Shinshin Quetiapine Tablets 200mg (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 the range of 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 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 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 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 indicate 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 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. Elderly patients Start elderly patients on 25 mg/day of this medicine 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 Start patients with renal or hepatic impairment on 25 mg/day of this medicine and gradually increase by 25～50 mg per day to the effective dose.

Child dose

4. Pediatric and Adolescents - The safety and efficacy of this medication 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 disorders or psychiatric illnesses; therefore, careful observation is required when prescribing to patients in this age group. During treatment, blood sugar levels may increase, thus patients with diabetes or risk factors for diabetes should regularly monitor their blood sugar levels. There is a rare risk of developing neuroleptic malignant syndrome, a severe side effect; if symptoms such as high fever, muscle rigidity, and changes in mental status occur, immediate medical attention is necessary. Long-term use of this medication may lead to movement disorders such as extrapyramidal symptoms or tardive dyskinesia; if such symptoms arise, dosage adjustment or discontinuation should be considered. There is an increased risk of death associated with the use of this drug in elderly patients with dementia, thus special caution is warranted. Hematological abnormalities such as agranulocytosis or neutropenia may occur, so patients with low white blood cell counts should have regular blood tests, and any signs of infection should be treated immediately. Patients at risk for cerebrovascular disease may have an increased risk of stroke with this drug; caution is advised. Due to the risk of venous thrombosis, patients with risk factors for thrombosis should be closely monitored and preventive measures should be taken before and during administration of this drug. In patients with cardiovascular diseases or hypotension, side effects such as orthostatic hypotension may occur, thus dosage adjustment and monitoring are necessary. Severe skin adverse reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported. If symptoms like skin rash, fever, or lymphadenopathy occur, immediate discontinuation and consultation with a physician are required. This medication should not be used in specific patients, including those in a comatose state, taking certain central nervous system depressants, those receiving epinephrine, patients with diabetes, and those with lactase deficiency. Patients with liver dysfunction, cardiovascular disease, a history of seizures, elderly patients, pregnant women, and nursing mothers should be treated with this medication cautiously, with dosage adjustments and condition monitoring being essential. This drug may cause various side effects such as drowsiness, dizziness, dry mouth, weight gain, and others; if these symptoms occur, consultation with a physician is necessary. When discontinuing, do not stop abruptly; instead, taper the dosage gradually, as sudden cessation can lead to withdrawal symptoms or worsening of symptoms. This medication may increase side effects when taken with other central nervous system depressants or alcohol, so caution is needed with concomitant use. Pregnant women or those capable of becoming pregnant should consult a physician before taking this drug, as it may affect the fetus; it is advisable for nursing mothers to avoid taking it. In cases of overdose, there is no specific antidote, so immediate medical treatment and intensive monitoring are required, as severe hypotension could occur, necessitating appropriate emergency care. This drug should be kept out of reach of children, and transferring it to other containers can lead to accidents; caution is advised.

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, sleepwalking, constipation, dyspepsia, vomiting, dysphagia, intestinal obstruction, bowel obstruction, dyspnea, rhinitis, tachycardia, palpitations, bradycardia, orthostatic hypotension, hypertension, hypersensitivity reactions, anaphylaxis, blurred vision, pain in the limbs, myalgia, rhabdomyolysis, priapism, galactorrhea, increased appetite, mild weakness, chest pain, hypersensitivity, fever, hypothermia, increased serum triglycerides, increased serum liver enzymes, increased serum creatine phosphokinase, thrombocytopenia, increased serum creatine phosphokinase, agranulocytosis, hepatitis, liver failure, urinary retention, drug reaction with eosinophilia and systemic symptoms (DRESS), skin vasculitis, insomnia, anxiety, neuroticism, headache, hallucinations, forgetfulness, aggressive behavior, confusion, neurosis, delusion, hypersexuality, unstable emotions, agitation, disorientation, abnormal thinking, suicide attempts, personality disorders, manic reactions, euphoria, chorea, migraine, depressive reactions, soliloquy, impulsive behavior, automatic movements, schizophrenic reactions, ataxia, mental confusion, hostility, akathisia, progressing, muscle rigidity, salivation, bradykinesia, gait abnormalities, movement disorders, dystonia, oculomotor dysfunction, slowed movement, eosinopenia, eosinophilia, anemia, thrombocytopenia, orthostatic hypotension, palpitations, hypotension, hypertension, bradycardia, arrhythmia, syncope, ECG abnormalities, vasodilation, thromboembolism, elevated AST, elevated ALT, increased LDH, increased ALP, elevated γ-GTP, hyperbilirubinemia, difficulty expectorating phlegm, increased cough, decreased appetite, abdominal pain, diarrhea, gastritis, gastrointestinal disorders, hematemesis, rectal disorders, pupillary reflex impairment, amblyopia, conjunctivitis, hyperprolactinemia, menstrual irregularities, thyroid disorders, hypercholesterolemia, hyperlipidemia, rash, itching, urinary disorders, urinary incontinence, increased BUN, ejaculation disorders, erectile dysfunction, lethargy, increased CK, increased sweating, weight loss, hyperkalemia, tongue paralysis, decreased sensation, obesity, edema, facial flushing, toothache, facial edema, neck stiffness, skin nodules, overdose, pelvic pain, dental disorders, gout, arthralgia, osteoarthritis, bursitis, myasthenia gravis, twitching, exacerbation reactions, accidental injury, ear disorders, taste disturbances, acne, thromboembolism, fatigue, visual disturbances, increased suicidal tendencies, paralytic ileus, rhabdomyolysis, acute withdrawal symptoms, neonatal withdrawal symptoms, recurrence of neuroleptic malignant syndrome, serotonin syndrome, pancreatitis, sleep apnea syndrome

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture, and kept in a cool place below 30 degrees Celsius. Proper storage helps maintain the drug's effectiveness for an extended period.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle