Medication info

Daewoong Bio Itopride Tablet (Itopride Hydrochloride)

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

MFDS item code 202000140 · Approved 2020.01.08

This product's status changed to Expired on 2025.01.08. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of functional dyspepsia symptoms (e.g., abdominal bloating, upper abdominal pain, and nausea)
Who uses it
Adults
Adult dosage
Adults: Administer itopride hydrochloride 50 mg orally per dose, 3 times daily before meals. Reduce the dose appropriately according to symptoms.

Ingredients

Manufacturer
Daewoong Bio Co., Ltd.

Efficacy & effects

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

  • Functional dyspepsia
  • abdominal bloating
  • epigastric pain
  • loss of appetite
  • heartburn
  • nausea
  • vomiting
View approved original text

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

Dosage and Administration

Adult dosage

Adults: Administer itopride hydrochloride 50 mg orally per dose, 3 times daily before meals. Reduce the dose appropriately according to symptoms.

Precautions

This medication should not be used in patients who have had allergic reactions to this drug or any of its components. This medication is contraindicated in patients with gastrointestinal issues such as gastrointestinal bleeding, mechanical obstruction, or perforation, as it may stimulate gastrointestinal motility and worsen their condition. Since this medication contains lactose, it should not be taken by patients with problems breaking down lactose, such as galactose intolerance or lactose deficiency. Serious allergic reactions like shock or anaphylaxis may occur while taking this medication, so if any symptoms appear, immediately stop taking the medication and consult a healthcare professional. Liver function disorders or jaundice symptoms may occur, so it is recommended to regularly check liver health while taking this medication. Gastrointestinal adverse effects like nausea, diarrhea, constipation, and abdominal pain may occur, so consult a doctor if symptoms persist. Neuropsychiatric symptoms such as headache, anxiety, sleep disturbances, and dizziness may occur, so caution is needed. Gynecomastia or elevated prolactin levels may occur, so if any unusual symptoms arise, stop taking the medication and consult a professional. Blood-related abnormalities like thrombocytopenia or leukopenia may occur, so regular blood tests and monitoring are necessary. Renal function tests may also be required, and elevations in BUN or creatinine levels may occur. Rarely, hypersensitivity reactions such as skin rash, erythema, or itching may occur, so inform a doctor immediately if symptoms occur. Extrapyramidal symptoms like tremors may present, and if they do, stop administration and consult a healthcare professional. Chest or back pain and fatigue have also been reported, so carefully monitor for any unusual symptoms. This drug enhances acetylcholine action, so use it with consideration, and it is recommended not to use it for prolonged periods if gastrointestinal symptoms do not improve. When taken with anticholinergics, the effectiveness of this medication may be reduced, so caution is needed in adjusting the timing of administration. Safety during pregnancy has not been established, so it should only be used cautiously when necessary; during breastfeeding, it may be excreted into breast milk, so administration should be avoided or breastfeeding should be discontinued if possible. Safety in children has not been sufficiently established, so caution is warranted in its use. In elderly patients, declining physical function may make them more susceptible to adverse reactions, so careful monitoring is needed, and dose adjustment or drug cessation may be considered as necessary. Lastly, this medication should be kept out of reach of children, and transferring it to another container may pose a risk of accident and deterioration of quality, so caution is advised.

Side effects

  • Shock
  • anaphylactic-like symptoms
  • hypotension
  • dyspnea
  • laryngeal edema
  • urticaria
  • pallor
  • sweating
  • hepatic dysfunction
  • jaundice
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  • nausea
  • diarrhea
  • constipation
  • abdominal pain
  • sialorrhea
  • 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
  • itching
  • tremor
  • chest pain
  • back pain
  • fatigue
  • heartburn
  • thirst
  • abdominal distention

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 best stored at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

For domestic use - 30 tablets/bottle, For domestic use - 500 tablets/

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.