Donghwa Quetiapine Tablets 200 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. The dose may be adjusted within 150～750 mg/day according to the individual patient's clinical response and tolerability. - Maintenance therapy has not been evaluated in adult patients 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: 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. The dose may be adjusted within 200～800 mg/day according to the individual patient's clinical response and tolerability, and the usual effective daily dose is 400～800 mg. (2) Treatment of depression associated with bipolar disorder: - Adults: This medicine is taken 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 the confirmatory clinical trial 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. Increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. Clinical trials have shown that the dose may be reduced to as low as 200 mg in patients who tolerate the medicine. (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. The dose administered twice daily may be adjusted within 300～800 mg/day according to clinical response and individual tolerability. It is important to use the lowest effective dose for maintenance therapy. 3. Older adults : As with other antipsychotics, this medicine should be administered with caution to older adults, particularly at the start of treatment. Start treatment at 25 mg/day and gradually increase by 25～50 mg daily. The effective dose in older adults may be lower than that in younger patients. 5. 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, it should be administered with caution to patients with known hepatic impairment. Start treatment with this medicine at 25 mg/day and gradually increase by 25～50 mg daily until an effective dose is reached.

Child dose

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

This drug is primarily used for the treatment of psychiatric disorders, especially prescribed for depression, schizophrenia, and bipolar disorder. During the course of taking this drug, there may be an increased risk of suicidal thoughts or behaviors, particularly in children, adolescents, and young adults. Careful judgment and ongoing monitoring by a physician are essential. There is a potential risk of elevated blood sugar levels, so diabetic patients or individuals at risk for diabetes should regularly check their blood sugar levels and be alert for symptoms of high blood sugar such as thirst and frequent urination. If symptoms such as severe muscle rigidity, high fever, or altered consciousness occur, a physician should be consulted immediately, as these may indicate a serious side effect known as neuroleptic malignant syndrome. Prolonged use may lead to involuntary movements of the hands, feet, or face, so if these symptoms appear, consultation with a physician is necessary. Elderly patients with dementia may be at increased risk of death when using this drug, hence special caution is needed. A significant decrease in leukocyte count may occur, so medical personnel should be informed immediately if infection symptoms or fever are present. Patients at risk for stroke should consult a physician before taking this medication. There may be issues with blood coagulation, so those with risk factors for venous thromboembolism should exercise caution, and if symptoms arise, immediate treatment is required. Patients with cardiovascular disease or hypotension should be cautious of dizziness or fainting due to orthostatic hypotension while taking this drug. Severe allergic reactions may occur, so if symptoms such as rashes, skin peeling, or fever develop, discontinue use immediately and consult a physician. Patients allergic to this drug, in a comatose state, or taking certain medications should not receive it, and diabetic patients are generally advised against its use. Patients with impaired liver function should start at a low dose and gradually adjust the dosage while monitoring their condition. Pregnant or breastfeeding women should consult a physician before taking this medication, and breastfeeding should be avoided if possible while on this drug. Drowsiness or reduced concentration may occur, so caution is advised when driving or operating hazardous machinery. There may be interactions with other medications, so it is crucial to inform healthcare providers of any other medications being taken. Abruptly stopping this drug may lead to withdrawal symptoms, so discontinuation should be done gradually under a physician's guidance. In cases of overdose, severe drowsiness, hypotension, and heart problems may occur; immediate emergency treatment is required. Keep this medication out of the reach of children and do not transfer to other containers for safety.

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 disturbances, seizures, restless legs syndrome, tardive dyskinesia, nightmares, sleepwalking, constipation, dyspepsia, vomiting, dysphagia, bowel obstruction, bowel occlusion, dyspnea, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, postural hypotension, hypertension, hypersensitivity reactions, anaphylaxis, blurred vision, pain in the limbs, myalgia, rhabdomyolysis, persistent erection, galactorrhea, increased appetite, mild weakness, peripheral edema, chest pain, hypersensitivity, fever, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, increased serum liver enzymes, increased serum creatine phosphokinase, thrombocytopenia, increased serum creatine phosphokinase, agranulocytosis, hepatitis, liver failure, urinary retention, urination disorders, urinary incontinence, ejaculation abnormalities, erectile dysfunction, fatigue, increased CK, increased sweating, weight loss, hyperkalemia, tongue paralysis, sensory diminution, obesity, edema, facial flushing, toothache, facial edema, neck stiffness, skin nodules, overdose, pelvic pain, dental disease, gout, arthralgia, osteoarthritis, bursitis, myasthenia gravis, spasms, worsening reactions, accidental injury, ear diseases, taste disorders, acne, insomnia, anxiety, irritability, headache, hallucinations, forgetfulness, aggressive reactions, confusion, neurosis, delusions, hypersexuality, emotional instability, agitation, confusion, abnormal thinking, suicide attempts, personality disorders, manic reactions, intoxication, chorea, migraines, depressive reactions, soliloquy, impulsive behavior, automatic movements, schizophrenia-like reactions, ataxia, delirium, hostility, inability to sit still, forward motion, muscle rigidity, saliva secretion, hypokinesia, gait abnormalities, movement disorders, dystonia, abnormal ocular movements, slow movements, hypersensitivity reactions, rash, itching, difficulty expectorating phlegm, increased coughing, loss of appetite, increased appetite, abdominal pain, diarrhea, gastritis, gastrointestinal disorders, hematemesis, rectal diseases, pupillary reflex impairment, amblyopia, conjunctivitis, hyperprolactinemia, menstrual abnormalities, thyroid disorders, hypercholesterolemia, hyperlipidemia, decreased T3, urination disorders, urinary incontinence, urinary retention, increased BUN, ejaculation abnormalities, erectile dysfunction, fatigue, increased CK, increased sweating, weight loss, hyperkalemia, tongue paralysis, sensory diminution, obesity, edema, facial flushing, toothache, facial edema, neck stiffness, skin nodules, overdose, pelvic pain, dental disease, gout, arthralgia, osteoarthritis, bursitis, myasthenia gravis, spasms, worsening reactions, accidental injury, ear diseases, taste disorders, acne, increased suicidal tendencies, paralytic ileus, rhabdomyolysis, acute renal failure, recurrence of neuroleptic malignant syndrome, acute withdrawal symptoms, serotonin syndrome, sleep apnea syndrome, pancreatitis

This medication should be stored in a tightly sealed container to prevent air and moisture exposure, and it is best kept at a cool temperature below 30 degrees Celsius to maintain its efficacy and safety.

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle