SINSIN Quetiapine Tablets 25 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, the dose should be adjusted to the usual effective daily dose of 300～400 mg. Depending on the individual 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 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, with or without food. 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 the individual 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, 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. An antidepressant effect was 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. 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 individual 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. 3. Elderly patients As with other antipsychotics, this medicine should be administered with caution to elderly patients, particularly when initiating treatment. Elderly patients should start this medicine at 25 mg/day, 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 The clearance of quetiapine after oral administration 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 this medicine at 25 mg/day, with gradual increases of 25～50 mg per day until the 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 suicide in young people with depression or psychiatric disorders; therefore, physicians should carefully assess the need for treatment and associated risks. It is not approved for use in children and adolescents, and families and caregivers should closely observe for changes in suicidal thoughts or behaviors during treatment. This medication may increase blood sugar levels, thus diabetic patients or those at risk for diabetes should regularly monitor their blood sugar and observe symptoms. Symptoms of hyperglycemia include thirst, frequent urination, and fatigue, and if such symptoms occur, medical advice should be sought immediately. Neuroleptic malignant syndrome is a serious side effect that may occur rarely, and if symptoms such as high fever, muscle rigidity, or altered consciousness appear, immediate treatment must be sought. Long-term use may result in extrapyramidal symptoms or tardive dyskinesia, so dosage adjustment or discontinuation should be considered if symptoms occur. The use of this medication is not recommended for elderly patients with dementia, as it may increase the risk of mortality. Severe blood abnormalities such as agranulocytosis or neutropenia may occur, thus regular monitoring of white blood cell counts is necessary, and immediate treatment is required for any signs of infection. Patients at risk for cerebrovascular disease should use this medication with particular caution, as there is also a risk of thrombosis; prompt action is necessary upon the onset of related symptoms. Patients with cardiovascular diseases or hypotension may experience dizziness or hypotension symptoms during initial dosing and should be closely monitored. Severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur, and if symptoms such as rash or fever appear, discontinuation of the medication should be immediate. This medication should not be administered to patients with specific illnesses or who are on certain medications, and in patients with liver dysfunction or the elderly, low doses should be started and monitoring should occur before increasing the dosage. Pregnant or breastfeeding women should consult their physician before taking this medication, as it may affect the fetus or newborn; particularly, in the third trimester of pregnancy, neonatal withdrawal symptoms may occur. This medication may commonly cause side effects such as drowsiness, dizziness, and dry mouth, so caution is warranted when driving or operating hazardous machinery. In case of drug overdose, there is no specific antidote; immediate medical attention should be sought, and it should not be combined with drugs like epinephrine. During the use of this medication, it is safest not to use alcohol or central nervous system depressants, and there may be interactions with other medications, thus one must inform the physician of any other medications being taken.

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, dyspepsia, vomiting, dysphagia, intestinal obstruction, bowel obstruction, dyspnea, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, hypersensitivity reactions, anaphylactic reaction, blurred vision, body pain, myalgia, rhabdomyolysis, priapism, galactorrhea, increased appetite, mild asthenia, peripheral edema, chest pain, hypersensitivity, fever, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, increased serum liver enzymes, increased eosinophils, elevated blood glucose levels, increased serum prolactin, thrombocytopenia, increased serum creatine phosphokinase, agranulocytosis, hepatitis, liver failure, urinary retention, cutaneous vasculitis, DRESS, rash, itching, dysuria, urinary incontinence, increased BUN, abnormal ejaculation, erectile dysfunction, fatigue, increased CK, increased sweating, weight loss, hyperkalemia, tongue paralysis, sensory impairment, obesity, edema, facial flushing, toothache, facial edema, neck stiffness, skin nodules, pelvic pain, dental disorders, gout, arthralgia, osteoarthritis, bursitis, myasthenia, convulsion, exacerbation reactions, accidental injuries, ear disorders, taste disturbances, acne, insomnia, anxiety, nervousness, headache, hallucinations, forgetfulness, aggressive reactions, confusion, psychosis, delusions, increased libido, emotional instability, agitation, confusion, abnormal thinking, suicide attempts, personality disorders, manic reactions, euphoria, chorea, migraine, depressive reactions, soliloquy, impulsive behavior, automatism, schizophrenia-like reactions, ataxia, mental confusion, hostility, inability to sit still, forward movement, muscle rigidity, salivation, bradykinesia, gait abnormalities, movement disorders, dystonia, abnormal eye movements, slow movements, anorexia, nausea, abdominal pain, diarrhea, abdominal distension, gastritis, gastrointestinal disorders, hematemesis, rectal disorders, damage to pupillary reflex, amblyopia, conjunctivitis, hyperprolactinemia, decreased T4, menstrual irregularities, thyroid disorders, hypercholesterolemia, dyslipidemia, decreased T3, dysuria, urinary incontinence, urinary retention, increased BUN, abnormal ejaculation, erectile dysfunction, fatigue, increased CK, increased sweating, weight loss, hyperkalemia, tongue paralysis, sensory impairment, obesity, edema, facial flushing, toothache, facial edema, neck stiffness, skin nodules, pelvic pain, dental disorders, gout, arthralgia, osteoarthritis, bursitis, myasthenia, convulsion, exacerbation reactions, accidental injuries, ear disorders, taste disturbances, acne, thromboembolism, increased suicidal tendencies, paralytic ileus, rhabdomyolysis, acute kidney failure, recurrence of neuroleptic malignant syndrome, acute withdrawal syndrome, serotonin syndrome, sleep apnea syndrome

This medication must be stored in a tightly closed container to protect it from air and moisture. It is also best stored at a cool temperature below 30 degrees Celsius.

Appearance

Pink round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle