Quetiapine Tablets 100 mg (Quetiapine Fumarate)

Adult dose

1. 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. 2. Bipolar disorder (1) 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. (2) 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. (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 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. 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. 5. 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.

This medication may increase the risk of suicidal thoughts and behaviors in younger patients with major depressive disorder or psychiatric illness, therefore, physicians must carefully assess the necessity and risks of treatment. Blood sugar levels may rise while taking this medication, and patients with diabetes or risk factors for diabetes should regularly monitor their blood sugar levels. This drug can rarely cause a serious side effect known as Neuroleptic Malignant Syndrome, so if symptoms such as high fever, muscle rigidity, or changes in mental status occur, medical personnel should be notified immediately. Long-term use may lead to extrapyramidal symptoms or tardive dyskinesia, so if abnormal symptoms appear, consult a physician. Elderly patients with dementia may have an increased risk of death, so special caution is required. This drug may cause blood abnormalities, such as leukopenia, so if symptoms of infection arise, medical personnel should be informed immediately, and regular blood tests should be conducted. Patients at risk for cerebrovascular disease should use this medication with caution, as the risk of thrombosis may increase, and preventive measures should be in place to address risk factors. Those with cardiovascular disease or hypotension should be closely monitored for dizziness or orthostatic hypotension symptoms during initial administration. This medication can cause serious skin reactions, so if symptoms such as rashes or fever appear, discontinue use immediately and consult medical personnel. Using this medication in combination with certain diseases or other medications may increase the risk of side effects, so it is essential to inform the physician of any other medications being taken. Pregnant or breastfeeding women should carefully consider the use of this medication due to potential effects on the fetus or neonate, after consulting with a physician. The safety and efficacy of this medication have not been established in children and adolescents, so its use should be avoided. In case of overdose, symptoms such as severe drowsiness, hypotension, and tachycardia may occur, so strict adherence to doses is necessary, and immediate emergency treatment is required in case of overdose. During the intake of this medication, drowsiness or decreased attention may occur during driving or machine operation, so caution is advised. When discontinuing use, abrupt cessation should be avoided and the dosage should be gradually reduced according to a physician's instructions to prevent 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, dysarthria, seizures, restless legs syndrome, tardive dyskinesia, nightmares, somnambulism, constipation, indigestion, vomiting, dysphagia, intestinal obstruction, bowel obstruction, dyspnea, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, hypersensitivity reaction, anaphylaxis, blurred vision, pain in the limbs, myalgia, rhabdomyolysis, priapism, galactorrhea, increased appetite, mild weakness, peripheral edema, chest pain, irritability, fever, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, increased serum liver enzymes, eosinophilia, elevated blood glucose levels, increased serum prolactin, thrombocytopenia, increased serum creatine phosphokinase, agranulocytosis, hepatitis, liver failure, urinary retention, increased sweating, weight loss, hyperkalemia, tongue paralysis, sensory impairment, obesity, edema, facial flushing, toothache, facial edema, neck stiffness, skin nodules, pelvic pain, dental disease, gout, arthralgia, arthritis, bursitis, myasthenia gravis, spasms, exacerbation reactions, accidental injury, ear disorders, taste disturbances, acne, thromboembolism, insomnia, anxiety, nervousness, headache, hallucinations, forgetfulness, aggressive reactions, confusion, neurosis, delusions, increased libido, unstable emotions, agitation, disorientation, abnormal thoughts, suicide attempts, personality disorders, manic reactions, euphoria, Huntington's disease, migraine, depressive reactions, monologue, impulsive behavior, automatism, schizophrenia-like reactions, ataxia, mental confusion, hostility, inability to sit still, advancing, muscle rigidity, salivation, bradykinesia, gait abnormalities, movement disorders, dystonia, abnormal eye movement, slow movements, hypersensitivity reactions, rash, itching, urination disorders, urinary incontinence, ejaculation disorders, erectile dysfunction, lethargy, increased CK, abnormal eye movement, sleep apnea syndrome, acute withdrawal syndrome, increased suicidal tendencies, paralytic ileus, rhabdomyolysis, increased serum prolactin, increased serum liver enzymes (ALT), increased γ-GT, thrombocytopenia, increased serum creatine phosphokinase, agranulocytosis, hepatitis, liver failure, urinary retention, thromboembolism, increased serum triglycerides, increased total cholesterol, decreased HDL cholesterol, weight gain, decreased hemoglobin, increased serum prolactin, worsening of hyperglycemia and existing diabetes, increased suicidal tendencies, seizures, neuroleptic malignant syndrome, extrapyramidal symptoms, tardive dyskinesia, rhabdomyolysis, severe neutropenia, agranulocytosis, severe skin adverse reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS)

This medication should be stored in a tightly closed container to prevent air or moisture from entering and should be kept in a cool place below 30 degrees Celsius. This will help maintain the drug's effectiveness and prevent degradation.

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle