Medication info
Abilify ODT 15 mg (Aripiprazole)

Abilify ODT 15 mg (Aripiprazole)

Prescription medicationOrally disintegrating Tablet경구
Ingredient · strength
Aripiprazole›15mg / 1 tablet
Manufacturer / importer
한국오츠카제약(주)
Appearance
Round tablets with yellow spots (imprint A641, 15)
Packaging
30 tablets (10 tablets/PTP X 3)
Approval status
Active

MFDS item code 201309521 · Approved 2013.09.30 · Insurance code 649900360

Summary

Main use
Treatment of schizophrenia and bipolar disorder (acute mania and mixed episodes)
Who takes it
Adults · Children
Adult dose
For adult schizophrenia, the recommended initial dosage is 10 mg or 15 mg once daily, regardless of meals. Dosing may be adjusted within the range of 10-30 mg daily; however, increases should not occur within 2 weeks. The maintenance therapy consists of 15 mg daily for more than 3 months. For adult bipolar disorder, the recommended initial dose is 15 mg once daily, and may be increased to 30 mg daily based on clinical response.
Child dose
Recommended dosage for adolescents with schizophrenia (aged 13-17 years) is 10 mg once daily, regardless of meals. Initial dose is 2 mg once daily, followed by 5 mg after 2 days, and 10 mg after another 2 days, then further increase to 5 mg as needed.

Ingredients

Manufacturer
한국오츠카제약(주)

Efficacy & effects

Treatment of schizophrenia and bipolar disorder (acute mania and mixed episodes)

  • Schizophrenia
  • acute mania associated with bipolar disorder
  • mixed episodes
  • major depressive disorder
  • irritability associated with autism spectrum disorder
  • Tourette's disorder
View approved original text

This medication is used for the treatment of schizophrenia and acute mania and mixed episodes associated with bipolar disorder. Additionally, it serves as an adjunctive therapy for major depressive disorder and is helpful in alleviating irritability associated with autism spectrum disorder. It is also used in the treatment of Tourette's disorder.

How to take

Adult dose

For adult schizophrenia, the recommended initial dosage is 10 mg or 15 mg once daily, regardless of meals. Dosing may be adjusted within the range of 10-30 mg daily; however, increases should not occur within 2 weeks. The maintenance therapy consists of 15 mg daily for more than 3 months. For adult bipolar disorder, the recommended initial dose is 15 mg once daily, and may be increased to 30 mg daily based on clinical response.

Child dose

Recommended dosage for adolescents with schizophrenia (aged 13-17 years) is 10 mg once daily, regardless of meals. Initial dose is 2 mg once daily, followed by 5 mg after 2 days, and 10 mg after another 2 days, then further increase to 5 mg as needed.

Precautions

This medication may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults with depression or psychiatric disorders; therefore, careful consultation with a doctor before use is essential. During the initial treatment phase, the patient's condition may worsen or unusual behaviors may appear, so family members and caregivers should observe the patient carefully and notify the healthcare provider immediately if any atypical signs are observed. When administering this medication to patients with bipolar disorder, it is important to verify the presence of mania or mixed episodes prior to treatment. Neuroleptic malignant syndrome, which can be fatal, may occur; therefore, if symptoms such as fever, muscle rigidity, and changes in mental status occur, medical attention should be sought immediately. Long-term use may result in irreversible abnormal movement symptoms, so it should be used at the minimum dosage and for the shortest duration possible, with medical consultation required if symptoms arise. Use of this medication in elderly patients with dementia may increase the risk of cerebrovascular accidents such as strokes and mortality; thus, it is advisable not to administer it to patients in this age group. Since this medication can affect blood sugar control, diabetic patients should monitor their blood sugar levels regularly and be vigilant for symptoms of hyperglycemia. There is a risk of venous thromboembolism; therefore, patients with thrombotic risk factors should be monitored carefully before and during administration. This medication contains aspartame, an artificial sweetener, and should not be taken by patients with phenylketonuria. Symptoms such as orthostatic hypotension, seizures, and drowsiness may occur, so caution is needed when driving or operating hazardous machinery. Aspiration pneumonia and dysphagia risks may be present, so particularly elderly patients should be monitored closely. Possible adverse reactions during the use of this medication include nausea, vomiting, constipation, headache, dizziness, insomnia, anxiety, drowsiness, weight gain, etc. If severe or sudden atypical symptoms occur during treatment, immediate consultation with a physician is necessary, along with regular examinations and monitoring.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, significant decrease in urine output

Mild side effects

  • Nausea
  • vomiting
  • constipation
  • headache
  • dizziness
  • akathisia
  • anxiety
  • insomnia
  • restlessness
  • drowsiness
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  • fatigue
  • increased appetite
  • nasopharyngitis
  • weight gain
  • tremors
  • sedation
  • hypersalivation
  • blurred vision
  • agitation
  • sialorrhea
  • lethargy
  • myalgia
  • muscle cramps
  • musculoskeletal stiffness
  • arthralgia
  • fever
  • rash
  • malaise
  • decreased appetite
  • cough
  • sore throat
  • runny nose
  • hirsutism
  • stuttering
  • hyperactivity
  • sleep disturbances
  • palpitations
  • abnormal sensations
  • numbness

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

Storage

This medication may be sensitive to air and moisture; therefore, it should be stored in a tightly sealed container. It is advisable to maintain the storage temperature between 1°C and 30°C room temperature to preserve the medication's efficacy for a longer period.

Appearance and packaging

Appearance

Round tablets with yellow spots (imprint A641, 15)

Package unit

30 tablets (10 tablets/PTP X 3)

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.