Samsung Quetiapine Tablet 200 mg (Quetiapine Fumarate)

Adult dose

Schizophrenia Adults: Take this medicine twice daily, regardless of meals. 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 5 onward, adjust the dose to the usual effective daily dose of 300～400 mg. Depending on the clinical response and tolerability of each patient, 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 reassessed regularly to determine the need for maintenance therapy. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: Adults: Take this medicine twice daily, regardless of meals. 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 the clinical response and tolerability of each patient, 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, regardless of meals. 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 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 with 600 mg. Increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. For 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 during 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 the range of 300～800 mg/day, administered twice daily. It is important to use the lowest effective dose for maintenance therapy. Elderly patients As with other antipsychotics, this medicine should be administered with caution to elderly patients, particularly when starting treatment. Elderly patients should start with 25 mg/day, with gradual increases of 25～50 mg per day. The effective dose in elderly patients may be lower than that in younger patients. Patients with renal or hepatic impairment Clearance after oral administration of quetiapine is reduced by approximately 25% in patients with renal or hepatic impairment. Because 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 with 25 mg/day, with gradual increases of 25～50 mg per day until the effective dose is reached.

Child dose

The safety and efficacy of this drug have not been established in children and adolescents.

This medication may increase the risk of suicidal thoughts or behavior in children and young adults with major depressive disorder or psychiatric disorders, so it should be discussed thoroughly with a physician before administration. In addition, blood sugar levels may rise during use, worsening symptoms of diabetes, so diabetic patients or those with risk factors should regularly check their blood sugar and closely observe symptoms. This medication can rarely cause neuroleptic malignant syndrome, which is accompanied by severe muscle rigidity and high fever, so if these symptoms occur, immediate consultation with healthcare professionals is necessary. With long-term use, involuntary muscle movements may occur, and if abnormal symptoms arise, dosage adjustment or discontinuation of the medication should be considered. In older patients with dementia, this medication may increase the risk of death, so it must be used with caution. Severe neutropenia or agranulocytosis, which is a rapid decrease in white blood cell count, may occur, so regular blood testing should be conducted and treatment should be initiated immediately if infection symptoms appear. Patients with a risk of cerebrovascular disease need to be particularly cautious, as the risk of stroke may increase with the use of this medication. There is a risk of venous thromboembolism, so patients with risk factors for thrombosis should be closely monitored and preventive measures should be taken before and during administration. This medication may cause orthostatic hypotension in patients with cardiovascular disease or hypotension, so symptoms of dizziness or fainting should be noted during initial dosage adjustment. This medication can cause serious skin reactions that may be life-threatening, so if symptoms such as skin rash or fever occur, immediate discontinuation and consultation with healthcare professionals are necessary. Moreover, this medication should not be administered to patients with specific allergies, patients in a state of coma, those taking central nervous system depressants, those receiving epinephrine, diabetic patients, or patients with lactose intolerance. Patients with impaired liver function, cardiovascular disease, seizure disorders, the elderly, pregnant women, and nursing mothers must be more closely monitored and have their dosages adjusted during use. Drowsiness or dizziness may occur during the use of this medication, so it is advised to avoid driving or operating dangerous machinery. Care should be taken regarding drug interactions, especially during concurrent use with strong hepatic enzyme inhibitors or central nervous system depressants. Women who are pregnant or breastfeeding should consult their doctor before taking this medication, as it may have an impact on the fetus or newborn. Lastly, the safety and effectiveness of this medication in children and adolescents have not been established, and it is not recommended.

• 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 sealed 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

White, round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle