Medication info
Seroquel 200 mg (Quetiapine Fumarate)

Seroquel 200 mg (Quetiapine Fumarate)

Prescription medicationTabletOral
Ingredient · strength
Quetiapine Fumarate›230.26mg / 1 tablet
Manufacturer / importer
Hana Pharmaceutical Co., Ltd.
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201905241 · Approved 2019.07.23 · Insurance code 657807310

Summary

Main use
Treatment of schizophrenia; treatment of bipolar episodes and prevention of recurrence
Who takes it
Adults · Children
Adult dose
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 to the usual effective daily dose of 300~400 mg. The dose may be adjusted within 150~750 mg/day according to the clinical response and tolerability of each patient. Maintenance therapy has not been evaluated in adult patients with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance therapy. 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, in increments of no more than 200mg per day. The dose may be adjusted within 200~800 mg/day according to the clinical response and tolerability of each patient; 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. An antidepressant effect was 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 indicate that the dose may be reduced to a minimum of 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 during acute treatment of bipolar disorder should be maintained on the same dose. The dose may be adjusted within 300~800 mg/day, administered twice daily, according to clinical response and each patient's tolerability. It is important to use the minimum effective dose for maintenance therapy. Elderly patients: As with other antipsychotic drugs, this medicine should be administered with caution to elderly patients, particularly at the start of treatment. Start elderly patients on 25 mg/day of this medicine and gradually increase the dose by 25~50 mg per day. The effective dose in elderly patients may be lower than that in younger patients. Patients with renal or hepatic impairment: Clearance after oral administration of quetiapine is reduced by approximately 25% in patients with renal or hepatic impairment. Quetiapine is primarily metabolized in the liver; therefore, administer with caution to patients with known hepatic impairment. In patients with renal or hepatic impairment, start this medicine at 25 mg/day and gradually increase by 25~50 mg per day to the effective dose.
Child dose
Children and adolescents: The safety and efficacy of this medicine have not been established in children and adolescents.

Ingredients

Manufacturer
Hana Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of schizophrenia; treatment of bipolar episodes and prevention of recurrence

  • Schizophrenia
  • manic episodes
  • depressive episodes
  • mixed episodes
View approved original text

This medication is used for schizophrenia and bipolar disorder. It alleviates symptoms in patients with schizophrenia and is effective for the acute treatment of manic and depressive episodes related to bipolar disorder type I. It also helps prevent recurrence in patients who have responded to manic, mixed, or depressive episodes. This medication is used to improve the symptoms of various mental disorders and prevent recurrence.

How to take

Adult dose

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 to the usual effective daily dose of 300~400 mg. The dose may be adjusted within 150~750 mg/day according to the clinical response and tolerability of each patient. Maintenance therapy has not been evaluated in adult patients with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance therapy. 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, in increments of no more than 200mg per day. The dose may be adjusted within 200~800 mg/day according to the clinical response and tolerability of each patient; 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. An antidepressant effect was 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 indicate that the dose may be reduced to a minimum of 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 during acute treatment of bipolar disorder should be maintained on the same dose. The dose may be adjusted within 300~800 mg/day, administered twice daily, according to clinical response and each patient's tolerability. It is important to use the minimum effective dose for maintenance therapy. Elderly patients: As with other antipsychotic drugs, this medicine should be administered with caution to elderly patients, particularly at the start of treatment. Start elderly patients on 25 mg/day of this medicine and gradually increase the dose by 25~50 mg per day. The effective dose in elderly patients may be lower than that in younger patients. Patients with renal or hepatic impairment: Clearance after oral administration of quetiapine is reduced by approximately 25% in patients with renal or hepatic impairment. Quetiapine is primarily metabolized in the liver; therefore, administer with caution to patients with known hepatic impairment. In patients with renal or hepatic impairment, start this medicine at 25 mg/day and gradually increase by 25~50 mg per day to the effective dose.

Child dose

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

Precautions

This medication is primarily used in the treatment of psychiatric disorders, especially prescribed for depression, mania, and schizophrenia. When taking this medication, there may be an increased risk of suicidal thoughts or behavior in some young patients, therefore close monitoring by a physician is necessary, especially for children, adolescents, and young adults. Blood sugar levels may rise, leading to diabetes or hyperglycemia-related issues, so diabetic patients or those with risk factors should have their blood sugar checked regularly. Serious neurological side effects such as muscle stiffness, high fever, and changes in mental status may occur; if symptoms appear, consult a doctor immediately. Long-term use may lead to abnormal movements, and if such movements occur, dosage adjustment is necessary. In elderly patients with dementia, the use of this medication may be associated with an increase in the risk of death, so caution is advised. There may be side effects characterized by a sudden drop in blood cell count, so if symptoms of infection or fever occur, notify medical personnel promptly. Due to the risk of thrombosis, careful management is needed before and after administering the drug if there are risk factors for thrombosis. Patients with heart conditions or low blood pressure may experience dizziness or fainting while taking this medication, thus it should be increased slowly and monitored closely. Severe skin reactions can occur infrequently, so if skin rashes, fever, or lymph node swelling develop, discontinue use immediately and consult a physician. This medication should not be administered to patients with specific allergies, in a comatose state, those taking central nervous system depressants, those receiving epinephrine, diabetic patients, and lactose intolerant patients. Caution is required for patients with impaired liver function or those with cardiovascular diseases, low blood pressure, a history of seizures, older adults, pregnant or nursing women, as careful monitoring and dosage adjustment may be necessary. Abrupt discontinuation of this medication can lead to withdrawal symptoms or symptom worsening; therefore, it should be tapered off as directed by a physician. Taking this medication with other central nervous system medications or alcohol may significantly increase drowsiness or decreased concentration, so caution is required. Women who are pregnant or nursing should consult their doctor before using this medication as it may affect the fetus or newborn. Caution is needed when driving or operating hazardous machinery while taking this medication. In cases of overdose, symptoms such as severe drowsiness, low blood pressure, and tachycardia may occur, necessitating immediate medical attention. This medication should be kept out of the reach of children and should not be transferred to another container.

