Cutima 25 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. 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

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

This medicine may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults with major depressive disorder or psychiatric conditions; therefore, the physician should carefully evaluate the need and risks of treatment. Additionally, patients taking this medication should be closely monitored for unusual behavioral changes including suicidal thoughts, actions, aggression, or anger. Family members or caregivers should also keep a close watch on the patient and notify the physician immediately if any abnormal signs are observed. This medication can cause elevated blood sugar levels and metabolic disturbances in patients with diabetes or those at risk for diabetes, so regular monitoring of blood sugar levels and careful observation of symptoms such as increased thirst, frequent urination, and fatigue are necessary. There is a risk of a rare but serious side effect known as Neuroleptic Malignant Syndrome, which may prompt immediate discontinuation of the medication and medical consultation if symptoms such as high fever, muscle rigidity, or mental status changes occur. Long-term use of this drug may lead to extrapyramidal symptoms or tardive dyskinesia; hence, consideration should be given to dosage adjustment or discontinuation if abnormal movements appear. In elderly patients with dementia, there may be an increased risk of death associated with the use of this drug, requiring special caution. This medication can cause severe neutropenia or agranulocytosis that leads to a drastic drop in the white blood cell count, so patients should seek immediate medical attention if any symptoms of infection or fever occur, and regular blood tests to monitor white blood cell counts should be conducted. Patients at high risk for cerebrovascular disease should be cautious about the possibility of stroke when using this medication. There is a risk of venous thromboembolism; therefore, careful monitoring and preventive measures are needed for patients with risk factors for thrombosis before and after taking this medication. Cardiovascular disease or hypotension patients may experience orthostatic hypotension when taking this medication; therefore, dosage adjustments and close monitoring according to symptoms are required. Severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reactions may occur, so if symptoms such as skin rash, fever, or lymphadenopathy appear, the medication should be discontinued immediately and the physician should be consulted. This drug should not be used in patients with allergies to specific components, in a state of coma, those taking central nervous system depressants, individuals receiving epinephrine, or diabetic patients. Patients with impaired liver function or those at risk for cardiovascular or cerebrovascular disease and hypotension should start on a lower dosage and gradually increase while monitoring their condition. Women who are pregnant or may become pregnant, or nursing mothers should use this medication cautiously as it may affect the fetus or newborn, and discontinuation during breastfeeding is recommended. While taking this medication, symptoms such as drowsiness, dizziness, dry mouth, weight gain, and changes in blood glucose and lipid levels may occur; if there are unusual symptoms, consultation with a physician is recommended. Care should be taken when driving or operating dangerous machinery, as the risk of side effects may increase when consuming alcohol or other central nervous system depressants. There are no specific antidotes for overdose of this medication, so one should seek appropriate treatment at a hospital immediately as severe hypotension or coma may occur. This drug should be kept out of the reach of children and should not be transferred to another container for safety.

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 associated with sleepwalking, constipation, dyspepsia, vomiting, dysphagia, intestinal obstruction, bowel obstruction, dyspnea, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, hypersensitivity, anaphylactic reaction, blurred vision, pain in extremities, myalgia, rhabdomyolysis, priapism, galactorrhea, increased appetite, mild weakness, peripheral edema, chest pain, hyperreactivity, fever, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, increased serum liver enzymes, increased serum creatine phosphokinase, thrombocytopenia, increased serum prolactin, withdrawal symptoms, insomnia, anxiety, nervousness, headache, hallucinations, forgetfulness, aggressive reactions, confusion, neurosis, delusions, hypersexuality, unstable emotions, agitation, disorientation, abnormal thoughts, suicide attempts, personality disorders, manic reactions, intoxication, chorea-acanthocytosis, migraine, depressive reactions, monologue, impulsive behavior, automatic movement, schizophrenia-like reactions, ataxia, mental confusion, hostility, inability to sit still, progression, muscle stiffness, salivation, akinesia, gait abnormalities, movement disorders, dyskinesia, abnormal eye movement, slowed movements, granulocytopenia, eosinophilia, anemia, thrombocytopenia, rash, itching, urination disorders, urinary incontinence, urinary retention, ejaculation disorders, erectile dysfunction, lethargy, increased CK, increased sweating, weight loss, hyperkalemia, tongue paralysis, sensory impairment, obesity, edema, facial flushing, toothache, facial swelling, neck stiffness, skin nodules, overdose, pelvic pain, dental disease, gout, arthralgia, arthritis, bursitis, myasthenia gravis, spasms, exacerbation reactions, accidental injury, ear disorders, taste abnormalities, acne, thromboembolism, suicidal tendencies, paralytic ileus, acute renal failure due to rhabdomyolysis, nausea, vomiting, insomnia, anxiety, nervousness, headache, hyperreactivity, fever, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, increased serum liver enzymes, increased serum creatine phosphokinase, thrombocytopenia, increased serum prolactin, withdrawal symptoms, insomnia, anxiety, nervousness, headache, hallucinations, forgetfulness, aggressive reactions, confusion, neurosis, delusions, hypersexuality, unstable emotions, agitation, disorientation, abnormal thoughts, suicide attempts, personality disorders, manic reactions, intoxication, chorea-acanthocytosis, migraine, depressive reactions, monologue, impulsive behavior, automatic movement, schizophrenia-like reactions, ataxia, mental confusion, hostility, inability to sit still, progression, muscle stiffness, salivation, akinesia, gait abnormalities, movement disorders, dyskinesia, abnormal eye movement, slowed movements, granulocytopenia, eosinophilia, anemia, thrombocytopenia, rash, itching, urination disorders, urinary incontinence, urinary retention, ejaculation disorders, erectile dysfunction, lethargy, increased CK, increased sweating, weight loss, hyperkalemia, tongue paralysis, sensory impairment, obesity, edema, facial flushing, toothache, facial swelling, neck stiffness, skin nodules, overdose, pelvic pain, dental disease, gout, arthralgia, arthritis, bursitis, myasthenia gravis, spasms, exacerbation reactions, accidental injury, ear disorders, taste abnormalities, acne, thromboembolism

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. Additionally, it is important to store this medication at a cool temperature below 30 degrees Celsius to maintain its effectiveness.

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle