Quetiapine 25 mg Tablets (Quetiapine Fumarate)

Adult dose

1. Schizophrenia Adults: Take this medicine 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, adjust the dose 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 tolerability. Maintenance therapy has not been evaluated in adult patients with schizophrenia. Patients should be reassessed regularly to determine whether maintenance therapy is needed. 2. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: Adults: Take this medicine 2 times daily, with or without food. Whether used 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 each patient's clinical response and tolerability; 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. Antidepressant effects were seen 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. In patients who tolerate the medicine, clinical trials have shown that the dose may be reduced to as low as 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 during acute treatment of bipolar disorder should continue on the same dose. Depending on clinical response and each patient's tolerability, the dose may be adjusted within a range of 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 antipsychotics, this medicine should be administered with caution to elderly patients, particularly when initiating treatment. Start elderly patients on 25 mg/day of this medicine and increase gradually 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. Since quetiapine is primarily metabolized in the liver, administer with caution to patients with known hepatic impairment. Start patients with renal or hepatic impairment on 25 mg/day of this medicine and increase gradually by 25～50 mg per day to the effective dose.

Child dose

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

This medication may increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults in relation to the use of antidepressants; thus, physicians should carefully consider this prior to administration. Additionally, blood sugar levels may rise during treatment, and patients with diabetes or risks for diabetes should regularly monitor their blood sugar and carefully observe for signs of hyperglycemia. Rarely, the medication may cause neuroleptic malignant syndrome, characterized by severe muscle rigidity, high fever, and autonomic dysregulation, and if symptoms are suspected, the healthcare provider should be notified immediately. Long-term use may result in tardive dyskinesia, which causes involuntary movements; therefore, consultation with a physician is advised if unusual symptoms occur. There may be an increased risk of death in elderly patients with dementia, so this drug is not recommended for dementia patients. This drug may cause a sharp decrease in white blood cell count, which necessitates monitoring for signs of infection, and treatment should be stopped if neutrophil counts are low. Patients at risk for cerebrovascular disease have an increased risk of stroke, so caution should be exercised. Due to the risk of venous thromboembolism, it is necessary to assess thrombotic risk factors and take preventive measures before and during treatment with this drug. Patients with cardiovascular disease or hypotension may experience dizziness and orthostatic hypotension upon initial administration, requiring careful monitoring. Severe skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, may occur; therefore, if a rash or fever develops, consumption should be stopped immediately, and a doctor should be consulted. This medication should not be administered to patients with certain allergies, in comatose states, using central nervous system depressants, receiving epinephrine, those with diabetes, or those who are lactose intolerant. Caution is warranted when administering to patients with impaired liver function, cardiovascular disease, history of cerebrovascular diseases, seizure disorders, the elderly, those at risk for suicide, and women who are pregnant or breastfeeding. Common side effects while taking this drug may include drowsiness, dizziness, dry mouth, weight gain, hematological changes, extrapyramidal symptoms, and symptoms such as muscle weakness and peripheral edema; patients should consult a healthcare provider if such symptoms occur. During consumption, activities requiring alertness, such as driving or operating machinery, should be done with care due to the risk of accidents caused by drowsiness or dizziness. Caution should be exercised when using this medication in conjunction with other central nervous system depressants or alcohol, as effects may be enhanced. Use during pregnancy should be considered cautiously as it may affect the fetus, and withdrawal symptoms can appear in newborns after birth; therefore, careful consideration is necessary when using during pregnancy. Breastfeeding should be avoided as there is a possibility that this drug may be excreted in breast milk. In cases of overdose, severe drowsiness, hypotension, and arrhythmias may occur, and prompt emergency treatment must be sought as there is no specific antidote.

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, dyspepsia, vomiting, dysphagia, intestinal obstruction, bowel obstruction, dyspnea, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, hypersensitivity reactions, anaphylactic reactions, blurred vision, pain in limbs, myalgia, rhabdomyolysis, priapism, galactorrhea, increased appetite, mild asthenia, chest pain, hyperreactivity, fever, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, elevated serum enzyme levels, increased serum creatine phosphokinase, thrombocytopenia, increased serum prolactin, insomnia, anxiety, neuroticism, headache, hallucinations, forgetfulness, aggressive responses, confusion, neurosis, delusions, hypersexuality, unstable emotions, agitation, disorientation, abnormal thoughts, suicidal attempts, personality disorders, manic reactions, intoxication, chorea-acanthocytosis, migraines, depressive reactions, monologue, impulsive behavior, automatic movements, schizophrenic reactions, ataxia, delirium, hostility, akathisia, forward motion, muscle rigidity, salivation, bradykinesia, gait abnormality, movement disorders, dystonia, ocular movement abnormalities, slow movements, granulocytopenia, eosinophilia, anemia, thrombocytopenia, difficulty in expectoration, increased cough, anorexia, abdominal pain, diarrhea, abdominal distension, gastritis, gastrointestinal disorders, hematemesis, rectal disorders, pupillary reflex damage, amblyopia, conjunctivitis, hyperprolactinemia, menstrual irregularities, thyroid disorders, hypercholesterolemia, hyperlipidemia, rash, itching, urination disorders, urinary incontinence, urinary retention, increased BUN, ejaculation abnormalities, erectile dysfunction, lethargy, elevated CK, increased sweating, weight loss, hyperkalemia, tongue paralysis, sensory decline, obesity, edema, facial flushing, toothache, facial edema, neck stiffness, skin nodules, overdose, pelvic pain, dental diseases, gout, arthralgia, arthritis, bursitis, myasthenia gravis, spasms, adverse reactions, accidental injuries, ear disease, taste disturbances, acne, thrombosis, suicidal tendencies, paralytic ileus, rhabdomyolysis, acute withdrawal symptoms, nausea due to acute withdrawal, vomiting, insomnia, recurrence of psychotic symptoms, involuntary movement disorders in emergencies, pancreatitis, sleep apnea syndrome

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture, preferably in a cool place below 30 degrees Celsius. This storage method will help maintain the drug's efficacy and ensure safe usage.

Appearance

Pink round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle