Medication info
Aripiprazole 15 mg Tablets

Aripiprazole 15 mg Tablets

Prescription medicationTablet경구
Ingredient · strength
Aripiprazole›15mg / 1 tablet
Manufacturer / importer
동화약품(주)
Appearance
Yellow round tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201310992 · Approved 2013.12.31 · Insurance code 642706270

Summary

Main use
Treatment of schizophrenia and bipolar disorder (acute mania and mixed episodes)
Who takes it
Adults · Children
Adult dose
1. Schizophrenia - Recommended initial dose is 10 mg or 15 mg once daily, regardless of meals. - Dose may be adjusted within the range of 10-30 mg per day and should not be increased within 2 weeks. - Maintenance therapy should be administered at a dose of 15 mg daily for more than 3 months with regular reevaluation required. 2. Treatment of manic and mixed episodes associated with bipolar disorder - Recommended initial dose is 15 mg once daily.
Child dose
1. Schizophrenia (adolescents aged 13-17 years) - Recommended dose is 10 mg once daily, regardless of meals. - Initial dose is 2 mg, then increased to 5 mg after 2 days, and again to 10 mg after another 2 days.

Ingredients

Manufacturer
동화약품(주)

Efficacy & effects

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

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

This medication is used to treat schizophrenia and improve acute mania and mixed episodes associated with bipolar disorder. It is also used as an adjunct treatment for major depressive disorder and may help alleviate irritability associated with autism spectrum disorder. Additionally, it is effective in alleviating symptoms of Tourette's disorder, thus being used to treat various psychiatric diseases.

How to take

Adult dose

1. Schizophrenia - Recommended initial dose is 10 mg or 15 mg once daily, regardless of meals. - Dose may be adjusted within the range of 10-30 mg per day and should not be increased within 2 weeks. - Maintenance therapy should be administered at a dose of 15 mg daily for more than 3 months with regular reevaluation required. 2. Treatment of manic and mixed episodes associated with bipolar disorder - Recommended initial dose is 15 mg once daily.

Child dose

1. Schizophrenia (adolescents aged 13-17 years) - Recommended dose is 10 mg once daily, regardless of meals. - Initial dose is 2 mg, then increased to 5 mg after 2 days, and again to 10 mg after another 2 days.

Precautions

This drug may increase the risk of suicidal thoughts or behaviors when given to children, adolescents, and young adults with major depressive disorder or other psychiatric conditions, so careful judgment by the physician is necessary when using it. Close monitoring of the patient's condition is especially required during the initial months of treatment or when adjusting doses, looking for signs of suicidal tendencies or abnormal behavior changes. Family members or guardians should also closely observe the patient and consult medical professionals immediately if any abnormal signs appear. This drug is not approved for use in treating depression in children. This drug can rarely cause a potentially fatal set of symptoms known as neuroleptic malignant syndrome. Symptoms may include high fever, muscle rigidity, altered consciousness, irregular heart rate and blood pressure, and sweating; if these symptoms are suspected, administration of the drug should be stopped immediately and emergency treatment sought. Long-term use of this drug may lead to the development of tardive dyskinesia, which is an irreversible extrapyramidal syndrome. The risk is particularly high in the elderly or those receiving high doses over a long period, thus administration should be kept to the minimum effective dose for the shortest duration possible, with regular monitoring for symptoms. In elderly patients with dementia, this drug increases the risk of stroke and mortality, so it is not used in the treatment of psychiatric disorders associated with dementia. Blood glucose levels may rise during treatment with this drug, potentially worsening symptoms of diabetes, so diabetic patients or those at risk should regularly monitor blood glucose levels and carefully observe for symptoms. This drug may increase the risk of thrombus formation, so patients with risk factors for thrombosis should consult with medical professionals before using this medication and take preventive measures. This drug should not be given to patients with hypersensitivity, nor to those with genetic issues such as lactose intolerance. Caution is advised for patients with orthostatic hypotension, seizure history, or those who may experience impaired judgment or motor abilities, temperature regulation difficulties, or swallowing difficulties; patients at high risk for suicide should be monitored carefully. Drowsiness, dizziness, anxiety, insomnia, extrapyramidal symptoms, akathisia, and other side effects may frequently occur with this drug; caution is needed when driving or operating dangerous machinery. If any unusual symptoms or side effects occur during treatment, immediate consultation with medical staff is necessary.

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, oral/ocular mucosal pain, shortness of breath or difficulty in breathing, asthma attack, cough with fever accompanying breathing abnormalities, jaundice of the skin or eyes, extreme drowsiness, sudden and very severe headaches, thunderclap headache, seizures, confusion, visual disturbances, paralysis, significantly reduced urinary output

Mild side effects

  • Nausea
  • vomiting
  • constipation
  • headache
  • dizziness
  • akathisia
  • anxiety
  • insomnia
  • restlessness
  • drowsiness
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  • fatigue
  • increased appetite
  • nasopharyngitis
  • weight gain
  • excessive salivation
  • blurred vision
  • tremor
  • sedation
  • agitation
  • hypersalivation
  • lethargy
  • decreased appetite
  • reduced taste sensation
  • stuttering
  • hyperactivity
  • sleep disorders
  • palpitations
  • abnormal sensations
  • numbness
  • hallucinations
  • gastrointestinal disturbances
  • urinary disorders
  • fever
  • thirst
  • irritability
  • upper respiratory infection
  • pain
  • skin rash

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 should be kept at room temperature between 1 degree and 30 degrees Celsius. Proper storage helps maintain the drug's effectiveness and ensures its safe use.

Appearance and packaging

Appearance

Yellow round 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.