Serokel Tablet 25 mg (Quetiapine Fumarate)

Adult dose

Adults: Take this medicine twice daily, regardless of meals. 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 dose of 300～400 mg daily. The dose may be adjusted within 150～750 mg/day according to each patient's clinical response and tolerability. Adults: Take this medicine twice daily, regardless of meals. 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 tolerability; the usual effective daily dose is 400～800 mg. Adults: Take this medicine once daily at bedtime, regardless of meals. 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 therapeutic 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. Increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. Clinical trials showed that the dose could be reduced to as low as 200 mg in patients who tolerate the medicine. Adults: Maintain 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 lowest effective dose for maintenance therapy. For older patients, initiate treatment with 25 mg/day and gradually increase by 25～50 mg per day; the effective dose in older adults may be lower than in younger patients. For patients with renal or hepatic impairment, initiate treatment with 25 mg/day and gradually increase by 25～50 mg per day to the effective dose.

Child dose

The safety and efficacy of this medication in children and adolescents have not been established.

This medication may increase the risk of suicidal thoughts or behavior when administered to children, adolescents, or young adults with depression or psychiatric disorders; hence, a careful assessment by a physician is required. Blood sugar levels may increase during the administration of this drug, and patients with diabetes or those at risk for hyperglycemia should have their blood sugar checked periodically. Severe side effects such as neuroleptic malignant syndrome may occur, requiring immediate treatment if symptoms such as high fever, muscle rigidity, or changes in mental state arise. Long-term use may result in extrapyramidal symptoms or tardive dyskinesia, so if symptoms appear, dose adjustment or discontinuation should be considered. It is advisable not to use this medication in elderly patients with dementia, as there is an increased risk of death associated with its use. Blood dyscrasias like agranulocytosis and neutropenia may occur rarely, thus regular monitoring of white blood cell counts is necessary. There is an increased risk of vascular events such as strokes when used in patients with a risk of cerebrovascular disease; caution is advised. Due to the risk of venous thromboembolism, patients with thrombotic risk factors should be assessed and preventive measures taken before and during treatment. Patients with cardiovascular diseases or hypotension may experience orthostatic hypotension during initial dosing; thus, careful monitoring is required. Severe skin adverse reactions (such as Stevens-Johnson syndrome and toxic epidermal necrolysis) may occur, and if symptoms like skin rash or fever present, drug discontinuation is immediate. This drug should not be administered to patients with hypersensitivity to its components, those in a coma, those on central nervous system depressants, those receiving epinephrine, diabetic patients, and those with lactose intolerance. Patients with impaired liver function, cardiovascular diseases or risks of hypotension, seizure disorders, elderly patients, those at risk of suicide, pregnant and nursing women require particular caution during administration. This medication may cause various side effects like drowsiness, dizziness, dry mouth, weight gain, dyslipidemia, extrapyramidal symptoms, speech disorders, seizures, restless leg syndrome, tardive dyskinesia, syncope, nightmares, sleepwalking, constipation, dyspepsia, vomiting, dysphagia, rhinitis, shortness of breath, tachycardia, palpitations, bradycardia, orthostatic hypotension, hypertension, leukopenia, hypersensitivity reactions, blurred vision, etc. During administration, activities requiring alertness such as driving or operating machinery should be approached with caution, and caution is advised when taken with alcohol or other central nervous system depressants. Women who are pregnant or may become pregnant should consult a physician before taking this medication, as it may affect the fetus; breastfeeding women are advised to avoid nursing. In cases of overdose, severe drowsiness, hypotension, anticholinergic effects, etc., may present; immediate medical attention is required for appropriate treatment. This medication should be kept out of the reach of children and not be transferred to other containers.

• Suicidal impulses
• suicidal tendencies
• hyperglycemia
• diabetic ketoacidosis
• diabetic coma
• aberrant high fever
• changes in mental state
• muscle rigidity
• autonomic dysregulation
• increased creatine phosphokinase

Store this medication in a sealed container to prevent air and moisture ingress, preferably in a cool place below 30 degrees Celsius. This will help maintain the effectiveness of the medication for a longer time.

Appearance

Pink, round, film-coated tablet

Package unit

30 tablets (10 tablets/PTP x 3)