Quetiapine Extended-Release Tablets 300 mg (Quetiapine Fumarate)

Adult dose

This medicine is administered once daily in the evening. Swallow the tablet 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: Start treatment with 300 mg of quetiapine, and adjust the dose within the range of 400∼800 mg daily according to the individual 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. In a confirmatory therapeutic clinical trial in patients with schizophrenia who had stabilized after receiving this medicine for 16 weeks and were treated for 1 year or until relapse, this medicine was effective in prolonging the time to relapse in patients with schizophrenia. The physician should periodically reassess each patient to determine the need for continued treatment. 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. Start treatment with 300 mg of quetiapine on Day 1 and increase to 600 mg on Day 2. From Day 3 onward, the dose may be adjusted within the range of 400∼800 mg daily 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: This medicine is used as monotherapy. The daily dose should be 50 mg of quetiapine 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 the range of 300∼800 mg daily 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: Start treatment with 50 mg on Day 1 and increase to 150 mg on Day 3. The efficacy of this medicine has been established at doses of 150∼300 mg daily. Adverse reactions increased in a dose-dependent manner. Doses exceeding 300 mg daily 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, and may take it 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 daily therapeutic 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. Elderly patients should start with a dose of 50 mg daily. Increase the dose by 50 mg daily until an effective dose is reached, according to the individual patient's clinical response and tolerability. ○ Patients with renal impairment: After oral administration of this medicine, 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 required. ○ 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. Patients with hepatic impairment should start with a dose of 50 mg daily. The dose may be increased by 50 mg daily until an effective dose is reached, according to the individual patient's clinical response and tolerability.

Child dose

The safety and efficacy of this medicine have not been established in children and adolescents younger than 18 years.

This medication is primarily used for the treatment of psychiatric disorders and is not approved for use in children and adolescents. During treatment with this medication, there is an increased risk of suicidal thoughts or behaviors, especially in young adults aged 18 to 24, so physicians must carefully assess the necessity and risks of treatment. Additionally, this medication can raise blood sugar levels, so patients with diabetes or those at risk for diabetes should regularly check and manage their blood sugar levels. Serious side effects such as neuroleptic malignant syndrome may occur rarely, presenting with fever, muscle rigidity, alterations in consciousness, and if these symptoms occur, treatment must be discontinued immediately and medical attention should be sought. Long-term use may result in extrapyramidal symptoms or tardive dyskinesia, therefore if unusual movements or symptoms appear, dosage adjustment or discontinuation should be considered. Elderly patients with dementia are advised against using this medication as it may increase the risk of death. Severe neutropenia or agranulocytosis resulting in a rapid decrease in white blood cell count may occur, thus blood tests should be performed regularly to check white blood cell counts. Individuals at risk for cerebrovascular disease, those with cardiovascular disease, hypotension, or liver impairment should use this medication cautiously, particularly at initiation due to the risk of orthostatic hypotension and dizziness. This medication can cause severe skin reactions, and if symptoms such as skin rash or fever occur, treatment should be stopped immediately and a doctor consulted. This medication may intensify sedation or decreased concentration when taken with other central nervous system depressants or alcohol, so caution is advised. Women who are pregnant, may become pregnant, or are breastfeeding should consult a physician before taking this medication, as it may affect the fetus and neonate. It is safer to avoid activities requiring alertness, such as driving or operating machinery, while taking this medication. Abrupt discontinuation of this medication can lead to withdrawal symptoms, so dosage should be gradually reduced according to medical advice when discontinuing. In cases of overdose, severe sedation, somnolence, hypotension, or symptoms may occur, and there is no specific antidote, so appropriate treatment should be sought immediately at a healthcare facility. This medication should be stored out of the reach of children, and it is advisable not to transfer it to another container.

Suicidal thoughts, suicidal behavior, hyperglycemia, ketoacidosis, hyperosmolar coma, death, fever, changes in mental state, muscle rigidity, irregular pulse, changes in blood pressure, tachycardia, sweating, cardiac arrhythmia, increased creatine phosphokinase, myoglobinuria, acute renal failure, tardive dyskinesia, drowsiness, dizziness, dry mouth, withdrawal symptoms, increased triglyceride levels, increased total cholesterol, decreased HDL cholesterol, weight gain, decreased hemoglobin, extrapyramidal symptoms, syncope, leukopenia, neutropenia, peripheral edema, dysarthria, seizures, restless legs syndrome, nightmares, somnambulism, constipation, dyspepsia, vomiting, dysphagia, intestinal obstruction, 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, hypersensitivity, fever, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, increased serum liver enzymes, increased eosinophils, increased serum prolactin, thrombocytopenia, increased serum creatine kinase, agranulocytosis, hepatitis, hepatic failure, urinary retention, drug reactions accompanied by eosinophilia and systemic symptoms, cutaneous vasculitis, paralytic ileus, acute renal failure due to rhabdomyolysis, thrombosis, fatigue, visual disturbances

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture, and it is advised to keep it at room temperature between 15 to 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness for a longer period.

Appearance

White to off-white, double convex, rectangular extended-release film-coated tablet

Package unit

60 tablets (10 tablets/blister x 6)