Tiapen Tablet 300 mg (Quetiapine Fumarate)

Adult dose

1. 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. The dose may be adjusted within 150～750 mg/day according to each patient's clinical response and tolerability. - Maintenance therapy has not been evaluated in adults with schizophrenia. Patients should be reevaluated regularly to determine the need for maintenance therapy. 2. 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 200mg per day. The dose may be adjusted within 200～800 mg/day according to each patient's clinical response and tolerability; 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 should reach 50 mg on day 1, 100 mg on day 2, 200 mg on day 3, and 300 mg on day 4. In the confirmatory clinical trial 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. Clinical trials indicate that the dose may be reduced to as low as 200 mg in patients who tolerate the medicine. (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 be maintained on the same dose. The dose may be adjusted within a range of 300～800 mg/day, administered twice daily, according to clinical response and each patient's tolerability. It is important to use the lowest effective dose for maintenance therapy. 3. Elderly patients : As with other antipsychotics, this medicine should be administered with caution to elderly patients, particularly at the start of treatment. Start at 25 mg/day and gradually increase by 25～50 mg per day. The effective dose in elderly patients may be lower than that in younger patients. 5. Patients with renal or hepatic impairment : Clearance after oral administration of quetiapine is reduced by approximately 25% in patients with renal or hepatic impairment. As quetiapine is metabolized primarily in the liver, administer with caution to patients with known hepatic impairment. Start this medicine at 25 mg/day and gradually increase by 25～50 mg per day to the effective dose.

Child dose

Pediatric and adolescent patients: Safety and efficacy have not been established.

This medication may increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults with major depressive disorder or psychiatric disorders; therefore, when administering to patients in this age group, careful evaluation of risks and benefits is required. Patients taking this medication may experience increased blood glucose levels, so individuals with diabetes or at risk of hyperglycemia should regularly monitor their blood sugar and carefully observe for symptoms of hyperglycemia. This medication can rarely cause a dangerous condition known as neuroleptic malignant syndrome, characterized by high fever, muscle rigidity, and altered mental status; if these symptoms occur, the healthcare provider should be notified immediately. Long-term use may lead to extrapyramidal symptoms or tardive dyskinesia, so if abnormal movement symptoms appear, consultation with a doctor is necessary. In elderly patients with dementia, the use of this medication may increase the risk of death; therefore, it is recommended not to use it in dementia patients. This medication may cause severe neutropenia or agranulocytosis, leading to a drastic decrease in white blood cell count, necessitating regular blood tests, and if signs of infection appear, the hospital must be visited immediately. Patients at risk of cerebrovascular disease should be cautious as this medication may increase stroke risk. There is a risk of venous thromboembolism; therefore, patients with thrombotic risks require caution before and during administration. Patients with cardiovascular disease or hypotension may experience orthostatic hypotension when taking this medication; they should be careful when standing up slowly and consult a physician if symptoms are severe. Severe skin adverse reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reactions may occur; if symptoms such as skin rash, fever, or lymphadenopathy appear, the medication should be discontinued immediately and healthcare personnel notified. This medication should not be administered to patients with hypersensitivity to certain components, patients in a comatose state, patients taking specific central nervous system depressants, patients receiving epinephrine, diabetes patients, and patients with lactose intolerance. Patients with impaired liver function or those with a history of cardiovascular diseases, cerebrovascular diseases, seizures, the elderly, patients at risk of suicide, pregnant and breastfeeding women should use this medication with caution and under strict medical supervision. Abruptly stopping this medication may lead to withdrawal symptoms; therefore, dosage should be gradually reduced upon discontinuation following a physician's instructions. Various side effects such as drowsiness, dizziness, dry mouth, weight gain may occur, so caution is needed when driving or operating dangerous machinery. This medication may interact with various drugs; if other medications are being taken, it is essential to inform healthcare professionals and consult about the combination with the drugs being taken. Pregnant or breastfeeding women should consult a physician regarding the administration of this medication, as it may affect the fetus or newborn. This medication's safety and efficacy have not been established in children or adolescents; therefore, it is preferable not to administer it to them. In case of overdose, symptoms such as severe drowsiness, sedation, hypotension may appear, and immediate appropriate treatment at a medical facility is required.

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

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture, and it is important to keep it at a cool temperature below 30 degrees Celsius. This will help maintain the efficacy of the medication and prevent degradation.

Appearance

White rectangular film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle