Quetiapine Tablets 100 mg (Quetiapine Fumarate)

Adult dose

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, adjust to the usual effective daily dose of 300～400 mg. The dose may be adjusted within 150～750 mg/day according to the individual patient's clinical response and drug tolerability. Acute treatment of manic episodes associated with bipolar I disorder Adults: This medicine 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, in increments of no more than 200mg per day. The dose may be adjusted within 200～800 mg/day according to the individual patient's clinical response and drug tolerability; the usual effective daily dose is 400～800 mg. 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 the pivotal 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 at 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. In patients who tolerate the medicine, clinical trials have shown 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. The dose may be adjusted to a twice-daily regimen within the range of 300～800 mg/day according to clinical response and each patient's tolerability. It is important to use the lowest effective dose for maintenance therapy. Elderly patients Treatment in elderly patients should be initiated at 25 mg/day of this medicine, with gradual increases of 25～50 mg per day; the effective dose in elderly patients may be lower than that in younger patients. Patients with renal or hepatic impairment Treatment in patients with renal or hepatic impairment should be initiated at 25 mg/day of this medicine, with gradual increases of 25～50 mg per day to the effective dose.

This medication may increase the risk of suicidal impulses or behaviors in children, adolescents, and young adults with major depressive disorder or psychiatric disorders; therefore, thorough consultation with a physician should be conducted before administration. Blood glucose levels may rise during treatment, and diabetic patients or those at risk for diabetes should monitor blood sugar regularly. This medication can rarely induce symptoms of severe neuroleptic malignant syndrome, and if symptoms such as high fever, muscle rigidity, or altered mental status appear, medical assistance should be sought immediately. Prolonged use may lead to movement disorders such as extrapyramidal symptoms or tardive dyskinesia, so consultation with a physician is needed if symptoms occur. Caution is necessary when using this medication in elderly patients with dementia, as it may increase the risk of mortality. This drug can decrease the white blood cell count in the blood; therefore, if symptoms of infection occur, medical attention should be sought immediately. Patients at risk for cerebrovascular diseases should be cautious when using this medication, especially if there is a high risk of stroke. Since there is a risk of thrombosis, patients with risk factors for venous thromboembolism should verify these risks before and during treatment and take preventive measures. Patients with cardiovascular diseases or hypotension may experience orthostatic hypotension when using this medication; thus, careful observation and gradual dose adjustments are necessary. This medication may cause severe allergic skin reactions, so if extensive skin rash, fever, lymphadenopathy, or other symptoms occur, treatment should be discontinued immediately and medical staff notified. Patients exhibiting hypersensitivity reactions or those who are in a coma, as well as those taking certain central nervous system depressants, receiving epinephrine, diabetic, or lactose intolerant patients, should not be treated with this medication. Patients with compromised liver function, cardiovascular disease, seizure disorders, the elderly, those at risk for suicide, and pregnant or breastfeeding women should use this medication cautiously. Various side effects such as drowsiness, dizziness, dry mouth, weight gain, blood lipid abnormalities, and others may occur; if any unusual symptoms arise, consultation with a physician is necessary. Discontinuation of this medication can lead to withdrawal symptoms or symptom exacerbation, so tapering off should always follow a physician's guidance. There may be drowsiness or decreased attention when driving or operating hazardous machinery; caution is advised. Use during pregnancy may lead to withdrawal symptoms or movement disorders in newborns, so it is important to consider the risks and benefits for both the fetus and mother; breastfeeding women should preferably avoid nursing while on this medication. In case of overdose, seek immediate medical attention; there is no specific antidote for this medication. This medication may interact with other drugs, so it is essential to inform the doctor of any medications being taken, especially when using central nervous system depressants, CYP3A4 inhibitors, or serotonergic agents.

Drowsiness, dizziness, dry mouth, withdrawal symptoms, increased triglycerides, 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-related symptoms, constipation, dyspepsia, vomiting, dysphagia, bowel obstruction, intestinal occlusion, dyspnea, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, hypersensitivity reactions, anaphylaxis, blurred vision, pain in the back, myalgia, rhabdomyolysis, priapism, galactorrhea, increased appetite, mild weakness, chest pain, hyperreactivity, fever, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, increased serum liver enzymes, increased eosinophils, increased blood glucose levels, increased serum prolactin, thrombocytopenia, increased serum creatine phosphokinase, agranulocytosis, hepatitis, liver failure, urinary retention, voiding disorders, incontinence, ejaculation issues, erectile dysfunction, fatigue, increased CK, increased sweating, weight loss, hyperkalemia, tongue paralysis, sensory loss, obesity, edema, facial flushing, toothache, facial edema, neck stiffness, skin nodules, pelvic pain, dental disease, gout, arthralgia, arthrosis, bursitis, myasthenia gravis, cramps, adverse reactions, accidental injury, ear disorders, dysgeusia, acne, insomnia, anxiety, hyperexcitability, headache, hallucinations, forgetfulness, aggressive reactions, confusion, neurosis, delusions, hypersexuality, unstable emotions, agitation, disorientation, abnormal thoughts, increased suicidal tendencies, personality disorders, manic reactions, euphoria, chorea-acanthocytosis, migraine, depressive reactions, monologue, impulsive behavior, automatism, schizophrenia-like reactions, ataxia, delirium, hostility, akathisia, progression, muscle rigidity, salivation, bradykinesia, gait abnormalities, movement disorders, dystonia, abnormal eye movements, slowed movements, thromboembolism, pulmonary embolism, venous thrombosis, thrombosis, increased suicidal tendencies, paralytic ileus, acute kidney failure due to rhabdomyolysis, acute withdrawal symptoms, fever, nausea, vomiting, insomnia, convulsions

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

Appearance

Yellow circular film-coated tablets

Package unit

30 tablets (10 tablets/PTP × 3), 30 tablets/bottle, 200 tablets/bottle