Side effects

Drowsiness, dizziness, dry mouth, withdrawal symptoms, increased triglyceride levels, increased total cholesterol, decreased HDL cholesterol, weight gain, decreased hemoglobin, extrapyramidal symptoms, fainting, neuroleptic malignant syndrome, leukopenia, neutropenia, peripheral edema, dysarthria, seizures, restless legs syndrome, tardive dyskinesia, nightmares, sleepwalking, constipation, dyspepsia, vomiting, swallowing difficulties, intestinal obstruction, bowel obstruction, shortness of breath, rhinitis, tachycardia, palpitations, bradycardia, cardiomyopathy, myocarditis, orthostatic hypotension, hypertension, leukopenia, hypersensitivity reactions, anaphylaxis, blurred vision, pain in the limbs, myalgia, rhabdomyolysis, priapism, galactorrhea, increased appetite, mild asthenia, peripheral edema, chest pain, hypersensitivity, fever, hypothermia, neonatal withdrawal symptoms, increased serum triglycerides, increased serum enzyme levels, increased creatine phosphokinase, thrombocytopenia, increased creatine phosphokinase, agranulocytosis, hepatitis, liver failure, urinary retention, increased sweating, weight loss, hyperkalemia, tongue paralysis, decreased sensation, obesity, edema, facial flushing, toothache, facial edema, neck stiffness, skin nodules, overdose, pelvic pain, dental disease, gout, arthralgia, arthritis, bursitis, myasthenia gravis, cramps, adverse reactions, accidental injury, ear disease, taste disturbances, acne, insomnia, anxiety, neuroexcitability, headache, hallucinations, forgetfulness, aggressive reactions, confusion, neurosis, delusions, hypersexuality, unstable emotions, agitation, disorientation, abnormal thought processes, suicide attempts, personality disorders, manic reactions, euphoria, chorea-acanthocytosis, migraine, depressive reactions, soliloquy, impulsive behavior, automatism, schizophrenia-like reactions, ataxia, mental confusion, hostility, inability to remain seated, forward movement, dysarthria, muscle rigidity, salivation, bradykinesia, abnormal gait, dyskinesia, swallowing difficulties, dystonia, ocular movement disorders, slow movements, thromboembolism, pulmonary embolism, venous thrombosis, thromboembolism, increased suicide tendency, paralytic ileus, rhabdomyolysis, acute renal failure, withdrawal symptoms, increased blood sugar, hyperglycemia, exacerbation of diabetes, increased serum prolactin, menstrual irregularities, thyroid disorders, hypercholesterolemia, hyperlipidemia, fever, sweating, weight loss, hypotension, fainting, palpitations, orthostatic hypotension, increased serum enzymes (ALT, AST), increased γ-GT, thrombocytopenia, increased serum creatine phosphokinase, agranulocytosis, hepatitis, liver failure, urinary retention, skin rash, extensive skin rash, exfoliative dermatitis, lymphadenopathy, eosinophilia, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction (DRESS), acute renal failure due to rhabdomyolysis, neuroleptic malignant syndrome, hypothermia, neonatal withdrawal symptoms, insomnia, anxiety, neuroexcitability, headache, hallucinations, forgetfulness, aggressive reactions, confusion, neurosis, delusions, hypersexuality, unstable emotions, agitation, disorientation, abnormal thought processes, suicide attempts, personality disorders, manic reactions, euphoria, chorea-acanthocytosis, migraine, depressive reactions, soliloquy, impulsive behavior, automatism, schizophrenia-like reactions, ataxia, mental confusion, hostility, inability to remain seated, forward movement, dysarthria, muscle rigidity, salivation, bradykinesia, abnormal gait, dyskinesia, swallowing difficulties, dystonia, ocular movement disorders, slow movements, thromboembolism, pulmonary embolism, venous thrombosis, thromboembolism, increased suicide tendency, paralytic ileus, rhabdomyolysis, acute renal failure, withdrawal symptoms, increased blood sugar, hyperglycemia, exacerbation of diabetes, increased serum prolactin, menstrual irregularities, thyroid disorders, hypercholesterolemia, hyperlipidemia, fever, sweating, weight loss, hypotension, fainting, palpitations, orthostatic hypotension, increased serum enzymes (ALT, AST), increased γ-GT, thrombocytopenia, increased serum creatine phosphokinase, agranulocytosis, hepatitis, liver failure, urinary retention, skin rash, extensive skin rash, exfoliative dermatitis, lymphadenopathy, eosinophilia, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction (DRESS), anaphylaxis

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in an airtight container to prevent air or moisture from entering, and it is best kept in a cool place below 30 degrees Celsius. By doing so, the effectiveness of the medication will be maintained for a longer duration and its quality will not change.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.