Myungmoon Quetiapine Tablets 300 mg (Quetiapine Fumarate)

Adult dose

Schizophrenia, adults: This drug 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, adjust to the usual effective dose of 300～400 mg daily. Depending on the clinical response and drug tolerability of each patient, the dose may be adjusted within 150～750 mg/day. Maintenance therapy has not been evaluated in adults with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance therapy. Acute treatment of manic episodes associated with bipolar I disorder, adults: This drug 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, with increases of no more than 200mg per day. Depending on the clinical response and drug tolerability of each patient, the dose may be adjusted within 200～800 mg/day; the usual effective daily dose is 400～800 mg. Treatment of depressive episodes associated with bipolar disorder, adults: This drug is taken once daily at bedtime, with or without food. The total daily dose 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. Dose increases 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. 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 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 drug should be administered with caution to older adults, particularly when starting treatment. Older patients should start this drug at 25 mg/day, with gradual increases of 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, it should be administered with caution in patients with known hepatic impairment. Patients with renal or hepatic impairment should start this drug at 25 mg/day, with gradual increases of 25～50 mg per day until an effective dose is reached.

Child dose

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

This drug is primarily used for treating psychiatric disorders, and its safety and efficacy have not been established in children or adolescents, so it is advisable not to use it in these populations. During treatment with this medication, there may be an increased risk of suicidal thoughts or behaviors, particularly among young adults aged 18 to 24, requiring careful monitoring by a physician. Blood sugar levels may increase; therefore, patients with diabetes or a family history of diabetes should regularly monitor their blood glucose and manage it according to their physician's instructions. There is a risk of a rare but severe side effect known as neuroleptic malignant syndrome; if high fever, muscle rigidity, or changes in mental state occur, immediate medical attention is necessary. Long-term use may lead to extrapyramidal symptoms or tardive dyskinesia, so if any unusual symptoms arise, dosage adjustments or discontinuation should be considered. In elderly patients with dementia, this medication may increase the risk of mortality, so caution is required. Blood cell count reductions, especially neutropenia, may occur; therefore, immediate consultation with medical staff is necessary in case of symptoms of infection or fever. Patients with cerebrovascular or cardiovascular diseases and hypotension should be cautious as the risk of orthostatic hypotension or thrombosis may increase with the use of this medication. Severe skin reactions may rarely occur, so if symptoms such as skin rash, fever, or lymphadenopathy appear, the medication should be discontinued immediately and medical advice sought. This medication may interact with specific drugs; therefore, if taking other medications, it is important to inform the doctor or pharmacist, especially that it should not be used with epinephrine. Pregnant or nursing women should consult a physician before taking this medication, and it is recommended to avoid use while breastfeeding. While taking this medication, symptoms such as drowsiness, dizziness, or dry mouth may occur, so caution is advised when driving or operating dangerous machinery. Abruptly stopping this medication may lead to withdrawal symptoms or worsening of mental symptoms; therefore, dosage should be gradually reduced according to a physician's instructions. During treatment with this medication, metabolic side effects such as weight gain, dyslipidemia, and increased prolactin levels may also be observed, necessitating regular health check-ups.

Drowsiness, dizziness, dry mouth, withdrawal symptoms, increased triglyceride levels, increased total cholesterol, decreased HDL cholesterol, weight gain, decreased hemoglobin, extrapyramidal symptoms, fainting, neuroleptic malignant syndrome, leukopenia, neutropenia, peripheral edema, speech disturbance, seizures, restless legs syndrome, tardive dyskinesia, nightmares, symptoms related to sleepwalking, constipation, indigestion, vomiting, dysphagia, bowel obstruction, intestinal occlusion, difficulty breathing, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, leukopenia, hypersensitivity reactions, anaphylaxis, blurred vision, back pain, myalgia, rhabdomyolysis, priapism, galactorrhea, increased appetite, mild weakness, peripheral edema, chest pain, hypersensitivity, fever, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, increased serum liver enzymes, increased serum creatine phosphokinase, thrombocytopenia, increased serum prolactin, insomnia, anxiety, nervousness, headache, hallucinations, forgetfulness, aggressive behavior, confusion, neurosis, delusions, hypersexuality, unstable emotions, agitation, disorientation, abnormal thinking, suicide attempts, personality disorders, manic reactions, intoxication, chorea-acanthocytosis, migraine, depressive reactions, monologue, impulsive behavior, automatisms, schizophrenia-like responses, ataxia, mental confusion, hostility, akathisia, forward motion, muscle rigidity, salivation, bradykinesia, gait abnormalities, movement disorders, dystonia, ocular movements abnormalities, slow movements, agranulocytosis, eosinophilia, anemia, thrombocytopenia, rash, itching, urination disorders, urinary incontinence, urinary retention, increased BUN, ejaculation abnormalities, erectile dysfunction, fatigue, increased CK, increased sweating, weight loss, hyperkalemia, tongue paralysis, sensory impairment, obesity, edema, facial flushing, dental pain, facial swelling, neck stiffness, skin nodules, overdose, pelvic pain, dental diseases, gout, arthralgia, arthropathy, bursitis, myasthenia, cramping, exacerbation reactions, accidental injury, ear diseases, taste disturbances, acne, thromboembolism, increased suicidal tendencies, paralytic ileus, rhabdomyolysis, acute kidney failure, withdrawal symptoms, nausea, vomiting, insomnia, anxiety, restlessness, panic disorder, agitation, hostility, aggressiveness, impulsivity, hypomania, mania, serotonin syndrome, acute withdrawal symptoms, nausea, vomiting, insomnia, recurrence of psychotic symptoms, emergency involuntary movement disorders, orthostatic hypotension, fainting, QT prolongation, cardiomyopathy, myocarditis, sleep apnea syndrome, pancreatitis, dysphagia, constipation, bowel obstruction, intestinal occlusion, elevated serum liver enzymes, increased serum triglycerides and cholesterol, increased blood glucose, symptoms of hyperglycemia, increased serum prolactin, increased serum creatine phosphokinase, agranulocytosis, anaphylaxis, rhabdomyolysis, neuroleptic malignant syndrome, severe neutropenia, agranulocytosis, severe cutaneous adverse reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reactions accompanied by eosinophilia and systemic symptoms

This medication should be stored in a tightly closed container to protect it from air and moisture, and it is important to keep it at a cool temperature below 30 degrees Celsius. This helps maintain the medication's effectiveness over time.

Appearance

White oblong film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle