Quetiapine Extended-release Tablet 150mg (Quetiapine Fumarate)

Adult dose

Administer this medicine once daily in the evening. Swallow this medicine whole; do not split, chew, or crush it. Avoid taking this medicine with food, or take it with a low-fat meal (approximately 300 calories). 1. Schizophrenia Adults: Initiate treatment with 300 mg of quetiapine, and adjust the dose within 400∼800 mg per day according to each patient's response and tolerability. The dose may be increased by up to 300 mg per day at intervals of 1 day. The safety of doses exceeding 800 mg per day has not been evaluated in clinical trials. 2. Bipolar disorder - Acute treatment of manic or mixed episodes associated with bipolar I disorder Adults: This medicine may be used as monotherapy or as adjunctive therapy to lithium or valproate. Initiate treatment with 300 mg of quetiapine on Day 1, increase to 600 mg on Day 2, and from Day 3 onward, adjust the dose within 400∼800 mg per day according to the individual patient's clinical response and tolerability. Recommended dosing schedule Treatment day Day 1 Day 2 Day 3 Dose of this medicine 300 mg 600 mg 400∼800 mg - Acute treatment of depressive episodes associated with bipolar disorder Adults: As monotherapy, the daily dose of this medicine, expressed as quetiapine, should be 50 mg on Day 1, 100 mg on Day 2, 200 mg on Day 3, and 300 mg on Day 4. Recommended dosing schedule Treatment day Day 1 Day 2 Day 3 Day 4 Dose of this medicine 50 mg 100 mg 200 mg 300 mg - Prevention of recurrence of bipolar disorder in patients who have responded to quetiapine treatment for manic, mixed, or depressive episodes To prevent recurrence of manic or mixed episodes or depression 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 within 300∼800 mg per day according to clinical response and each patient's tolerability. It is important to use the lowest effective dose for maintenance therapy. 3. Adjunctive treatment of major depressive disorder ○ Adults: Initiate treatment with 50 mg on Day 1 and increase the dose to 150 mg on Day 3. The efficacy of this medicine has been established at 150∼300 mg per day. Adverse reactions increased in a dose-dependent manner. Doses exceeding 300 mg per day have not been studied. ○ Switching from immediate-release tablets: Patients taking immediate-release quetiapine fumarate tablets may switch to this medicine for convenience of administration; it can be administered once daily at the same total daily dose. Individual dose adjustment may be necessary. ○ Elderly patients: As with other antipsychotics, this medicine should be administered with caution in elderly patients, particularly when initiating treatment. The dose should be increased gradually, and the therapeutic daily dose may be lower than that in adult patients. The mean plasma clearance of quetiapine may be reduced by 30∼50% in elderly patients compared with adult patients. Initiate treatment in elderly patients at 50 mg per day. Increase the dose by 50 mg per day until an effective dose is reached, according to each patient's clinical response and tolerability. ○ Patients with renal impairment: After oral administration of this medicine, the mean oral clearance in patients with severe renal impairment (creatinine clearance 10∼30 mL/min/1.73 m2) is reduced by 25% compared with adult patients; however, dose adjustment is generally not necessary. ○ Patients with hepatic impairment: Quetiapine is primarily metabolized in the liver; therefore, this medicine should be administered with caution to patients with hepatic impairment, particularly when initiating treatment. Initiate treatment in patients with hepatic impairment at 50 mg per day and increase the dose by 50 mg per day until an effective dose is reached, according to each patient's clinical response and tolerability.

Child dose

Children and adolescents 18 years of age or younger: The safety and efficacy of this medicine have not been established.

This drug is used to treat psychiatric disorders, particularly prescribed for depression, bipolar disorder, and schizophrenia. The safety and efficacy of this drug have not been established in children or adolescents, so it is not recommended. During the use of this drug, there may be an increase in suicidal thoughts or behaviors; therefore, young adults aged 18 to 24 should be monitored more closely. Patients with diabetes or risk factors for diabetes should regularly check and manage blood sugar levels while taking this drug. Severe hyperglycemia, neuroleptic malignant syndrome, extrapyramidal symptoms, and tardive dyskinesia may occur, so changes in symptoms should be monitored closely. Elderly patients with dementia may have an increased risk of death, so caution is required in its use. Blood cell counts may decrease sharply, so white blood cell and neutrophil counts should be regularly checked, and if symptoms of infection arise, medical attention should be sought immediately. This drug may lower blood pressure or affect heart rate, so patients with cardiovascular diseases should take it with care. Severe skin reactions may occur, so if there are symptoms such as skin rash, fever, or lymph node swelling, use should be discontinued immediately and healthcare professionals should be consulted. This drug acts on the central nervous system and may cause drowsiness, dizziness, and decreased concentration, so caution is needed when driving or operating machinery. Women who are pregnant or breastfeeding should consult a doctor, as this drug may affect the fetus or newborn. Patients with impaired liver and kidney function, the elderly, patients with cardiovascular diseases, and those with a history of seizures should start with a low dose and gradually increase while being carefully monitored. The effects may be enhanced if this drug is taken with other central nervous system depressants or alcohol, so caution is needed when used together. Overdose may result in severe drowsiness, hypotension, and increased heart rate. As there is no specific antidote, immediate visit to a medical facility for appropriate treatment is necessary. This drug should be stored out of reach of children and should not be transferred to other containers.

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, symptoms related to somnambulism, constipation, dyspepsia, vomiting, dysphagia, intestinal obstruction, respiratory distress, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, hypersensitivity reaction, anaphylactic reaction, blurred vision, pain in the limbs, 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, elevated blood glucose levels, increased serum prolactin, thrombocytopenia, increased serum creatine phosphokinase, agranulocytosis, hepatitis, liver failure, urinary retention, drug reactions accompanied by eosinophilia and systemic symptoms, cutaneous vasculitis, increased suicidal tendencies, paralytic ileus, rhabdomyolysis, thromboembolism, fatigue, visual disturbances

This drug should be stored in a tightly sealed container to avoid exposure to air or moisture. It is important to maintain storage temperature between 15 to 30 degrees Celsius.

Appearance

White to grayish-white, bilaterally convex, rectangular, extended-release film-coated tablet

Package unit

60 tablets (10 tablets/PTP × 6)