Medication info

Donggu Itopride Hydrochloride Tablet 50 mg

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

MFDS item code 201307590 · Approved 2013.06.03

This product's status changed to Expired on 2024.12.03. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of functional dyspepsia symptoms (such as abdominal bloating, upper abdominal pain, 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
Donggu Bio Pharmaceutical Co., Ltd.

Efficacy & effects

Relief of functional dyspepsia symptoms (such as abdominal bloating, upper abdominal pain, and nausea)

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

This drug is used to relieve gastrointestinal symptoms such as abdominal bloating, upper abdominal pain, loss of appetite, heartburn, nausea, and vomiting 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 drug should not be used in patients who have had an allergic reaction to this drug or its components. Administration to patients with gastrointestinal bleeding, mechanical bowel obstruction, perforation, and other conditions where gastrointestinal motility stimulation may be harmful should be avoided. This drug contains lactose, so it should not be used in patients with lactose intolerance or genetic lactose metabolism disorders. While using this drug, severe allergic reactions such as shock or anaphylaxis may occur; if symptoms appear, administration should be immediately stopped, and appropriate treatment should be sought. As it may affect liver function, if liver enzyme levels increase or jaundice symptoms appear, administration should be stopped and medical attention should be sought. Gastrointestinal symptoms such as nausea, diarrhea, constipation, abdominal pain, and increased saliva secretion may occur, so caution is required. Central nervous system symptoms such as headaches, anxiety, sleep disturbances, and dizziness may also occur. If endocrine abnormalities such as gynecomastia or elevated prolactin levels occur, use should be discontinued, and a doctor should be consulted. Regular blood tests may be necessary as platelet or white blood cell counts may decrease; administration should be stopped if abnormalities are found. It may also impact kidney function, so it is advisable to undergo renal function tests. Rarely, hypersensitivity reactions such as skin rash, redness, and itchiness may occur; if unusual symptoms arise, a doctor should be notified immediately. Extrapyramidal symptoms such as tremors may also occur, and administration should be stopped if these symptoms appear. Caution is also needed in case of chest or back pain and fatigue. This drug enhances the action of acetylcholine, so it should be used with consideration of this effect, and if gastrointestinal symptoms do not improve, long-term use should be avoided. When used with anticholinergics, the effect of this drug may be diminished; thus, the intervals of administration should be adjusted or used with caution. Safety during pregnancy is not established, hence it should be administered only when deemed necessary by a doctor, and during breastfeeding, administration should be avoided or breastfeeding should be discontinued as this drug may be secreted in breast milk. Safety in children has not been sufficiently confirmed, so it should be used cautiously. Elderly patients may exhibit adverse reactions more readily due to decreased physical function, so symptoms should be carefully monitored, and dose adjustments should be made if necessary. This drug should be kept out of the reach of children, and it is advisable not to transfer it to other containers for safety and quality maintenance.

Side effects

  • Shock
  • anaphylactic-like symptoms
  • hypotension
  • respiratory distress
  • laryngeal edema
  • urticaria
  • pallor
  • sweating
  • liver dysfunction
  • jaundice
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  • nausea
  • diarrhea
  • constipation
  • abdominal pain
  • increased saliva
  • headache
  • anxiety
  • sleep disturbances
  • dizziness
  • gynecomastia
  • elevated prolactin
  • thrombocytopenia
  • leukopenia
  • elevated BUN
  • elevated creatinine
  • elevated AST
  • elevated ALT
  • elevated γ-GTP
  • elevated ALP
  • rash
  • erythema
  • pruritus
  • tremor
  • chest pain
  • back pain
  • fatigue
  • heartburn
  • thirst
  • abdominal distention

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

Storage

This drug should be stored in a sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature. Storing it this way helps preserve the drug's efficacy and prevent deterioration.

Appearance and packaging

Appearance

White round film-coated tablets

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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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.