Quetiapine Tablet 12.5 mg (Quetiapine Fumarate)

Adult dose

Schizophrenia - Adults: Take this medicine 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 drug 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. Acute treatment of manic episodes associated with bipolar I disorder - Adults: Take this medicine twice daily, with or without food. As monotherapy or as adjunctive therapy with 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 drug tolerability, the dose may be adjusted within 200～800 mg/day; the usual effective daily dose is 400～800 mg. Treatment of depression associated with bipolar disorder - Adults: Take this medicine once daily at bedtime, with or without food. The total daily dose 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. In patients who tolerate the medicine, clinical trial data indicate that the dose may be reduced to as low as 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 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 a range of 300～800 mg/day, administered twice daily. It is important to use the minimum effective dose for maintenance therapy. Older adults: As with other antipsychotics, this medicine should be administered with caution to older adults, particularly when initiating treatment. Older patients should start at 25 mg/day and have the dose gradually increased by 25～50 mg per day; the effective dose in older adults may be lower than in younger patients. Patients with renal or hepatic impairment: Oral clearance of quetiapine is reduced by approximately 25% in patients with renal or hepatic impairment. Since quetiapine is primarily metabolized in the liver, administer with caution to patients with known hepatic impairment. Patients with renal or hepatic impairment should start at 25 mg/day, with the dose gradually increased by 25～50 mg per day to the effective dose.

Child dose

The safety and efficacy in pediatric and adolescent populations have not been established.

This drug is mainly used for the treatment of mental disorders, including depression, schizophrenia, and bipolar disorder. During the use of this drug, there may be an increase in suicidal thoughts or behaviors, particularly in young patients aged 18 to 24, who should be closely monitored. Furthermore, this medication can elevate blood sugar levels, so patients with diabetes or those at risk for diabetes should regularly monitor their blood glucose levels. Rarely, severe muscle rigidity and high fever may occur and could indicate neuroleptic malignant syndrome; if any unusual symptoms arise, immediate consultation with healthcare professionals is required. Long-term use may lead to extrapyramidal symptoms or tardive dyskinesia, such as involuntary movements of the face or extremities; if these symptoms occur, patients should discuss with their doctor. For elderly patients with dementia, there may be an increased risk of death, and this medication is not recommended for use. Severe neutropenia or agranulocytosis has been rarely reported; if symptoms of infection occur, the hospital must be notified immediately. Patients at risk for cerebrovascular disease may have an increased risk of stroke when using this medication, necessitating caution. This medication may increase the risk of thrombosis, and patients with thrombotic risk factors should be carefully monitored before and after administration. Patients with cardiovascular disease or hypotension may experience dizziness or fainting due to orthostatic hypotension, requiring careful dosage adjustment and monitoring. Serious skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may occur; if symptoms like skin rash or fever appear, patients should immediately discontinue the medication and consult a healthcare professional. This medication is not to be administered to patients with specific allergies, comatose states, those taking central nervous system depressants, those receiving epinephrine, diabetic patients, or those with lactose intolerance. Patients with impaired liver function, cardiovascular diseases, a history of seizures, elderly patients, those at risk of suicide, as well as pregnant or breastfeeding women should be administered with caution and closely monitored during treatment. Common adverse reactions during treatment can include drowsiness, dizziness, dry mouth, weight gain, changes in blood lipids and glucose levels, among others; if these symptoms are severe, patients should consult their doctor. This medication acts on the central nervous system and may induce drowsiness or decreased attention; caution is necessary when driving or operating dangerous machinery. Taking this medication during pregnancy may affect the fetus, and withdrawal symptoms may occur in newborns after birth; therefore, pregnant women should consult with a doctor before use. Breastfeeding women are advised to avoid breastfeeding while using this medication, as it may be transmitted through breast milk. Sudden discontinuation of this medication can lead to withdrawal symptoms; therefore, if discontinuing, the dosage should be reduced gradually as per the doctor's instructions. In the event of an overdose, immediate medical attention is required, and there is no specific antidote for this medication. When storing this drug, keep it out of reach of children and avoid transferring it to other containers.

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, speech disorders, seizures, restless legs syndrome, tardive dyskinesia, nightmares, sleepwalking, constipation, indigestion, vomiting, dysphagia, intestinal obstruction, intestinal occlusion, rhinitis, respiratory distress, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, leukopenia, hypersensitivity reactions, anaphylaxis, blurred vision, pain in limbs, myalgia, rhabdomyolysis, priapism, galactorrhea, increased appetite, mild weakness, chest pain, hyperreactivity, fever, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, increased serum enzyme levels, increased eosinophils, increased blood sugar levels to hyperglycemia, increased serum prolactin, thrombocytopenia, increased serum creatine phosphokinase, agranulocytosis, hepatitis, liver failure, urinary retention, urination disorders, incontinence, ejaculation disorders, erectile dysfunction, fatigue, increased CK, increased sweating, weight loss, hyperkalemia, tongue paralysis, sensory loss, obesity, edema, facial flushing, toothache, facial swelling, neck stiffness, skin nodules, pelvic pain, dental diseases, gout, arthralgia, arthritis, bursitis, myasthenia gravis, spasms, adverse reactions, accidental injuries, ear diseases, dysgeusia, acne, insomnia, anxiety, irritability, headache, hallucinations, forgetfulness, aggressive reactions, stupor, neurosis, delusions, hypersexuality, emotional instability, agitation, confusion, abnormal thoughts, suicidal attempts, personality disorders, manic reactions, euphoria, chorea, migraine, depressive reactions, soliloquy, impulsive behavior, automatism, schizophrenia-like reactions, ataxia, delirium, hostility, inability to sit still, forward movement, muscle rigidity, salivation, bradykinesia, gait abnormalities, dyskinesia, dystonia, abnormal eye movements, slow movements, loss of appetite, nausea, abdominal pain, diarrhea, gastritis, gastrointestinal diseases, hematemesis, rectal diseases, pupillary reflex damage, amblyopia, conjunctivitis, hyperprolactinemia, decreased T4, menstrual disorders, thyroid diseases, hypercholesterolemia, hyperlipidemia, rash, itching, urination disorders, incontinence, urinary retention, increased BUN, ejaculation disorders, erectile dysfunction, thromboembolism, paralytic ileus, rhabdomyolysis, acute renal failure, increased suicidal tendencies, withdrawal symptoms, insomnia, nausea, headache, diarrhea, hyperreactivity, anxiety, restlessness, panic disorders, excitement, hostility, aggression, impulsivity, hypomania, mania, serotonin syndrome, acute withdrawal symptoms, nausea, vomiting, recurrence of psychotic symptoms, emergency involuntary movement disorders, sleep apnea syndrome, pancreatitis

This medication may be sensitive to air or moisture, so it should be stored in a well-sealed container. It is advisable to keep it at room temperature between 1 to 30 degrees Celsius, avoiding extremes of heat or cold.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle, 200 tablets/bottle