Quroquel Sustained Release 50mg (Quetiapine Fumarate)

Adult dose

Administer this medicine once daily in the evening. Swallow the tablet whole; do not split, chew, or crush it. This medicine may be taken without food or with a low-fat meal (approximately 300 calories). 1. Schizophrenia Adults: Start treatment with 300 mg of quetiapine, and adjust the dose to 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. 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 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 daily according to the individual patient's clinical response and drug tolerability. Recommended dosing schedule Day of treatment 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 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 Day of treatment 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 responded to quetiapine treatment for manic, mixed, or depressive episodes To prevent recurrence of mania, mixed episodes, or depression associated with bipolar disorder, patients who responded to quetiapine during acute treatment of bipolar disorder should continue 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 minimum effective dose for maintenance treatment. 3. Adjunctive treatment of major depressive disorder ○ Adults: Start this medicine at 50 mg on day 1 and increase to 150 mg on day 3. The efficacy of this medicine has been established at 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 cautiously to elderly patients, particularly when initiating treatment. The dose should be increased gradually, and the daily therapeutic dose may be lower than that for 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 at a dose of 50 mg daily. Increase the dose by 50 mg daily 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 that in adult patients; however, dose adjustment is generally not required. ○ Patients with hepatic impairment: Since quetiapine is primarily metabolized in the liver, this medicine should be administered cautiously to patients with hepatic impairment, particularly when initiating treatment. Patients with hepatic impairment should start at a dose of 50 mg daily, and the dose may be increased by 50 mg daily 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 medication is mainly used for the treatment of psychiatric disorders. While taking this medication, thoughts or behaviors of suicide may increase, so both the doctor and family should closely monitor the patient's condition, especially in younger patients. Patients with diabetes or risk factors for diabetes should regularly check and manage blood glucose levels, and report immediately if symptoms of hyperglycemia occur. Severe neurological side effects such as muscle rigidity, hyperthermia, and altered consciousness may occur, so abnormal symptoms should be reported to medical personnel immediately. Prolonged use may lead to involuntary movements or symptoms of muscle disorders, and dosage adjustments or discontinuation should be considered if these symptoms arise. Use is not recommended in elderly patients with dementia due to an increased risk of mortality. Severe side effects such as a rapid decrease in blood cell count have been rarely reported, so medical attention should be sought immediately if symptoms of infection or fever occur. Patients at risk of stroke or with cardiovascular diseases need special caution when using this medication. This medication may increase the risk of thrombosis, so patients with risk factors for thrombosis should verify and take preventive measures in advance. Orthostatic hypotension may cause dizziness or fainting, so care should be taken at the beginning of treatment or during dosage increases. Women who are pregnant or breastfeeding should consult with a doctor as the use of this medication may affect the fetus or newborn. This medication is not recommended for children and adolescents under 18 years of age as its safety and efficacy have not been established. Overdose may cause severe side effects, so it is essential to strictly adhere to the prescribed dosage and seek immediate medical attention in case of an overdose. Common side effects such as drowsiness, dizziness, dry mouth may occur, so caution should be taken when driving or operating machinery. The use of this medication with other central nervous system depressants or alcohol may increase side effects, so caution is advised when used in combination. This medication is metabolized in the liver; therefore, patients with reduced liver function should start at a low dose and monitor their condition, adjusting the dosage as needed. It is important to routinely check blood tests and health status during treatment and report any abnormal symptoms to medical personnel immediately.

Drowsiness, dizziness, dry mouth, withdrawal symptoms, increased triglyceride levels, increased total cholesterol, decreased HDL cholesterol, weight gain, decreased hemoglobin, extrapyramidal symptoms, weight gain, syncope, neuroleptic malignant syndrome, leukopenia, neutropenia, peripheral edema, dizziness, headache, dysarthria, seizures, restless legs syndrome, tardive dyskinesia, syncope, nightmares, symptoms related to sleepwalking, constipation, indigestion, vomiting, difficulty swallowing, bowel obstruction, shortness of breath, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, leukopenia, hypersensitivity reactions, anaphylaxis, blurred vision, pain in various parts, myalgia, rhabdomyolysis, persistent erection, galactorrhea, increased appetite, mild asthenia, peripheral edema, chest pain, hypersensitivity, fever, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, increased total cholesterol, decreased HDL cholesterol, decreased hemoglobin, increased serum liver enzymes, decreased neutrophil count, increased eosinophil count, increased blood glucose levels to hyperglycemic levels, increased serum prolactin, decreased total T4, decreased platelet count, increased serum creatine phosphokinase, agranulocytosis, hepatitis, liver failure, urinary retention, drug reactions accompanied by eosinophilia and systemic symptoms, cutaneous vasculitis, increased suicidal tendency, paralytic ileus, rhabdomyolysis, thromboembolism, fatigue, visual disturbances

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

Appearance

White to grayish-white, double convex, round, sustained-release film-coated tablet

Package unit

60 tablets (10 tablets/PTP x 6)