Shinshin Quetiapine Tablets 100 mg (Quetiapine Fumarate)

Adult dose

1. 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 tolerability, the dose may be adjusted within the range of 150～750 mg/day. 2. 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 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. Depending on the individual patient's clinical response and 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. An antidepressant effect was observed with both 300 mg and 600 mg, but there was no additional benefit with 600 mg. Increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. For patients who tolerate the medicine, clinical trials have shown that the dose may be reduced to a minimum of 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 for acute treatment of bipolar disorder should continue on the same dose. Depending on clinical response and individual tolerability, the dose may be adjusted within the range of 300～800 mg/day, administered twice daily. It is important to use the lowest effective dose for maintenance therapy. 3. Elderly patients : As with other antipsychotics, this medicine should be administered with caution to elderly patients, particularly when initiating treatment. Elderly patients should start this medicine at 25 mg/day, with gradual increases of 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 : The clearance of quetiapine after oral administration 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 to patients with known hepatic impairment. Patients with renal or hepatic impairment should start this medicine at 25 mg/day, with gradual increases of 25～50 mg per day until the effective dose is reached.

This medication should be used cautiously in children, adolescents, and young adults with major depressive disorder or psychiatric illnesses, as there may be an increased risk of suicidal thoughts or behaviors. Diabetic patients or those at risk for hyperglycemia should regularly monitor their blood sugar levels and closely observe symptoms of hyperglycemia, such as thirst or frequent urination. This medication may rarely cause a serious side effect known as neuroleptic malignant syndrome, so immediate medical consultation is necessary if symptoms such as high fever, muscle rigidity, or changes in mental status occur. Prolonged use may lead to extrapyramidal symptoms and tardive dyskinesia, so if abnormal symptoms appear, dosage adjustment or discontinuation should be considered. Elderly patients with dementia may have an increased risk of mortality, requiring special caution. Severe neutropenia or agranulocytosis may occur, so regular monitoring of white blood cell counts is needed, and immediate treatment should be sought if any signs of infection are present. For patients at risk of cerebrovascular disease, there may be an increased risk of stroke, necessitating careful administration. There is a risk of thrombosis, so patients with risk factors for venous thrombosis should take preventive measures. Patients with cardiovascular diseases or hypotension may experience side effects like orthostatic hypotension; therefore, dosage should be gradually adjusted while monitoring their condition. Severe skin adverse reactions may occur, so if symptoms such as widespread skin rash, fever, or lymphadenopathy appear, medication should be stopped immediately. This medication should not be administered to patients with specific genetic lactose intolerance, and caution is necessary when used in patients in a comatose state or combined with certain central nervous system depressants. Patients with impaired liver function may have elevated blood concentrations, so they should start with a lower dose and gradually increase as needed. Women who are pregnant or breastfeeding should consult their physician before using this medication, as it may cause adverse effects in the fetus or newborn. This medication may cause central nervous system side effects such as drowsiness and dizziness, so caution is advised when driving or operating hazardous machinery. As there is a possibility of drug interactions, inform healthcare providers of any other medications in use, especially strong hepatic enzyme inhibitors should not be used in combination. When discontinuing use, do not stop abruptly; dosage should be reduced gradually to prevent withdrawal symptoms or exacerbation of symptoms. In case of overdose, there is no specific antidote, so immediate medical attention should be sought for appropriate treatment.

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 disorder, seizures, restless legs syndrome, tardive dyskinesia, nightmares, somnambulism, constipation, dyspepsia, vomiting, dysphagia, intestinal obstruction, bowel obstruction, dyspnea, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, hypersensitivity reactions, anaphylaxis, blurred vision, pain in the limbs, myalgia, rhabdomyolysis, priapism, galactorrhea, increased appetite, mild weakness, chest pain, irritability, fever, hypothermia, increased serum triglycerides, increased serum liver enzymes, increased serum creatine phosphokinase, thrombocytopenia, increased serum creatine phosphokinase, agranulocytosis, hepatitis, hepatic failure, urinary retention, drug reaction with eosinophilia and systemic symptoms (DRESS), vasculitis, insomnia, anxiety, neural hyperexcitability, headache, hallucinations, memory loss, aggressive reactions, confusion, neurosis, delusions, hypersexuality, unstable emotions, agitation, disorientation, abnormal thoughts, suicide attempts, personality disorders, manic reactions, euphoria, chorea-acanthocytosis, migraine, depressive reactions, monologue, impulsive behavior, automatic movements, schizoaffective reactions, ataxia, delirium, hostility, akathisia, anteversion, muscle rigidity, salivation, bradykinesia, abnormal gait, movement disorders, dystonia, oculomotor abnormalities, slowed movements, eosinophilia, anemia, thrombocytopenia, blurred vision, urinary disorders, urinary incontinence, urinary retention, increased BUN, abnormal ejaculation, erectile dysfunction, fatigue, increased CK, increased sweating, weight loss, hyperkalemia, tongue paralysis, sensory impairment, obesity, edema, facial flushing, toothache, facial edema, neck stiffness, skin nodules, overdose, pelvic pain, dental disease, gout, arthralgia, arthrosis, bursitis, myasthenia gravis, cramping, adverse reactions, accidental injury, ear diseases, taste disorders, acne, thromboembolism, suicidal tendencies, paralytic ileus, rhabdomyolysis, acute renal failure, neonatal withdrawal symptoms, recurrence of neuroleptic malignant syndrome, acute withdrawal symptoms

Store this medication in a tightly closed container to prevent air or moisture from entering, and keep it in a cool place below 30 degrees Celsius. This storage method helps maintain the medication's effectiveness and prevents it from degrading.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle