Medication info

Itopride Tablet (Itopride Hydrochloride)

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

MFDS item code 201507996 · Approved 2015.11.30

This product's status changed to Expired on 2025.11.30. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of symptoms of functional dyspepsia (e.g., abdominal bloating, heartburn, and nausea)
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
KPMG Co., Ltd.

Efficacy & effects

Improvement of symptoms of functional dyspepsia (e.g., abdominal bloating, heartburn, and nausea)

  • Abdominal bloating
  • upper abdominal pain
  • loss of appetite
  • heartburn
  • nausea
  • vomiting
View approved original text

This medication helps relieve gastrointestinal symptoms such as abdominal bloating, upper abdominal pain, loss of appetite, heartburn, nausea, or vomiting that occur due to functional dyspepsia. It aids in improving these symptoms, allowing patients to have a more comfortable digestion. Thus, it is used to treat various gastrointestinal symptoms caused by 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 patients who are allergic to this drug or its components or have a history of hypersensitivity reactions. As this drug stimulates gastrointestinal motility, it may be harmful to patients with gastrointestinal problems such as gastrointestinal bleeding, mechanical obstruction, or perforation. Additionally, since this drug contains lactose, patients with genetic metabolic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take it. While taking this drug, serious allergic reactions such as shock or anaphylaxis may occur, so symptoms should be carefully monitored. If there is a sudden drop in blood pressure or symptoms such as shortness of breath, hives, or sweating, the medication should be stopped immediately, and medical assistance should be sought. As liver function abnormalities may occur, liver function tests (AST, ALT, γ-GTP, etc.) should be conducted regularly, and the medication should be discontinued if liver dysfunction or jaundice symptoms appear. This drug can affect the digestive system, which may result in symptoms such as nausea, diarrhea, constipation, abdominal pain, and increased salivation. Central nervous system symptoms such as headache, anxiety, sleep disturbances, and dizziness may also occur rarely, so caution is advised. Endocrine abnormalities such as gynecomastia or increased prolactin levels may appear; if unusual symptoms occur, the medication should be stopped, and advice from a physician should be sought. If blood tests reveal thrombocytopenia or leukopenia, the medication should be discontinued, and appropriate treatment should be received. It may also affect kidney function, so it is advisable to regularly check BUN or creatinine levels. If hypersensitivity reactions such as skin rash, redness, or itching occur while taking this medication, it should be stopped immediately. Extrapyramidal symptoms such as tremors may occur, and if symptoms are present, consultation with a physician is necessary. Symptoms such as chest or back pain and fatigue may rarely occur, so one should closely monitor physical condition. This drug enhances acetylcholine action, so it should be used cautiously considering this point. If gastrointestinal symptoms do not improve, care should be taken not to continue use for an extended period. When taken with anticholinergics, the effectiveness of this medication may decrease, so caution should be exercised with sufficient intervals between doses. Pregnant women or those who may become pregnant should use this medication only when the benefits of therapy outweigh the risks, as its safety has not been established. If breastfeeding, this drug may pass into breast milk, so it is advisable to avoid taking it; if unavoidable, breastfeeding should be discontinued. Safety in children has not been fully established, so it should be administered cautiously to children. Older adults may experience adverse reactions more easily due to decreased bodily function, so symptoms should be closely monitored, and dosage adjusted if necessary. This drug should be kept out of reach of children and stored in a tightly closed container to prevent accidental ingestion or degradation of the drug quality.

Side effects

  • Shock
  • symptoms resembling anaphylaxis
  • hypotension
  • dyspnea
  • laryngeal edema
  • urticaria
  • pallor
  • sweating
  • hepatic dysfunction
  • jaundice
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  • nausea
  • diarrhea
  • constipation
  • abdominal pain
  • increased salivation
  • headache
  • agitation
  • sleep disorders
  • dizziness
  • gynecomastia
  • increased prolactin
  • thrombocytopenia
  • leukopenia
  • increased BUN
  • elevated creatinine
  • increased AST
  • increased ALT
  • elevated γ-GTP
  • increased ALP
  • rash
  • erythema
  • pruritus
  • tremors
  • 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 closed container to prevent air or moisture intrusion. It is best to keep the storage temperature between 1 degree and 30 degrees Celsius at room temperature. This storage method will help maintain the medication's efficacy and safety.

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.

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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.