KetaPin Tablets 100 mg (Quetiapine Fumarate)

Adult dose

1. Schizophrenia - Adults: This medicine is taken 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, the dose should be adjusted to the usual effective daily dose of 300～400 mg. Depending on each 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. 2. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: - Adults: This medicine is taken 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, in increments of no more than 200mg per day. Depending on each patient's clinical response and tolerability, the dose may be adjusted within the range of 200～800 mg/day, and the usual effective daily dose is 400～800 mg. (2) Treatment of depression associated with bipolar disorder: - Adults: This medicine is taken 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 the pivotal 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 indicate that the dose may be reduced to a minimum of 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 in the acute treatment of bipolar disorder should continue on the same dose. Depending on clinical response and each patient's tolerability, the dose may be adjusted within the range of 300～800 mg/day, administered twice daily. It is important to use the minimum effective dose for maintenance therapy. 3. Elderly patients : As with other antipsychotic drugs, this medicine should be administered with caution to elderly patients, particularly when initiating treatment. Elderly patients should start treatment with 25 mg/day of this medicine, with gradual increases of 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. Since quetiapine is primarily metabolized in the liver, it should be administered with caution to patients with known hepatic impairment. Patients with renal or hepatic impairment should start treatment with 25 mg/day of this medicine, with gradual increases of 25～50 mg per day until the effective dose is reached.

This medication may increase the risk of suicidal thoughts or behavior in children, adolescents, and young adults with major depressive disorder or psychiatric disorders, so careful judgment by a physician is necessary when administering it to patients in these age groups. This medication can raise blood sugar levels, so patients with diabetes or those at risk for diabetes should regularly monitor and manage their blood sugar. While taking this medication, neuroleptic malignant syndrome, a rare but severe neurological side effect, may occur; therefore, if symptoms such as high fever, muscle rigidity, or changes in consciousness arise, consult a physician immediately. Long-term use may lead to movement disorders such as extrapyramidal symptoms or tardive dyskinesia, so if abnormal symptoms arise, consider dosage adjustment or discontinuation. In elderly patients with dementia, this medication may increase the risk of mortality, so caution is needed in its use. Severe neutropenia or agranulocytosis may occur rarely, so regular blood tests to check white blood cell counts are necessary. In patients at high risk of cerebrovascular disease, there may be an increased possibility of stroke, thus careful use is required. There is a risk of venous thromboembolism, so patients with thrombosis risk factors should be vigilant and observe symptoms. Patients with cardiovascular diseases or hypotension, especially during initial administration, should be cautious of dizziness or fainting due to orthostatic hypotension. This medication can cause severe skin reactions, so if symptoms such as rash, fever, or lymph node swelling occur, discontinue use immediately. Patients with specific diseases or on certain medications, as well as pregnant or breastfeeding individuals and the elderly, should be administered carefully according to a physician’s instructions, and sudden cessation should be avoided, tapering should be gradual. During treatment with this medication, side effects such as drowsiness, dizziness, dry mouth, and weight gain may occur, so be cautious when driving or operating hazardous machinery. In case of overdose, seek medical attention immediately for appropriate emergency treatment; there is no specific antidote. This medication is not recommended for children and adolescents as its safety and efficacy have not been established.

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

Store this medication in a tightly sealed container to protect it from air and moisture. Additionally, it is important to keep it in a cool place below 30 degrees Celsius to maintain the effectiveness of the medication.

Appearance

Yellow, round film-coated tablets

Package unit

30 tablets/bottle, 200 tablets/bottle