Samsung Quetiapine Tablets 25 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 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. 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. 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 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: This medicine 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 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. Dose 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 the 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. 3. Older adults As with other antipsychotics, this medicine 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 or hepatic impairment After oral administration, 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. 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

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

This drug is primarily used for the treatment of psychiatric disorders, particularly depression, schizophrenia, and bipolar disorder. Taking this medication can increase the risk of suicidal thoughts or behaviors, particularly in young patients aged 18 to 24, who should be closely monitored. Blood sugar levels may increase, so patients with diabetes or risk factors for diabetes should regularly monitor their blood sugar levels and pay close attention to symptoms of high blood sugar such as thirst, frequent urination, and weakness. Although rare, a serious neurological side effect known as Neuroleptic Malignant Syndrome can occur, so if symptoms like high fever, muscle rigidity, or changes in mental status appear, immediate consultation with a healthcare provider is necessary. With long-term use, extrapyramidal symptoms or tardive dyskinesia may present, so patients should inform their doctor if they experience unusual movements or discomfort. Elderly patients with dementia may have an increased risk of mortality associated with the use of this medication, which requires special caution. Severe neutropenia or agranulocytosis can occur, so patients should notify healthcare providers immediately if they experience symptoms of infection or fever. In patients with cerebrovascular disease risk, there may be an increased risk of stroke, and caution should be exercised. Due to the potential for venous thromboembolism, preventive measures should be taken and patients monitored regularly if they have risk factors for thrombosis. Patients with cardiovascular diseases or hypotension need to be especially careful as orthostatic hypotension symptoms may appear during initial dosage adjustments. This drug can cause severe skin reactions, so if symptoms like skin rash, fever, or swollen lymph nodes occur, take immediate action and consult with healthcare providers. This medication is not to be administered to patients with certain genetic conditions or diabetes, and patients with liver function impairment should start with a lower dose and be monitored. Pregnant or breastfeeding women should consult with their doctor as this medication may affect the fetus or newborn. Drowsiness or dizziness can occur while taking this medication, so caution is advised while driving or operating machinery. Abruptly discontinuing this medication can lead to withdrawal symptoms or worsening symptoms, so tapering off doses under a doctor's guidance is essential when discontinuing. Additionally, it can interact with other medications, so any other drugs being taken must be reported to healthcare providers, especially when combined with central nervous system depressants or cardiovascular medications. In case of overdose, immediate medical attention is necessary, and as there is no specific antidote, intensive symptom management is important. Finally, it should be stored out of the reach of children, and the container should not be tampered with.

• 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 sealed container to avoid exposure to air or moisture. It is also important to keep it in a cool place below 30 degrees Celsius to maintain its effectiveness.

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle