Seroafin Tablet 100 mg (Quetiapine Fumarate)

Adult dose

1. Schizophrenia Adults: This medicine is taken 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, 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 regularly reassessed to determine whether maintenance therapy is needed. 2. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: Adults: This medicine is taken twice daily, regardless of meals. 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; 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, 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 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 have shown 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. 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 antipsychotics, this medicine should be administered with caution to elderly patients, particularly when starting 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: 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 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 an effective dose is reached.

Child dose

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

This medication can increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults with major depressive disorder or psychiatric conditions; therefore, a physician should carefully assess its necessity. This medication may raise blood sugar levels, so diabetic patients or those at risk for diabetes should have regular blood sugar checks for management and should closely monitor for symptoms of hyperglycemia such as thirst and frequent urination. Rarely during treatment, Neuroleptic Malignant Syndrome can occur, characterized by severe muscle rigidity, high fever, and changes in mental status. If abnormal symptoms occur, consult a healthcare professional immediately. Long-term use may lead to tardive dyskinesia, which involves involuntary movements of the face or mouth; if such symptoms are observed, dosage adjustment or discontinuation should be considered. Careful monitoring is required if this drug is used in elderly patients with dementia as there may be an increased risk of mortality. This medication can lower white blood cell counts, increasing the risk of infection, so patients with low white blood cell counts should discontinue use and be vigilant for infection symptoms. When prescribed to patients at risk for cerebrovascular diseases, careful consideration should be given to the potential increased risk of stroke and related conditions. This drug can increase the risk of venous thromboembolism, so patients with thrombotic risk factors should take preventive measures and notify healthcare professionals immediately if symptoms develop. Patients with cardiovascular diseases or hypotension may experience orthostatic hypotension, particularly during dosage adjustments, and should be monitored closely while gradually increasing the dose. Severe skin reactions, fever, and lymphadenopathy can occur; if these symptoms arise, discontinue use and consult a physician immediately. This medication should not be given to patients with allergies to specific components, in a coma, on certain central nervous system depressants, receiving epinephrine, diabetic patients, or those with lactose intolerance. Patients with liver function impairments or at risk for cardiovascular diseases, cerebrovascular diseases, or hypotension should start on a low dose and closely monitor their condition for dosage adjustments. Women who are pregnant or breastfeeding must be cautious due to potential risks to the fetus or newborn and should avoid breastfeeding during treatment as recommended by their physician. This medication can cause drowsiness, dizziness, and reduced attention, so patients should avoid driving or operating hazardous machinery while taking it. Suddenly stopping this medication may result in withdrawal symptoms or worsening of symptoms; thus doses should be gradually reduced according to a physician's instructions. Caution is needed when taken with other central nervous system medications or alcohol as effects may be enhanced, and interactions may occur with certain antifungals, antibiotics, and other medications, requiring consultation with a physician.

Drowsiness, dizziness, dry mouth, withdrawal symptoms, increased triglyceride levels, increased total cholesterol, decreased HDL cholesterol, weight gain, decreased hemoglobin, extrapyramidal symptoms, syncope, neuroleptic malignant syndrome, leukopenia, neutropenia, peripheral edema, dysarthria, seizures, restless legs syndrome, tardive dyskinesia, nightmares, sleepwalking, constipation, indigestion, vomiting, difficulty swallowing, intestinal obstruction, rhinitis, dyspnea, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, leukopenia, hypersensitivity reaction, anaphylaxis, blurred vision, pain in various areas, myalgia, rhabdomyolysis, persistent erection, galactorrhea, increased appetite, mild weakness, peripheral edema, chest pain, hypersensitivity, fever, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, increased serum liver enzymes, increased blood creatine phosphokinase, thrombocytopenia, increased serum prolactin, insomnia, anxiety, nervousness, headache, hallucinations, forgetfulness, aggressive response, confusion, neurosis, delusions, hypersexuality, unstable emotions, agitation, disorientation, abnormal thoughts, suicide attempts, personality disorders, manic reactions, intoxication, chorea-acanthocytosis, migraine, depressive reactions, monologue, impulsive behavior, automatic movements, schizoid reactions, ataxia, mental confusion, hostility, akathisia, progressive movements, muscle rigidity, saliva secretion, bradykinesia, abnormal gait, movement disorders, dystonia, oculomotor abnormalities, slow movements, granulocytopenia, eosinophilia, anemia, thrombocytopenia, difficulty expectorating, increased cough, loss of appetite, abdominal pain, diarrhea, gastritis, gastrointestinal disorders, hematemesis, rectal diseases, optic reflex impairment, amblyopia, conjunctivitis, hyperprolactinemia, menstrual irregularities, thyroid disorders, hypercholesterolemia, hyperlipidemia, rash, itching, urination disorders, urinary incontinence, urinary retention, increased BUN, ejaculation abnormalities, erectile dysfunction, lethargy, increased CK, increased sweating, weight loss, hyperkalemia, tongue paralysis, sensory loss, obesity, edema, facial flushing, toothache, facial edema, neck stiffness, skin nodules, overdose, pelvic pain, dental diseases, gout, arthralgia, arthritis, bursitis, myasthenia gravis, spasms, worsening responses, accidental injury, ear diseases, dysgeusia, acne, thromboembolism, paralytic ileus, rhabdomyolysis, acute renal failure, suicidal tendencies, suicidal impulses, suicidal behaviors, suicide attempts, increased suicidal tendencies, onset of suicidal tendencies, prodromal symptoms of suicidal tendencies, suicide attempts, suicidal ideation, suicidal impulses, suicidal behaviors, increased risk of suicidal tendencies, acute withdrawal symptoms, nausea, vomiting, insomnia, recurrence of psychotic symptoms, emergency involuntary movement disorders, akathisia, isoform disorders, movement disorders

This medication should be stored in a well-sealed container to prevent moisture and air exposure, kept in a cool place away from direct sunlight, ideally below 30 degrees Celsius. Storing it this way will help maintain the medication's efficacy and prevent degradation.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle