Quetiapine Tablets 50 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. 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 regularly reassessed 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 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 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: Take this medicine once daily at 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 were administered as follows: 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. The recommended daily dose is 300 mg. Antidepressant effects were 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. In patients who tolerate the medicine, clinical trials indicate 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 the range of 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 with caution to elderly patients, particularly when initiating treatment. Start elderly patients at 25 mg/day and gradually increase by 25～50 mg daily; the effective dose in elderly patients may be lower than that in younger patients. 5. Patients with renal or hepatic impairment: The 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. In patients with renal or hepatic impairment, start this medicine at 25 mg/day and gradually increase by 25～50 mg daily to the effective dose.

Child dose

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

This medication is mainly used for the treatment of psychiatric disorders, and it is essential to adhere to various precautions during its use. Firstly, there may be an increase in suicidal thoughts or behaviors while taking this medication, thus caution must be exercised in administering it to children, adolescents, and young adults, and both patients and their families should observe symptoms closely. Furthermore, blood sugar levels may rise or diabetes may worsen; hence, patients with diabetes or risk factors should undergo regular blood sugar tests. Rarely, serious adverse effects such as Neuroleptic Malignant Syndrome may occur, and if symptoms such as high fever, muscle rigidity, or altered consciousness arise, immediate consultation with a medical professional is necessary. Long-term use may lead to tardive dyskinesia, which can cause movement abnormalities, so changes in symptoms should be monitored. Increased risk of death in dementia patients has been noted, hence the use of this medication is not recommended for them. It may also cause severe neutropenia or agranulocytosis, resulting in a sharply reduced white blood cell count, requiring regular blood tests. Patients with an increased risk of cerebrovascular disease or venous thromboembolism should be particularly cautious when using this medication. Patients with cardiovascular diseases or hypotension may experience dizziness or orthostatic hypotension; hence, dosage adjustment and monitoring are crucial. Severe skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may manifest; if symptoms such as a rash or fever occur, discontinue use immediately and consult a medical professional. This medication is not administered to patients with specific conditions or statuses, such as those in a comatose state, those taking certain central nervous system depressants, patients receiving epinephrine, or lactose intolerant patients. Caution should be exercised in administering this medication to patients with impaired liver function, cardiovascular conditions, a history of seizures, the elderly, and pregnant or breastfeeding women; their conditions should be carefully monitored during administration. This medication may cause common side effects such as drowsiness, dizziness, and dry mouth, necessitating caution when driving or operating hazardous machinery. Moreover, there are numerous interactions with other medications, particularly those affecting the central nervous system, CYP3A4 inhibitors, and serotonin-related drugs, so caution is advised when co-administering. During pregnancy, this medication may affect the fetus and should only be administered when absolutely necessary. It is advised that nursing mothers avoid breastfeeding while on this medication. Abrupt discontinuation of the medication may lead to withdrawal symptoms or worsening of symptoms; therefore, it should be tapered down gradually. In the case of overdose, immediate medical attention is necessary for proper treatment, as there is no specific antidote available. Lastly, this medication is not recommended for use in children and adolescents due to the lack of established safety and efficacy.

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 impairment, seizures, restless legs syndrome, tardive dyskinesia, nightmares, sleepwalking, dry mouth, constipation, indigestion, vomiting, dysphagia, intestinal obstruction, bowel obstruction, dyspnea, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, leukopenia, hypersensitivity reactions, anaphylaxis, blurred vision, pain in the back, myalgia, rhabdomyolysis, persistent erection, galactorrhea, increased appetite, mild asthenia, peripheral edema, chest pain, hypersensitivity, fever, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, increased total cholesterol, decreased HDL cholesterol, weight gain, decreased hemoglobin, increased serum liver enzymes, decreased neutrophil count, increased eosinophil count, increased blood sugar levels to hyperglycemic levels, increased serum prolactin, thrombocytopenia, agranulocytosis, hepatitis, liver failure, urinary retention, constipation, decreased appetite, nausea, vomiting, abdominal pain, bowel obstruction, diarrhea, indigestion, abdominal distension, gastritis, gastrointestinal disorders, hematemesis, rectal disorders, pupillary reflex impairment, amblyopia, conjunctivitis, hyperprolactinemia, menstrual irregularities, thyroid disorders, hypercholesterolemia, hyperlipidemia, rash, itching, urination disorders, urinary incontinence, urinary retention, increased BUN, abnormalities in ejaculation, erectile dysfunction, lethargy, increased CK, increased sweating, weight loss, hyperkalemia, tongue paralysis, sensory loss, obesity, edema, facial flushing, toothache, facial edema, neck stiffness, skin nodules, pelvic pain, dental diseases, gout, arthralgia, osteoarthritis, bursitis, myasthenia gravis, spasms, exacerbation reactions, accidental injuries, ear disorders, taste disturbances, acne, insomnia, anxiety, nervousness, headache, hallucinations, memory loss, aggressive responses, confusion, psychoneurosis, delusions, hypersexuality, emotional instability, agitation, confusion, abnormal thoughts, increased suicidal tendencies, personality disorders, manic responses, intoxication, chorea-acanthocytosis, migraine, depressive reactions, soliloquy, impulsive behavior, automatism, schizophrenia-like responses, ataxia, mental confusion, hostility, inability to sit still, advancing, muscle rigidity, salivation, bradykinesia, gait abnormalities, movement disorders, muscle tone disorders, oculomotor abnormalities, slow movements, thromboembolism, pulmonary thromboembolism, venous thromboembolism, thromboembolism, increased suicidal tendencies, paralytic ileus, rhabdomyolysis, acute renal failure, withdrawal symptoms, neuroleptic malignant syndrome, hypothermia, neonatal withdrawal symptoms

This medication should be stored in a tightly sealed container as it may be sensitive to air or moisture. To maintain the drug's efficacy, it should be stored at a cool temperature below 30 degrees Celsius.

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 200 tablets/bottle