Medication info
Aripiprazole Tablet 10 mg

Aripiprazole Tablet 10 mg

Prescription medicationTablet경구
Ingredient · strength
Aripiprazole›10mg / 1 tablet
Manufacturer / importer
하나제약(주)
Appearance
Pink oblong tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201603078 · Approved 2016.05.30

Summary

Main use
Treatment of schizophrenia and bipolar disorder (acute mania and mixed episodes)
Who takes it
Adults · Children
Adult dose
Schizophrenia - The recommended initial dose is 10 mg or 15 mg once daily regardless of meals. - The dose can be adjusted within the range of 10-30 mg once daily, and it should not be increased before reaching a steady state within 2 weeks. - Efficacy of maintenance therapy has been demonstrated with a daily dose of 15 mg for more than 3 months. Treatment of mania and mixed episodes associated with bipolar disorder - The recommended initial dose is 15 mg once daily regardless of meals.
Child dose
Schizophrenia in adolescents (13-17 years) - Recommended dosage is 10 mg once daily regardless of meals. - Initial dose of 2 mg once daily, increase to 5 mg after 2 days, and further increase to 10 mg after another 2 days.

Ingredients

Manufacturer
하나제약(주)

Efficacy & effects

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

  • Schizophrenia
  • acute mania related to bipolar disorder
  • mixed episodes
  • major depressive disorder
  • hypersensitivity related to autism spectrum disorder
  • Tourette syndrome
View approved original text

This medicine is used to treat schizophrenia, acute mania, and mixed episodes related to bipolar disorder, as an adjunctive treatment for major depressive disorder, hypersensitivity related to autism spectrum disorder, and Tourette syndrome.

How to take

Adult dose

Schizophrenia - The recommended initial dose is 10 mg or 15 mg once daily regardless of meals. - The dose can be adjusted within the range of 10-30 mg once daily, and it should not be increased before reaching a steady state within 2 weeks. - Efficacy of maintenance therapy has been demonstrated with a daily dose of 15 mg for more than 3 months. Treatment of mania and mixed episodes associated with bipolar disorder - The recommended initial dose is 15 mg once daily regardless of meals.

Child dose

Schizophrenia in adolescents (13-17 years) - Recommended dosage is 10 mg once daily regardless of meals. - Initial dose of 2 mg once daily, increase to 5 mg after 2 days, and further increase to 10 mg after another 2 days.

Precautions

This drug is primarily used for the treatment of psychiatric disorders, particularly depression, schizophrenia, and bipolar disorder. While taking this medicine, there may be an increase in suicidal thoughts or behaviors, especially in children, adolescents, and young adults, hence careful assessment and continuous monitoring by a physician are necessary. During the early stages of treatment, depression symptoms may worsen, or unusual behavioral changes such as suicidal impulses, anxiety, agitation, or aggression may occur, so family members or caregivers must closely observe the patient. In patients with bipolar disorder, this drug may cause manic or mixed episodes, so the risk of bipolar disorder should be assessed before treatment. This drug can cause a rare but serious side effect known as neuroleptic malignant syndrome, which can be fatal, and if symptoms like high fever, muscle rigidity, or changes in mental state occur, immediate medical attention is needed. Prolonged use may lead to irreversible abnormal movement disorders, so if symptoms appear, immediate consultation with a physician is required. In elderly patients with dementia, this drug may increase the risk of stroke and mortality, so it is not recommended for the treatment of dementia-related mental disorders. Diabetic patients or those at risk of high blood sugar should regularly monitor their blood sugar levels, and if symptoms of high blood sugar appear, they must inform their healthcare provider immediately. This drug may increase the risk of thrombosis, so caution is needed for patients who have risk factors for thrombosis. This drug should not be used by individuals with allergic reactions or lactose intolerance. Patients with orthostatic hypotension, a history of seizures, and cognitive or motor function impairment should use this drug cautiously, as it may cause drowsiness or dizziness, requiring caution while driving or operating dangerous machinery. Thermoregulation ability may be impaired, so caution is required in hot environments or in cases of dehydration. Elderly patients with swallowing difficulties or at risk of aspiration pneumonia should be especially careful. Common side effects may include nausea, vomiting, constipation, headache, dizziness, anxiety, insomnia, drowsiness (including sedation), fatigue, weight gain, and there may be abnormal movement symptoms or muscle tension. If severe side effects occur, immediate consultation with healthcare providers is necessary, and regular health check-ups and monitoring are required during medication.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash associated with high fever, blisters, peeling skin, pain in the mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough+fever, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion, vision abnormalities, paralysis, urination problems

Mild side effects

  • Nausea
  • vomiting
  • constipation
  • headache
  • dizziness
  • akathisia
  • anxiety
  • insomnia
  • restlessness
  • drowsiness (including sedation)
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  • fatigue
  • increased appetite
  • blurred vision
  • tremors
  • hypersalivation
  • rhinitis
  • weight gain
  • agitation
  • sedation
  • drooling
  • lethargy
  • decreased appetite
  • fever
  • cough
  • sore throat
  • thirst
  • irritability
  • stuttering
  • hyperactivity
  • sleep disturbances
  • palpitations
  • eye movement disorders
  • numbness
  • abnormal sensations
  • hallucinations
  • dyspepsia
  • urinary problems

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

Storage

This medication must be stored in a tightly sealed container to avoid exposure to air and moisture. The recommended storage temperature is between 1°C and 30°C at room temperature.

Appearance and packaging

Appearance

Pink oblong 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.