Medication info
Izipatpin 300 mg (Quetiapine Fumarate)

Izipatpin 300 mg (Quetiapine Fumarate)

Prescription medicationTabletOral
Ingredient · strength
Quetiapine Fumarate›345.39mg / 1 tablet
Manufacturer / importer
Huons Co., Ltd.
Appearance
White oblong film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201802582 · Approved 2018.06.20

Summary

Main use
Treatment and prevention of recurrence of bipolar disorder (manic and depressive episodes, etc.); treatment of schizophrenia
Who takes it
Adults
Adult dose
1. Schizophrenia Adults: This medication 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 the dose to the usual effective daily dose of 300~400 mg. The dose may be adjusted within 150~750 mg/day according to the individual 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. 2. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: Adults: This medication is taken twice daily, with or without food. As monotherapy or 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, with increases of no more than 200mg per day. The dose may be adjusted within 200~800 mg/day according to the individual patient's clinical response and tolerability; the usual effective daily dose is 400~800 mg. (2) Treatment of depression associated with bipolar disorder: Adults: This medication is taken once daily at bedtime, with or without food. The total daily dose for the first 4 days is titrated to 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 . (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 individual tolerability, the dose administered twice daily may be adjusted within the range of 300~800 mg/day. It is important to use the minimum effective dose for maintenance therapy. 3. Older adults Start treatment with 25 mg/day of this medication and gradually increase by 25~50 mg per day. The effective dose in older adults may be lower than that in younger patients. 5. Patients with renal or hepatic impairment Start treatment with 25 mg/day of this medication and gradually increase by 25~50 mg per day to the effective dose.

Ingredients

Manufacturer
Huons Co., Ltd.

Efficacy & effects

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

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

This medication helps improve the mental symptoms of patients with schizophrenia. It is also effective for the acute treatment of manic episodes and depressive episodes associated with bipolar disorder type 1. Quetiapine is used to prevent relapse in patients who have responded to treatment for mania, mixed, or depressive episodes. Therefore, this medication plays a crucial role in treating the various symptoms of schizophrenia and bipolar disorder and preventing relapses.

How to take

Adult dose

1. Schizophrenia Adults: This medication 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 the dose to the usual effective daily dose of 300~400 mg. The dose may be adjusted within 150~750 mg/day according to the individual 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. 2. Bipolar disorder (1) Acute treatment of manic episodes associated with bipolar I disorder: Adults: This medication is taken twice daily, with or without food. As monotherapy or 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, with increases of no more than 200mg per day. The dose may be adjusted within 200~800 mg/day according to the individual patient's clinical response and tolerability; the usual effective daily dose is 400~800 mg. (2) Treatment of depression associated with bipolar disorder: Adults: This medication is taken once daily at bedtime, with or without food. The total daily dose for the first 4 days is titrated to 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 . (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 individual tolerability, the dose administered twice daily may be adjusted within the range of 300~800 mg/day. It is important to use the minimum effective dose for maintenance therapy. 3. Older adults Start treatment with 25 mg/day of this medication and gradually increase by 25~50 mg per day. The effective dose in older adults may be lower than that in younger patients. 5. Patients with renal or hepatic impairment Start treatment with 25 mg/day of this medication and gradually increase by 25~50 mg per day to the effective dose.

Precautions

This medication requires caution in patients with suicidal tendencies, especially in children, adolescents, and young adults. Like antidepressants, this medication may increase the risk of suicidal impulses or behaviors, so the patient's condition should be closely monitored in the early stages of treatment. Patients taking this medication may have an increased risk of hyperglycemia or worsening diabetes, so blood sugar levels should be checked regularly, and symptoms of hyperglycemia should be carefully monitored. There is a risk of a rare but severe side effect known as neuroleptic malignant syndrome; if symptoms such as high fever, muscle rigidity, or changes in mental status occur, medical personnel should be notified immediately. Prolonged use may lead to extrapyramidal symptoms or tardive dyskinesia, so if abnormal movements or symptoms occur, patients should consult their physician. In elderly patients with dementia, an increased risk of death has been reported; therefore, special caution is needed when using this medication. Blood abnormalities such as severe neutropenia or agranulocytosis may occur, so white blood cell counts should be regularly checked, and immediate action should be taken if symptoms of infection appear. For patients with a history of cerebrovascular disease or cardiovascular disease, there may be an increased risk of vascular disorders, such as stroke, when taking this medication, so it should be administered with caution. There is also a risk of venous thromboembolism, so patients with risk factors for thrombosis should be identified in advance and preventive measures taken. Patients with liver dysfunction should have their dosages adjusted and their condition closely monitored, and women who are pregnant or breastfeeding should consult with medical personnel, as this medication can affect the fetus or newborn. This medication can cause various side effects such as drowsiness, dizziness, dry mouth, and weight gain, so caution is needed when driving or operating machinery. There are many drug interactions; patients taking other medications must inform their doctor or pharmacist, especially when used with central nervous system depressants or CYP3A4 inhibitors. Abruptly stopping this medication may result in withdrawal symptoms or a worsening of psychiatric symptoms, so the dosage must be reduced gradually. Serious side effects may occur in cases of overdose; therefore, the prescribed administration and dosage must be strictly followed. Keep this medication out of the reach of children and do not change the container arbitrarily.

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
  • dyspepsia
  • vomiting
  • difficulty swallowing
  • bowel obstruction
  • intestinal occlusion
  • dyspnea
  • rhinitis
  • tachycardia
  • palpitations
  • bradycardia
  • cardiomyopathy
  • myocarditis
  • orthostatic hypotension
  • hypertension
  • hypersensitivity reaction
  • anaphylaxis
  • blurred vision
  • pain
  • myalgia
  • rhabdomyolysis
  • priapism
  • galactorrhea
  • increased appetite
  • mild weakness
  • peripheral edema
  • chest pain
  • irritability
  • fever
  • hypothermia
  • increased serum triglycerides
  • increased serum liver enzymes
  • increased eosinophils
  • hyperglycemia
  • increased serum prolactin
  • thrombocytopenia
  • agranulocytosis
  • hepatitis
  • hepatic failure
  • urinary retention
  • micturition disorders
  • urinary incontinence
  • abnormal ejaculation
  • erectile dysfunction
  • fatigue
  • increased CK
  • increased sweating
  • weight loss
  • hyperkalemia
  • tongue paralysis
  • sensory impairment
  • obesity
  • edema
  • facial flushing
  • toothache
  • facial swelling
  • stiff neck
  • skin nodules
  • pelvic pain
  • dental diseases
  • gout
  • arthralgia
  • arthrosis
  • bursitis
  • myasthenia
  • spasms
  • exacerbation reactions
  • accidental injuries
  • ear diseases
  • taste disorders
  • acne
  • insomnia
  • anxiety
  • nervousness
  • headache
  • hallucinations
  • forgetfulness
  • aggressive reactions
  • confusion
  • neurosis
  • delusions
  • hypersexuality
  • unstable emotions
  • agitation
  • disorientation
  • abnormal thoughts
  • suicidal tendencies
  • paralytic ileus
  • rhabdomyolysis
  • acute renal failure
  • fever
  • nausea
  • vomiting
  • insomnia
  • anxiety
  • restlessness
  • panic disorder
  • excitement
  • hostility
  • aggressiveness
  • impulsivity
  • akathisia
  • hypomania
  • mania
  • serotonin syndrome
  • coma
  • hypotension
  • sedation
  • tachycardia
  • anticholinergic effects
  • acute withdrawal syndrome
  • sleep apnea syndrome
  • pancreatitis
  • aspiration pneumonia

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

Storage

This medication can be sensitive to air and moisture; therefore, it must be stored in a tightly closed container. Additionally, it is crucial to store it in a cool place below 30 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

White oblong film-coated tablets

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.