Izitapine 100 mg Tablet (Quetiapine Fumarate)

Adult dose

Schizophrenia Adults: This medication 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 the dose to the usual effective daily dose of 300～400 mg. The dose may be adjusted within 150～750 mg/day according to the individual patient's clinical response and tolerability. Maintenance therapy has not been evaluated in adults with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance therapy. Acute treatment of manic episodes associated with bipolar I disorder Adults: This medication is taken twice daily, with or without food. As monotherapy or 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, with increases of no more than 200mg per day. The dose may be adjusted within 200～800 mg/day according to the individual patient's clinical response and tolerability; the usual effective daily dose is 400～800 mg. Treatment of depression associated with bipolar disorder Adults: This medication is taken once daily at bedtime, with or without food. The total daily dose for the first 4 days is titrated to 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 medication, 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. For patients who tolerate the medication, clinical trials indicate that the dose may be reduced to a minimum of 200 mg . 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 individual tolerability, the dose administered twice daily may be adjusted within the range of 300～800 mg/day. It is important to use the minimum effective dose for maintenance therapy. Older adults: Start treatment with 25 mg/day of this medication and gradually increase by 25～50 mg per day. The effective dose in older adults may be lower than that in younger patients. Patients with renal or hepatic impairment: Start treatment with 25 mg/day of this medication 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 medication have not been established in children and adolescents.

This medication is mainly used for the treatment of psychiatric disorders, particularly to alleviate symptoms of schizophrenia or bipolar disorder. When taking this medication, there is an increased risk of suicidal thoughts or behaviors, so especially young patients between the ages of 18 and 24 require careful monitoring by a physician. It may affect blood sugar control, so diabetic patients or those at risk of diabetes should have their blood sugar regularly monitored. Severe neurological side effects such as muscle rigidity, high fever, or changes in mental status may occur, and if these symptoms appear, immediate notification to healthcare professionals is necessary. Long-term use may result in involuntary movements or muscle abnormalities, so periodic evaluation is needed. It is recommended not to use this medication in elderly dementia patients, and caution is advised for patients with cardiovascular diseases or hypotension. This medication may cause serious skin reactions, so if symptoms such as skin rash or fever occur, discontinue use immediately and consult a physician. Interactions may occur when used in conjunction with certain diseases or medications, so it's essential to inform about any current medications being taken, and use with alcohol should be avoided. Pregnant or breastfeeding women must consult a physician before using this medication, and it is not recommended for children or adolescents as safety has not been established. In case of overdose, severe drowsiness, hypotension, and heart problems may occur, necessitating immediate emergency treatment. During the use of this medication, caution should be exercised when driving or operating dangerous machinery, and doses should not be stopped abruptly but gradually reduced according to the doctor's instructions. Store in a place out of reach of children, and it is advised not to transfer to other containers for storage.

Drowsiness, dizziness, dry mouth, withdrawal symptoms, increased triglyceride levels, total cholesterol increase, decreased HDL cholesterol, weight gain, decreased hemoglobin, extrapyramidal symptoms, syncope, neuroleptic malignant syndrome, leukopenia, neutropenia, peripheral edema, speech disorders, seizures, restless legs syndrome, tardive dyskinesia, nightmares, sleepwalking, constipation, dyspepsia, vomiting, dysphagia, intestinal obstruction, rhinitis, dyspnea, tachycardia, palpitations, bradycardia, orthostatic hypotension, hypertension, leukopenia, hypersensitivity reactions, anaphylaxis, blurred vision, pain in the back, myalgia, rhabdomyolysis, priapism, galactorrhea, increased appetite, mild asthenia, peripheral edema, chest pain, hyperreactivity, fever, hypothermia, increased serum triglycerides, increased serum enzymes, increased serum creatine phosphokinase, thrombocytopenia, increased serum prolactin, insomnia, anxiety, nervousness, headache, hallucinations, forgetfulness, aggressive reactions, confusion, neurosis, delusions, hypersexuality, emotional instability, agitation, disorientation, abnormal thoughts, suicide attempts, personality disorders, manic reactions, euphoria, chorea, migraine, depressive reactions, monologue, impulsive behavior, automatic movement, psychotic reactions, ataxia, delirium, hostility, akathisia, forward movement, muscle rigidity, salivation, bradykinesia, gait abnormalities, movement disorders, dystonia, abnormal eye movements, slowed movement, granulocytopenia, eosinophilia, anemia, thrombocytopenia, rash, itching, urination disorders, urinary incontinence, urinary retention, ejaculation disorders, erectile dysfunction, lethargy, increased CK, increased sweating, weight loss, hyperkalemia, tongue paralysis, sensory impairment, obesity, edema, facial flushing, toothache, facial edema, neck stiffness, skin nodules, overdose, pelvic pain, dental disease, gout, arthralgia, arthrosis, bursitis, myasthenia gravis, cramps, exacerbation reactions, accidental injury, ear disease, taste disorders, acne, thromboembolism, paralytic ileus, rhabdomyolysis, acute renal failure, neonatal withdrawal symptoms, recurrence of neuroleptic malignant syndrome, increased suicidal tendencies

This medication should be stored in a sealed container to protect it from air and moisture, and it is important to keep it in a cool place below 30 degrees Celsius. This storage maintains the medication's efficacy and prevents deterioration.

Appearance

Yellow round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle