotics, this drug should be administered with caution to older adults, particularly when initiating treatment. Older patients should start 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 and hepatic impairment Clearance after oral administration of quetiapine is reduced by approximately 25% in patients with renal or hepatic impairment. As quetiapine is primarily metabolized in the liver, use with caution in patients with known hepatic impairment. Patients with renal or hepatic impairment should start at 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 drug have not been established in children and adolescents.

This drug may increase the risk of suicidal thoughts or behaviors in young patients with depression or psychiatric disorders, so the patient's condition must be closely monitored before and during administration. Blood sugar may increase, therefore, diabetic patients or those with risk factors for diabetes should regularly check blood sugar levels, and immediately consult medical personnel if high blood sugar symptoms occur. This drug can, in rare cases, cause neuroleptic malignant syndrome, characterized by severe muscle rigidity and high fever, so if such symptoms occur, the medication must be stopped immediately, and treatment should be sought. Long-term use may result in tardive dyskinesia, a disorder characterized by involuntary movements, so consideration should be given to dose adjustment or discontinuation if symptoms occur. In elderly patients with dementia, there may be an increased risk of death, and it is recommended that this medication not be used. Severe neutropenia or agranulocytosis may occur with a drastic decrease in the number of white blood cells, so blood tests should be conducted to regularly check white blood cell counts. Patients with a risk of cerebrovascular disease should be cautious as the likelihood of stroke may increase. This medication may increase the risk of venous thromboembolism, so patients with thrombotic risk factors should take preventive measures. Patients with cardiovascular disease or low blood pressure may experience orthostatic hypotension or dizziness, so it is recommended to start at a lower dose and gradually increase while monitoring their condition. Severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS syndrome have been reported, and if skin rashes, fever, or lymphadenopathy appear, the medication should be stopped immediately. Patients with hypersensitivity to this drug, those in a comatose state, those taking certain central nervous system depressants, those receiving epinephrine, diabetic patients, and lactose intolerant patients should not be administered this drug. Patients with impaired liver function, a history of cardiovascular disease, cerebrovascular disease, or seizures, elderly patients, pregnant or breastfeeding women should be administered with caution, requiring dose adjustments and monitoring. This drug can cause side effects such as drowsiness, dizziness, dry mouth, weight gain, lipid abnormalities, extrapyramidal symptoms, speech disorders, seizures, restless legs syndrome, tardive dyskinesia, fainting, nightmares, sleepwalking, constipation, indigestion, vomiting, rhinitis, tachycardia, palpitations, bradycardia, blurred vision, pain of various kinds, muscle pain, priapism, galactorrhea, increased appetite, among others. In cases of overdose, there are no specific antidotes, therefore supportive treatment according to symptoms and intensive medical management is needed, and medications like epinephrine should not be used. This drug is not recommended for children and adolescents as its safety and efficacy have not been established in this population. Patients taking this medication should be cautious while driving or operating machinery due to the possibility of drowsiness or decreased attention. The risk of side effects may increase when taken with alcohol or other central nervous system depressants, so caution is advised. There are drug interactions with this medication, so patients taking other medications should inform their healthcare providers. Pregnant women should consider the risks and benefits to the fetus carefully before taking this medication, and breastfeeding women are recommended to avoid breastfeeding.

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

This medication should be stored in a tightly closed container, protected from air and moisture, and kept at a cool temperature below 30 degrees Celsius. Storing it this way will help maintain the drug's effectiveness for a longer period.

Appearance

White round film-coated tablet

Package unit

30 tablets/box [10 tablets/PTPX3], 100 tablets/bottle