Quetiapine Tablets 12.5 mg (Quetiapine Fumarate)

Adult dose

Schizophrenia Adults: This product 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 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 150～750 mg/day. Maintenance therapy has not been evaluated in adult patients with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance therapy. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: Adults: This product 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, 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 200～800 mg/day; the usual effective daily dose is 400～800 mg. (2) Treatment of depression associated with bipolar disorder: Adults: This product 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 product, 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. In patients who tolerate the medication, reduction to as low as 200 mg has been shown to be possible in clinical trials. (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 twice-daily dose may be adjusted within the range of 300～800 mg/day. It is important to use the minimum effective dose for maintenance therapy. Elderly patients As with other antipsychotics, this product should be administered with caution to elderly patients, especially at the start of treatment. Elderly patients should start at 25 mg/day and have their dose gradually increased by 25～50 mg per day. The effective dose in elderly patients may be lower than that in younger patients. Patients with renal or hepatic impairment Clearance after oral administration of quetiapine 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 at 25 mg/day and have their dose gradually increased by 25～50 mg per day to the effective dose.

Child dose

Children and adolescents: The safety and efficacy of this product have not been established in children and adolescents.

This medication may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults, so caution is advised when prescribing it. Especially for patients aged 18 to 24, physicians should carefully evaluate the risks and benefits. This drug can raise blood sugar levels, therefore diabetic patients or those at risk for diabetes should have their blood glucose levels regularly monitored and symptoms observed. Rarely, a serious side effect called Neuroleptic Malignant Syndrome may occur, so if high fever, muscle rigidity, or changes in mental state arise, immediate medical attention is required. Long-term use may lead to extrapyramidal symptoms or tardive dyskinesia, so consultation with a physician should be sought if such symptoms develop. The use of this medication is not recommended for elderly patients with dementia due to an increased risk of death. Severe neutropenia and agranulocytosis may occur, thus white blood cell counts should be monitored regularly, and treatment should be sought immediately if infection symptoms arise. Patients with cerebrovascular disease or cardiovascular disease may be at an increased risk of stroke while using this medication, hence particular attention is required. There is a risk of venous thromboembolism; therefore, patients with thromboembolic risk factors should be carefully monitored before and during treatment. Orthostatic hypotension may occur, necessitating dosage adjustment if dizziness or fainting symptoms present. This drug acts on the central nervous system and may cause drowsiness or dizziness; caution is advised during driving or operating hazardous machinery. Pregnant or nursing women should consult their doctor about using this medication, as it may affect the fetus or newborn. Abrupt discontinuation may lead to withdrawal symptoms or worsening of symptoms, thus the dosage should be gradually decreased. This medication may interact with other drugs, so inform your physician or pharmacist if there are any concomitant medications, especially with central nervous system depressants or CYP3A4 inhibitors. Serious allergic reactions may occur, so if rash, fever, lymphadenopathy, or other symptoms present, discontinue use immediately and consult medical personnel. In case of overdose, severe drowsiness, hypotension, and anticholinergic side effects may occur, requiring immediate emergency treatment.

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, symptoms related to sleepwalking, constipation, indigestion, vomiting, dysphagia, bowel obstruction, bowel occlusion, rhinitis, respiratory distress, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, hypersensitivity reactions, anaphylactic reactions, blurred vision, pain in the back, 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 (ALT), increased γ-GT, increased blood creatine phosphokinase, thrombocytopenia, increased serum prolactin, insomnia, anxiety, nervousness, headache, hallucinations, forgetfulness, aggressive behavior, confusion, psychosis, delusions, hypersexuality, unstable emotions, agitation, disorientation, abnormal thoughts, suicidal attempts, personality disorders, manic reactions, intoxication, chorea-acanthocytosis, migraines, depressive reactions, monologue, impulsive behavior, automatism, schizoid reactions, ataxia, mental confusion, hostility, akathisia, protrusion, muscle rigidity, salivation, bradykinesia, gait abnormalities, movement disorders, dystonia, oculomotor abnormalities, slowed movements, agranulocytosis, eosinophilia, anemia, thrombocytopenia, rash, itching, urinary disorders, incontinence, urinary retention, abnormal ejaculation, erectile dysfunction, lethargy, increased CK, increased sweating, weight loss, hyperkalemia, tongue paralysis, sensory reduction, obesity, edema, facial flushing, toothache, facial edema, neck stiffness, skin nodules, overdose, pelvic pain, dental disorders, gout, arthralgia, osteoarthritis, bursitis, myasthenia gravis, cramps, exacerbation reactions, accidental injury, ear disorders, dysgeusia, acne, thrombosis, paralytic ileus, rhabdomyolysis, acute renal failure, hyperglycemia, worsening diabetes, increased suicidal tendencies, recurrence of neuroleptic malignant syndrome, acute withdrawal symptoms, serotonin syndrome

Store this medication in a sealed container to protect it from air and moisture. It is advisable to maintain the storage temperature between 1 and 30 degrees Celsius.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle