Quetin Tablet 100 mg (Quetiapine Fumarate)

Adult dose

1. Schizophrenia - Adults: This medicine is taken 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 4 onward, the dose should be adjusted to the usual effective daily dose of 300～400 mg. Depending on the clinical response and drug tolerability of each patient, the dose may be adjusted within the range of 150～750 mg/day. 2. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: - Adults: This medicine is taken twice daily, regardless of meals. 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 clinical response and drug tolerability of each patient, the dose may be adjusted within the range of 200～800 mg/day, and 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, 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 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 there was no additional benefit with 600 mg. Increases to doses above 300 mg should be initiated by a physician experienced in treating bipolar disorder. In patients who tolerate the medicine, clinical trials have shown 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 tolerability of each patient, the dose may be adjusted within the range of 300～800 mg/day, administered twice daily. It is important to use the minimum effective dose for maintenance therapy. 3. Elderly patients : As with other antipsychotics, this medicine should be administered with caution to elderly patients, particularly when starting treatment. Elderly patients should start treatment with this medicine at 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. 5. Patients with renal or hepatic impairment : Patients with renal or hepatic impairment should start treatment with this medicine at 25 mg/day, with gradual increases of 25～50 mg per day until the effective dose is reached.

Child dose

The safety and efficacy in pediatric and adolescent patients have not been established.

This medication is primarily used for treating psychiatric disorders, and its safety has not been established in children and adolescents, so it is advised not to use it in these populations. During treatment with this medication, the risk of suicidal thoughts or behaviors may increase, especially in young adults between the ages of 18 and 24, so patients and caregivers should carefully monitor for such changes. Blood sugar levels may rise, so diabetic patients or those at risk of diabetes should regularly test and manage their blood sugar. Rare but serious side effects such as Neuroleptic Malignant Syndrome may occur, so if symptoms like high fever, muscle rigidity, or changes in mental status appear, immediate medical attention should be sought. Long-term use may result in movement disorders such as extrapyramidal symptoms and tardive dyskinesia, and dosage adjustment or discontinuation should be considered if such symptoms develop. Elderly patients with dementia may have an increased risk of death when using this medication, so it should be used with caution. Severe neutropenia or agranulocytosis may occur, so regular monitoring of white blood cell counts is necessary and immediate treatment should be sought if any signs of infection appear. Patients at risk of cerebrovascular disease may have an increased risk of stroke, so caution is needed. There is a risk of venous thrombosis, so factors that may increase the risk of thrombosis should be assessed and preventive measures taken. Patients with cardiovascular disease or hypotension may experience orthostatic hypotension, so a lower initial dose should be started, and they should be closely monitored. Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, may occur, and the medication should be discontinued immediately if skin abnormalities occur. This medication should not be used in patients with hypersensitivity to specific components, those in a comatose state, patients taking central nervous system depressants, patients receiving epinephrine, diabetic patients, or those with lactose intolerance. Patients with compromised liver function, cardiovascular disease, epilepsy, elderly patients, those at risk of suicide, pregnant and breastfeeding women should use this medication with special caution. Discontinuing this medication suddenly may lead to withdrawal symptoms or worsening of symptoms, so doses should be reduced gradually. Drowsiness, dizziness, and other side effects may occur while taking this medication, so caution is needed when driving or operating dangerous machinery, and it is advisable to avoid alcohol while taking it. This medication may interact with various drugs, so if taking other medications, it is crucial to consult with healthcare professionals.

• 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 sealed container to prevent exposure to air and moisture, and it is best to keep it in a cool place below 30 degrees Celsius. By storing it this way, the effectiveness of the medication can be maintained for a longer period.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle