Aiquapin Tablets 300 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, adjust 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 drug 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: This medicine is taken twice daily, with or without food. As monotherapy or as adjunctive therapy with 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 200～800 mg/day according to each patient's clinical response and drug tolerability; 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 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 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 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 during acute treatment of bipolar disorder should continue on the same dose. The dose may be adjusted within 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 when initiating treatment. Start elderly patients on 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 Oral clearance of quetiapine is reduced by approximately 25% in patients with renal or hepatic impairment. Since quetiapine is primarily metabolized in the liver, administer with caution to patients with known hepatic impairment. Start patients with renal or hepatic impairment on 25 mg/day and gradually increase by 25～50 mg per day to the effective dose.

Child dose

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

This medication is mainly used for the treatment of psychiatric disorders, and safety and efficacy have not been adequately established in children and adolescents, so its use is not recommended. During treatment with this medication, there may be an increase in suicidal thoughts or behaviors, thus close monitoring by a physician is needed, especially for young patients. There is a risk of increased blood sugar levels, so patients with diabetes or family history of diabetes should regularly check their blood sugar. Neuroleptic Malignant Syndrome, characterized by severe muscle rigidity, high fever, and altered consciousness, may rarely occur, so any unusual symptoms should be reported to medical personnel immediately. With long-term use, tardive dyskinesia, such as involuntary movements of the face or tongue, and hands and feet may occur, and management or discontinuation of the medication may be required if these symptoms arise. There is an increased risk of death in elderly patients with dementia, so this medication is not used in such patients. There may be a risk of severe neutropenia or agranulocytosis, which can lead to decreased blood cell counts, so if fever or symptoms of infection occur, medical attention should be sought immediately. Patients at risk of cerebrovascular diseases should be monitored carefully, as there is also a risk of thromboembolism, so symptoms such as leg pain, swelling, or shortness of breath should be observed during treatment. Patients with cardiovascular disease or hypotension should be especially careful for dizziness or orthostatic hypotension symptoms at the beginning of treatment. Severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported rarely, and if skin rashes, fever, or lymphadenopathy occur, the medication should be discontinued immediately and medical attention sought. This medication may interact with specific drugs, so if you are taking other medications, you should inform your doctor or pharmacist. Women who are pregnant or breastfeeding should consult medical personnel before taking this medication, as it may affect the fetus or newborn. In case of overdose, symptoms such as severe drowsiness, hypotension, and tachycardia may occur requiring immediate emergency treatment. Drowsiness or dizziness may occur during treatment, so caution is advised while driving or operating hazardous machinery. Discontinuing this medication suddenly may lead to withdrawal symptoms, so it is safer to taper off the dosage gradually. It is essential for all patients to consult medical personnel immediately upon experiencing any abnormal symptoms to receive appropriate action.

• 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 closed container to protect it from air and moisture. Additionally, it is important to store the medication in a cool place below 30 degrees Celsius to maintain its effectiveness.

Appearance

White oblong film-coated tablets

Package unit

For domestic use - 30 tablets/bottle, For domestic use - 100 tablets/bottle