Hanwha Quetiapine Tablets 200 mg (Quetiapine Fumarate)

Adult dose

1. 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 the dose 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: Take this medicine 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, with increases of no more than 200 mg 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, 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. 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 have shown that the dose may be reduced to as low as 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 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 at the start of treatment. Treatment in elderly patients should be initiated 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 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. Treatment in patients with renal or hepatic impairment should be initiated at 25 mg/day, with gradual increases of 25～50 mg per day until an effective dose is reached.

Child dose

The safety and efficacy of this drug have not been established in children and adolescents.

This medication may increase the risk of suicidal thoughts or behavior in children, adolescents, and young adults with major depressive disorder or psychiatric illnesses; therefore, doctors should be consulted beforehand, and careful observation is required. It may raise blood sugar levels in some patients, potentially worsening diabetes or hyperglycemic conditions. Regular blood sugar monitoring is essential for diabetic patients or those with risk factors for diabetes, along with careful observation for symptoms. A rare but serious side effect known as neuroleptic malignant syndrome may occur, and if symptoms such as high fever, muscle rigidity, or changes in mental status arise, immediate medical attention is necessary. Prolonged use may lead to extrapyramidal symptoms or tardive dyskinesia, so if any abnormal symptoms occur, consider consulting a doctor for dosage adjustment or discontinuation. Use in elderly patients with dementia is not recommended, as it may increase the risk of mortality, thus requiring special caution. Serious blood-related side effects such as agranulocytosis or leukopenia may occur; hence, white blood cell counts should be monitored regularly, and if signs of infection appear, immediatly notify healthcare professionals. Patients with a risk of cerebrovascular disease should use this medication cautiously, as it may increase the risk of thrombosis or stroke. There is a risk of venous thromboembolism, and patients with risk factors should monitor their condition closely before and during treatment and take necessary preventive measures. Patients with cardiovascular diseases or hypotension may experience orthostatic hypotension at the initial dose, thus requiring gradual dosage adjustments and careful monitoring. Severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS syndrome may arise; if symptoms like widespread rash, fever, or lymphadenopathy develop, immediately discontinue medication and seek medical care. This medication should not be administered to patients with hypersensitivity to certain components, those in a coma, patients using barbiturate central nervous system depressants, patients receiving epinephrine, diabetic patients, or those with lactose intolerance. In patients with impaired liver function, drug metabolism may be slower, so initiate therapy with a lower dose and closely monitor their condition while gradually increasing dosage. Pregnant or nursing women may have side effects on the fetus or newborn, so consultation with a doctor is essential to decide on use, and breastfeeding should be avoided during use. Common side effects of this medication include drowsiness, dizziness, dry mouth, and weight gain; caution is required when driving or operating dangerous machinery. Abrupt cessation of the medication may lead to withdrawal symptoms or worsening of symptoms, so follow the doctor's instructions to gradually reduce the dosage. Concomitant use with other central nervous system depressants or alcohol may enhance sedation or central nervous system depression; caution is advised. While on this medication, family members or caregivers should closely observe for suicidal thoughts, aggression, or abnormal behavioral changes, and report any concerning symptoms to healthcare professionals immediately.

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, sleepwalking, constipation, indigestion, vomiting, difficulty swallowing, bowel obstruction, intestinal blockage, difficulty breathing, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, leukopenia, hypersensitivity reactions, anaphylactic reactions, blurred vision, pain in the back, myalgia, rhabdomyolysis, persistent erection, galactorrhea, increased appetite, mild weakness, peripheral edema, chest pain, irritability, fever, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, increased serum liver enzymes, increased eosinophils, increased blood sugar to hyperglycemic levels, increased serum prolactin, thrombocytopenia, agranulocytosis, hepatitis, liver failure, urinary retention, increased sweating, weight loss, hyperkalemia, tongue paralysis, sensory reduction, obesity, edema, facial flushing, toothache, facial swelling, neck stiffness, skin nodules, pelvic pain, dental disease, gout, arthralgia, arthritis, bursitis, myasthenia gravis, cramps, adverse reactions, accidental injury, ear disorders, taste disorders, acne, thromboembolism, insomnia, anxiety, neurosensitivity, headache, hallucinations, amnesia, aggressive reactions, confusion, psychosis, delusions, hypersexuality, emotional instability, agitation, disorientation, abnormal thoughts, suicide attempts, personality disorders, manic reactions, euphoria, chorea, migraine, depressive reactions, soliloquy, impulsive behavior, automatism, schizophrenic reactions, ataxia, mental confusion, hostility, inability to sit still, forward motion, muscle rigidity, salivation, bradykinesia, gait abnormalities, movement disorders, dystonia, oculomotor abnormalities, slow movements, decreased appetite, abdominal pain, diarrhea, gastritis, gastrointestinal disorders, hematemesis, rectal disorders, pupillary reflex damage, amblyopia, conjunctivitis, hyperprolactinemia, menstrual irregularities, thyroid disorders, hypercholesterolemia, hyperlipidemia, rash, itching, urinary disorders, incontinence, ejaculation disorders, erectile dysfunction, lethargy, increased CK, sleep apnea syndrome, acute withdrawal symptoms, increased suicidal tendencies, paralytic ileus, rhabdomyolysis

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture and is best kept at a cool temperature below 30 degrees Celsius. Proper storage can help maintain the effectiveness of the medication for a longer period.

Appearance

White, round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle