Quetiapine Tablets 25 mg (Quetiapine Fumarate)

Adult dose

Schizophrenia Adults: This medicine should be 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 adult patients with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance therapy. Bipolar disorder Acute treatment of manic episodes associated with bipolar I disorder Adults: This medicine should be 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, with increases 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. Treatment of depression associated with bipolar disorder Adults: This medicine should be taken once daily at bedtime, with or without food. The total daily dose should reach 300 mg by Day 4, with 50 mg on Day 1, 100 mg on Day 2, and 200 mg on Day 3. In the confirmatory clinical trials of this medicine, doses were administered as follows: 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. 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. For patients who tolerate the medicine, clinical trials indicate that the dose may be reduced to as low as 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 for 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. 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 and the dose should be gradually increased by 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 to patients with known hepatic impairment. Patients with renal or hepatic impairment should start with 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 medicine have not been established in children and adolescents.

This medication can increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults with major depressive disorder or psychiatric illnesses; therefore, the physician must carefully evaluate the need for treatment and risk. Patients taking this medication should be closely monitored for abnormal behavioral changes such as suicidal tendencies, disease worsening, and aggression, and family members or caregivers should also watch the patient carefully. Patients with diabetes or at risk of hyperglycemia should periodically check blood glucose control, and observe closely for symptoms of hyperglycemia such as thirst, polyuria, and weight changes. A serious side effect known as neuroleptic malignant syndrome can rarely occur; symptoms such as high fever, muscle rigidity, and changes in mental status should be reported to a doctor immediately. Long-term use can result in extrapyramidal symptoms or tardive dyskinesia; if abnormal motor symptoms occur, consideration should be given to dose adjustment or discontinuation. In elderly patients with dementia, there is an increased risk of death, and this medication is not recommended. Leukopenia or severe neutropenia may occur; therefore, infection symptoms and blood tests should be closely monitored. Patients with a risk of cerebrovascular disease should use this medication with caution and evaluate risk factors in advance considering the risk of venous thromboembolism. Patients with cardiovascular disease or hypotension should be cautious of dizziness or fainting related to orthostatic hypotension during initial dose adjustment. There is a risk of severe skin adverse reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis; if widespread skin rashes, fever, or lymphadenopathy occur, discontinue use immediately. This medication should not be given to patients with hypersensitivity to specific components, those in a coma, those taking central nervous system depressants, those receiving epinephrine, or diabetic patients. Patients with liver disease are at risk for increased blood concentration and should start at a low dose and be closely monitored, gradually increasing the dose. Pregnant or breastfeeding women should consider potential side effects to the fetus or newborn, weighing the risks and benefits carefully when administering; it is preferable to avoid taking this medication while breastfeeding. Common side effects may include drowsiness, dizziness, dry mouth, weight gain, blood glucose and lipid abnormalities, extrapyramidal symptoms, etc., and consultation with a doctor is necessary if symptoms occur. This medication can affect the central nervous system, causing drowsiness and decreased attention; caution is required when driving or operating dangerous machinery. Due to many drug interactions, inform the physician of any other medications being taken, especially when combined with strong CYP3A4 inhibitors or central nervous system depressants. Do not abruptly discontinue; instead, gradually reduce the dose to prevent acute withdrawal symptoms.

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, difficulty swallowing, intestinal obstruction, bowel occlusion, shortness of breath, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, hypersensitivity reactions, anaphylaxis, blurred vision, pain in extremities, myalgia, rhabdomyolysis, priapism, galactorrhea, increased appetite, mild asthenia, peripheral edema, chest pain, irritability, fever, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, increased serum liver enzymes, increased serum creatine phosphokinase, thrombocytopenia, increased serum prolactin, menstrual irregularities, thyroid diseases, hypercholesterolemia, hyperlipidemia, rash, itching, urinary disorders, incontinence, urinary retention, ejaculation disorders, erectile dysfunction, lethargy, increased CK, increased sweating, weight loss, hyperkalemia, tongue paralysis, sensory loss, obesity, edema, facial flushing, toothache, facial edema, neck stiffness, skin nodules, overdose, pelvic pain, dental diseases, gout, arthralgia, osteoarthritis, bursitis, myasthenia gravis, convulsions, exacerbation reactions, accidental injury, ear diseases, taste disturbances, acne, insomnia, anxiety, hyperexcitability, headache, hallucinations, forgetfulness, aggressive reactions, confusion, neurosis, delusions, hypersexuality, emotional instability, agitation, disorientation, abnormal thoughts, suicide attempts, personality disorders, manic reactions, intoxication, chorea, migraine, depressive reactions, soliloquy, impulsive behavior, automatism, schizoid reactions, ataxia, mental confusion, hostility, inability to sit still, forward movement, muscle rigidity, salivation, bradykinesia, gait abnormalities, movement disorders, dystonia, abnormal eye movements, slow movements, orthostatic hypotension, palpitations, hypotension, hypertension, bradycardia, arrhythmia, syncope, abnormal ECG, vasodilation, thromboembolism, difficulty expectorating phlegm, increased cough, decreased appetite, increased appetite, nausea, vomiting, abdominal pain, diarrhea, abdominal distension, gastritis, gastrointestinal disorders, hematemesis, rectal disorders, pupillary reflex impairment, amblyopia, conjunctivitis, hyperprolactinemia, decreased T4, decreased T3, increased sweating, weight loss, hyperkalemia, tongue paralysis, sensory loss, obesity, edema, facial flushing, toothache, facial edema, neck stiffness, skin nodules, overdose, pelvic pain, dental diseases, gout, arthralgia, osteoarthritis, bursitis, myasthenia gravis, convulsions, exacerbation reactions, accidental injury, ear diseases, taste disturbances, acne, thromboembolism, increased suicidal tendencies, paralytic ileus, rhabdomyolysis, acute renal failure, acute withdrawal syndrome, recurrence of neuroleptic malignant syndrome, neonatal withdrawal symptoms, withdrawal symptoms, suicidal tendencies, suicidal impulses, suicidal behavior

This medication should be stored in a tightly closed container to protect it from air and moisture and kept in a cool place below 30 degrees Celsius. Storing it this way can help maintain the drug's effectiveness for a long time.

Appearance

Pink circular film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle