Quetiapine 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, 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 150～750 mg/day. Maintenance treatment has not been evaluated in adults with schizophrenia. Patients should be reassessed regularly to determine whether maintenance treatment is needed. Acute treatment of manic episodes associated with bipolar I disorder - Adults: This medicine is taken twice daily, with or without food. Whether used 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 200 mg per day. Depending on each patient's clinical response and tolerability, the dose may be adjusted within 200～800 mg/day; 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 should reach 300 mg by day 4, with doses of 50 mg on day 1, 100 mg on day 2, and 200 mg on day 3. 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 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 indicate 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 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 a range of 300～800 mg/day, administered twice daily. It is important to use the minimum effective dose for maintenance treatment. Elderly patients: As with other antipsychotics, this medicine should be administered with caution to elderly patients, particularly at the start of treatment. Elderly patients should start at 25 mg/day and the dose should be increased gradually by 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: 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. Patients with renal or hepatic impairment should start at 25 mg/day and the dose should be increased gradually by 25～50 mg per day until an effective dose is reached.

Child dose

Safety and efficacy in children and adolescents have not been established.

This medication may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults, and a careful assessment of necessity and risk should be made by the physician before administration. Blood sugar may increase during treatment, and patients with diabetes or risk factors for diabetes should monitor their blood sugar regularly. There may be a rare but serious side effect called neuroleptic malignant syndrome. If symptoms like high fever or muscle rigidity occur, contact your doctor immediately. Prolonged use may lead to movement disorders such as extrapyramidal symptoms or tardive dyskinesia; consult your doctor if symptoms arise. Elderly patients with dementia may have an increased risk of death; discuss with your doctor whether this medication is appropriate. Severe neutropenia or agranulocytosis may occur, so notify healthcare professionals immediately if there are any signs of infection or fever. Caution should be exercised when prescribing to patients with a risk of cerebrovascular disease, and preventive measures should be considered due to the possibility of venous thromboembolism. Patients with cardiovascular disease or hypotension should be closely monitored for orthostatic hypotension associated with this medication. Severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur; if symptoms like skin rash or fever arise, consult a healthcare provider immediately. Do not use in patients with hypersensitivity to this medication, in a comatose state, certain central nervous system depressants, patients receiving epinephrine, or patients with diabetes. Patients with impaired liver function, cardiovascular disease, older adults, pregnant and nursing mothers should use this medication with caution, and dosage adjustment and monitoring of conditions are necessary. Common side effects may include drowsiness, dizziness, dry mouth, weight gain, etc., so caution is advised when driving or operating dangerous machinery. There are potential drug interactions, so inform your doctor or pharmacist of any other medications taken, particularly when combined with strong liver enzyme inhibitors or central nervous system depressants. During pregnancy, this medication may cause withdrawal symptoms in newborns, so women of childbearing age should consult with their doctor, and it is recommended to avoid use while breastfeeding. Abrupt discontinuation of this medication may result in withdrawal symptoms or worsening symptoms, so taper off the dosage gradually as directed by your doctor.

• Drowsiness
• dizziness
• dry mouth
• withdrawal symptoms
• increased triglyceride levels
• increased total cholesterol
• decreased HDL cholesterol
• weight gain
• decreased hemoglobin
• extrapyramidal symptoms

This medication is sensitive to air and moisture, so it should be stored in a sealed container. It is also advisable to keep it at cool temperatures below 30 degrees Celsius.

Appearance

Yellow round film-coated tablet

Package unit

[Domestic] 30 tablets/bottle, 100 tablets/bottle [Export] 30 tablets (10 tablets/PTP x3), 100 tablets (10 tablets/PTP x10)