Tidefin 25 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, adjust 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. 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 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 200～800 mg/day according to the individual patient's clinical response and 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 before 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 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. Dose increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. For 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 for 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 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 cautiously to elderly patients, particularly at the start of treatment. Elderly patients should begin with 25 mg/day, with gradual increases of 25～50 mg per day; the effective dose in elderly patients may be lower than in younger patients. 5. Patients with renal or hepatic impairment: Clearance after oral administration of quetiapine is reduced by approximately 25% in patients with renal or hepatic impairment. Because 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 begin with 25 mg/day, 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 medication may increase the risk of suicidal thoughts and behavior in children, adolescents, and young adults with major depressive disorder or other psychiatric disorders, so it should be used cautiously under professional judgment. Patients with diabetes or those at risk for diabetes should regularly monitor their blood glucose levels while taking this medication and be adequately educated about the symptoms of hyperglycemia, both for themselves and their families. This medication can rarely cause a serious side effect known as neuroleptic malignant syndrome, so if symptoms such as high fever, muscle rigidity, or changes in mental state occur, they should inform healthcare providers immediately. Prolonged use may lead to extrapyramidal symptoms or tardive dyskinesia, so if unusual symptoms appear, dosage adjustment or discontinuation should be considered. Elderly patients with dementia may have an increased risk of death when using this medication, so extra caution is necessary. Blood-related abnormalities such as severe neutropenia or agranulocytosis may occur, so regular blood tests should be conducted, and treatment should be initiated immediately if any signs of infection appear. Caution is required when administering to patients at risk for cerebrovascular disease, as there may be an increased risk of stroke. There is a risk of venous thromboembolism, so patients with thrombotic risk factors should verify and take preventive measures. Patients with cardiovascular disease or hypotension should be aware of the potential for dizziness or fainting due to orthostatic hypotension during initial administration. Severe skin adverse reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis) may rarely occur, so if symptoms such as skin rash or fever appear, take the medication, stop immediately, and consult a healthcare provider. Patients with hypersensitivity to this medication, those in a comatose state, those taking certain central nervous system depressants, those receiving epinephrine, those with diabetes, and those with lactose intolerance should not use this medication. Patients with impaired liver function should start at a lower dose and closely monitor their condition while adjusting the dosage. Pregnant or nursing women should consult a doctor before use as it may have effects on the fetus or newborn, and during nursing, breastfeeding should be avoided. This medication may cause various side effects such as drowsiness, dizziness, dry mouth, and weight gain, so caution is advised during driving or operating hazardous machinery. Interaction with other medications may occur while taking this medication, so it is essential to inform healthcare providers of any other medications being taken, especially strong liver enzyme inhibitors or central nervous system depressants. Abrupt discontinuation of the medication may lead to withdrawal symptoms or worsening of symptoms, so dosages should be gradually reduced according to a doctor's instructions. In case of overdose, immediate medical attention should be sought, and since there are no specific antidotes, symptom-based supportive care is necessary.

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, somnambulism, constipation, indigestion, vomiting, dysphagia, intestinal obstruction, bowel obstruction, rhinitis, dyspnea, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, leukopenia, hypersensitivity reactions, anaphylactic reactions, blurred vision, pain in limbs, myalgia, rhabdomyolysis, priapism, galactorrhea, increased appetite, mild asthenia, peripheral edema, chest pain, hyperreactivity, fever, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, increased serum liver enzymes, increased eosinophils, increased blood glucose levels to hyperglycemia, increased serum prolactin, thrombocytopenia, increased serum creatine phosphokinase, agranulocytosis, hepatitis, liver failure, urinary retention, urinary disorders, incontinence, abnormal ejaculation, erectile dysfunction, fatigue, increased CK, increased sweating, hyperkalemia, tongue paralysis, decreased sensation, obesity, edema, facial flushing, toothache, facial edema, neck stiffness, skin nodules, pelvic pain, dental diseases, gout, joint pain, arthropathy, bursitis, myasthenia gravis, cramps, exacerbation reactions, accidental injury, ear diseases, taste disturbances, acne, insomnia, anxiety, nervousness, headache, hallucinations, forgetfulness, aggressive reactions, confusion, neurosis, delusions, hypersexuality, emotional instability, agitation, disorientation, abnormal thinking, suicide attempts, personality disorders, manic reactions, euphoria, chorea, migraine, depressive reactions, monologue, impulsive behavior, automatic movement, schizophrenic reactions, ataxia, mental confusion, hostility, akathisia, forward motion, muscle rigidity, salivation, bradykinesia, gait abnormalities, movement disorders, dystonia, abnormal eye movements, slow movements, reduced appetite, nausea, abdominal pain, diarrhea, gastritis, gastrointestinal diseases, hematemesis, rectal diseases, impaired pupil reaction, amblyopia, conjunctivitis, hyperprolactinemia, menstrual irregularities, thyroid diseases, hypercholesterolemia, hyperlipidemia, rash, itching, urinary disorders, incontinence, urinary retention, increased BUN, abnormal ejaculation, erectile dysfunction, thromboembolism, pulmonary embolism, venous thrombosis, acute withdrawal symptoms, nausea, vomiting, insomnia, cramps, paralytic ileus, rhabdomyolysis, myalgia, asthenia, increased CK, increased myoglobin in blood and urine, acute kidney failure, increased suicidal tendencies

This medication should be stored in a tightly closed container to prevent exposure to air and moisture, away from direct sunlight, and in a cool place below 30 degrees Celsius.

Appearance

Pink, round, film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle