Medication info
Seroquel 25 mg (Quetiapine Fumarate)

Seroquel 25 mg (Quetiapine Fumarate)

Prescription medicationTabletOral
Ingredient · strength
Quetiapine Fumarate›28.78mg / 1 tablet
Manufacturer / importer
Daewong Bio Co., Ltd.
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202002307 · Approved 2020.04.02 · Insurance code 694002920

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
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. 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. Older adults As with other antipsychotics, this medicine should be administered with caution to older adults, particularly when initiating treatment. 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. 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 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
Daewong 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
  • mixed episodes
View approved original text

This medication is used for the treatment of schizophrenia and is effective in the acute treatment of manic episodes and depressive episodes related to bipolar disorder type 1. It also helps prevent relapse of bipolar disorder in patients whose condition has improved with quetiapine. Overall, this medication effectively improves various symptoms of schizophrenia and bipolar disorder.

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 the range of 150~750 mg/day according to each patient's clinical response and tolerability. 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. Older adults As with other antipsychotics, this medicine should be administered with caution to older adults, particularly when initiating treatment. 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. 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 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 may increase the risk of suicidal thoughts or behaviors in young patients with major depressive disorder or psychiatric disorders; therefore, careful judgment and continuous monitoring are necessary before administration. Blood glucose levels may rise during treatment with this medication, so patients with diabetes or those at risk for diabetes should regularly check their blood sugar and carefully monitor for symptoms of hyperglycemia such as thirst or frequent urination. This medication can rarely cause a serious side effect known as neuroleptic malignant syndrome, which includes symptoms such as high fever, muscle stiffness, and changes in mental state; if these symptoms occur, immediately inform medical personnel. Long-term use may lead to movement disorders such as extrapyramidal symptoms or tardive dyskinesia, so if abnormal movements are observed, dosage adjustment or discontinuation should be considered. In elderly patients with dementia, the risk of death may increase; therefore, special caution is needed. This medication may decrease the number of neutrophils in the blood, thereby increasing the risk of infections; if the white blood cell count is low, administration should be discontinued and symptoms of infections should be closely monitored. Patients at risk for cerebrovascular disease may have a higher likelihood of stroke, so careful administration is warranted. Venous thromboembolism may occur, so those with risk factors for thrombosis should be closely monitored and preventative measures taken before and after administration. Patients with cardiovascular disease or hypotension may experience orthostatic hypotension with this medication; therefore, they should change positions slowly and monitor for symptoms. Severe skin reactions may occur; if severe rashes, swelling, or fever develop, immediately discontinue the medication and consult with medical personnel. This medication should not be administered to patients with certain allergies, patients in a coma, or those taking central nervous system depressants. Patients with impaired liver function may have increased blood levels, so treatment should start at a low dose and closely monitored for appropriate dosage adjustments. Pregnant or breastfeeding women should only use this medication when absolutely necessary, as it may affect the fetus or newborn; breastfeeding is recommended to be avoided during treatment. This medication may cause drowsiness or dizziness, so caution is needed when driving or operating dangerous machinery. There are many drug interactions, so inform medical personnel of any other medications; particularly, it should not be used in conjunction with epinephrine. Sudden cessation of this medication may lead to withdrawal symptoms, so dosage should be reduced gradually for safety. There is no specific antidote for overdose; immediate medical management is required, and if serious symptoms occur, emergency treatment should be sought.

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
  • sleepwalking
  • constipation
  • indigestion
  • vomiting
  • dysphagia
  • intestinal obstruction
  • bowel obstruction
  • dyspnea
  • rhinitis
  • tachycardia
  • palpitations
  • bradycardia
  • cardiomyopathy
  • myocarditis
  • orthostatic hypotension
  • hypertension
  • hypersensitivity reactions
  • anaphylaxis
  • blurred vision
  • pain in limbs
  • myalgia
  • rhabdomyolysis
  • persistent erection
  • galactorrhea
  • increased appetite
  • mild weakness
  • peripheral edema
  • chest pain
  • irritability
  • fever
  • hypothermia
  • neonatal withdrawal symptoms
  • increased serum triglycerides
  • increased serum liver enzymes
  • increased eosinophils
  • elevated blood sugar level
  • increased serum prolactin
  • thrombocytopenia
  • increased serum creatine phosphokinase
  • agranulocytosis
  • hepatitis
  • liver failure
  • urinary retention
  • urination disorders
  • urinary incontinence
  • ejaculation abnormalities
  • erectile dysfunction
  • lethargy
  • increased CK
  • increased sweating
  • weight loss
  • hyperkalemia
  • tongue paralysis
  • sensory decrease
  • obesity
  • edema
  • facial flushing
  • toothache
  • facial edema
  • neck stiffness
  • skin nodules
  • pelvic pain
  • dental disease
  • gout
  • arthralgia
  • arthritis
  • bursitis
  • myasthenia gravis
  • tremors
  • exacerbation reactions
  • accidental injury
  • ear disease
  • taste disturbances
  • acne
  • insomnia
  • anxiety
  • hyperexcitability
  • headache
  • hallucinations
  • forgetfulness
  • aggressive reactions
  • confusion
  • neurosis
  • delusions
  • hypersexuality
  • unstable emotions
  • agitation
  • disorientation
  • abnormal thinking
  • suicide attempts
  • personality disorders
  • manic reactions
  • euphoria
  • chorea-acanthocytosis
  • migraines
  • depressive reactions
  • monologue
  • impulsive behavior
  • automatisms
  • schizophrenic reactions
  • ataxia
  • mental confusion
  • hostility
  • inability to sit still
  • forwardness
  • muscle rigidity
  • salivation
  • akinesia
  • gait abnormalities
  • movement disorders
  • abnormal muscle tone
  • oculomotor disturbances
  • slow movements
  • insomnia
  • anxiety
  • hyperexcitability
  • drowsiness
  • headache
  • dizziness
  • nausea
  • vomiting
  • abdominal pain
  • diarrhea
  • anorexia
  • increased appetite
  • abdominal distension
  • gastritis
  • gastrointestinal disorders
  • hematemesis
  • rectal disorders
  • pupillary reflex impairment
  • amblyopia
  • conjunctivitis
  • menstrual irregularities
  • thyroid disorders
  • hypercholesterolemia
  • hyperlipidemia
  • rash
  • itching
  • urination disorders
  • urinary incontinence
  • urinary retention
  • increased BUN
  • ejaculation abnormalities
  • erectile dysfunction
  • lethargy
  • increased sweating
  • hyperkalemia
  • tongue paralysis
  • sensory decrease
  • obesity
  • edema
  • facial flushing
  • toothache
  • facial edema
  • neck stiffness
  • skin nodules
  • pelvic pain
  • dental disease
  • gout
  • arthralgia
  • arthritis
  • bursitis
  • myasthenia gravis
  • tremors
  • exacerbation reactions
  • accidental injury
  • ear disease
  • taste disturbances
  • acne

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is also important to store it in a cool place below 30 degrees Celsius to prevent degradation.

Appearance and packaging

Appearance

Pink 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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.