Serotonin 300 mg Tablets (Quetiapine Fumarate)

Adult dose

1. Schizophrenia Adults: This drug is taken 2 times 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. The dose may be adjusted within 150～750 mg/day according to each patient's clinical response and drug tolerability. 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 drug is taken 2 times daily, with or without food. As monotherapy or as adjunctive therapy to mood stabilizers (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, with increases of no more than 200mg per day. The dose may be adjusted within 200～800 mg/day according to each patient's clinical response and drug tolerability; the usual effective daily dose is 400～800 mg. (2) Treatment of depression associated with bipolar disorder: Adults: This drug 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 drug, 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. In patients who tolerate the drug, reduction to as low as 200 mg has been shown to be possible in clinical trials. (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 be maintained on the same dose. Depending on clinical response and each patient's tolerability, the dose may be adjusted within 300～800 mg/day, administered 2 times daily. It is important to use the minimum effective dose for maintenance therapy. 3. Elderly patients: As with other antipsychotic drugs, this drug should be administered with caution to elderly patients, particularly at the start of treatment. Elderly patients should start this drug 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: Clearance after oral administration of quetiapine 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 this drug at 25 mg/day, with gradual increases of 25～50 mg per day until an effective dose is reached.

Child dose

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

This medication may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults with major depressive disorder or psychiatric disorders, so careful judgment and ongoing observation are necessary when prescribing to this age group. In some patients taking this medication, blood sugar levels may rise, worsening diabetes or leading to life-threatening conditions in severe cases, so diabetic patients or those at risk for diabetes should regularly check blood sugar and consult a physician immediately if abnormal symptoms arise. This medication can rarely cause a serious side effect known as neuroleptic malignant syndrome, characterized by symptoms such as high fever, muscle rigidity, and changes in mental state. If these symptoms occur, discontinue use immediately and seek medical attention. Long-term use may result in extrapyramidal symptoms or tardive dyskinesia, so if abnormal movements are observed, consider dose adjustment or discontinuation. In elderly patients with dementia, it is recommended not to use this medication due to an increased risk of death, requiring special caution if used. This medication may reduce the white blood cell count in the blood, increasing the risk of severe infections, so if the white blood cell count decreases, discontinue administration immediately and be vigilant for infection symptoms. For patients at risk for cerebrovascular disease, this medication may increase the risk of stroke; hence it should be used with caution. There is a risk of venous thromboembolism, so patients at risk for thrombosis should check risk factors and take preventive measures before using this medication. Patients with cardiovascular disease or hypotension may experience orthostatic hypotension while taking this medication, thus needing symptom observation and dose adjustment. This medication can cause serious skin reactions; if widespread skin rash, fever, or lymph node swelling occurs, discontinue use immediately and inform healthcare professionals. This drug should not be given to patients with hypersensitivity to this drug, those in comatose states, those taking certain central nervous system depressants, those receiving epinephrine, diabetic patients, and those with certain genetic lactose intolerance. Patients with impaired liver function may have increased blood concentration of this medication, so a low dose should be started with close monitoring of condition. Pregnant or nursing individuals should be cautious when taking this medication due to potential impacts on the fetus or newborn, and it is recommended to avoid use during breastfeeding. Abrupt discontinuation of this medication may cause withdrawal symptoms, hence dosage should be gradually reduced. This medication may cause drowsiness, dizziness, and decreased attention, so caution is needed when driving or operating dangerous machinery. Co-administration with other central nervous system depressants or alcohol may increase side effects, so caution is advised when taken together. Co-administration with certain antifungals, antibiotics, and antivirals may significantly increase drug concentration, so avoid or adjust dosing as necessary. In case of overdose, there is no specific antidote, and appropriate treatment and intensive monitoring based on symptoms are required.

Drowsiness, dizziness, dry mouth, withdrawal symptoms, increased triglyceride levels, increased total cholesterol, decreased HDL cholesterol, weight gain, decreased hemoglobin, extrapyramidal symptoms, fainting, neuroleptic malignant syndrome, leukopenia, neutropenia, peripheral edema, speech disturbance, seizures, restless legs syndrome, tardive dyskinesia, nightmares, sleepwalking, constipation, dyspepsia, vomiting, difficulty swallowing, intestinal obstruction, bowel obstruction, dyspnea, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, hypersensitivity reactions, anaphylaxis, blurred vision, pain in various parts, myalgia, rhabdomyolysis, priapism, galactorrhea, increased appetite, mild weakness, chest pain, irritability, fever, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, increased serum liver enzymes, increased serum creatine phosphokinase, thrombocytopenia, increased serum prolactin, insomnia, anxiety, nervousness, headache, hallucinations, forgetfulness, aggressive reactions, confusion, neurosis, delusions, hypersexuality, unstable emotions, agitation, confusion, abnormal thoughts, suicide attempt, personality disorder, manic reactions, euphoria, chorea-acanthocytosis, migraine, depressive reactions, monologue, impulsive behavior, automatism, psychotic reactions, ataxia, mental confusion, hostility, akathisia, movement forward, muscle rigidity, salivation, bradykinesia, abnormal gait, movement disorders, dystonia, oculomotor abnormalities, slowed movements, granulocytopenia, eosinophilia, anemia, thrombocytopenia, increased sweating, weight loss, hyperkalemia, tongue paralysis, sensory loss, obesity, edema, facial flushing, toothache, facial edema, neck stiffness, skin nodules, overdose, pelvic pain, dental disease, gout, arthralgia, osteoarthritis, bursitis, myasthenia gravis, spasms, exacerbation reactions, accidental injuries, ear diseases, taste disturbances, acne, thromboembolism, paralytic ileus, rhabdomyolysis, acute renal failure, increased suicidal tendencies, hyperglycemia, worsening of diabetes, withdrawal symptoms, recurrence of neuroleptic malignant syndrome, neonatal withdrawal symptoms, acute withdrawal syndrome, serotonin syndrome, sleep apnea syndrome, pancreatitis, aspiration pneumonia, constipation, intestinal obstruction, bowel obstruction, fever, increased serum triglycerides and cholesterol, elevated serum liver enzymes, increased serum creatine phosphokinase, thrombocytopenia, increased serum prolactin, decreased thyroid hormone, increased blood sugar, increased eosinophils in the blood, decreased leukocytes in the blood, decreased neutrophils in the blood, anaphylactic reaction, rhabdomyolysis, cardiomyopathy, myocarditis, thromboembolism, venous thrombosis, palpitations, tachycardia, bradycardia, arrhythmia, fainting, orthostatic hypotension, hypotension, increased sweating, weight loss, hyperkalemia, tongue paralysis, sensory loss, obesity, edema, facial flushing, toothache, facial edema, neck stiffness, skin nodules, pelvic pain, dental diseases, gout, arthralgia, osteoarthritis, bursitis, myasthenia gravis, spasms, exacerbation reactions, accidental injuries, ear diseases, taste disturbances, acne

This medication should be stored in a sealed container to protect it from air and moisture. Additionally, it is important to store it in a cool place at temperatures below 30 degrees Celsius to maintain its effectiveness.

Appearance

White oval film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle