Medication info
Seroquel 200 mg (Quetiapine Fumarate)

Seroquel 200 mg (Quetiapine Fumarate)

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

MFDS item code 202002304 · Approved 2020.04.02 · Insurance code 694002890

Summary

Main use
Treatment of schizophrenia and bipolar disorder (e.g., manic and depressive episodes); prevention of recurrence
Who takes it
Adults · Children
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 to the usual effective daily dose of 300~400 mg. The dose may be adjusted within the range of 150~750 mg/day according to each patient's clinical response and tolerability. Maintenance treatment has not been evaluated in adults with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance treatment. 2. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: Adults: Take this medicine twice daily, with or without food. Whether used 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 200 mg per day. The dose may be adjusted within the range of 200~800 mg/day according to each patient's clinical response and tolerability; 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 should reach 300 mg by day 4: 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 a minimum of 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. The dose may be adjusted within the range of 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 treatment. 3. Older adults Older patients should start this medicine 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. 5. Patients with renal or hepatic impairment Patients with renal or hepatic impairment should start this medicine at 25 mg/day, with gradual increases of 25~50 mg per day until the effective dose is reached.
Child dose
The safety and efficacy in children and adolescents have not been established.

Ingredients

Manufacturer
Daewoong Bio Co., Ltd.

Efficacy & effects

Treatment of schizophrenia and bipolar disorder (e.g., manic and depressive episodes); prevention of recurrence

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

This medication is used for the treatment of schizophrenia and is also effective in managing various symptoms of bipolar disorder. Specifically, it is used for the acute treatment of manic episodes and depressive episodes associated with bipolar disorder type 1. Moreover, it helps prevent the recurrence of bipolar disorder in patients who respond to treatment for manic, mixed, or depressive episodes. Hence, it is used to improve symptoms in patients with schizophrenia and bipolar disorder and to prevent the recurrence of the disease.

How to take

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 to the usual effective daily dose of 300~400 mg. The dose may be adjusted within the range of 150~750 mg/day according to each patient's clinical response and tolerability. Maintenance treatment has not been evaluated in adults with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance treatment. 2. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: Adults: Take this medicine twice daily, with or without food. Whether used 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 200 mg per day. The dose may be adjusted within the range of 200~800 mg/day according to each patient's clinical response and tolerability; 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 should reach 300 mg by day 4: 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 a minimum of 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. The dose may be adjusted within the range of 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 treatment. 3. Older adults Older patients should start this medicine 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. 5. Patients with renal or hepatic impairment Patients with renal or hepatic impairment should start this medicine at 25 mg/day, with gradual increases of 25~50 mg per day until the effective dose is reached.

Child dose

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

Precautions

This medication can increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults with major depressive disorder or psychiatric conditions, so careful judgment by a physician and close monitoring by patients and caregivers are needed. During treatment with this medication, blood sugar levels may increase, and patients with diabetes or risk factors for diabetes should regularly monitor their blood sugar. Rarely, symptoms of severe neuroleptic malignant syndrome may occur, requiring immediate medical attention if high fever, muscle rigidity, or changes in mental status are observed. Long-term use may result in movement disorders such as extrapyramidal symptoms or tardive dyskinesia; dose adjustments should be made if symptoms develop. For elderly patients with dementia, increased risk of death has been reported; therefore, the use of this medication is not recommended. Blood abnormalities such as agranulocytosis or neutropenia may occur, requiring regular monitoring of white blood cell counts and immediate treatment for any signs of infection. Patients with risk factors for stroke should use this medication carefully due to an increased risk of cerebrovascular diseases. There is a risk of venous thromboembolism, so risk factors should be evaluated in advance, and preventative measures should be taken. Patients with cardiovascular diseases or hypotension may experience orthostatic hypotension, so dose adjustments and monitoring are necessary. Severe skin adverse reactions might occur; if symptoms such as rash, skin peeling, or fever arise, discontinue use and consult a physician immediately. This medication should not be administered to specific patients, for example, those with hypersensitivity, comatose states, those taking central nervous system depressants, those administered epinephrine, diabetics or those with a history of diabetes, or those with lactose intolerance. In patients with liver dysfunction, cardiovascular diseases, epilepsy, the elderly, those at risk of suicide, pregnant or nursing women, careful administration is required along with dose adjustments and monitoring of the patient's condition. This medication may cause a variety of side effects, including drowsiness, dizziness, dry mouth, weight gain, blood sugar and lipid level changes, so consult a physician if symptoms arise. Acute withdrawal symptoms may appear upon discontinuation; therefore, dosage should be gradually reduced. Caution is advised when driving or operating dangerous machinery, especially when taken with alcohol or central nervous system depressants. Pregnant or nursing women should consult their physician before use, as it may affect the fetus and newborn; avoiding use during nursing is advised. In the case of overdose, immediate medical attention is required; there is no specific antidote, so supportive care will be provided based on symptoms. This medication should be kept out of reach of children and should not be transferred to other containers for safety.

Side effects

  • Drowsiness
  • dizziness
  • dry mouth
  • withdrawal symptoms
  • increased triglyceride levels
  • increased total cholesterol
  • decreased HDL cholesterol
  • weight gain
  • decreased hemoglobin
  • extrapyramidal symptoms
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  • syncope
  • neuroleptic malignant syndrome
  • leukopenia
  • neutropenia
  • peripheral edema
  • dysarthria
  • seizures
  • restless legs syndrome
  • tardive dyskinesia
  • nightmares
  • symptoms related to sleepwalking
  • constipation
  • dyspepsia
  • vomiting
  • dysphagia
  • intestinal obstruction
  • intestinal occlusion
  • dyspnea
  • rhinitis
  • tachycardia
  • palpitations
  • bradycardia
  • cardiomyopathy
  • myocarditis
  • orthostatic hypotension
  • hypertension
  • hypersensitivity reactions
  • anaphylaxis
  • blurred vision
  • pain in the back
  • myalgia
  • rhabdomyolysis
  • priapism
  • galactorrhea
  • increased appetite
  • mild weakness
  • peripheral edema
  • chest pain
  • hypersensitivity
  • fever
  • hypothermia
  • neonatal withdrawal symptoms
  • increased serum triglycerides
  • increased serum liver enzymes
  • eosinophilia
  • elevated blood sugar levels
  • increased serum prolactin
  • thrombocytopenia
  • increased serum 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
  • osteoarthritis
  • bursitis
  • myasthenia gravis
  • spasms
  • exacerbation reactions
  • accidental injury
  • ear diseases
  • dysgeusia
  • acne
  • thromboembolism
  • insomnia
  • anxiety
  • nervousness
  • headache
  • hallucinations
  • forgetfulness
  • aggressive reactions
  • confusion
  • neurosis
  • delusions
  • hypersexuality
  • unstable emotions
  • agitation
  • disorientation
  • abnormal thoughts
  • suicide attempts
  • personality disorders
  • manic reactions
  • euphoria
  • chorea
  • migraines
  • depressive reactions
  • soliloquy
  • impulsive behavior
  • automatic movements
  • schizophrenic reactions
  • ataxia
  • delirium
  • hostility
  • akathisia
  • forwardness
  • muscle rigidity
  • salivation
  • bradykinesia
  • gait abnormalities
  • abnormal movements
  • dystonia
  • oculomotor abnormalities
  • slow movements
  • hypersensitivity reactions
  • rash
  • itching
  • urination disorders
  • urinary incontinence
  • urinary retention
  • increased BUN
  • ejaculation abnormalities
  • erectile dysfunction
  • lethargy
  • increased CK
  • oculomotor abnormalities
  • sleep apnea syndrome
  • acute withdrawal symptoms
  • increased suicidal tendencies
  • paralytic ileus
  • rhabdomyolysis
  • increased serum prolactin
  • thyroid diseases
  • hypercholesterolemia
  • hyperlipidemia
  • menstrual irregularities

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

Storage

This medication should be stored in a closed container to prevent air or moisture exposure. Additionally, it is important to store it in a cool place below 30 degrees Celsius to maintain its effectiveness.

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.

Questions about this medicine

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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.