Hanhwa Quetiapine Tablets 300mg (Quetiapine Fumarate)

Adult dose

Schizophrenia Adults: Take this medicine twice daily, with or without food. The total daily dose for the first 4 days is 50 mg on day 1, 100 mg on day 2, 200 mg on day 3, and 300 mg on day 4. From day 4 onward, adjust the dose to the usual effective daily dose of 300～400 mg. Depending on the individual patient's clinical response and tolerability, the dose may be adjusted within the range of 150～750 mg/day. Maintenance therapy has not been evaluated in adults with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance therapy. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: Adults: Take this medicine twice daily, with or without food. As monotherapy or as adjunctive therapy to a mood stabilizer (lithium or valproate), the total daily dose for the first 4 days is 100 mg on day 1, 200 mg on day 2, 300 mg on day 3, and 400 mg on day 4. The total daily dose may be increased to 800 mg by day 6, with increases of no more than 200 mg per day. Depending on the individual patient's clinical response and tolerability, the dose may be adjusted within the range of 200～800 mg/day; the usual effective daily dose is 400～800 mg. (2) Treatment of depression associated with bipolar disorder: Adults: Take this medicine once daily at bedtime, with or without food. The total daily dose for the first 4 days should reach 50 mg on day 1, 100 mg on day 2, 200 mg on day 3, and 300 mg on day 4. In confirmatory clinical trials of this medicine, doses of 50 mg on day 1, 100 mg on day 2, 200 mg on day 3, 300 mg on day 4, 400 mg on day 5, and up to 600 mg on day 8 were administered. The recommended daily dose is 300 mg. Antidepressant effects were observed with both 300 mg and 600 mg, but there was no additional benefit with 600 mg. Increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. In patients who tolerate the medicine, clinical trials have shown that the dose may be reduced to as low as 200 mg. (3) Prevention of recurrence of bipolar disorder: Adults: To prevent recurrence of manic, mixed, or depressive episodes associated with bipolar disorder, patients who responded to quetiapine during acute treatment of bipolar disorder should continue on the same dose. Depending on clinical response and individual tolerability, the dose may be adjusted within the range of 300～800 mg/day, administered twice daily. It is important to use the lowest effective dose for maintenance therapy. Elderly patients: As with other antipsychotics, this medicine should be administered with caution to elderly patients, particularly at the start of treatment. Treatment in elderly patients should be initiated at 25 mg/day, with gradual increases of 25～50 mg per day. The effective dose in elderly patients may be lower than that in younger patients. Patients with renal or hepatic impairment: Clearance after oral administration of quetiapine is reduced by approximately 25% in patients with renal or hepatic impairment. Since quetiapine is primarily metabolized in the liver, it should be administered with caution to patients with known hepatic impairment. Treatment in patients with renal or hepatic impairment should be initiated at 25 mg/day, with gradual increases of 25～50 mg per day until an effective dose is reached.

Child dose

Children and adolescents: The safety and efficacy of this medicine have not been established in children and adolescents.

This medication is primarily used in psychiatric treatment, and special caution is needed in children, adolescents, and young adults with suicidal tendencies, as it may increase the risk of suicidal thoughts or behavior. Since it can raise blood sugar levels, diabetic patients or those at risk of diabetes should check their blood sugar levels regularly, and patients and their families should be adequately informed about hyperglycemia symptoms. This drug rare can cause a serious side effect known as Neuroleptic Malignant Syndrome, which manifests as high fever, muscle rigidity, or changes in mental status, necessitating immediate discontinuation and treatment. Long-term use may lead to movement disorders such as extrapyramidal symptoms or tardive dyskinesia, so dose adjustments or discontinuation should be considered if abnormal symptoms occur. In elderly patients with dementia, the risk of death may be increased, so use should be avoided or administered with caution. Severe neutropenia or agranulocytosis, which can result in a rapid decrease in white blood cell count, may occur, requiring regular blood tests and immediate consultation with a physician if infection symptoms arise. For patients at risk of cerebrovascular disease, there may be an increased risk of stroke, so caution is necessary. There is also a risk of venous thromboembolism, requiring verification of thrombosis risk factors and preventive measures. Patients with cardiovascular disease or hypotension may experience orthostatic hypotension as a result of this medication, necessitating dose adjustments and monitoring. Severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS syndrome may occur, so immediate discontinuation is necessary if symptoms such as rash, fever, or lymphadenopathy arise. This medication is contraindicated in patients with allergies to specific components, in a comatose state, those taking central nervous system depressants, undergoing epinephrine treatment, diabetic patients, and those with lactose intolerance. Caution is warranted when administering to patients with liver dysfunction, cardiovascular diseases, epilepsy, the elderly, suicidal risk patients, pregnant women, and breastfeeding mothers. This medication can cause various side effects, including drowsiness, dizziness, dry mouth, and weight gain, so care should be taken when driving or operating machinery. When taken with other central nervous system depressants or alcohol, side effects may worsen, requiring caution. During pregnancy, this medication may affect the fetus, so pregnant women should consult with a physician before taking it, and it is advisable to avoid medication while breastfeeding. In case of overdose, symptoms such as drowsiness, hypotension, and tachycardia may arise, and since there is no specific antidote, emergency treatment and intensive care are necessary. This medication is not recommended for children and adolescents as its safety and efficacy have not been established. Elderly patients should start at low doses as drug metabolism may be slower, gradually increasing the dose as needed.

• Drowsiness
• dizziness
• dry mouth
• withdrawal symptoms
• increased triglyceride levels
• increased total cholesterol
• decreased HDL cholesterol
• weight gain
• reduced hemoglobin
• extrapyramidal symptoms

This medication can be sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, it is important to store it in a cool place below 30 degrees to maintain its efficacy.

Appearance

White oblong film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle