Cutima Tablet 200 mg (Quetiapine Fumarate)

Adult dose

1. Schizophrenia Adults: Take this medicine 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, adjust 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 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: Take this medicine twice daily, with or without food. As monotherapy or adjunctive therapy with 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, 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 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 observed 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. Clinical trials indicate that the dose may be reduced to a minimum of 200 mg in patients who tolerate the medicine. (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. The dose may be adjusted within 300～800 mg/day, administered twice daily, according to clinical response and each patient's tolerability. 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 at the start of 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 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 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 may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults with major depressive disorder or other psychiatric illnesses; therefore, the physician must carefully evaluate risks and benefits before prescribing. During treatment, blood glucose may rise or diabetes may worsen, so patients with diabetes or risk factors for diabetes should regularly monitor blood glucose and be carefully observed. Rarely, this medication may cause neuroleptic malignant syndrome, which is characterized by severe muscle rigidity, high fever, and autonomic instability, necessitating immediate medical attention if such symptoms occur. Long-term use may pose a risk of tardive dyskinesia, causing involuntary movements; if abnormal symptoms occur, dosage adjustment or discontinuation should be considered. Elderly patients with dementia may have an increased risk of death associated with this medication, hence special caution is required. This drug can rarely cause severe neutropenia or agranulocytosis, thus patients with low white blood cell counts should undergo regular blood tests, and if infection symptoms appear, they should inform healthcare providers immediately. Patients with a risk of cerebrovascular disease may experience an increased risk of stroke when treated with this medication, thus they should be carefully monitored. Due to the risk of venous thromboembolism, patients with risk factors for thrombosis should take preventive measures against thrombosis before and during treatment with this medication. Patients with cardiovascular disease or hypotension may experience symptoms like orthostatic hypotension or tachycardia when administered this drug; hence, initiating treatment at a low dose and monitoring the patient's condition closely is essential. This medication may cause severe skin reactions including Stevens-Johnson syndrome and toxic epidermal necrolysis, so if symptoms like rash, fever, or lymphadenopathy occur, the patient should cease taking the medication and consult a healthcare provider immediately. This medication should not be administered to patients with known allergies to certain ingredients, those in a state of coma, patients taking central nervous system depressants like barbiturates, those being treated with epinephrine, diabetic patients, or those with lactose intolerance. Patients with impaired liver function or at risk of cardiovascular or cerebrovascular disease and hypotension should use this medication cautiously, starting with a lower dose and gradually increasing it. Pregnant women or those potentially pregnant and breastfeeding mothers should discuss with their doctor before using this medication, as it may affect the fetus or newborn. This drug can cause drowsiness, dizziness, and decreased attention, necessitating caution when driving or operating hazardous machinery. Abrupt discontinuation of this drug may lead to withdrawal symptoms or worsening of symptoms; therefore, dosage should be tapered gradually under a physician's guidance when stopping treatment. In case of overdose, symptoms such as severe drowsiness, hypotension, and tachycardia may occur, and as there are no specific antidotes, immediate medical treatment should be sought. This medication may enhance side effects when used with other central nervous system depressants or alcohol; therefore, caution is advised during concurrent use. Additionally, co-administration with certain antifungal agents, antibiotics, or antiviral medications may significantly increase the blood concentration of this drug, so it is crucial to consult with a physician or pharmacist regarding other medications being taken. This medication may cause changes in blood glucose, lipids, liver function, and blood counts, so regular testing and monitoring are necessary.

• 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 closed container to protect it from air and moisture, ideally at a cool temperature of below 30 degrees Celsius. Storing it this way will help maintain the medication's efficacy over time.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle