Seroquel Extended-Release 150 mg (Quetiapine Fumarate)

Adult dose

This medicine is administered once daily in the evening. Swallow this medicine whole; do not split, chew, or crush it. Avoid taking this medicine with food, or take it with a low-fat meal (approximately 300 calories). Schizophrenia Adults: Start treatment with quetiapine 300 mg; adjust the dose to 400～800 mg per day according to the response and tolerability of each patient. The dose may be increased by up to 300 mg per day at intervals of 1 day. The safety of doses exceeding 800 mg per day has not been evaluated in clinical trials. In a confirmatory therapeutic clinical trial in patients with schizophrenia who had been stabilized after receiving this medicine for 16 weeks and were treated for 1 year or until relapse, this medicine was effective in prolonging the time to relapse in patients with schizophrenia. The physician should periodically reassess each patient to determine the need for continued treatment. Bipolar disorder Acute treatment of manic or mixed episodes associated with bipolar I disorder Adults: This medicine may be used as monotherapy or as adjunctive therapy to lithium or valproate. Start with quetiapine 300 mg on day 1 and increase to 600 mg on day 2. From day 3 onward, adjust the dose within 400～800 mg per day according to the clinical outcome and drug tolerability of each patient. Recommended dosing schedule Day 1 300 mg Day 2 600 mg Day 3 400～800 mg Acute treatment of depressive episodes associated with bipolar disorder Adults: As monotherapy, administer this medicine at a daily dose of quetiapine 50 mg on day 1, 100 mg on day 2, 200 mg on day 3, and 300 mg on day 4. Recommended dosing schedule Day 1 50 mg Day 2 100 mg Day 3 200 mg Day 4 300 mg Prevention of recurrence of manic, mixed, or depressive episodes in patients who have responded to quetiapine treatment For prevention of 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. The dose may be adjusted within 300～800 mg per day according to the clinical response and tolerability of each patient. It is important to use the lowest effective dose for maintenance therapy. Adjunctive treatment of major depressive disorder Adults: Start this medicine at 50 mg on day 1 and increase to 150 mg on day 3. The efficacy of this medicine has been established at 150～300 mg per day. Adverse reactions increased in a dose-dependent manner. Doses exceeding 300 mg per day have not been studied. Switching from immediate-release tablets: Patients taking immediate-release quetiapine fumarate tablets may switch to this medicine for convenience of administration, taking the same total daily dose once daily. Individual dose adjustment may be necessary. Elderly patients: As with other antipsychotics, this medicine should be administered with caution in elderly patients, particularly when initiating treatment. The dose should be increased gradually, and the daily therapeutic dose may be lower than that for adult patients. The mean plasma clearance of quetiapine may be reduced by 30～50% in elderly patients compared with adult patients. Start elderly patients at a dose of 50 mg per day. Increase the dose by 50 mg per day according to the clinical response and tolerability of each patient until an effective dose is reached. Patients with renal impairment: After oral administration of this medicine, the mean oral creatinine clearance in patients with severe renal impairment (creatinine clearance 10～30 mL/min/1.73 m2) is reduced by 25% compared with adult patients; however, dose adjustment is generally not necessary. Patients with hepatic impairment: Quetiapine is primarily metabolized in the liver; therefore, administer this medicine with caution to patients with hepatic impairment, particularly when initiating treatment. Start patients with hepatic impairment at a dose of 50 mg per day and increase the dose by 50 mg per day according to the clinical response and tolerability of each patient until an effective dose is reached.

Child dose

Children and adolescents 18 years of age and younger: The safety and efficacy of this medicine have not been established.

This medication is used for the treatment of psychiatric disorders and is especially beneficial for alleviating symptoms of depression or bipolar disorder. During the use of this medication, there may be an increase in suicidal thoughts or behaviors, thus careful monitoring is necessary, especially in children, adolescents, and young adults. Patients with diabetes or high blood sugar symptoms should regularly check and manage their blood sugar levels, and caution is required in those with risk factors for diabetes. This drug can rarely cause serious neuroleptic side effects known as Neuroleptic Malignant Syndrome; therefore, if high fever, muscle stiffness, or changes in mental state occur, medical attention should be sought immediately. With long-term use, movement disorders such as extrapyramidal symptoms or tardive dyskinesia may occur; if symptoms appear, it is important to consult a physician. This drug is not approved for use in elderly patients with dementia, as it may increase the risk of death, and its use should be avoided. This medication may affect the white blood cell count; if signs of infection appear, it is crucial to consult a healthcare professional. Blood tests to confirm the condition are important. Patients with cardiovascular disease or hypotension, as well as those with cerebrovascular diseases, should be cautious of hypotension or other cardiovascular side effects when taking this medication. This drug can cause severe skin side effects; if rashes or unusual skin symptoms occur, the medication should be discontinued immediately and the healthcare provider informed. During treatment, avoid co-administering with other central nervous system depressants or alcohol, as interacting with specific medications may alter the effects; consult a doctor before combining medications. Women who are pregnant or breastfeeding should consult a physician before taking this medication, as it may affect the fetus or newborn. This drug is not recommended for children and adolescents under 18 years of age, as its safety and efficacy have not been established. In case of overdose, symptoms such as drowsiness, hypotension, and tachycardia may occur; strict adherence to the dosage is important, and any unusual symptoms should be reported to medical personnel immediately. Store this medication out of reach of children, and be careful not to transfer it to other containers. Finally, while taking this medication, side effects such as weight gain, drowsiness, dizziness, and dry mouth may be common; if symptoms are severe, consult a doctor.

Drowsiness, dizziness, dry mouth, withdrawal symptoms, increased triglyceride levels, increased total cholesterol, decreased HDL cholesterol, weight gain, decreased hemoglobin, extrapyramidal symptoms, weight gain, syncope, neuroleptic malignant syndrome, leukopenia, neutropenia, peripheral edema, speech disorders, seizures, restless legs syndrome, tardive dyskinesia, nightmares, symptoms related to sleepwalking, constipation, dyspepsia, vomiting, dysphagia, intestinal obstruction, bowel obstruction, dyspnea, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, hypersensitivity reactions, anaphylaxis, blurred vision, pain in the back, myalgia, rhabdomyolysis, priapism, galactorrhea, increased appetite, mild weakness, peripheral edema, chest pain, hyperreactivity, fever, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, elevated serum liver enzymes, increased eosinophil count, increased blood glucose levels to hyperglycemic levels, increased serum prolactin, thrombocytopenia, increased serum creatine phosphokinase, agranulocytosis, hepatitis, liver failure, urinary retention, drug reactions with eosinophilia and systemic symptoms, cutaneous vasculitis, increased suicidal tendencies, paralytic ileus, rhabdomyolysis, thromboembolism, fatigue, visual disturbances

This medication must be stored in a tightly sealed container to avoid exposure to air or moisture. Additionally, it is important to maintain a storage temperature between 15 to 30 degrees Celsius (59 to 86 degrees Fahrenheit). This will help to preserve the drug's effectiveness and safety.

Appearance

White capsule-shaped, biconvex film-coated tablets

Package unit

60 tablets (10 tablets/PTPX6)