Quetiapine Tablets 300 mg (Quetiapine fumarate)

Adult dosage

1. Schizophrenia - Adults: This medicine 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 the clinical response and drug 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 whether maintenance therapy is needed. 2. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: - Adults: This medicine 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 the clinical response and drug tolerability of each patient, the dose may be adjusted within the range of 200～800 mg/day, 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, 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 pivotal 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 at 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 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 for acute treatment of bipolar disorder should continue on the same dose. Depending on the 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. Older adults : As with other antipsychotics, this medicine should be administered with caution to older adults, particularly when initiating treatment. Older patients should start with 25 mg/day and have their dose gradually increased by 25～50 mg per day. The effective dose in older adults may be lower than that in younger patients. 5. Patients with renal or hepatic impairment : The clearance of quetiapine after oral administration 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. Patients with renal or hepatic impairment should start with 25 mg/day and have their dose gradually increased by 25～50 mg per day until an effective dose is reached.

Children's dosage

4. Pediatrics and Adolescents: The safety and efficacy of this medication have not been established in children and adolescents.

This medication may increase the risk of suicidal thoughts or behavior in younger individuals with depression or psychiatric disorders, so before administration, physicians should carefully assess the risks and benefits. Patients receiving this medication may be at risk for elevated blood sugar levels, so those with diabetes or risk factors for hyperglycemia should regularly monitor their blood sugar and closely observe symptoms. Neuroleptic malignant syndrome, a serious side effect, can occur rarely; if symptoms such as high fever, muscle rigidity, and changes in mental status occur, medical attention should be sought immediately. Long-term use may lead to extrapyramidal symptoms or tardive dyskinesia; if such abnormal symptoms develop, dose adjustments or discontinuation should be considered. It is preferable not to use this medication in dementia patients as it may increase the risk of death. Severe neutropenia may occur; therefore, treatment should be stopped in patients with low white blood cell counts, and attention should be given to infection symptoms. Caution is needed in patients with a risk of cerebrovascular disease, as there is also a risk of venous thromboembolism, so the risk factors for thrombosis should be identified, and preventive measures should be taken. For patients with cardiovascular disease or hypotension, orthostatic hypotension may occur upon initial dose escalation, thus caution is required. This drug should not be administered to patients with hypersensitivity to it, to those in a comatose state, to those concurrently using certain central nervous system depressants, to patients receiving epinephrine, to those with diabetes, and to patients intolerant to lactose. Patients with impaired liver function, cardiovascular disease, a history of seizures, the elderly, patients at risk of suicide, pregnant women, and nursing mothers should be administered this medication with caution, starting at a lower dose, and monitoring the condition closely. This drug has various side effects, including drowsiness, dizziness, dry mouth, constipation, orthostatic hypotension; therefore, consultation with a physician is necessary if symptoms arise. Care should be taken when driving or operating dangerous machinery, and abrupt discontinuation of the medication may lead to withdrawal symptoms, so tapering should be done slowly. This drug may enhance its effects when combined with other central nervous system medications or alcohol, so caution is required, and potential interactions with specific drugs should be communicated to the physician. During pregnancy, it may affect the fetus, so it should be administered only when necessary, and it is advisable to avoid use during breastfeeding. Use in children or adolescents should be avoided, as safety and efficacy have not been established. In case of overdose, immediate medical treatment is required, and since there is no antidote for this drug, supportive treatment based on symptoms is necessary. This medication should be kept out of the reach of children and should not be transferred to another container.

Drowsiness, dizziness, dry mouth, weakness, constipation, tachycardia, orthostatic hypotension, dyspepsia, syncope, neuroleptic malignant syndrome, leukopenia, neutropenia, peripheral edema, extrapyramidal symptoms, dysarthria, seizures, restless legs syndrome, tardive dyskinesia, nightmares, dysphagia, rhinitis, increased appetite, withdrawal symptoms, hypersensitivity reaction, anaphylaxis, priapism, galactorrhea, increased serum creatine phosphokinase, increased serum triglycerides, increased total cholesterol, decreased HDL cholesterol, weight gain, increased serum liver enzymes, decreased neutrophil count, increased blood glucose levels to hyperglycemia, increased serum prolactin, thrombocytopenia, insomnia, nervousness, headache, hallucinations, forgetfulness, aggressive reactions, confusion, neurosis, delusions, hypersexuality, unstable emotions, agitation, disorientation, abnormal thoughts, suicide attempts, personality disorders, manic reactions, euphoria, chorea, migraine, depressive reactions, monologue, impulsive behavior, automatism, schizophrenic responses, ataxia, mental confusion, hostility, inability to sit still, advancing, muscle rigidity, salivation, bradykinesia, gait abnormalities, dyskinesia, abnormal muscle tone, ocular motility abnormalities, slowed movement, granulocytopenia, anemia, thrombocytopenia, orthostatic hypotension, palpitations, hypotension, hypertension, bradycardia, arrhythmia, ECG abnormalities, vasodilation, thromboembolism, elevated AST, elevated ALT, increased LDH, increased ALP, elevated γ-GTP, hyperbilirubinemia, difficulty expectorating, increased cough, anorexia, nausea, vomiting, abdominal pain, intestinal obstruction, diarrhea, abdominal distension, gastritis, gastrointestinal disorders, hematemesis, rectal disorders, pupillary reflex impairment, amblyopia, conjunctivitis, hyperprolactinemia, decreased T4, menstrual irregularities, thyroid disorders, hypercholesterolemia, hyperlipidemia, decreased T3, rash, pruritus, urinary disorders, urinary incontinence, urinary retention, increased BUN, abnormal ejaculation, erectile dysfunction, lethargy, increased CK, increased sweating, weight loss, hyperkalemia, tongue paralysis, sensory impairment, obesity, edema, facial flushing, toothache, facial swelling, neck stiffness, skin nodules, overdose, pelvic pain, dental disorders, gout, arthralgia, arthrosis, bursitis, myasthenia gravis, spasms, adverse reactions, incidental injury, ear disorders, taste abnormalities, acne, thromboembolism, withdrawal symptoms, suicidal tendencies, paralytic ileus, rhabdomyolysis

This medication should be stored in a sealed container to prevent exposure to air or moisture, and it is important to maintain a temperature below 30 degrees Celsius. By storing it this way, the effectiveness of the medication can be maintained for a longer period.

Appearance

White, oblong film-coated tablet

Package unit

30 tablets/bottle. 100 tablets/bottle