KetaPin 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 the dose 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 each patient's clinical response and tolerability. 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: Take this medicine twice daily, with or without food. When used 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 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 the pivotal 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. In patients who tolerate the medicine, clinical trials indicate that the dose may be reduced to as low as 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 during 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 therapy. 3. Older adults As with other antipsychotics, this medicine should be administered with caution to older adults, particularly when initiating treatment. Older patients should start with 25 mg/day of this medicine, with gradual increases of 25～50 mg per day; the effective dose in older adults 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, it should be administered with caution in patients with known hepatic impairment. Patients with renal or hepatic impairment should start with 25 mg/day of this medicine, with gradual increases of 25～50 mg per day until an effective dose is reached.

Child dose

4. 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 and behaviors in children and adolescents with major depressive disorder or other psychiatric conditions, so careful monitoring is required. This medication can raise blood sugar levels, and patients with diabetes or risk factors for diabetes should periodically check their blood glucose levels. There is a risk of serious side effects known as Neuroleptic Malignant Syndrome, so if symptoms such as high fever, muscle rigidity, or changes in mental state occur, immediate medical attention should be sought. Long-term use may lead to extrapyramidal symptoms and tardive dyskinesia, so if unusual symptoms arise, dose adjustment or discontinuation should be considered. Elderly patients with dementia may have an increased risk of death, so it is best not to use this medication. This medication can cause severe agranulocytosis or neutropenia, so regular blood tests to monitor white blood cell counts are necessary. Caution is advised in patients at risk of cerebrovascular disease, as there is also a risk of venous thromboembolism, requiring evaluation of risk factors and preventive measures. Patients with cardiovascular disease or hypotension should be monitored closely, as side effects such as orthostatic hypotension may occur. Severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur, so symptoms such as skin rash or fever should be closely monitored. Patients with hypersensitivity to this medication, those in a coma, those taking specific central nervous system depressants, patients receiving epinephrine, diabetic patients, or lactose-intolerant patients should not be administered this medication. Patients with liver dysfunction or a history of cardiovascular disease or seizures, the elderly, and pregnant or breastfeeding women should take this medication with caution, with dose adjustments and monitoring needed. This medication can cause a variety of side effects including drowsiness, dizziness, dry mouth, weight gain, and changes in blood glucose and lipid levels, so patients should consult their doctor if symptoms occur. Upon discontinuation, acute withdrawal symptoms may appear, so the dose should be reduced gradually. This medication acts on the central nervous system and may cause drowsiness or decreased attention, so caution is needed when driving or operating machinery. There may be interactions with other medications, so if there are concurrent medications, patients must inform their doctor or pharmacist, especially avoiding co-administration with potent CYP3A4 inhibitors. If a pregnant woman takes this medication, side effects may occur in the fetus or newborn, so the decision to use it during pregnancy should be made with caution, and breastfeeding women are advised to avoid breastfeeding. Safety has not been established for children and adolescents, so it is preferable not to administer it to them. For the elderly, initiate treatment at a low dose and gradually increase while carefully monitoring for side effects. In case of overdose, seek immediate medical attention for appropriate treatment, as there is no specific antidote; treatment should be symptomatic. This medication should be kept out of reach of children and should not be transferred to other containers.

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, speech disturbance, seizures, restless legs syndrome, tardive dyskinesia, nightmares, sleepwalking, constipation, dyspepsia, vomiting, dysphagia, intestinal obstruction, bowel obstruction, rhinitis, dyspnea, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, hypersensitivity reactions, anaphylactic reactions, blurred vision, pain in the limbs, myalgia, rhabdomyolysis, priapism, galactorrhea, increased appetite, mild asthenia, chest pain, irritability, fever, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, increased serum transaminases, increased serum creatine kinase levels, thrombocytopenia, increased serum prolactin, insomnia, anxiety, nervousness, headache, hallucinations, forgetfulness, aggressive behavior, confusion, neurosis, delusions, hypersexuality, emotional instability, agitation, confusion, abnormal thinking, suicide attempt, personality disorder, manic reactions, intoxication, chorea-acanthocytosis, migraine, depressive reactions, soliloquy, impulsive behavior, automatism, schizoaffective reactions, ataxia, mental confusion, hostility, akathisia, progression, speech disturbance, muscle rigidity, salivation, bradykinesia, abnormal gait, movement disorders, dystonia, ocular movement disorders, slow movements, granulocytopenia, eosinophilia, anemia, thrombocytopenia, rash, itching, urination disorders, urinary incontinence, urinary retention, abnormal ejaculation, erectile dysfunction, lethargy, increased CK, increased sweating, weight loss, hyperkalemia, tongue paralysis, sensory impairment, obesity, edema, facial flushing, dental pain, facial edema, neck stiffness, skin nodules, overdose, pelvic pain, dental disease, gout, arthralgia, osteoarthritis, bursitis, myasthenia, cramps, exacerbation reactions, incidental injury, ear disease, dysgeusia, acne, thromboembolism, increased suicidal tendency, paralytic ileus, acute renal failure due to rhabdomyolysis, insomnia, anxiety, nervousness, headache, hallucinations, forgetfulness, aggressive behavior, confusion, neurosis, delusions, hypersexuality, emotional instability, agitation, confusion, abnormal thinking, suicide attempt, personality disorder, manic reactions, intoxication, chorea-acanthocytosis, migraine, depressive reactions, soliloquy, impulsive behavior, automatism, schizoaffective reactions, ataxia, mental confusion, hostility, akathisia, progression, speech disturbance, muscle rigidity, salivation, bradykinesia, abnormal gait, movement disorders, dysphonia, dystonia, ocular movement disorders, slow movements, granulocytopenia, eosinophilia, anemia, thrombocytopenia, rash, itching, urination disorders, urinary incontinence, urinary retention, abnormal ejaculation, erectile dysfunction, lethargy, increased CK, increased sweating, weight loss, hyperkalemia, tongue paralysis, sensory impairment, obesity, edema, facial flushing, dental pain, facial edema, neck stiffness, skin nodules, overdose, pelvic pain, dental disease, gout, arthralgia, osteoarthritis, bursitis, myasthenia, cramps, exacerbation reactions, incidental injury, ear disease, dysgeusia, acne

This medication should be stored in an airtight container to prevent exposure to air or moisture, and it is recommended to keep it in a cool place below 30 degrees Celsius. This ensures that the medication's effectiveness is maintained for a longer period and can be used safely.

Appearance

white round film-coated tablet

Package unit

30 tablets/bottle, 200 tablets/bottle