Seroquel Tablets 25 Milligrams (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 to the usual effective daily dose of 300～400 mg. The dose may be adjusted within 150～750 mg/day according to the clinical response and tolerability of each patient. - Maintenance therapy has not been evaluated in adult patients 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 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. The dose may be adjusted within 200～800 mg/day according to the clinical response and tolerability of each patient; 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 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. An antidepressant effect was observed with 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. Clinical trials indicate that the dose may be reduced to a minimum of 200 mg in patients who tolerate the medicine. (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 be maintained on the same dose. The dose may be adjusted within 300～800 mg/day, administered twice daily, according to clinical response and each patient's tolerability. It is important to use the minimum effective dose for maintenance therapy. 3. Elderly patients: As with other antipsychotic drugs, this medicine should be administered with caution to elderly patients, particularly at the start of treatment. Start elderly patients on 25 mg/day of this medicine and gradually increase the dose 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: Clearance after oral administration of quetiapine is reduced by approximately 25% in patients with renal or hepatic impairment. Quetiapine is primarily metabolized in the liver; therefore, administer with caution to patients with known hepatic impairment. In patients with renal or hepatic impairment, start this medicine at 25 mg/day and gradually increase by 25～50 mg per day to the effective dose.

Child dose

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

This medication is primarily used for the treatment of psychiatric disorders, especially prescribed for depression, schizophrenia, and bipolar disorder. When taking this medication, there may be an increase in suicidal tendencies. Thus, young patients between the ages of 18 and 24 should be observed more closely. Additionally, since there is a risk of elevated blood sugar levels worsening diabetes, it is crucial for patients with diabetes or a family history of diabetes to carefully manage their blood sugar levels. This medication can rarely cause a serious side effect known as Neuroleptic Malignant Syndrome, so if symptoms such as high fever, muscle rigidity, or changes in mental state appear, medical consultation should be sought immediately. Prolonged use may lead to extrapyramidal symptoms or tardive dyskinesia, and if abnormal symptoms occur, dosage adjustment or discontinuation should be considered. In elderly patients with dementia, the risk of death may increase, therefore, its use is not recommended. Severe neutropenia with a rapid decrease in white blood cell count may occur, so if symptoms of infection or fever arise, immediate medical care should be obtained. Patients at risk for cerebrovascular disease should be cautious, as the risk of stroke may increase when taking this medication. There is also a reported risk of venous thromboembolism, so it is important to check for risk factors for thrombosis and take preventive measures. Patients with cardiovascular diseases or hypotension may experience orthostatic hypotension during initial dosage adjustment, requiring careful administration. Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, may occur, so if skin rashes or fever develop, the medication should be stopped immediately and healthcare providers should be notified. This medication should not be administered to patients with allergies to specific ingredients, or those in a coma, or those receiving epinephrine, or patients with diabetes. Patients with liver dysfunction may have an increased plasma concentration of the drug, so they should start at a low dose and be closely monitored. Women who are pregnant or nursing should consult a doctor before taking it, as it may affect the fetus or newborn. This medication may cause drowsiness and dizziness; thus caution is required when operating vehicles or dangerous machinery. Taking this medication with other central nervous depressants or alcohol can exacerbate side effects, so caution is advised. Sudden discontinuation may lead to withdrawal symptoms, thus the dosage should be gradually reduced as per the physician's instruction. There is no specific antidote for overdose, therefore, immediate treatment at a medical facility must be sought. While taking this medication, regular monitoring of blood tests, blood sugar, and cardiovascular status is important, and any abnormal symptoms should be reported to healthcare providers immediately.

