Quetiapine 200 mg Tablets (Quetiapine Fumarate)

Adult dosage

1. 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, the dose should be adjusted to the usual effective daily dose of 300～400 mg. Depending on each patient's clinical response and tolerability, the dose may be adjusted within the range of 150～750 mg/day. - Maintenance therapy has not been evaluated in adults with schizophrenia. Patients should be regularly reassessed to determine the need for maintenance therapy. 2. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: - Adults: This drug 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 each 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 drug 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 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. (3) Prevention of recurrence of bipolar disorder: - Adults: To prevent recurrence of manic, mixed, and depressive episodes associated with bipolar disorder, patients who responded to quetiapine for acute treatment of bipolar disorder should be maintained on the same dose. Depending on clinical response and each patient's tolerability, the dose administered twice daily may be adjusted within the range of 300～800 mg/day. It is important to use the minimum effective dose for maintenance therapy. 3. Older adults : As with other antipsychotic drugs, this drug should be administered with caution to older adults, particularly at the start of treatment. Treatment in older patients should be initiated 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. 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, it should be administered with caution to patients with known hepatic impairment. Treatment in patients with renal or hepatic impairment should be initiated at 25 mg/day, with gradual increases of 25～50 mg per day until the effective dose is reached.

Children's dosage

Safety and efficacy have not been established in pediatric and adolescent populations.

This medication is primarily used for the treatment of psychiatric disorders, and the risk of suicidal thoughts or behaviors may be increased, especially in young patients, so careful monitoring is required. Blood sugar levels may rise during treatment, so patients with diabetes or risk factors should regularly check their blood sugar and monitor for abnormal symptoms. A rare but serious side effect known as neuroleptic malignant syndrome can occur, so if high fever, muscle stiffness, or changes in consciousness arise, immediate consultation with healthcare professionals is necessary. Long-term use may lead to movement disorders such as extrapyramidal symptoms or tardive dyskinesia, so dose adjustments or discontinuation should be considered if symptoms appear. In elderly patients with dementia, the risk of death may be increased, so it is advisable not to use this medication. Severe neutropenia, characterized by a rapid decrease in white blood cell count, may occur, and blood tests should be conducted regularly to monitor levels. Patients with cerebrovascular or cardiovascular disease may have increased risk of stroke when taking this medication, thus it should be used cautiously. There is a risk of venous thromboembolism, so symptoms or risk factors related to thrombosis should be monitored and preventive measures taken. Orthostatic hypotension can cause dizziness or fainting, especially upon initial use or dose increases, so caution is warranted. This medication should not be administered to patients with known allergies to specific components, those in a comatose state, those using central nervous system depressants, those receiving epinephrine, or those with diabetes. Patients with impaired liver function, cardiovascular disease, elderly patients, pregnant and breastfeeding women should use this medication cautiously, with careful observation needed for dose adjustments and monitoring. Common side effects during treatment include drowsiness, dizziness, dry mouth, constipation, tachycardia, orthostatic hypotension, dyspepsia, fainting, nightmares, restless legs syndrome, insomnia, anxiety, irritability, headache, hallucinations, forgetfulness, aggressive responses, confusion, neurosis, delusions, hypersexuality, unstable emotions, agitation, confusion, abnormal thoughts, suicide attempts, personality disorders, manic reactions, euphoria, chorea, migraine, depressive reactions, monologues, and impulsive behaviors. The medication may affect the fetus if taken during pregnancy, and breastfeeding women are advised to avoid breastfeeding while on this medication. Abrupt discontinuation may lead to withdrawal symptoms and worsening of symptoms, so it is essential to gradually reduce the dose under medical supervision when discontinuing. In cases of overdose, severe drowsiness, hypotension, tachycardia, etc., may occur, and since no specific antidote is available, immediate medical attention is required. This medication is not recommended for use in children and adolescents since safety and efficacy have not been established.

Drowsiness, dizziness, dry mouth, weakness, constipation, tachycardia, orthostatic hypotension, dyspepsia, syncope, neuroleptic malignant syndrome, leukopenia, neutropenia, peripheral edema, extrapyramidal symptoms, speech disorder, seizures, restless legs syndrome, tardive dyskinesia, nightmares, dysphagia, rhinitis, increased appetite, withdrawal symptoms, neuroleptic malignant syndrome, increased serum creatine phosphokinase, increased serum triglycerides, increased total cholesterol, decreased HDL cholesterol, weight gain, increased serum liver enzymes, decreased neutrophil count, increased blood sugar levels to hyperglycemic levels, increased serum prolactin, thrombocytopenia, anaphylactic reaction, prolonged erection, galactorrhea, hypersensitivity, insomnia, anxiety, nervousness, headache, hallucinations, forgetfulness, aggressive behavior, confusion, neurosis, delusions, hypersexuality, mood instability, agitation, disorientation, abnormal thoughts, suicide attempts, personality disorder, manic reaction, euphoria, chorea, migraine, depressive reaction, monologue, impulsive behavior, automatism, schizophrenic reaction, ataxia, mental confusion, hostility, akathisia, forward movement, muscle rigidity, salivation, bradykinesia, gait abnormalities, dyskinesia, dystonia, abnormal eye movements, slowed movements, granulocytopenia, anemia, thrombocytopenia, orthostatic hypotension, palpitation, hypotension, hypertension, bradycardia, arrhythmia, abnormal ECG, vasodilation, thromboembolism, increased AST, increased ALT, increased LDH, increased ALP, increased γ-GTP, hyperbilirubinemia, difficulty expelling phlegm, increased cough, loss of appetite, nausea, vomiting, abdominal pain, bowel obstruction, diarrhea, abdominal bloating, gastritis, gastrointestinal disorders, hematemesis, rectal disorders, impaired pupillary reflex, amblyopia, conjunctivitis, hyperprolactinemia, decreased T4, menstrual irregularities, thyroid disorders, hypercholesterolemia, hyperlipidemia, decreased T3, rash, itching, urinary disorders, urinary incontinence, urinary retention, increased BUN, ejaculatory disorders, erectile dysfunction, fatigue, increased CK, increased sweating, weight loss, hyperkalemia, tongue paralysis, sensory decline, obesity, edema, facial flushing, toothache, facial edema, neck stiffness, skin nodules, overdose, pelvic pain, dental disorders, gout, arthralgia, osteoarthritis, bursitis, myasthenia gravis, cramps, exacerbation reactions, accidental injury, ear disorders, taste disturbances, acne, thromboembolism, paralytic ileus

Store this medication in a tightly sealed container to prevent exposure to air and moisture, and keep the temperature below 30 degrees. Storing it this way helps maintain the efficacy of the medication for a longer period.

Appearance

White, round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle