Cuorekel Tablet 200 mg (Quetiapine Fumarate)

Adult dose

1. Schizophrenia - Adults: This medicine is taken 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, the dose should be adjusted to the usual effective daily dose of 300～400 mg. Depending on the individual patient's clinical response and tolerability, the dose may be adjusted within the range of 150～750 mg/day. - 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: This medicine is taken 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. Depending on the individual patient's clinical response and 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: This medicine 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 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 at 600 mg. Any dose increase above 300 mg should be initiated by a physician experienced in treating bipolar disorder. In 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 treatment at the same dose. Depending on clinical response and each patient's tolerability, the dose may be adjusted within the range of 300～800 mg/day, administered twice daily. 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 when initiating treatment. Elderly patients should start treatment with this medicine 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 : The clearance of quetiapine after oral administration 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 treatment with this medicine at 25 mg/day, with gradual increases of 25～50 mg per day until the effective dose is reached.

Child dose

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

This medication is primarily used to treat psychiatric disorders and is prescribed especially for patients in states such as depression or schizophrenia. There may be an increased risk of suicidal thoughts or behaviors during the course of taking this medication, particularly in children, adolescents, and young adults, thus careful evaluation and ongoing monitoring by a physician are needed. Patients with diabetes or a family history of diabetes should regularly monitor their blood glucose levels as there is a risk of abnormal increases in blood sugar. If symptoms such as excessive thirst or increased urination appear, immediate consultation with a physician is necessary. Serious side effects like Neuroleptic Malignant Syndrome can occur rarely, characterized by severe muscle rigidity, high fever, and altered mental state. If such symptoms arise, medication should be discontinued immediately and medical assistance sought. Long-term use may lead to movement abnormalities, so if symptoms such as involuntary movements or muscle stiffness occur, contact a physician. Use in elderly patients with dementia is not recommended, as there may be an increased risk of death and special caution is required. This medication can affect the immune system, leading to a decrease in white blood cell count, thus if any signs of infection develop, immediate contact with a medical facility is crucial. There is a risk of thrombosis, so if symptoms such as leg pain, swelling, or sudden difficulty breathing occur, immediate treatment is needed. Patients with cardiovascular diseases or hypotension may experience dizziness or orthostatic hypotension during administration of this medication, so special care should be taken during the initial dosage. Severe skin reactions may occur rarely; if widespread rashes, skin peeling, or fever appear, discontinue medication immediately and visit a hospital. This medication should not be used in patients with allergies to certain components, in a comatose state, who are on other central nervous system depressants, who are receiving epinephrine treatment, or in diabetic patients. Patients with compromised liver function, those with cardiovascular or cerebrovascular diseases, patients with a history of seizures, elderly individuals, pregnant or breastfeeding women should be especially cautious when taking this medication, requiring dosage adjustments and continuous monitoring of their condition. Abrupt discontinuation of the medication may lead to withdrawal symptoms such as nausea, vomiting, and insomnia, so dosage should be gradually reduced under medical supervision. This medication can commonly cause side effects such as drowsiness, dizziness, dry mouth, weight gain, and so forth. Caution is required when driving or operating dangerous machinery. This medication may interact with other drugs, so it is essential to inform your doctor or pharmacist about any other medications being taken. Women who are pregnant or breastfeeding should consult a physician before taking this medication due to potential effects on the fetus or newborn.

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, symptoms related to sleepwalking, constipation, dyspepsia, vomiting, dysphagia, bowel obstruction, intestinal obstruction, dyspnea, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, hypersensitivity reactions, anaphylaxis, blurred vision, pain in limbs, myalgia, rhabdomyolysis, prolonged erection, galactorrhea, increased appetite, mild weakness, peripheral edema, chest pain, hypersensitivity, fever, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, increased serum liver enzymes (ALT), increased γ-GT, increased serum creatine phosphokinase, thrombocytopenia, increased serum prolactin, withdrawal symptoms, insomnia, anxiety, nervousness, headache, hallucinations, forgetfulness, aggressive responses, confusion, neurosis, delusions, hypersexuality, unstable emotions, agitation, confusion, abnormal thoughts, suicide attempt, personality disorder, manic reaction, euphoria, chorea-acanthocytosis, migraine, depressive reaction, monologue, impulsive behavior, automatism, schizophrenia reaction, ataxia, mental confusion, hostility, akathisia, forward motion, muscle rigidity, salivation, bradykinesia, gait abnormalities, movement disorders, dystonia, abnormal eye movements, slowed movement, neutropenia, eosinophilia, anemia, thrombocytopenia, rash, itching, urinary disorders, urinary incontinence, urinary retention, increased BUN, ejaculation abnormalities, erectile dysfunction, fatigue, increased 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 disease, gout, joint pain, arthropathy, bursitis, myasthenia, spasms, exacerbation reactions, accidental injury, ear disorders, taste disturbances, acne, thromboembolism, increased suicidal tendencies, paralytic intestinal obstruction, rhabdomyolysis, acute renal failure, exacerbation of hyperglycemia and diabetes, pancreatitis, sleep apnea syndrome, acute withdrawal syndrome

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture, and kept in a cool place below 30 degrees Celsius.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 200 tablets/bottle