Curol Kelsabongjeong 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 quetiapine 300 mg, and adjust the dose within the range of 400∼800 mg/day according to the individual patient's response and tolerability. The dose may be increased by up to 300 mg/day at intervals of 1 day. The safety of doses exceeding 800 mg/day has not been evaluated in clinical trials. In a confirmatory therapeutic clinical trial in patients with schizophrenia who had been stabilized after receiving this medicine for 16 weeks and were then 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 is administered as monotherapy or as adjunctive therapy to lithium or valproate. Initiate treatment with quetiapine 300 mg on day 1, increase to 600 mg on day 2, and from day 3 onward, adjust the dose within the range of 400∼800 mg/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: This medicine is administered as monotherapy at a daily dose of quetiapine 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 manic, mixed, or depressive episodes in patients who responded to quetiapine treatment for manic, mixed, or depressive episodes For prevention of recurrence of manic or mixed episodes and depression associated with bipolar disorder, patients who responded to quetiapine during acute treatment of bipolar disorder should be maintained on the same dose. The dose may be adjusted within the range of 300∼800 mg/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 medicine has been established at 150∼300 mg/day. Adverse reactions increased in a dose-dependent manner. Doses exceeding 300 mg/day have not been studied. ○ Switching from immediate-release tablets: Patients taking quetiapine fumarate immediate-release tablets may be switched to this medicine for convenience of administration, with once-daily dosing at the same total daily dose. Individual dose adjustment may be necessary. ○ Older adults: As with other antipsychotic drugs, this medicine should be administered with caution to older adults, particularly when initiating treatment. The dose should be increased gradually, and the therapeutic daily dose may be lower than that for adult patients. The mean plasma clearance of quetiapine may be reduced by 30∼50% in older patients compared with adult patients. Initiate treatment in older adults at a dose of 50 mg/day. Increase the dose by 50 mg/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 required. ○ Patients with hepatic impairment: Since quetiapine is primarily metabolized in the liver, this medicine should be administered with caution to patients with hepatic impairment, particularly when initiating treatment. Initiate treatment in patients with hepatic impairment at a dose of 50 mg/day and increase the dose by 50 mg/day until an effective dose is reached, according to each patient's clinical response and tolerability.

Child dose

The safety and efficacy of this drug have not been established in children and adolescents 18 years of age or younger.

This medication may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults, so physicians should carefully evaluate the need for treatment versus the risk. This medication can elevate blood sugar levels, so patients with diabetes or risk factors for diabetes should regularly monitor and manage their blood sugar levels. During treatment with this medication, there is a rare but serious side effect called Neuroleptic Malignant Syndrome that may occur. If symptoms such as high fever, muscle rigidity, or changes in mental state appear, medical attention should be sought promptly. Long-term use may lead to movement disorders such as extrapyramidal symptoms or tardive dyskinesia; therefore, if these symptoms occur, dosage adjustment or discontinuation should be considered. Elderly patients with dementia may face an increased risk of mortality; hence, this medication should be used cautiously. Blood dyscrasias such as agranulocytosis or neutropenia may occur, necessitating regular white blood cell counts and immediate treatment if infection symptoms arise. This medication must be used with particular caution in patients with a history of cardiovascular disease, cerebrovascular disease, or hypotension, as orthostatic hypotension or dizziness may occur upon initial dosing. Severe skin adverse reactions may rarely occur, thus, if symptoms such as skin rash, fever, or lymph node swelling appear, use should be discontinued immediately and a physician consulted. This medication should not be administered to patients with certain diseases or who are taking specific drugs, especially in states of coma or those undergoing epinephrine treatment. In patients with reduced liver function or the elderly, especially those at risk for suicide, treatment should begin with a low dose and be increased gradually while being monitored closely. During treatment with this medication, side effects such as drowsiness, dizziness, dry mouth, weight gain, and blood lipid abnormalities may commonly occur, and these symptoms should be managed appropriately. This medication affects the central nervous system and may cause drowsiness or decreased attention, thus it is advisable to avoid driving or operating machinery after taking it. There may be interactions with other medications during treatment, especially when used with potent liver enzyme inhibitors or central nervous system depressants, so caution is required. Pregnant or breastfeeding women should consult a physician before taking this medication, and caution should be exercised as withdrawal symptoms may occur in newborns. Abrupt discontinuation of this medication may lead to withdrawal symptoms, thus it is recommended to taper off the dosage gradually under a physician's guidance. In cases of overdose, severe drowsiness, hypotension, and tachycardia may occur, necessitating immediate emergency treatment, although there is no specific antidote. Store out of reach of children and take care not to transfer to other containers.

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 disorders, seizures, restless legs syndrome, tardive dyskinesia, nightmares, symptoms related to sleepwalking, constipation, indigestion, vomiting, difficulty swallowing, intestinal obstruction, dyspnea, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, leukopenia, hypersensitivity reactions, anaphylactic reactions, blurred vision, pain in the back, myalgia, rhabdomyolysis, priapism, galactorrhea, increased appetite, mild weakness, peripheral edema, chest pain, irritability, fever, hypothermia, increased serum triglycerides, increased serum liver enzymes, decreased neutrophil count, increased eosinophil count, elevated blood glucose levels, increased serum prolactin, thrombocytopenia, elevated serum creatine phosphokinase, agranulocytosis, hepatitis, liver failure, urinary retention, drug reactions accompanied by eosinophilia and systemic symptoms, cutaneous vasculitis, neonatal withdrawal symptoms, increased suicidal ideation, paralytic ileus, rhabdomyolysis, thromboembolism, fatigue, visual disturbances

This medication should be stored in a tightly sealed container to avoid exposure to air and moisture. Additionally, it is best to store the medication at room temperature between 15 to 30 degrees Celsius, avoiding extremes in temperature.

Appearance

White to grayish-white, double-sided convex, oblong, extended-release film-coated tablet

Package unit

60 tablets (10 tablets/PTP x 6)