Medication info
Quatin Tablets 25 mg (Quetiapine Fumarate)

Quatin Tablets 25 mg (Quetiapine Fumarate)

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

MFDS item code 201802733 · Approved 2018.06.29 · Insurance code 661905080

Summary

Main use
Treatment of schizophrenia and treatment and prevention of recurrence of bipolar disorder (manic or depressive episodes, etc.)
Who takes it
Adults · Children
Adult dose
1. Schizophrenia - Adults: Take this medication twice daily, regardless of meals. 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 each patient's clinical response and tolerability of the medication. - 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 medication twice daily, regardless of meals. 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 each patient's clinical response and tolerability of the medication; the usual effective daily dose is 400~800 mg. (2) Treatment of depression associated with bipolar disorder: - Adults: Take this medication once daily at bedtime, regardless of meals. 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 the pivotal 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 with 600 mg. Increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. In 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 in the acute treatment of bipolar disorder should continue on the same dose. The dose may be adjusted within the range of 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 antipsychotics, this medication should be administered with caution to elderly patients, especially at the start of treatment. Elderly patients should start treatment with 25 mg/day of this medication, 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 : The oral clearance of quetiapine is decreased 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 treatment with 25 mg/day of this medication, with gradual increases of 25~50 mg per day until the effective dose is reached.
Child dose
The safety and efficacy of this medication have not been established in children and adolescents.

Ingredients

Manufacturer
Youngpoong Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medication is used for the treatment of schizophrenia and bipolar disorder. It is particularly effective in the acute treatment of manic episodes and depressive episodes in patients with bipolar disorder type I. Additionally, it helps prevent relapses in patients who show responses during manic, mixed, or depressive episodes of bipolar disorder. This drug is used to improve symptoms and stabilize the patient's life by reducing the risk of relapse.

How to take

Adult dose

1. Schizophrenia - Adults: Take this medication twice daily, regardless of meals. 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 each patient's clinical response and tolerability of the medication. - 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 medication twice daily, regardless of meals. 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 each patient's clinical response and tolerability of the medication; the usual effective daily dose is 400~800 mg. (2) Treatment of depression associated with bipolar disorder: - Adults: Take this medication once daily at bedtime, regardless of meals. 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 the pivotal 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 with 600 mg. Increases above 300 mg should be initiated by a physician experienced in treating bipolar disorder. In 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 in the acute treatment of bipolar disorder should continue on the same dose. The dose may be adjusted within the range of 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 antipsychotics, this medication should be administered with caution to elderly patients, especially at the start of treatment. Elderly patients should start treatment with 25 mg/day of this medication, 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 : The oral clearance of quetiapine is decreased 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 treatment with 25 mg/day of this medication, with gradual increases of 25~50 mg per day until the effective dose is reached.

Child dose

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

Precautions

This medication is primarily used to treat psychiatric disorders, and there are various precautions during its use. Firstly, this medication may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults; therefore, careful decision-making by the doctor and close monitoring of changes in the patient's condition by the patient and their family are necessary when administering it to these age groups. Furthermore, glucose levels may rise during the use of this medication, so diabetic patients or those with risk factors for diabetes should regularly check their blood sugar levels and be aware of high blood sugar symptoms. In severe cases, a rare side effect known as neuroleptic malignant syndrome may occur, characterized by symptoms such as high fever, muscle rigidity, and changes in mental state, which requires immediate discontinuation of the medication and treatment. Long-term use may lead to tardive dyskinesia, so if there are any unusual movements, consultation with a physician is recommended. Elderly patients with dementia may face an increased risk of mortality; therefore, the use of this medication is not recommended. There can be severe neutropenia or agranulocytosis resulting from a rapid decrease in white blood cells, necessitating monitoring of white blood cell counts through blood tests in the initial months after starting treatment. Patients at risk of cerebrovascular disease or venous thromboembolism should be more cautious when using this medication, and those with cardiovascular disease or hypotension may experience orthostatic hypotension during initial administration, requiring careful attention. Additionally, this medication carries the risk of severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, and DRESS syndrome, so if symptoms like skin rashes or fever occur, the medication should be discontinued immediately, and a doctor should be consulted. This medication should not be administered to patients with specific diseases or conditions; dosage adjustments and thorough monitoring are needed for patients with liver impairment, pregnant women, and the elderly. Common side effects such as drowsiness, dizziness, and dry mouth may occur during treatment, so care should be taken when driving or operating hazardous machinery. There are many drug interactions, requiring caution when combined with other central nervous system depressants, specific antibiotics, and antifungals; particularly, it should not be used together with epinephrine. Women who are pregnant or breastfeeding must consult a doctor before taking this medication, as it may affect the fetus or newborn. Lastly, abruptly discontinuing this medication may lead to withdrawal symptoms or worsening of symptoms; therefore, any discontinuation must be done gradually under a doctor’s guidance.

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
  • headache
  • speech disorders
  • seizures
  • restless legs syndrome
  • tardive dyskinesia
  • nightmares
  • sleepwalking
  • constipation
  • indigestion
  • vomiting
  • difficulty swallowing
  • intestinal obstruction
  • bowel obstruction
  • rhinitis
  • shortness of breath
  • tachycardia
  • palpitations
  • bradycardia
  • cardiomyopathy
  • myocarditis
  • orthostatic hypotension
  • hypertension
  • hypersensitivity reactions
  • anaphylaxis
  • blurred vision
  • pain in limbs
  • myalgia
  • rhabdomyolysis
  • priapism
  • galactorrhea
  • increased appetite
  • mild asthenia
  • chest pain
  • irritability
  • fever
  • hypothermia
  • neonatal withdrawal symptoms
  • increased serum triglycerides
  • increased serum liver enzymes
  • increased blood creatine phosphokinase
  • thrombocytopenia
  • increased blood creatine phosphokinase
  • hepatitis
  • liver failure
  • urinary retention
  • urination disorders
  • urinary incontinence
  • ejaculation abnormalities
  • erectile dysfunction
  • fatigue
  • increased CK
  • increased sweating
  • weight loss
  • hyperkalemia
  • tongue paralysis
  • sensory reduction
  • obesity
  • edema
  • facial flushing
  • tooth pain
  • facial swelling
  • neck stiffness
  • skin nodules
  • pelvic pain
  • dental disease
  • gout
  • arthralgia
  • arthritis
  • bursitis
  • myasthenia gravis
  • cramps
  • adverse reactions
  • accidental injury
  • ear diseases
  • taste disturbances
  • acne
  • insomnia
  • anxiety
  • irritability
  • hallucinations
  • amnesia
  • aggressive reactions
  • confusion
  • neurosis
  • delusions
  • hypersexuality
  • unstable emotions
  • excitement
  • disorientation
  • abnormal thoughts
  • suicide attempts
  • personality disorders
  • manic reactions
  • euphoria
  • chorea-acanthocytosis
  • migraine
  • depressive reactions
  • soliloquy
  • impulsive behavior
  • automatism
  • schizophrenic reactions
  • ataxia
  • mental confusion
  • hostility
  • inability to sit still
  • forwardness
  • muscle rigidity
  • salivation
  • bradykinesia
  • gait abnormalities
  • movement disorders
  • abnormal muscle tone
  • oculomotor abnormalities
  • slowed movements
  • loss of appetite
  • abdominal pain
  • diarrhea
  • abdominal bloating
  • gastritis
  • gastrointestinal disorders
  • hematemesis
  • rectal disorders
  • damaged pupillary reflex
  • amblyopia
  • conjunctivitis
  • hyperprolactinemia
  • menstrual irregularities
  • thyroid disorders
  • hypercholesterolemia
  • hyperlipidemia
  • rash
  • itching
  • urination disorders
  • urinary incontinence
  • urinary retention
  • increased BUN
  • ejaculation abnormalities
  • erectile dysfunction
  • thromboembolism
  • paralytic ileus
  • rhabdomyolysis
  • increased suicidal tendencies

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 or moisture and is best kept at a cool temperature below 30 degrees Celsius. Storing it this way helps maintain the effectiveness of the medication for a longer time.

Appearance and packaging

Appearance

Pink round 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.

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.