Dongwha Quetiapine Tablet 12.5 mg (Quetiapine Fumarate)

Adult dose

1. 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 the dose to the usual effective daily dose of 300～400 mg. Depending on the individual patient's clinical response and drug 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: Take this medicine twice daily, with or without food. As monotherapy or as adjunctive therapy to a mood stabilizer (lithium or valproic acid), 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 drug 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 the 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 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 for acute treatment of bipolar disorder should continue on the same dose. Depending on clinical response and each patient's tolerability, the dose given twice daily may be adjusted within the range of 300～800 mg/day. It is important to use the lowest effective dose for maintenance therapy. 3. Elderly patients As with other antipsychotics, this medicine should be administered with caution to elderly patients, particularly at the start of treatment. In elderly patients, start treatment with 25 mg/day and gradually increase by 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 After oral administration of quetiapine, clearance is reduced by approximately 25% in patients with renal or hepatic impairment. Quetiapine is primarily metabolized in the liver, so it should be administered with caution to patients with known hepatic impairment. In patients with renal or hepatic impairment, start treatment with this medicine at 25 mg/day and gradually increase by 25～50 mg per day to the effective dose.

Child dose

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

This medication may increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults with major depressive disorder or other psychiatric conditions, thus physicians should carefully evaluate the risks and benefits before administration. During treatment with this medication, patients and caregivers should closely monitor for changes in behavior, such as worsening depression symptoms, suicidal thoughts, and aggression, and consult a physician immediately if abnormal symptoms arise. This medication can elevate blood glucose levels and worsen symptoms of hyperglycemia or diabetes, so patients with diabetes or blood glucose management issues should regularly monitor and manage their blood glucose levels. A rare but serious side effect known as Neuroleptic Malignant Syndrome may occur, characterized by symptoms such as high fever, muscle rigidity, and changes in mental status; if these symptoms appear, discontinue the medication immediately and seek medical attention. With long-term use, movement disorders such as extrapyramidal symptoms or tardive dyskinesia may occur, and if these symptoms develop, the patient should consult with their physician to consider dose adjustments or discontinuation of the treatment. The use of this medication in elderly patients with dementia may increase the risk of death, necessitating special caution. This drug can cause severe neutropenia and agranulocytosis; patients with low white blood cell counts should avoid administration or monitor their condition through regular blood tests. Caution is advised when prescribing this medication to patients at risk for cerebrovascular disease, as it may increase the risk of stroke, and there is also a risk of venous thromboembolism; patients with risk factors for thrombosis should take preventive measures. Patients with cardiovascular disease, cerebrovascular disease, or hypotension should be closely monitored for orthostatic hypotension or heart-related side effects during administration of this medication. This drug may induce severe skin adverse reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS syndrome, so if symptoms like skin rashes, fever, or lymphadenopathy occur, discontinue use immediately and seek medical evaluation. This medication should not be administered to specific patients, including those with hypersensitivity to any ingredients, those in coma, patients using central nervous system depressants such as barbiturates, patients receiving epinephrine, diabetic patients, and those with lactose intolerance. Patients with impaired liver function, cardiovascular disease, a history of seizures, elderly patients, those at risk of suicide, pregnant and breastfeeding women should have their dosages adjusted and closely monitored during treatment with this medication. This medication can cause a variety of side effects including drowsiness, dizziness, dry mouth, weight gain, changes in blood glucose and lipid levels, etc.; if symptoms persist or worsen, consult a physician. Abrupt discontinuation of this medication may result in withdrawal symptoms or exacerbation of symptoms, thus the dosage should be gradually reduced. Caution is necessary when taking this medication in conjunction with other central nervous system drugs or alcohol, as it may increase side effects such as drowsiness. Inform your physician of any current medications to avoid potential drug interactions. Women who are pregnant or breastfeeding should consult their physician before administration, as it may affect the fetus or newborn; it is recommended to avoid breastfeeding during treatment. The safety and efficacy of this medication in pediatric and adolescent populations have not been established, hence it is advisable to avoid its use in these groups. Elderly patients may have a slower metabolic rate with this drug, increasing the risk of side effects; starting with lower doses and gradually increasing while closely monitoring their condition is warranted. In cases of overdose, symptoms such as drowsiness, sedation, hypotension, and increased heart rate may occur, and since there is no specific antidote, appropriate emergency treatment should be sought immediately.

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

This medication should be stored in a tightly closed container to protect it from air and moisture, and it is advisable to keep it at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness and prevent degradation.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle