Medication info

Apizole Tablet 15 mg (Aripiprazole)

Prescription medicationApproval withdrawn
Ingredient · strength
Aripiprazole›Strength being verified
Manufacturer / importer
유니메드제약(주)
Appearance
Yellow round tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201110055 · Approved 2011.11.15

This product's status changed to Approval withdrawn on 2023.02.28. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of schizophrenia symptoms
Who uses it
Adults
Adult dosage
The recommended initial dose for the treatment of schizophrenia is 10 mg or 15 mg taken once daily, regardless of meals. The dose can be adjusted within the range of 10-30 mg per day, and it should not be increased before reaching a steady-state within 2 weeks. For maintenance therapy, it is recommended to administer this drug for 26 weeks after the symptoms stabilize. When switching from an existing antipsychotic medication, the existing dose should be gradually reduced while starting this medication. CYP3A4 inhibitors or CYP2D

Ingredients

Manufacturer
유니메드제약(주)

Efficacy & effects

Improvement of schizophrenia symptoms

  • Schizophrenia
View approved original text

This medication is used for the treatment of schizophrenia.

Dosage and Administration

Adult dosage

The recommended initial dose for the treatment of schizophrenia is 10 mg or 15 mg taken once daily, regardless of meals. The dose can be adjusted within the range of 10-30 mg per day, and it should not be increased before reaching a steady-state within 2 weeks. For maintenance therapy, it is recommended to administer this drug for 26 weeks after the symptoms stabilize. When switching from an existing antipsychotic medication, the existing dose should be gradually reduced while starting this medication. CYP3A4 inhibitors or CYP2D

Precautions

This medication may increase the risk of suicidal thoughts or behavior in children, adolescents, and young adults with major depressive disorder or psychiatric disorders. During the treatment, family members and caregivers should carefully monitor for any worsening of the patient's condition or unusual behavioral changes. Patients suspected of having bipolar disorder must receive a thorough diagnosis and evaluation from a specialist before using this medication. This medication can cause a serious side effect known as Neuroleptic Malignant Syndrome; if symptoms such as high fever, muscle rigidity, or altered consciousness occur, medical attention should be sought immediately. Prolonged use may result in irreversible tardive dyskinesia; therefore, it should be used at the minimum effective dose for the shortest duration, and any symptoms should be discussed with healthcare professionals. Elderly patients with dementia may have an increased risk of cerebrovascular accidents like strokes; thus, this medication is not recommended for treating dementia-related psychiatric disorders. Blood sugar levels may increase or diabetes may get worse, so diabetic patients should regularly monitor their blood glucose control. There is a risk of venous thromboembolism, so patients with risk factors for thrombosis should exercise caution before and after using this medication. Patients with an allergy to this medication or lactose intolerance should not take it. Patients with orthostatic hypotension, a history of seizures, or impaired judgment or motor skills should use this medication cautiously, as dizziness or drowsiness may occur. The ability to regulate deep body temperature may be impaired, requiring caution during high-temperature environments or intense exercise. Patients with dysphagia are at risk of aspiration pneumonia and should take precautions. This medication can cause a variety of side effects, including drowsiness, dizziness, insomnia, anxiety, headaches, vomiting, constipation, fatigue, weight gain, and more; if any unusual symptoms occur, consult with healthcare professionals. Particularly, side effects may be more pronounced at the beginning of treatment or when changing dosages, so careful monitoring is necessary.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or breathing difficulties, asthma attack, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and severe headaches, thunderclap headaches, seizures, confusion of consciousness, visual disturbances, paralysis, urination issues

Mild side effects

  • Nausea
  • vomiting
  • constipation
  • headache
  • dizziness
  • akathisia
  • anxiety
  • insomnia
  • restlessness
  • drowsiness
Show 27 more
  • fatigue
  • increased appetite
  • nasopharyngitis
  • weight gain
  • hypersalivation
  • blurred vision
  • tremors
  • muscle pain
  • muscle rigidity
  • limb pain
  • muscle cramps
  • restlessness
  • sedation
  • sore throat
  • cough
  • upper respiratory infection
  • weight loss
  • decreased appetite
  • reduced sense of taste
  • stuttering
  • hyperactivity
  • sleep disturbances
  • palpitations
  • abnormal sensations
  • numbness
  • hallucinations
  • gastrointestinal disorders

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is advisable to maintain the storage temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow round 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.

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.