Cloquel Tablet 25mg (Quetiapine Fumarate)

Adult dose

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 drug 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. 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 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 200 mg per day. Depending on the individual patient's clinical response and drug 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. Increases to doses above 300 mg should be initiated by a physician experienced in treating bipolar disorder. In patients who tolerate the medicine, reduction to a minimum of 200 mg has been reported 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 continue on the same dose. Depending on the 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 therapy. Older adults As with other antipsychotics, this medicine should be administered with caution to older adults, particularly when initiating treatment. In older patients, start treatment with 25 mg/day of this medicine and gradually increase by 25～50 mg per day. The effective dose in older adults may be lower than that in younger patients. 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 treatment with 25 mg/day of this medicine and gradually increase by 25～50 mg per day to the effective dose.

Child dose

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

This medication is mainly used for treating psychiatric disorders, and there may be an increased risk of suicide, so it should be used with caution, especially in children, adolescents, and young adults. Blood glucose levels may rise during treatment with this medication; therefore, patients with diabetes or those at risk of diabetes should periodically check their blood sugar and be monitored closely. Rarely, serious side effects such as Neuroleptic Malignant Syndrome, which can present with severe muscle rigidity, high fever, and changes in mental state, can occur, and immediate medical attention is required if such symptoms appear. Prolonged use may cause tardive dyskinesia, which is characterized by abnormal movements, and if any unusual symptoms arise, it’s important to consult a physician to consider dosage adjustment or discontinuation. Elderly patients with dementia may have an increased risk of death when using this medication, requiring special caution. This medication may cause severe neutropenia or agranulocytosis with a drastic reduction in white blood cell count, hence white blood cell counts should be regularly monitored with blood tests, especially in the early stages of treatment. Patients at risk for cerebrovascular diseases may face an increased risk of stroke when using this medication, necessitating careful administration. There is a risk of thrombosis; thus, patients with risk factors should be closely monitored and take preventive measures before and during the use of this medication. Patients with cardiovascular diseases or those with a risk of hypotension may experience dizziness or orthostatic hypotension upon initial doses, so dosage should be titrated slowly. This medication can cause severe skin allergic reactions; thus, if symptoms such as skin rash, fever, or lymphadenopathy occur, usage should be discontinued immediately and a physician consulted. Patients who have had allergic reactions to this medication or its constituents, those in a coma, those concurrently using certain neuroleptics, those receiving epinephrine, patients with diabetes, and some patients with hereditary metabolic disorders should not use this medication. Patients with impaired liver function, cardiovascular diseases, cerebrovascular conditions, or those at risk of hypotension, those with a history of seizures, elderly patients, those with a high risk of suicide, and pregnant or nursing women should use this medication cautiously and may need dosage adjustments while being closely monitored. Common side effects include drowsiness, dizziness, xerostomia, withdrawal symptoms, increased triglyceride levels, elevated total cholesterol, decreased HDL cholesterol, weight gain, decreased hemoglobin, extrapyramidal symptoms, speech disturbances, seizures, restless legs syndrome, tardive dyskinesia, fainting, nightmares, sleepwalking, constipation, dyspepsia, vomiting, swallowing difficulties, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, leukopenia, hypersensitivity. Caution is needed when driving or operating hazardous machinery, and combining with other central nervous system depressants or alcohol can enhance side effects. During pregnancy, especially in the third trimester, neonatal withdrawal symptoms or movement disorders may occur; therefore, careful consideration of risks and benefits is necessary before administering to pregnant women. Breastfeeding women are advised to avoid breastfeeding while taking this medication. In cases of overdose, there is no specific antidote, and intensive medical management is required, as hypotension or cardiovascular abnormalities may occur, necessitating appropriate treatment. This medication should be kept out of the reach of children, and it should not be transferred to other containers arbitrarily.

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

This medication should be stored in a tightly sealed container to prevent air or moisture from entering, ideally at a cool temperature below 30 degrees Celsius. Proper storage can help maintain the medication's efficacy over time.

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle, 200 tablets/bottle