Cloquel Tablet 300 mg (Quetiapine Fumarate)

Adult dose

1. Schizophrenia Adults: Take this drug twice daily, regardless of meals. 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 the range of 150～750 mg/day according to the individual patient's clinical response and tolerability. Maintenance treatment has not been evaluated in adult patients with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance treatment. 2. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: Adults: Take this drug twice daily, regardless of meals. 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 the range of 200～800 mg/day according to the individual 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 drug once daily at bedtime, regardless of meals. 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 at 600 mg. Increases to doses above 300 mg should be initiated by a physician experienced in treating bipolar disorder. In patients who tolerate the drug, 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 on 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 minimum effective dose for maintenance treatment. 3. Elderly patients As with other antipsychotics, this drug should be administered with caution to elderly patients, particularly when initiating treatment. Start elderly patients on 25 mg/day and gradually increase 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 After oral administration of quetiapine, clearance 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. In patients with renal or hepatic impairment, start this drug 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 drug have not been established in children and adolescents.

This medication may increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults with major depressive disorder or other psychiatric disorders, so the physician should carefully consider the necessity and risks of treatment. All patients taking this medication, regardless of age, should be carefully monitored for abnormal behavioral changes such as worsening of the condition, suicidal tendencies, and aggression, and family members or caretakers should also observe the patient closely. This medication may increase the risk of hyperglycemia or diabetes, so patients with diabetes or a family history of diabetes should regularly check blood sugar levels and be aware of symptoms of hyperglycemia. Serious side effects known as neuroleptic malignant syndrome may rarely occur, and if symptoms such as high fever, muscle rigidity, or autonomic nervous system dysfunction appear, administration should be stopped immediately and treatment sought. Long-term use may result in extrapyramidal symptoms or tardive dyskinesia; if symptoms occur, consideration should be given to dose adjustment or discontinuation. Use in elderly patients with dementia may increase the risk of death, so caution is advised. Severe neutropenia and agranulocytosis may occur; patients with low white blood cell counts should discontinue treatment and carefully monitor for signs of infection. Patients at risk of cerebrovascular disease may experience an increased risk of stroke while using this medication, requiring careful administration. There is a risk of venous thrombosis, so patients with risk factors for thrombosis should be closely monitored and preventive measures taken before and after administration. Patients with cardiovascular disease or hypotension may experience side effects such as orthostatic hypotension, so careful monitoring is required during initial dose adjustments. Severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS syndrome may occur; if symptoms such as skin rash, fever, or lymphadenopathy appear, medication should be stopped immediately. This medication should not be administered to patients with hypersensitivity to the drug, comatose patients, those taking specific central nervous system depressants, patients receiving epinephrine, diabetic patients, or patients with lactose intolerance. Caution is also required for patients with liver disorders, cardiovascular disease, cerebrovascular disease, epilepsy, the elderly, those at risk of suicide, pregnant women, and nursing mothers; dosage adjustments and monitoring of the condition are necessary. Various adverse reactions including drowsiness, dizziness, dry mouth, weight gain, extrapyramidal symptoms, dysarthria, seizures, restless legs syndrome, tardive dyskinesia, syncope, nightmares, sleepwalking, constipation, dyspepsia, vomiting, swallowing difficulties, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, leukopenia, and hypersensitivity may occur, so caution is advised. This medication affects the central nervous system and may induce drowsiness or decreased attention, necessitating caution when driving or operating dangerous machinery. When administered to pregnant women, withdrawal symptoms or extrapyramidal disorders may occur in the newborn, therefore the risks and benefits for the fetus must be carefully considered; nursing mothers are advised to avoid breastfeeding during treatment. In case of overdose, specific antidotes are unavailable, requiring immediate intensive care and monitoring by medical personnel, and the administration of epinephrine and dopamine should be avoided. When storing this medication, keep it out of reach of children and do not transfer it to other containers.

• Drowsiness
• dizziness
• dry mouth
• withdrawal symptoms
• increased triglyceride levels
• increased total cholesterol
• decreased HDL cholesterol
• weight gain
• decreased hemoglobin
• extrapyramidal symptoms

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container and kept at a cool temperature below 30 degrees Celsius.

Appearance

White oval film-coated tablet

Package unit

30 tablets/bottle, 200 tablets/bottle