Medication info
Itoproz Tablet (Itopride Hydrochloride)

Itoproz Tablet (Itopride Hydrochloride)

Prescription medicationTabletOral
Ingredient · strength
Itopride Hydrochloride›50mg / 1 tablet
Manufacturer / importer
Medix Pharmaceutical Co., Ltd.
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201901494 · Approved 2019.03.11

Summary

Main use
Relief of functional dyspepsia symptoms (abdominal bloating, heartburn, nausea, etc.)
Who takes it
Adults
Adult dose
○ Adults: Administer 50 mg of itopride hydrochloride orally 3 times daily before meals. Adjust the dose appropriately according to symptoms.

Ingredients

Manufacturer
Medix Pharmaceutical Co., Ltd.

Efficacy & effects

Relief of functional dyspepsia symptoms (abdominal bloating, heartburn, nausea, etc.)

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

This medication is used to relieve various gastrointestinal symptoms caused by functional dyspepsia, including 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. Adjust the dose appropriately according to symptoms.

Precautions

This medication should not be used in patients with an allergic reaction or hypersensitivity history to this medication or its ingredients. It should not be administered to patients for whom gastrointestinal stimulation may be harmful, such as those with gastrointestinal bleeding, mechanical obstruction, or perforation. Since this medication contains lactose, it should not be used in patients with genetic issues such as lactose intolerance, lactose enzyme deficiency, or glucose-galactose malabsorption. Serious allergic reactions, such as shock or anaphylaxis, may occur during treatment, so symptoms should be closely monitored. Liver dysfunction or jaundice may occur, so liver function tests should be checked regularly, and medication should be discontinued immediately if abnormalities are found. Gastrointestinal symptoms such as nausea, diarrhea, constipation, abdominal pain, and increased salivation may occur. Neurological side effects such as headache, anxiety, sleep disturbances, and dizziness may occur. Endocrine-related symptoms may include gynecomastia or increased prolactin levels, so medication should be stopped if these symptoms appear. Blood tests may show decreased platelets or white blood cell count, so regular blood tests are necessary, and medication should be discontinued if abnormalities are found. It may affect kidney function, so blood levels of BUN and creatinine should be monitored. Hypersensitivity reactions such as skin rash, redness, and itching may rarely occur, so medication should be stopped if symptoms appear. Extrapyramidal symptoms such as tremors may occur, so symptom observation is necessary, and medication should be stopped if abnormalities are noted. Chest or back pain and fatigue may occur, so symptoms should be carefully monitored. This medication enhances the action of acetylcholine, so this should be considered when using it, and long-term use is not recommended if gastrointestinal symptoms do not improve. Caution is needed when taken with anticholinergics, as it may reduce the effectiveness of this medication, so dosage intervals should be adjusted accordingly. The safety during pregnancy has not been established, and it should only be administered when the benefits of treatment exceed the risks, while it may be excreted in breast milk, so it is recommended to avoid use or discontinue breastfeeding if possible. Safety in children has not been sufficiently confirmed, so caution is required for use. In the elderly, decreased physiological function may make adverse reactions more likely, so symptoms should be closely observed, and dosage adjustments or temporary cessation should be considered as needed. Keep out of reach of children and store in a safe place; transferring to another container can pose risks of accidents and degradation of quality.

Side effects

  • Shock
  • anaphylaxis-like symptoms
  • hypotension
  • dyspnea
  • laryngeal edema
  • urticaria
  • pallor
  • sweating
  • hepatic dysfunction
  • jaundice
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  • nausea
  • diarrhea
  • constipation
  • abdominal pain
  • increased salivation
  • headache
  • anxiety
  • sleep disturbances
  • 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 should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1°C and 30°C.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 300 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.