Medication info
Curoquel Tablet 100 mg (Quetiapine Fumarate)

Curoquel Tablet 100 mg (Quetiapine Fumarate)

Prescription medicationTabletOral
Ingredient · strength
Quetiapine Fumarate›115.13mg / 1 tablet
Manufacturer / importer
Myungjin Pharmaceutical Co., Ltd.
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle, 200 tablets/bottle
Approval status
Active

MFDS item code 200709901 · Notified 2007.08.28 · Insurance code 651901980

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
Schizophrenia - Adults: Take this medication 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 therapy has not been evaluated in adults with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance therapy. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder - Adults: Take this medication twice daily, with or without food. Whether used as monotherapy or as adjunctive therapy with 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 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. Bipolar disorder (2) Treatment of depression associated with bipolar disorder - Adults: Take this medication 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 medication, 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 at 600 mg. Increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. For patients who tolerate the medication, clinical trials indicate that the dose may be reduced to a minimum of 200 mg. Bipolar disorder (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 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, administered twice daily. It is important to use the minimum effective dose for maintenance therapy. Elderly patients: As with other antipsychotics, this medication should be administered with caution in elderly patients, particularly when initiating treatment. Elderly patients should start 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. Patients with renal or hepatic impairment: 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 in patients with known hepatic impairment. Patients with renal or hepatic impairment should start this medication at 25 mg/day, with gradual increases of 25~50 mg per day until an effective dose is reached.
Child dose
The safety and efficacy of this medication have not been established in children and adolescents.

Ingredients

Manufacturer
Myungjin Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of bipolar disorder (manic and depressive episodes) and prevention of recurrence; 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. In particular, it is effective for the acute treatment of manic and depressive episodes in bipolar disorder, as well as for preventing recurrence. It helps alleviate symptoms and improve the quality of life for patients.

How to take

Adult dose

Schizophrenia - Adults: Take this medication 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 therapy has not been evaluated in adults with schizophrenia. Patients should be reassessed regularly to determine the need for maintenance therapy. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder - Adults: Take this medication twice daily, with or without food. Whether used as monotherapy or as adjunctive therapy with 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 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. Bipolar disorder (2) Treatment of depression associated with bipolar disorder - Adults: Take this medication 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 medication, 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 at 600 mg. Increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. For patients who tolerate the medication, clinical trials indicate that the dose may be reduced to a minimum of 200 mg. Bipolar disorder (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 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, administered twice daily. It is important to use the minimum effective dose for maintenance therapy. Elderly patients: As with other antipsychotics, this medication should be administered with caution in elderly patients, particularly when initiating treatment. Elderly patients should start 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. Patients with renal or hepatic impairment: 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 in patients with known hepatic impairment. Patients with renal or hepatic impairment should start this medication at 25 mg/day, with gradual increases of 25~50 mg per day until an effective dose is reached.

Child dose

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

Precautions

This medication may increase the risk of suicide, so caution is particularly needed when prescribing to children, adolescents, and young adults. Blood sugar levels may rise during treatment, so patients with diabetes or risk factors for diabetes should frequently monitor their blood glucose control. Serious side effects such as Neuroleptic Malignant Syndrome may occur, so if symptoms like high fever, muscle rigidity, or changes in mental state appear, consult a doctor immediately. Long-term use may lead to extrapyramidal symptoms or tardive dyskinesia, so if abnormal movements are observed, discontinuation or dosage adjustment is necessary. The use of this medication has not been approved for elderly patients with dementia, and there may be an increased risk of death, so it should be used cautiously. Blood abnormalities such as agranulocytosis or neutropenia may occur rarely, so be alert for symptoms of infection and have regular blood tests. Patients with a risk of cerebrovascular disease or venous thrombosis should take special caution when using this medication. Patients with cardiovascular disease or hypotension may experience orthostatic hypotension during initial dosage adjustment, so careful monitoring is required. Severe skin adverse reactions have been reported; if symptoms such as rash, peeling, or fever occur, discontinue use immediately and consult a doctor. Patients with hypersensitivity to this medication, coma, or who are on certain medications should not receive this drug. Patients with impaired liver function should start with a lower dose and gradually increase while monitoring their condition. Women who are pregnant or nursing should consult a doctor before using this medication, as it may affect the fetus or newborn. Sudden discontinuation may cause withdrawal symptoms, so the dosage should be reduced gradually, and care should be taken when driving or operating machinery due to drowsiness or dizziness. The side effects may worsen when this medication is taken with other CNS depressants or alcohol, so caution is advised. In case of overdose, severe drowsiness, hypotension, and anticholinergic symptoms may occur, so seek immediate medical attention.

Side effects

  • Drowsiness
  • dizziness
  • dry mouth
  • withdrawal symptoms
  • increased triglyceride levels
  • elevated total cholesterol
  • decreased HDL cholesterol
  • weight gain
  • decreased hemoglobin
  • extrapyramidal symptoms
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  • syncope
  • neuroleptic malignant syndrome
  • leukopenia
  • neutropenia
  • peripheral edema
  • headache
  • speech disturbance
  • seizures
  • restless legs syndrome
  • tardive dyskinesia
  • nightmares
  • sleepwalking
  • constipation
  • dyspepsia
  • vomiting
  • difficulty swallowing
  • intestinal obstruction
  • bowel occlusion
  • dyspnea
  • rhinitis
  • tachycardia
  • palpitations
  • bradycardia
  • cardiomyopathy
  • myocarditis
  • orthostatic hypotension
  • hypertension
  • hypersensitivity reaction
  • anaphylaxis
  • blurred vision
  • pain in the limbs
  • myalgia
  • rhabdomyolysis
  • priapism
  • galactorrhea
  • increased appetite
  • mild weakness
  • chest pain
  • hypersensitivity
  • fever
  • hypothermia
  • neonatal withdrawal symptoms
  • increased serum triglycerides
  • increased serum liver enzymes
  • elevated serum prolactin
  • thrombocytopenia
  • increased serum creatine phosphokinase
  • agranulocytosis
  • hepatitis
  • hepatic failure
  • urinary retention
  • urinary disorders
  • incontinence
  • ejaculatory dysfunction
  • erectile dysfunction
  • lethargy
  • increased CK
  • increased sweating
  • weight loss
  • hyperkalemia
  • tongue paralysis
  • sensory reduction
  • obesity
  • edema
  • facial flushing
  • toothache
  • facial swelling
  • neck rigidity
  • skin nodules
  • pelvic pain
  • dental disease
  • gout
  • arthralgia
  • arthritis
  • bursitis
  • myasthenia
  • spasms
  • exacerbation reactions
  • incidental injury
  • ear disease
  • taste disturbances
  • acne
  • insomnia
  • anxiety
  • neuropathy
  • hallucinations
  • forgetfulness
  • aggressive reactions
  • confusion
  • nervousness
  • delusions
  • hypersexuality
  • unstable emotions
  • turmoil
  • confusion
  • abnormal thoughts
  • suicide attempts
  • personality disorders
  • manic reactions
  • euphoria
  • chorea-acanthocytosis
  • migraines
  • depressive reactions
  • soliloquy
  • impulsive behavior
  • automatic movements
  • schizophrenia reactions
  • ataxia
  • mental confusion
  • hostility
  • akathisia
  • forward movement
  • muscular rigidity
  • salivation
  • bradykinesia
  • gait abnormalities
  • movement disorders
  • dyskinesia
  • oculomotor disturbances
  • slow movements
  • rash
  • itching
  • difficulty expelling phlegm
  • increased coughing
  • loss of appetite
  • abdominal pain
  • diarrhea
  • abdominal distension
  • gastritis
  • gastrointestinal disorders
  • hematemesis
  • rectal diseases
  • pupillary reflex damage
  • amblyopia
  • conjunctivitis
  • hyperprolactinemia
  • menstrual irregularities
  • thyroid disorders
  • hypercholesterolemia
  • hyperlipidemia
  • urinary disorders
  • incontinence
  • urinary retention
  • increased BUN
  • increased sweating
  • weight loss
  • hyperkalemia
  • tongue paralysis
  • sensory reduction
  • obesity
  • edema
  • facial flushing
  • toothache
  • facial swelling
  • neck rigidity
  • skin nodules
  • pelvic pain
  • dental disease
  • gout
  • arthralgia
  • arthritis
  • bursitis
  • myasthenia
  • spasms
  • exacerbation reactions
  • incidental injury
  • ear disease
  • taste disturbances
  • acne
  • thromboembolism
  • increased suicidal ideation
  • paralytic ileus
  • rhabdomyolysis
  • acute kidney failure
  • acute withdrawal syndrome
  • insomnia
  • nausea
  • diarrhea
  • vomiting
  • headache
  • hypersensitivity
  • anxiety
  • agitation
  • panic disorder
  • excitement
  • hostility
  • aggression
  • impulsivity
  • hypomania
  • mania
  • serotonin syndrome
  • decreased body temperature
  • pancreatitis
  • sleep apnea syndrome

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 and moisture, and it is important to maintain a temperature below 30 degrees. Proper storage will help maintain the medication's efficacy.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 200 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.