Medication info

Aphizole Tablet 5mg (Aripiprazole)

Prescription medicationApproval withdrawn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Approval withdrawn

MFDS item code 201110057 · 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This product's status changed to Approval withdrawn on 2023.02.28.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 symptoms of schizophrenia
Who uses it
Adults · Children
Adult dosage
For the treatment of schizophrenia, the recommended initial dose for adults is 10 mg or 15 mg 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 two weeks necessary to reach a steady state. For maintenance therapy, it is recommended to administer the drug for 26 weeks following stabilization of symptoms, and it should be reassessed intermittently. From existing antipsychotic medications.
Children's dosage
Maintenance therapy for schizophrenia in adolescents has not been studied.

Ingredients

Manufacturer
유니메드제약(주)

Efficacy & effects

Improvement of symptoms of schizophrenia

  • Schizophrenia
View approved original text

This medicine is used for schizophrenia, also known as psychotic disorder.

Dosage and Administration

Adult dosage

For the treatment of schizophrenia, the recommended initial dose for adults is 10 mg or 15 mg 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 two weeks necessary to reach a steady state. For maintenance therapy, it is recommended to administer the drug for 26 weeks following stabilization of symptoms, and it should be reassessed intermittently. From existing antipsychotic medications.

Children's dosage

Maintenance therapy for schizophrenia in adolescents has not been studied.

Precautions

This medication is primarily used for the treatment of psychiatric disorders, and is prescribed especially for depression, schizophrenia, and bipolar disorder. It may increase the risk of suicidal thoughts or behaviors in children, adolescents, and young adults, so the patient's condition should be closely monitored during treatment. Family members or caregivers should also pay close attention to changes in the patient's behavior and consult with medical professionals immediately if any unusual symptoms occur. This medication can cause a serious side effect called neuroleptic malignant syndrome, which includes high fever, muscle rigidity, changes in mental state, irregular heartbeat, and blood pressure. If these symptoms appear, immediate medical attention is necessary. Long-term use may result in irreversible tardive dyskinesia, thus treatment duration and dosage should be kept to a minimum while regularly checking the patient's condition. In particular, it is not recommended for dementia patients as it may increase the risk of stroke or cerebrovascular incidents. It may affect blood glucose control, so diabetic patients or those at risk of diabetes should regularly check their blood glucose levels, and should consult medical professionals immediately if symptoms of hyperglycemia appear. It may cause orthostatic hypotension, therefore caution is needed especially in patients with cardiovascular diseases or those at risk of hypotension. Patients with a history of seizures, or those at high risk for seizures, should consult a medical professional prior to using this medication, and should closely monitor for seizure symptoms during treatment. This medication may cause drowsiness, dizziness, or impaired judgment; therefore, caution should be exercised when driving or operating dangerous machinery. It may affect thermal regulation, and exposure to excessive exercise or high temperatures should be avoided to prevent dehydration. Patients with dysphagia face a risk of aspiration pneumonia, thus special attention is needed when administering this medication. While taking this medication, the risk of suicide and changes in mental state should be closely monitored. If necessary, dosage adjustments or discontinuation should be considered. This medicine should not be administered to patients with certain genetic lactose degradation disorders, and should be avoided in cases of hypersensitivity. When administering, start with the minimum effective dose and observe the patient's response, reevaluating the necessity of long-term treatment regularly. Various side effects may occur with this medication; therefore, if symptoms such as nausea, vomiting, constipation, headache, dizziness, insomnia, anxiety, drowsiness, weight gain, tremors, muscle rigidity, etc., arise, it is essential to inform medical professionals. If any adverse reactions or changes in symptoms occur during treatment, immediate consultation with medical personnel is critical for appropriate response.

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 mouth/eye mucous membranes, shortness of breath or difficulty breathing, asthma attacks, cough+fever with breathing difficulties, jaundice (yellowing of the skin or eyes), extreme drowsiness, sudden and severe headaches, thunderclap headache, seizures, confusion of consciousness, vision disturbances, paralysis, urinary issues.

Mild side effects

  • Nausea
  • vomiting
  • constipation
  • headache
  • dizziness
  • akathisia
  • anxiety
  • insomnia
  • restlessness
  • extrapyramidal symptoms
Show 25 more
  • drowsiness
  • fatigue
  • increased appetite
  • nasopharyngitis
  • weight gain
  • sedation
  • tremors
  • blurred vision
  • hypersalivation
  • somnolence
  • thirst
  • upper respiratory infection
  • coordination-motor abnormalities
  • speech disorders
  • Parkinsonism
  • cogwheel rigidity
  • memory impairment
  • reduced motor function
  • hypotonia
  • muscle hypertonia
  • akinesia
  • tardive dyskinesia
  • motor retardation
  • generalized seizures
  • chorea.

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture, and should be kept at room temperature between 1 to 30 degrees Celsius. This will help maintain the effectiveness and ensure safe usage of the medication.

Appearance and packaging

Appearance

Blue rectangular 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.