Medication info

Itopride HCl Tablet

Prescription medicationTabletOralExpired
Ingredient · strength
Itopride Hydrochloride›50mg / 1 tablet
Manufacturer / importer
Korea Pharma Bio Co., Ltd.
Appearance
White, round film-coated tablet
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Expired

MFDS item code 200600311 · Notified 2006.03.31

This product's status changed to Expired on 2026.01.01. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of functional dyspepsia symptoms (abdominal bloating, upper abdominal pain, nausea, etc.)
Who takes it
Adults
Adult dose
○ Adults: Administer 50 mg of itopride hydrochloride orally 3 times daily before meals. Reduce the dose as appropriate according to symptoms.

Ingredients

Manufacturer
Korea Pharma Bio Co., Ltd.

Efficacy & effects

Improvement of functional dyspepsia symptoms (abdominal bloating, upper abdominal pain, nausea, etc.)

  • Abdominal distension
  • epigastric pain
  • loss of appetite
  • heartburn
  • nausea
  • vomiting
View approved original text

This medicine is effectively used for various digestive symptoms caused by functional dyspepsia, such as abdominal distension, epigastric pain, loss of appetite, heartburn, nausea, and vomiting. It helps alleviate digestive discomfort for the patient and improve gastric function to reduce symptoms. It is useful in managing these symptoms to prevent them from persisting or worsening, thereby contributing to the reduction of daily life discomfort. Therefore, it is used to improve unpleasant digestive symptoms associated with functional dyspepsia.

How to take

Adult dose

○ Adults: Administer 50 mg of itopride hydrochloride orally 3 times daily before meals. Reduce the dose as appropriate according to symptoms.

Precautions

This medication should not be used by individuals who have had allergic reactions to this drug or its components. It should not be administered to patients with gastrointestinal bleeding, obstruction, or perforation, as gastrointestinal motility may be harmful. Furthermore, this medication contains lactose, so it should not be given to patients with galactose intolerance or certain genetic lactose metabolic disorders. While taking this medication, serious allergic reactions such as shock or anaphylaxis may occur, so if symptoms such as hypotension, difficulty breathing, or hives appear, the patient should immediately stop taking the medication and seek medical assistance. It is important to periodically check liver enzyme levels, as hepatic dysfunction or jaundice may occur. Gastrointestinal symptoms such as nausea, diarrhea, constipation, abdominal pain, and increased salivation may appear, as well as neurological symptoms such as headache, anxiety, sleep disturbances, and dizziness. Hormonal changes such as gynecomastia or increased prolactin levels, and hematological adverse reactions like thrombocytopenia or leukopenia may also occur, so regular blood testing is necessary. Due to potential effects on kidney and liver function, monitoring BUN, creatinine, and liver enzyme levels is required. Rarely, skin rashes, itching, and tremors may occur, and if these adverse reactions are suspected, the patient should immediately stop taking the medication and consult a healthcare professional. This drug enhances the action of acetylcholine, so careful consideration should be given during use, and if gastrointestinal symptoms do not improve, long-term use should be avoided. If taken with anticholinergic medications, the effects of this drug may be reduced, so care should be taken to adjust the dosing intervals accordingly. Women who are pregnant or may become pregnant should only use this medication when the benefits of treatment outweigh the risks, as its safety has not been established. During breastfeeding, since this medication may be secreted in breast milk, administration should be avoided whenever possible, and if necessary, breastfeeding should be discontinued. The safety of this medication in children has not been sufficiently established, so caution is advised when using it, and elderly patients may experience adverse reactions more readily due to decreased bodily functions, therefore symptom observation and dosage adjustment are necessary. This medication should be kept out of reach of children, and transferring it to another container can lead to safety incidents and quality degradation, so care should be taken.

Side effects

  • Shock
  • anaphylactic-like symptoms
  • low blood pressure
  • difficulty breathing
  • laryngeal edema
  • hives
  • pallor
  • sweating
  • liver dysfunction
  • jaundice
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  • nausea
  • diarrhea
  • constipation
  • abdominal pain
  • increased salivation
  • headache
  • anxiety
  • sleep disturbances
  • dizziness
  • gynecomastia
  • increased prolactin
  • thrombocytopenia
  • leukopenia
  • increased BUN
  • increased creatinine
  • increased AST
  • increased ALT
  • increased γ-GTP
  • increased ALP
  • rash
  • erythema
  • itching
  • tremor
  • chest pain
  • back pain
  • fatigue
  • heartburn
  • thirst
  • abdominal distension

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 it is advisable to keep it at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

White, round film-coated tablet

Package unit

30 tablets/bottle, 500 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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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.