Medication info
Aripiprazole 5 mg Tablets (Aripiprazole)

Aripiprazole 5 mg Tablets (Aripiprazole)

Prescription medicationTablet경구
Ingredient · strength
Aripiprazole›5mg / 1 tablet
Manufacturer / importer
환인제약(주)
Appearance
Blue oval-shaped tablet
Packaging
Domestic use - 30 tablets/bottle, Domestic use - 100 tablets/bottle, Export - 30 tablets/box [10 tablets/PTPx3]
Approval status
Active

MFDS item code 201205266 · Approved 2012.05.31 · Insurance code 657202400

Summary

Main use
Treatment of schizophrenia, bipolar disorder (acute mania and mixed episodes)
Who takes it
Adults · Children
Adult dose
1. Schizophrenia\n- The recommended initial dose is 10 mg or 15 mg once daily, irrespective of meals.\n- The dose can be adjusted within the range of 10-30 mg daily, but the dosage should not be increased before reaching steady state in less than 2 weeks.\n- Maintenance therapy is administered at 15 mg daily for 3 months or longer, with regular reevaluation.\n\n2. Acute mania and mixed episodes associated with bipolar disorder.
Child dose
1. Schizophrenia in adolescents (13-17 years old)\n- The recommended dose is 10 mg once daily, irrespective of meals.\n- Initial dose is 2 mg once daily, increased to 5 mg after 2 days, and then to 10 mg after another 2 days, with a maintenance of 5 mg.

Ingredients

Manufacturer
환인제약(주)

Efficacy & effects

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

  • Schizophrenia
  • acute mania
  • mixed episodes
  • major depressive disorder
  • irritability
  • Tourette's disorder
View approved original text

This medication is used for schizophrenia, acute mania and mixed episodes associated with bipolar disorder, adjunctive treatment for major depressive disorder, irritability associated with autism spectrum disorder, and Tourette's disorder.

How to take

Adult dose

1. Schizophrenia\n- The recommended initial dose is 10 mg or 15 mg once daily, irrespective of meals.\n- The dose can be adjusted within the range of 10-30 mg daily, but the dosage should not be increased before reaching steady state in less than 2 weeks.\n- Maintenance therapy is administered at 15 mg daily for 3 months or longer, with regular reevaluation.\n\n2. Acute mania and mixed episodes associated with bipolar disorder.

Child dose

1. Schizophrenia in adolescents (13-17 years old)\n- The recommended dose is 10 mg once daily, irrespective of meals.\n- Initial dose is 2 mg once daily, increased to 5 mg after 2 days, and then to 10 mg after another 2 days, with a maintenance of 5 mg.

Precautions

This medication is primarily used for the treatment of psychiatric disorders and must be administered with caution.\n\nFirstly, this medication may increase suicidal tendencies; therefore, close monitoring for suicidal thoughts or behaviors, and worsening depression, especially during the initial treatment or dosage adjustments in children, adolescents, and young adults is essential.\n\nIn patients with bipolar disorder, it is crucial to assess the risk of bipolar disorder before starting this medication, and caution is needed as manic or mixed episodes may occur.\n\nAdditionally, this medication can cause a severe side effect known as Neuroleptic Malignant Syndrome. If any signs such as high fever, muscle rigidity, or changes in mental status occur, inform medical professionals immediately.\n\nThere may also be irreversible abnormal movement symptoms known as tardive dyskinesia, so periodic monitoring for these symptoms is required during long-term use.\n\nIn elderly patients with dementia, there is an increased risk of stroke or death; therefore, this medication is not used for the treatment of dementia-related psychiatric disorders.\n\nPatients with diabetes or those at risk for hyperglycemia should regularly monitor blood sugar levels while taking this medication. If symptoms of hyperglycemia arise, consult a healthcare provider immediately.\n\nThis medication can cause orthostatic hypotension, necessitating caution if symptoms of dizziness or fainting occur. Care should be taken when administering to patients with cardiovascular diseases or unstable blood pressure.\n\nPatients with a history of seizures or those at risk for seizures also need to be cautious while taking this medication, as it may impair judgment or motor skills, so driving or operating dangerous machinery should be avoided.\n\nThere may be a reduction in temperature regulation; hence caution should be exercised during excessive exercise or exposure to high-temperature environments.\n\nIn patients with dysphagia, the risk of aspiration pneumonia may increase, requiring special attention.\n\nThis medication should not be administered to patients with irritability or genetic lactose intolerance.\n\nAdverse reactions associated with this medication include nausea, vomiting, constipation, headache, dizziness, insomnia, drowsiness, weight gain, extrapyramidal symptoms, etc. If these symptoms are severe or persistent, consult medical professionals.\n\nIn case of overdose, seek immediate medical attention for appropriate management, and it is safest to use this medication at the lowest effective dose as directed by a physician.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, peeling skin, mucosal pain in mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities combined with cough + fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, and urination.

Mild side effects

  • Nausea
  • vomiting
  • constipation
  • headache
  • dizziness
  • akathisia
  • anxiety
  • insomnia
  • restlessness
  • drowsiness
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  • fatigue
  • increased appetite
  • nasopharyngitis
  • weight gain
  • sedation
  • tremors
  • extrapyramidal symptoms
  • blurred vision
  • hypersalivation
  • fever
  • sialorrhea
  • somnolence
  • malaise
  • diarrhea
  • epigastric pain
  • thirst
  • irritability
  • nasopharyngitis
  • increased insulin levels in the blood
  • sleep talking
  • hirsutism
  • dry mouth
  • and no mucosal pain in mouth/eyes
  • decreased appetite
  • musculoskeletal pain
  • muscle pain.

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air and moisture. It is advisable to maintain the storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Blue oval-shaped tablet

Package unit

Domestic use - 30 tablets/bottle, Domestic use - 100 tablets/bottle, Export - 30 tablets/box [10 tablets/PTPx3]

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.