Medication info
Seroquel 100 mg (Quetiapine Fumarate)

Seroquel 100 mg (Quetiapine Fumarate)

Prescription medicationTabletOral
Ingredient · strength
Quetiapine Fumarate›115.13mg / 1 tablet
Manufacturer / importer
Hana Pharmaceutical Co., Ltd.
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201905240 · Approved 2019.07.23 · Insurance code 657807320

Summary

Main use
Treatment of bipolar disorder (manic and depressive episodes) and prevention of recurrence; treatment of schizophrenia
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 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. 2. 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. 3. 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. 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. 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 bipolar disorder (manic and depressive episodes) and prevention of recurrence; treatment of schizophrenia

  • Schizophrenia
  • manic episode
  • depressive episode
  • mania
  • mixed episode
View approved original text

This medication is used for the treatment of schizophrenia and bipolar disorder. It is particularly effective for the acute treatment of manic episodes and depressive episodes associated with bipolar disorder Type I. It also helps prevent relapse of bipolar disorder in patients who have responded to treatment for mania, mixed, or depressive episodes. This medication is utilized for controlling various symptoms and preventing relapse.

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 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. 2. 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. 3. 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. 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. 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 may increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults with major depressive disorder or other psychiatric disorders, so caution is needed when used. Blood sugar levels may rise during treatment, so regular monitoring is necessary for patients with diabetes or risk factors for diabetes. A rare but serious side effect known as Neuroleptic Malignant Syndrome may occur; seek immediate medical attention if symptoms such as high fever, muscle rigidity, or changes in mental status appear. Long-term use of this medication may lead to extrapyramidal symptoms or tardive dyskinesia, so dosage adjustments or discontinuation should be considered if symptoms arise. In elderly patients with dementia, the use of this medication may increase the risk of death, so special caution is needed. Blood abnormalities such as neutropenia and agranulocytosis may occur; white blood cell counts should be monitored regularly, and immediate treatment should be sought for symptoms of infection. Caution is warranted in patients with a risk of cerebrovascular disease due to an increased risk of stroke and other complications. The risk of venous thromboembolism should be assessed, and preventive measures should be taken. Patients with cardiovascular diseases or hypotension should be particularly cautious of dizziness or fainting related to orthostatic hypotension, especially during initial dosing. Severe skin adverse reactions may occur; if symptoms such as rash, fever, or lymph node swelling appear, the medication should be discontinued immediately. This medication should not be used in certain patients, such as those in coma, those treated with CNS depressants like barbiturates, patients receiving epinephrine, or those who are lactose intolerant. Caution is required when administering this medication to patients with liver dysfunction, the elderly, those at risk for suicide, those with a family history or risk factors for diabetes, and pregnant or breastfeeding women. This medication may cause drowsiness, dizziness, dry mouth, weight gain, extrapyramidal symptoms, and various other side effects. Consult with healthcare professionals if any unusual symptoms occur. In case of overdose, symptoms such as severe drowsiness, hypotension, or tachycardia may manifest, requiring immediate emergency treatment. Patients should be cautious when driving or operating hazardous machinery during treatment, and the risk of side effects may increase when taken with alcohol or other CNS depressants. Pregnant or breastfeeding women should consult healthcare professionals as this medication may affect the fetus or newborn.

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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  • fainting
  • neuroleptic malignant syndrome
  • leukopenia
  • neutropenia
  • peripheral edema
  • speech disorders
  • seizures
  • restless legs syndrome
  • tardive dyskinesia
  • nightmares
  • symptoms related to sleepwalking
  • constipation
  • dyspepsia
  • vomiting
  • dysphagia
  • intestinal obstruction
  • bowel obstruction
  • dyspnea
  • rhinitis
  • tachycardia
  • palpitations
  • bradycardia
  • cardiomyopathy
  • myocarditis
  • orthostatic hypotension
  • hypertension
  • hypersensitivity reactions
  • anaphylactic reactions
  • blurred vision
  • pain in the back
  • myalgia
  • rhabdomyolysis
  • priapism
  • galactorrhea
  • increased appetite
  • mild weakness
  • peripheral edema
  • chest pain
  • hypersensitivity
  • fever
  • hypothermia
  • newborn withdrawal symptoms
  • increased serum triglycerides
  • increased serum liver enzymes (ALT)
  • increased γ-GT
  • increased eosinophils
  • elevated blood glucose levels
  • increased serum prolactin
  • thrombocytopenia
  • increased serum creatine phosphokinase
  • agranulocytosis
  • hepatitis
  • liver failure
  • urinary retention
  • increased sweating
  • weight loss
  • hyperkalemia
  • tongue paralysis
  • loss of sensation
  • obesity
  • edema
  • facial flushing
  • toothache
  • facial edema
  • neck stiffness
  • skin nodules
  • overdose
  • pelvic pain
  • dental disease
  • gout
  • arthralgia
  • arthrosis
  • bursitis
  • myasthenia gravis
  • rigidity
  • worsening reaction
  • accidental injury
  • ear disease
  • taste disorders
  • acne
  • thromboembolic disease
  • insomnia
  • anxiety
  • neuroexcitation
  • headache
  • hallucinations
  • forgetfulness
  • aggressive reactions
  • confusion
  • nervousness
  • delusion
  • increased libido
  • unstable emotions
  • agitation
  • disorientation
  • abnormal thinking
  • suicide attempt
  • personality disorder
  • manic reaction
  • intoxication
  • chorea and athetosis
  • migraine
  • depressive reaction
  • monologue
  • impulsive behavior
  • automatic movement
  • schizophrenic reaction
  • ataxia
  • mental confusion
  • hostility
  • inability to sit still
  • advancing
  • muscle stiffness
  • salivation
  • hypokinesia
  • gait abnormalities
  • movement disorders
  • muscle tone disorder
  • oculomotor abnormalities
  • slow movements
  • hematological granulocytopenia
  • anemia
  • thrombocytopenia
  • rash
  • itching
  • urination disorders
  • incontinence
  • urinary retention
  • abnormal ejaculation
  • erectile dysfunction
  • fatigue
  • increased CK

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

Storage

This medication may be sensitive to air and humidity, so it should be stored in a sealed container. Also, it is important to store it in a cool place at or below 30 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

Yellow 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.