Medication info

Ganapride Tablets (Itopride Hydrochloride)

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

MFDS item code 201305008 · Approved 2013.02.14

Summary

Main use
Improvement of functional dyspepsia symptoms (e.g., abdominal distension, 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
Huons Bio Pharmaceutical Co., Ltd.

Efficacy & effects

Improvement of functional dyspepsia symptoms (e.g., abdominal distension, upper abdominal pain, and nausea)

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

This medication is used to relieve various gastrointestinal symptoms associated with functional dyspepsia, such as abdominal bloating, upper abdominal pain, loss of appetite, heartburn, nausea, and vomiting.

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 in patients who have had an allergic reaction to this drug or its ingredients. It should not be administered to patients for whom gastrointestinal motility stimulation could be harmful, such as those with gastrointestinal bleeding, obstruction, or perforation. Additionally, it contains lactose, so it should not be used in patients with lactose intolerance, galactose intolerance, or genetic metabolic disorders. During treatment, patients must be closely monitored for serious allergic reactions such as shock, breathing difficulties, and low blood pressure. There may be liver dysfunction or symptoms of jaundice, so regular liver function tests should be conducted, and the medication should be discontinued immediately if abnormal symptoms occur. Gastrointestinal adverse effects such as nausea, diarrhea, constipation, abdominal pain, and increased salivation may occur, so symptoms must be monitored. Neurological symptoms such as headaches, anxiety, sleep disturbances, and dizziness may also arise, requiring caution. If endocrine abnormalities such as gynecomastia or increased prolactin levels occur, patients must consult a physician immediately. Regular blood tests are necessary as thrombocytopenia or leukopenia may appear in blood tests. Kidney function tests may show increased BUN and creatinine levels, so renal status should be monitored. Elevated liver enzymes and allergic reactions such as skin rashes and itching may rarely occur, requiring discontinuation of the medication if abnormal symptoms are observed. Symptoms such as tremors, chest pain, and fatigue have also been reported, so patients should observe any changes in their condition closely. This medication enhances acetylcholine action, so it should be used cautiously with this in mind. If gastrointestinal symptoms do not improve, long-term use is not recommended. When taking it with anticholinergics, care should be taken as the effectiveness of this medication may be diminished; intervals between doses should be adjusted accordingly. Pregnant women or women who may become pregnant should only take this medication if absolutely necessary due to the lack of established safety. Breastfeeding women should avoid this medication as it may be excreted in breast milk; if unavoidable, breastfeeding should be discontinued. Safety in children has not been sufficiently established, so caution in use is advised. Elderly patients may have decreased bodily functions, making adverse reactions more likely, thus close monitoring of symptoms and possible dosage adjustments may be required. This medication should be kept out of reach of children and transferring it to another container can pose risks of accidental ingestion and quality deterioration.

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
  • feelings of anxiety
  • sleep disorders
  • dizziness
  • gynecomastia
  • elevated prolactin
  • thrombocytopenia
  • leukopenia
  • elevated BUN
  • elevated creatinine
  • elevated AST
  • elevated ALT
  • elevated γ-GTP
  • elevated ALP
  • rash
  • redness
  • 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 must be stored in a tightly sealed container to prevent air and moisture intrusion. It is important to maintain storage temperatures between 1 degree and 30 degrees Celsius. Proper storage will help ensure the medication's effectiveness.

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.