Quetiapine 300 mg Tablet (Quetiapine Fumarate)

Adult dosage

Schizophrenia Adults: This drug is taken 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, the dose should be adjusted to the usual effective daily dose of 300～400 mg. Depending on each patient's clinical response and tolerability, the dose may be adjusted within the range of 150～750 mg/day. Acute treatment of manic episodes associated with bipolar I disorder Adults: This drug is taken 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, in increments of no more than 200mg per day. Depending on each 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. Treatment of depression associated with bipolar disorder Adults: This drug is taken 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 drug, 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 drug, clinical trials indicate that the dose may be reduced to a minimum of 200 mg. Prevention of recurrence of bipolar disorder Adults: To prevent recurrence of manic, mixed, and depressive episodes associated with bipolar disorder, patients who responded to quetiapine for acute treatment of bipolar disorder should be maintained on the same dose. Depending on clinical response and each patient's tolerability, the dose administered twice daily may be adjusted within the range of 300～800 mg/day. It is important to use the minimum effective dose for maintenance therapy. Older adults Treatment in older patients should be initiated at 25 mg/day, with gradual increases of 25～50 mg per day. The effective dose in older adults may be lower than that in younger patients. Patients with renal or 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 the effective dose is reached.

Children's dosage

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

This medication is primarily used to treat psychiatric disorders, particularly to alleviate symptoms of depression and schizophrenia. While taking this drug, there may be an increased risk of suicidal thoughts or behavior, especially in children, adolescents, and young adults, necessitating close observation. Patients with diabetes or risk factors for diabetes may experience elevated blood sugar levels; therefore, regular monitoring of blood glucose is essential, and if symptoms of hyperglycemia occur, immediate consultation with a physician is advised. This medication may rarely induce a serious neurological side effect called Neuroleptic Malignant Syndrome. If high fever, muscle rigidity, or changes in mental state occur, immediate medical attention is necessary. Long-term use may lead to movement disorders such as extrapyramidal symptoms or tardive dyskinesia, thus dose adjustment or cessation should be considered if abnormal symptoms arise. Elderly patients with dementia may have an increased risk of mortality; therefore, avoiding use in this population is recommended. Severe neutropenia may occur, so regular checks of white blood cell counts and vigilance for infection symptoms are important. Patients with cardiovascular diseases or hypotension should exercise caution, as orthostatic hypotension or heart-related abnormalities may arise. This drug should not be administered to specific patients, such as those in comatose states or when used with certain medications; it should also not be used in lactose-intolerant patients. Pregnant or breastfeeding women should carefully consider the use of this drug due to potential effects on the fetus or newborn and should consult with a physician before making a decision. Common side effects such as drowsiness, dizziness, dry mouth, constipation, increased heart rate, orthostatic hypotension, indigestion, fainting, leukopenia, peripheral edema, nightmares, dyspepsia, dysphagia, rhinitis, hyperprolactinemia, increased appetite, mild fatigue, irritability, increased serum triglycerides, increased total cholesterol, decreased HDL cholesterol, weight gain, increased serum liver enzymes (ALT, AST), decreased neutrophil count, and thrombocytopenia may occur; if these symptoms are severe, medical attention should be sought. Taking this medication with other central nervous system depressants or alcohol may intensify side effects, hence co-administration should be avoided or undertaken with caution. In cases of overdose, severe hypotension or coma may occur, so it’s crucial to adhere strictly to prescribed dosage and not to modify the dosage without a doctor's guidance. Safety and efficacy of this drug in children and adolescents have not been established, thus its use in this age group is not advisable. Caution should be exercised while driving or operating hazardous machinery; if symptom exacerbation or adverse reactions occur, immediate consultation with a healthcare professional is advised.

Drowsiness, dizziness, dry mouth, weakness, constipation, tachycardia, orthostatic hypotension, dyspepsia, syncope, neuroleptic malignant syndrome, leukopenia, neutropenia, peripheral edema, extrapyramidal symptoms, speech disturbances, seizures, restless legs syndrome, tardive dyskinesia, nightmares, dysphagia, rhinitis, appetite increase, withdrawal symptoms, hypersensitivity reactions, anaphylactic reactions, priapism, galactorrhea, increased serum creatine phosphokinase, increased serum triglycerides, increased total cholesterol, decreased HDL cholesterol, weight gain, increased serum liver enzymes, increased blood glucose levels to hyperglycemia, increased serum prolactin, thrombocytopenia, insomnia, anxiety, irritability, headache, hallucinations, amnesia, aggressive reactions, confusion, neurosis, delusions, hypersexuality, unstable emotions, agitation, disorientation, abnormal thinking, suicide attempts, personality disorders, manic reactions, euphoria, chorea-acanthocytosis, migraines, depressive reactions, soliloquy, impulsive behaviors, automatism, schizoaffective reactions, ataxia, mental confusion, hostility, inability to sit still, muscle rigidity, salivation, bradykinesia, gait abnormalities, movement disorders, dystonia, abnormal eye movements, slow movements, granulocytopenia, anemia, thromboembolism, liver failure, difficulty expectorating phlegm, increased cough, loss of appetite, nausea, vomiting, abdominal pain, intestinal obstruction, diarrhea, 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, ejaculation disorders, erectile dysfunction, apathy, increased CK, increased sweating, weight loss, hyperkalemia, tongue paralysis, sensory decline, obesity, edema, facial flush, toothache, facial edema, neck stiffness, skin nodules, overdose, pelvic pain, dental disorders, gout, arthralgia, osteoarthritis, bursitis, myasthenia gravis, spasms, exacerbation reactions, accidental injuries, ear disorders, taste disorders, acne, thromboembolism, increased suicidal tendencies, paralytic ileus,

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture and kept at a cool temperature below 30 degrees Celsius. Proper storage will help maintain the drug's efficacy.

Appearance

White, oval film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle