Quetiapine Sustained Release Tablets 200 mg (Quetiapine Fumarate)

Adult dose

Administer this medication once daily in the evening. Swallow the tablet whole; do not split, chew, or crush it. Avoid taking this medication with food, or take it with a low-fat meal (approximately 300 calories). 1. Schizophrenia Adults: Initiate treatment at 300 mg of quetiapine. Adjust the dose within the range of 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. In a therapeutic confirmatory clinical trial in patients with schizophrenia who had been stabilized after receiving this medication for 16 weeks and were treated for 1 year or until relapse, this medication 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 medication may be used as monotherapy or as adjunctive therapy to lithium or valproate. Initiate treatment on Day 1 at 300 mg of quetiapine, increase to 600 mg on Day 2, and from Day 3 onward adjust the dose within the range of 400∼800 mg per day according to the individual patient's clinical response and tolerability. Recommended dosing schedule Day of treatment Day 1 Day 2 Day 3 Dose of this medication 300 mg 600 mg 400∼800 mg - Acute treatment of depressive episodes associated with bipolar disorder Adults: This medication 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 Day of treatment Day 1 Day 2 Day 3 Day 4 Dose of this medication 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 Patients who responded to quetiapine during acute treatment of bipolar disorder should continue on the same dose to prevent recurrence of mania, mixed episodes, or depression associated with bipolar disorder. The dose may be adjusted within the range of 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 to 150 mg on Day 3. The efficacy of this medication 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 be switched to this medication for convenience of administration; it can be administered once daily at the same total daily dose. Individual dose adjustment may be required. ○ Elderly patients: As with other antipsychotics, administer this medication 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 medication, mean oral clearance is reduced by 25% in patients with severe renal impairment (creatinine clearance 10∼30 mL/min/1.73 m2) compared with adult patients; however, dose adjustment is generally not required. ○ Patients with hepatic impairment: Since quetiapine is primarily metabolized in the liver, administer this medication 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 and younger: The safety and efficacy of this medication have not been established.

This medication should be used cautiously in individuals with suicidal tendencies. Particularly, there may be an increased risk of suicidal thoughts or behaviors in young adults and adolescents aged 18 to 24, so a careful assessment of necessity and risk should be done by the physician. This medication may increase the risk of hyperglycemia or diabetes. Individuals who already have diabetes or risk factors for diabetes should frequently check and monitor their blood sugar levels, and any signs of hyperglycemia should be confirmed immediately. A serious side effect known as Neuroleptic Malignant Syndrome may rarely occur, which is accompanied by symptoms such as high fever, muscle rigidity, and changes in mental status; if these symptoms occur, the medication should be discontinued immediately, and treatment should be sought. Long-term use may lead to movement disorders such as extrapyramidal symptoms or tardive dyskinesia. If such symptoms occur, consideration should be given to reducing or discontinuing the medication. It is advisable not to use this medication in elderly patients with dementia, as the risk of death may increase. This medication can reduce the white blood cell count in blood, potentially increasing the risk of infection, so regular blood tests should be used to monitor white blood cell counts. In patients at risk for cerebrovascular disease, using this medication may increase the risk of stroke, so careful monitoring is required. Due to the risk of venous thromboembolism, patients with risk factors for thrombosis should carefully observe for symptoms of thrombosis before and after medication use. In certain patient populations, including those with cardiovascular disease, hypotension, liver impairment, a history of seizures, the elderly, pregnant women, and breastfeeding women, dose adjustments and careful monitoring are necessary. Serious skin reactions, such as Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN), may occur; if skin rashes or fever appear, the medication should be stopped immediately, and a doctor should be consulted. Common side effects such as drowsiness, dizziness, dry mouth, weight gain, and changes in blood sugar and lipid levels may occur, and these can impact daily activities. There are many drug interactions, so caution is needed when used with other central nervous system medications, antidepressants, antifungals, and liver enzyme inducers. In particular, concurrent use with epinephrine may lead to severe drops in blood pressure and should be avoided. Pregnant or breastfeeding women should consult with a physician before using this medication, as withdrawal symptoms may appear in newborns, necessitating careful consideration. This medication is not recommended for children and adolescents under 18 years of age, as safety and efficacy have not been established. In case of overdose, symptoms such as drowsiness, sedation, hypotension, and cardiac irregularities may occur, and immediate medical intervention and intensive care are necessary as there is no specific antidote. This medication should be stored out of reach of children, and it is advisable not to transfer it to another container. Caution should be taken when driving or operating machinery during treatment, and medication should not be stopped abruptly but rather tapered off gradually.

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, speech disorder, seizure, restless legs syndrome, tardive dyskinesia, syncope, nightmares, symptoms related to somnambulism, constipation, dyspepsia, vomiting, dysphagia, intestinal obstruction, dyspnea, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, leukopenia, hypersensitivity reaction, anaphylaxis, blurred vision, pain in various areas, myalgia, rhabdomyolysis, priapism, galactorrhea, increased appetite, mild weakness, peripheral edema, chest pain, hypersensitivity, fever, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, increased serum liver enzymes, decreased neutrophil count, increased eosinophil count, elevated blood sugar levels, increased serum prolactin, thrombocytopenia, increased serum creatine phosphokinase, agranulocytosis, hepatitis, hepatic failure, urinary retention, drug reactions associated with eosinophilia and systemic symptoms, cutaneous vasculitis, increased suicidal tendencies, paralytic ileus, rhabdomyolysis, thromboembolism, fatigue, visual disturbances

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture, and it is best stored at room temperature between 15 and 30 degrees Celsius. Proper storage helps in maintaining the medication's effectiveness and safety.

Appearance

White to off-white, biconvex, tablet-shaped, sustained-release film-coated tablet

Package unit

60 tablets (10 tablets/PTP x 6)