Drowsiness, dizziness, dry mouth, withdrawal symptoms, increased triglyceride levels, increased total cholesterol, decreased HDL cholesterol, weight gain, decreased hemoglobin, extrapyramidal symptoms, syncope, neuroleptic malignant syndrome, leukopenia, neutropenia, peripheral edema, dysarthria, seizures, restless legs syndrome, tardive dyskinesia, nightmares, sleepwalking, constipation, indigestion, vomiting, dysphagia, intestinal obstruction, bowel obstruction, dyspnea, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, leukopenia, hypersensitivity reactions, anaphylaxis, blurred vision, pain in the back, myalgia, rhabdomyolysis, priapism, galactorrhea, increased appetite, mild asthenia, peripheral edema, chest pain, hypersensitivity, fever, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, increased serum liver enzymes, increased serum creatine kinase, thrombocytopenia, increased serum prolactin, insomnia, anxiety, irritability, headache, hallucinations, forgetfulness, aggressive behavior, confusion, neurosis, delusions, hypersexuality, unstable emotions, agitation, disorientation, abnormal thinking, suicide attempts, personality disorder, manic reactions, intoxication, chorea-acanthocytosis, migraine, depressive reactions, monologue, impulsive behavior, automatic movement, schizoid reactions, ataxia, mental confusion, hostility, akathisia, forward movement, dysarthria, muscle rigidity, salivation, bradykinesia, abnormal gait, movement disorders, dysphagia, dystonia, abnormalities in eye movement, slow movement, agranulocytosis, eosinophilia, anemia, thrombocytopenia, itching, urination disorders, urinary incontinence, urinary retention, ejaculation disorders, erectile dysfunction, lethargy, increased CK, increased sweating, weight loss, hyperkalemia, tongue paralysis, sensory impairment, obesity, edema, facial flushing, toothache, facial edema, neck stiffness, skin nodules, overdose, pelvic pain, dental disease, gout, arthralgia, arthritis, bursitis, myasthenia gravis, cramps, exacerbation reactions, accidental injury, ear disorders, taste disturbances, acne, thromboembolism, suicidal tendencies, paralytic ileus, rhabdomyolysis, acute kidney injury, hyperglycemia, worsening of diabetes, withdrawal symptoms, nausea, vomiting, insomnia, neuroleptic malignant syndrome, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, increased total cholesterol, decreased HDL cholesterol, weight gain, decreased hemoglobin, increased serum liver enzymes (ALT), increased γ-GT, decreased neutrophil count, increased eosinophil count, increased blood glucose levels to hyperglycemic levels, increased serum prolactin, thrombocytopenia, agranulocytosis, hepatitis, liver failure, urinary retention, bowel obstruction, fever, infection, increased serum creatine kinase, rhabdomyolysis, cardiomyopathy, myocarditis, anaphylaxis, seizures, sleepwalking, nightmares, insomnia, anxiety, irritability, headache, hallucinations, forgetfulness, aggressive behavior, confusion, neurosis, delusions, hypersexuality, unstable emotions, agitation, disorientation, abnormal thinking, suicide attempts, personality disorder, manic reactions, intoxication, chorea-acanthocytosis, migraine, depressive reactions, monologue, impulsive behavior, automatic movement, schizoid reactions, ataxia, mental confusion, hostility, akathisia, forward movement, dysarthria, muscle rigidity, salivation, bradykinesia, abnormal gait, movement disorders, dysphagia, dystonia, abnormalities in eye movement, slow movement, agranulocytosis, eosinophilia, anemia, thrombocytopenia, itching, urination disorders, urinary incontinence, urinary retention, ejaculation disorders, erectile dysfunction, lethargy, increased CK, increased sweating, weight loss, hyperkalemia, tongue paralysis, sensory impairment, obesity, edema, facial flushing, toothache, facial edema, neck stiffness, skin nodules, overdose, pelvic pain, dental disease, gout, arthralgia, arthritis, bursitis, myasthenia gravis, cramps, exacerbation reactions, accidental injury, ear disorders, taste disturbances, acne, thromboembolism, pulmonary embolism, venous thromboembolism, breathlessness due to thromboembolism, chest pain, limb pain, edema

This medication must be stored in a tightly closed container to prevent 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 tablets

Package unit

30 tablets/bottle, 100 tablets/bottle