Medication info
Seroquel 25 mg (Quetiapine Fumarate)

Seroquel 25 mg (Quetiapine Fumarate)

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

MFDS item code 201603843 · Approved 2016.06.23 · Insurance code 642003950

Summary

Main use
Treatment and prevention of recurrence of bipolar disorder, and treatment of schizophrenia
Who takes it
Adults · Children
Adult dose
1. Schizophrenia - Adults: This drug is taken 2 times 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. The dose may be adjusted within 150~750 mg/day according to each patient's clinical response and drug tolerability. - Maintenance therapy has not been evaluated in adults with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance therapy. 2. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: - Adults: This drug is taken 2 times daily, with or without food. As monotherapy or as adjunctive therapy to mood stabilizers (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, with increases of no more than 200mg per day. The dose may be adjusted within 200~800 mg/day according to each patient's clinical response and drug tolerability; the usual effective daily dose is 400~800 mg. (2) 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 with 600 mg. Increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. In patients who tolerate the drug, reduction to as low as 200 mg has been shown to be possible in clinical trials. (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 be maintained on the same dose. Depending on clinical response and each patient's tolerability, the dose may be adjusted within 300~800 mg/day, administered 2 times daily. It is important to use the minimum effective dose for maintenance therapy. 3. Elderly patients: As with other antipsychotic drugs, this drug should be administered with caution to elderly patients, particularly at the start of treatment. Elderly patients should start this drug at 25 mg/day, with gradual increases of 25~50 mg per day; the effective dose in elderly patients may be lower than that in younger patients. 5. Patients with renal or hepatic impairment: Clearance after oral administration of quetiapine 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 drug at 25 mg/day, with gradual increases of 25~50 mg per day until an effective dose is reached.
Child dose
4. Children and adolescents: The safety and efficacy of this drug have not been established in children and adolescents.

Ingredients

Manufacturer
Hyundai Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment and prevention of recurrence of bipolar disorder, and treatment of schizophrenia

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

This medication is used to alleviate symptoms in patients with schizophrenia. It is also effective in managing various symptoms in patients with bipolar disorder. Specifically, it helps in the acute treatment of manic and depressive episodes and contributes to the prevention of recurrence. Due to these effects, it plays an important role in improving patients' mental health and promoting stable living.

How to take

Adult dose

1. Schizophrenia - Adults: This drug is taken 2 times 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. The dose may be adjusted within 150~750 mg/day according to each patient's clinical response and drug tolerability. - Maintenance therapy has not been evaluated in adults with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance therapy. 2. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: - Adults: This drug is taken 2 times daily, with or without food. As monotherapy or as adjunctive therapy to mood stabilizers (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, with increases of no more than 200mg per day. The dose may be adjusted within 200~800 mg/day according to each patient's clinical response and drug tolerability; the usual effective daily dose is 400~800 mg. (2) 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 with 600 mg. Increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. In patients who tolerate the drug, reduction to as low as 200 mg has been shown to be possible in clinical trials. (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 be maintained on the same dose. Depending on clinical response and each patient's tolerability, the dose may be adjusted within 300~800 mg/day, administered 2 times daily. It is important to use the minimum effective dose for maintenance therapy. 3. Elderly patients: As with other antipsychotic drugs, this drug should be administered with caution to elderly patients, particularly at the start of treatment. Elderly patients should start this drug at 25 mg/day, with gradual increases of 25~50 mg per day; the effective dose in elderly patients may be lower than that in younger patients. 5. Patients with renal or hepatic impairment: Clearance after oral administration of quetiapine 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 drug at 25 mg/day, with gradual increases of 25~50 mg per day until an effective dose is reached.

