Samsung Quetiapine Tablet 300 mg (Quetiapine Fumarate)

Adult dose

1. Schizophrenia - Adults: Take this medicine 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 5 onward, adjust the dose to the usual effective daily dose of 300～400 mg. Depending on the clinical response and tolerability of each patient, 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: Take this medicine twice daily, regardless of meals. Whether used 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 200 mg per day. Depending on the clinical response and tolerability of each patient, 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 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 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 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 during 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 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 starting treatment. Elderly patients should start with 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 : 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 start with 25 mg/day, with gradual increases of 25～50 mg per day until the effective dose is reached.

Child dose

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

This medication is used to treat psychiatric disorders and is particularly prescribed for depression, schizophrenia, and bipolar disorder. During the use of this medication, there may be an increased risk of suicidal thoughts or behaviors; therefore, especially young patients between 18 and 24 years of age require careful monitoring. Blood sugar levels may increase, so patients with diabetes or those at risk for diabetes should periodically check their blood sugar and be aware of symptoms of high blood sugar, such as thirst and frequent urination. A rare condition called neuroleptic malignant syndrome, which is a serious side effect, may occur; in this case, symptoms such as high fever, muscle rigidity, and changes in mental status should be reported to a healthcare professional immediately. With long-term use, extrapyramidal symptoms or tardive dyskinesia may arise, and if abnormal motor symptoms occur, medication adjustments may be necessary. Elderly patients with dementia may have an increased risk of death, so caution is advised in their use. There may be a decrease in blood cell counts, particularly neutropenia and agranulocytosis; thus, if there are signs of infection or fever, consulting with healthcare personnel is essential. Patients with cardiovascular diseases or low blood pressure should be cautious, as this medication can induce orthostatic hypotension, especially during initial doses. Severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reactions have also been reported; if skin rashes or fever occur, immediate discontinuation of the medication and consultation with a physician is advised. This medication should not be administered to patients with specific allergies, those in a comatose state, patients taking central nervous system depressants, patients undergoing epinephrine administration, diabetic patients, and those with lactose intolerance. Patients with liver dysfunction, cardiovascular diseases or cerebrovascular diseases, seizure disorders, elderly patients, pregnant and nursing women should be administered with caution, requiring dosage adjustments and condition monitoring. Common side effects like drowsiness, dizziness, dry mouth, weight gain, changes in blood lipids, etc., may occur and could affect daily life, necessitating caution. This medication acts on the central nervous system, potentially inducing drowsiness or decreased attention, so caution is advised when driving or operating dangerous machinery. In case of overdose, symptoms such as severe hypotension, sedation, tachycardia, etc., may occur, and as there is no specific antidote, immediate medical attention should be sought for appropriate treatment. This medication may interact with other drugs, so if other medications are being taken, it is imperative to inform healthcare professionals, especially when combined with potent hepatic enzyme inhibitors or inducers. Use during pregnancy can affect the fetus, so women who may become pregnant should consult a physician before taking, and nursing mothers are advised to avoid breastfeeding. The safety of this medication in children and adolescents has not been established, so its use in this population is not recommended. Elderly individuals may have a slower metabolism of medications, so starting with a lower dose and closely monitoring their condition is advised.

Drowsiness, dizziness, dry mouth, withdrawal symptoms, increased triglyceride levels, elevated total cholesterol, decreased HDL cholesterol, weight gain, decreased hemoglobin, extrapyramidal symptoms, fainting, neuroleptic malignant syndrome, leukopenia, neutropenia, peripheral edema, speech disorders, seizures, restless legs syndrome, tardive dyskinesia, nightmares, symptoms related to sleepwalking, constipation, dyspepsia, vomiting, difficulty swallowing, intestinal obstruction, bowel obstruction, shortness of breath, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, hypersensitivity reactions, anaphylaxis, blurred vision, pain in the back, myalgia, rhabdomyolysis, priapism, galactorrhea, increased appetite, mild weakness, peripheral edema, chest pain, hyperreactivity, fever, hypothermia, neonatal withdrawal symptoms, elevated serum triglycerides, increased serum liver enzymes, increased eosinophils, elevated blood sugar levels, increased serum prolactin, thrombocytopenia, increased serum creatine phosphokinase, agranulocytosis, hepatitis, liver failure, urinary retention, increased sweating, weight loss, hyperkalemia, tongue paralysis, sensory impairment, obesity, edema, facial flushing, toothache, facial swelling, neck stiffness, skin nodules, pelvic pain, dental diseases, gout, arthralgia, osteoarthritis, bursitis, myasthenia gravis, spasms, exacerbation reactions, accidental injury, ear disorders, dysgeusia, acne, insomnia, anxiety, irritability, headache, hallucinations, forgetfulness, aggressive reactions, confusion, psychosis, delusions, hypersexuality, unstable emotions, agitation, disorientation, abnormal thinking, suicidal attempts, personality disorders, manic reactions, euphoria, chorea, migraines, depressive reactions, monologue, impulsive behavior, automatism, schizophrenic reactions, ataxia, mental confusion, hostility, inability to remain seated, advancing, muscle rigidity, salivation, bradykinesia, gait abnormalities, movement disorders, dystonia, abnormal eye movements, slowed movement, thromboembolism, pulmonary embolism, venous thrombosis, thromboembolism, suicidal tendencies, paralytic ileus, rhabdomyolysis, myalgia, weakness, elevated CK, increased myoglobin levels in blood and urine

This medication should be stored in a tightly sealed container, protected from air and moisture. Additionally, for maintaining its effectiveness, it is important to store it at a cool temperature below 30 degrees Celsius.

Appearance

White rectangular film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle