Medication info
Seroquel 300 mg (Quetiapine Fumarate)

Seroquel 300 mg (Quetiapine Fumarate)

Prescription medicationTabletOral
Ingredient · strength
Quetiapine Fumarate›345.39mg / 1 tablet
Manufacturer / importer
Alvogen Korea Co., Ltd.
Appearance
White capsule-shaped film-coated tablet
Packaging
30 tablets (10 tablets/PTPx3)
Approval status
Active

MFDS item code 200410325 · Approved 2004.08.12 · Insurance code 652606760

Summary

Main use
Treatment and prevention of recurrence of bipolar disorder (manic and depressive episodes, etc.); treatment of schizophrenia
Who takes it
Adults · Children
Adult dose
Schizophrenia Adults: This product 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, adjust to the usual effective daily dose of 300~400 mg. Depending on the individual patient's clinical response and tolerability, the dose may be adjusted within the range of 150~750 mg/day. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder Adults: This product 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 individual patient's clinical response and tolerability, the dose may be adjusted within the range of 200~800 mg/day; the usual effective daily dose is 400~800 mg. (2) Treatment of depression associated with bipolar disorder Adults: This product 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 product, 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. Clinical trial data indicate that the dose may be reduced to a minimum of 200 mg in patients who tolerate the medication. (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 clinical response and each patient's tolerability, the dose may be adjusted within the range of 300~800 mg/day, given in 2 divided doses. It is important to use the minimum effective dose for maintenance therapy. Older adults: Start this product at 25 mg/day and gradually increase by 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: Start this product at 25 mg/day and gradually increase by 25~50 mg per day to the effective dose.
Child dose
4. Children and Adolescents: The safety and efficacy of this medication have not been established in children and adolescents.

Ingredients

Importer
Alvogen Korea Co., Ltd.

Efficacy & effects

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

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

This medication is used for schizophrenia and bipolar disorder. It helps alleviate symptoms in schizophrenia patients and is effective for acute treatment of manic and depressive episodes in bipolar disorder type 1. Additionally, it is used to prevent relapses in patients who have responded to manic, mixed, or depressive episodes.

How to take

Adult dose

Schizophrenia Adults: This product 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, adjust to the usual effective daily dose of 300~400 mg. Depending on the individual patient's clinical response and tolerability, the dose may be adjusted within the range of 150~750 mg/day. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder Adults: This product 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 individual patient's clinical response and tolerability, the dose may be adjusted within the range of 200~800 mg/day; the usual effective daily dose is 400~800 mg. (2) Treatment of depression associated with bipolar disorder Adults: This product 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 product, 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. Clinical trial data indicate that the dose may be reduced to a minimum of 200 mg in patients who tolerate the medication. (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 clinical response and each patient's tolerability, the dose may be adjusted within the range of 300~800 mg/day, given in 2 divided doses. It is important to use the minimum effective dose for maintenance therapy. Older adults: Start this product at 25 mg/day and gradually increase by 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: Start this product at 25 mg/day and gradually increase by 25~50 mg per day to the effective dose.

Child dose

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

Precautions

This medication may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults with major depressive disorders or psychiatric conditions. Therefore, it is essential for the physician to carefully evaluate the necessity and risks when prescribing. This medication can increase the risk of hyperglycemia or diabetes, so patients with diabetes or risk factors should regularly check blood sugar levels and monitor symptoms. Serious side effects like neuroleptic malignant syndrome may occur, so if symptoms like high fever, muscle rigidity, or changes in mental state arise, immediate medical attention is required. Long-term use may lead to movement disorders such as tardive dyskinesia, so treatment should be paused or dosages adjusted if abnormal symptoms develop. In elderly patients with dementia, there may be an increased risk of mortality, so use is not advised. This medication may cause severe neutropenia or agranulocytosis, hence regular blood tests should be conducted to monitor white blood cell counts. Patients at risk of cerebrovascular diseases should exercise caution while using this medication, and preventive measures should be taken to address thrombosis risks. Patients with cardiovascular diseases or hypotension should be cautious, as this medication can cause orthostatic hypotension. Severe skin reactions like Stevens-Johnson syndrome and toxic epidermal necrolysis may occur, so if symptoms like rash or fever arise, immediate discontinuation of the medication is vital. This medication may interact with certain conditions or drugs, so it is crucial to inform the physician or pharmacist about any medications being taken. Pregnant or breastfeeding individuals should make a careful decision when prescribing this medication, as it may affect the fetus or newborn. The safety for children and adolescents has not been established, generally limiting its use in this age group. Elderly patients may have a higher risk of side effects due to slower drug metabolism; thus, starting at a lower dose and careful monitoring of the condition is recommended. In case of overdose, symptoms like severe drowsiness, hypotension, and tachycardia may arise, necessitating immediate emergency treatment. Drowsiness or dizziness may occur during treatment, thus caution should be exercised when driving or operating dangerous machinery. Abrupt discontinuation of the medication can lead to withdrawal symptoms, so dosage should be decreased gradually as directed by a physician.

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 disorders
  • seizures
  • restless legs syndrome
  • tardive dyskinesia
  • nightmares
  • sleepwalking
  • constipation
  • dyspepsia
  • vomiting
  • difficulty swallowing
  • intestinal obstruction
  • bowel obstruction
  • shortness of breath
  • rhinitis
  • tachycardia
  • palpitations
  • bradycardia
  • cardiomyopathy
  • myocarditis
  • orthostatic hypotension
  • hypertension
  • hypersensitivity reactions
  • anaphylaxis
  • blurred vision
  • pain in the limbs
  • myalgia
  • rhabdomyolysis
  • priapism
  • galactorrhea
  • increased appetite
  • mild weakness
  • peripheral edema
  • chest pain
  • hypersensitivity
  • fever
  • hypothermia
  • increased serum triglycerides
  • increased serum liver enzymes
  • increased serum creatine phosphokinase
  • thrombocytopenia
  • increased serum creatine phosphokinase
  • agranulocytosis
  • hepatitis
  • liver failure
  • urinary retention
  • increased sweating
  • weight loss
  • hyperkalemia
  • tongue paralysis
  • sensory loss
  • obesity
  • edema
  • facial flushing
  • toothache
  • facial edema
  • neck stiffness
  • skin nodules
  • overdose
  • pelvic pain
  • dental disease
  • gout
  • arthralgia
  • arthritis
  • bursitis
  • myasthenia gravis
  • spasms
  • adverse reactions
  • accidental injury
  • ear disorders
  • taste disturbances
  • acne
  • thrombosis
  • insomnia
  • anxiety
  • neurogenic irritability
  • 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 behaviors
  • automatism
  • schizophrenia reactions
  • ataxia
  • mental confusion
  • hostility
  • inability to sit still
  • forward movement
  • muscle rigidity
  • salivation
  • bradykinesia
  • abnormal gait
  • movement disorders
  • dystonia
  • abnormal eye movement
  • slow movements
  • hypersensitivity reactions
  • rash
  • itching
  • urinary disorders
  • urinary incontinence
  • urinary retention
  • increased BUN
  • ejaculation disorders
  • erectile dysfunction
  • lethargy
  • increased CK
  • increased sweating
  • hyperkalemia
  • tongue paralysis
  • sensory loss
  • obesity
  • edema
  • facial flushing
  • toothache
  • facial edema
  • neck stiffness
  • skin nodules
  • overdose
  • pelvic pain
  • dental disease
  • gout
  • arthralgia
  • arthritis
  • bursitis
  • myasthenia gravis
  • spasms
  • adverse reactions
  • accidental injury
  • ear disorders
  • taste disturbances
  • acne
  • thrombosis
  • paralytic ileus
  • rhabdomyolysis
  • neonatal withdrawal symptoms

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture, and it is essential to keep it in a cool place below 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness for a longer duration.

Appearance and packaging

Appearance

White capsule-shaped film-coated tablet

Package unit

30 tablets (10 tablets/PTPx3)

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.