Child dose

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

Precautions

This medication should be used cautiously in children, adolescents, and young adults with major depressive disorder or other psychiatric disorders, as it may increase the risk of suicidal thoughts or behaviors. Patients and caregivers should closely monitor for worsening depressive symptoms, suicidal thoughts, or abnormal behavioral changes such as aggression during the use of this medication. This medication can increase blood sugar levels, and patients with diabetes or those at risk for diabetes should monitor and manage their blood sugar levels regularly. Serious side effects such as neuroleptic malignant syndrome can occur rarely, so if high fever, muscle rigidity, or changes in mental state occur, medical attention should be sought immediately. Long-term use may lead to extrapyramidal symptoms or tardive dyskinesia, so any unusual symptoms should be discussed with a physician. In elderly patients with dementia, this medication may increase the risk of death, so use should be avoided or approached with caution. This medication can cause blood abnormalities such as agranulocytosis and neutropenia, so prompt medical care is necessary upon the occurrence of infection symptoms. Caution is advised as there may be an increased risk of stroke in patients with cerebrovascular disease. The risk of venous thromboembolism should be assessed, particularly in patients with risk factors. Patients with cardiovascular diseases or hypotension should be careful of orthostatic hypotension, dizziness, or fainting, especially when starting treatment. Severe skin side effects such as Stevens-Johnson syndrome and toxic epidermal necrolysis can occur, so if a widespread rash or fever develops, the medication should be stopped immediately and medical advice sought. This medication should not be used in patients with allergies to certain ingredients, those in a coma, those taking specific central nervous system depressants, patients receiving epinephrine, diabetic patients, or those with lactose intolerance. Patients with impaired liver function may have elevated blood concentrations, so treatment should start at a low dose with careful monitoring. Women who are pregnant or breastfeeding should consult a doctor before use as it may affect the fetus or newborn. This medication may cause drowsiness, dizziness, or decreased attention, so caution is necessary when driving or operating hazardous machinery. Be cautious of the enhanced effects when taken with other central nervous system depressants or alcohol, as this can result in increased risk. There is a risk of serotonin syndrome, so symptoms should be closely monitored if taken with serotonin-related medications. Abrupt cessation of this medication may result in withdrawal symptoms or recurrence of psychotic symptoms, so dosage should be tapered gradually. Overdose may lead to severe drowsiness, hypotension, arrhythmias, and require immediate emergency treatment. Keep out of reach of children and do not transfer 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
  • speech disorder
  • seizures
  • restless leg syndrome
  • tardive dyskinesia
  • nightmares
  • sleepwalking
  • constipation
  • indigestion
  • vomiting
  • dysphagia
  • intestinal obstruction
  • bowel obstruction
  • shortness of breath
  • rhinitis
  • tachycardia
  • palpitations
  • bradycardia
  • cardiomyopathy
  • myocarditis
  • orthostatic hypotension
  • hypertension
  • hypersensitivity reaction
  • anaphylaxis
  • blurred vision
  • pain in the extremities
  • myalgia
  • rhabdomyolysis
  • prolonged erection
  • galactorrhea
  • increased appetite
  • mild weakness
  • chest pain
  • hyperreactivity
  • fever
  • hypothermia
  • neonatal withdrawal symptoms
  • increased serum triglycerides
  • increased serum liver enzymes
  • increased eosinophils
  • hyperglycemia
  • increased serum prolactin
  • thrombocytopenia
  • increased serum creatine phosphokinase
  • agranulocytosis
  • hepatitis
  • liver failure
  • urinary retention
  • increased sweating
  • weight loss
  • hyperkalemia
  • tongue paralysis
  • sensory impairment
  • obesity
  • edema
  • facial flushing
  • toothache
  • facial swelling
  • neck stiffness
  • skin nodules
  • pelvic pain
  • dental disease
  • gout
  • arthralgia
  • arthritis
  • bursitis
  • myasthenia gravis
  • chorea
  • exacerbation reaction
  • accidental injury
  • ear disease
  • taste disorder
  • acne
  • insomnia
  • anxiety
  • nervousness
  • headache
  • hallucinations
  • forgetfulness
  • aggressive reaction
  • confusion
  • neurosis
  • delusions
  • hypersexuality
  • unstable emotions
  • agitation
  • disorientation
  • abnormal thinking
  • suicide attempt
  • personality disorder
  • manic reaction
  • euphoria
  • chorea-acanthocytosis
  • migraine
  • depressive reaction
  • monologue
  • impulsive behavior
  • automatism
  • schizophrenia-like reaction
  • ataxia
  • mental confusion
  • hostility
  • inability to sit still
  • forward movement
  • muscle rigidity
  • salivation
  • hypokinesia
  • gait abnormality
  • movement disorder
  • dystonia
  • oculomotor dysfunction
  • slowness of movement
  • hypersensitivity reaction
  • rash
  • itching
  • urinary disorder
  • urinary incontinence
  • ejaculation disorder
  • erectile dysfunction
  • fatigue
  • increased CK
  • thromboembolism
  • paralytic ileus
  • rhabdomyolysis
  • increased risk of suicidality

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, and should ideally be stored in a cool place below 30 degrees Celsius. This way, the therapeutic effects of the medication can be maintained for a long time.

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.

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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.