Ketapin Tablet 300mg (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 the range of 150～750 mg/day according to each patient's clinical response and tolerability. Maintenance therapy has not been evaluated in adult patients 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: Take this medicine twice daily, with or without food. When used 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. The dose may be adjusted within the range of 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 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 at 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 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 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. Older adults As with other antipsychotics, this medicine should be administered with caution to older adults, particularly when initiating treatment. Older patients should start with 25 mg/day of this medicine, with gradual increases of 25～50 mg per day; the effective dose in older adults may be lower than that in younger patients. 5. Patients with renal or hepatic impairment After oral administration of quetiapine, clearance 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 in patients with known hepatic impairment. Patients with renal or hepatic impairment should start with 25 mg/day of this medicine, 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 drug may increase the risk of suicidal thoughts or behaviors in young patients with depression or psychiatric disorders; therefore, the physician must carefully assess the necessity and risks of treatment. It is particularly not approved for use in children and adolescents, and family members and guardians should closely observe any behavioral changes during administration. This drug may raise blood sugar levels, worsening diabetes, so patients with diabetes or risk factors should regularly monitor blood glucose and be alert for symptoms of hyperglycemia. Rare but serious side effects such as neuroleptic malignant syndrome may occur, so immediate consultation with a physician is recommended if there are symptoms such as high fever, muscle rigidity, or changes in mental status. Prolonged use may lead to extrapyramidal symptoms or tardive dyskinesia; changes in dosage or discontinuation should be considered if abnormal symptoms appear. There may be an increased risk of death in elderly patients with dementia; therefore, caution or avoidance of this drug's use is advised. Severe neutropenia or agranulocytosis resulting in a significant drop in white blood cells may occur, necessitating monitoring of infection risk through blood tests. For patients with cerebrovascular or cardiovascular disease, this medication may increase the risk of stroke and should be administered with caution, considering the risk of venous thromboembolism. Initially, postural hypotension may cause dizziness or fainting, so precautions, such as rising slowly, are necessary. If symptoms of severe skin reactions, such as Stevens-Johnson syndrome or toxic epidermal necrolysis appear, use of the medication should be stopped immediately and medical advice sought. This medication should be started at a lower dose in patients with impaired liver function or the elderly and increased while carefully observing their condition. Pregnant or breastfeeding women should consult a physician before administration, as it may affect the fetus or newborn. Abrupt discontinuation may lead to withdrawal symptoms; therefore, it is safe to taper off the dosage gradually. Caution should be taken when combined with other central nervous system depressants or alcohol, as it may intensify drowsiness or impaired concentration. This medication requires careful attention during driving or operating hazardous machinery, especially at the start of treatment or after a dosage change. Serious side effects such as severe hypotension, sedation, and cardiac issues may occur in cases of overdose, requiring emergency treatment; there is no specific antidote.

• Drowsiness
• dizziness
• dry mouth
• withdrawal symptoms
• increased triglycerides
• 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 and moisture, and the temperature should be maintained below 30 degrees. By storing it this way, the efficacy of the medication can be well preserved and deterioration prevented.

Appearance

White rectangular film-coated tablet

Package unit

30 tablets/bottle, 200 tablets/bottle