Medication info

Dantone Tablets (Itopride Hydrochloride)

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

MFDS item code 202003347 · Approved 2020.05.08

This product's status changed to Expired on 2025.05.08. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement 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
The U Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medication is used to relieve various digestive symptoms caused by functional dyspepsia, such as abdominal distension, 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 allergic reactions to this medicine or its components. It should also not be administered to patients for whom gastrointestinal motility 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 disorders that prevent the digestion of lactose. Severe allergic reactions such as shock or anaphylaxis may occur during the course of treatment, and administration should be stopped immediately, and appropriate treatment should be sought if symptoms appear. Liver function disorders or jaundice may occur, so liver health should be monitored closely. Gastrointestinal symptoms such as nausea, diarrhea, constipation, abdominal pain, and increased salivation may also appear. Neurological symptoms like headaches, anxiety, sleep disturbances, and dizziness may occur. Endocrine abnormalities such as gynecomastia or elevated prolactin levels may occur, so patients should consult their doctor if any unusual symptoms arise. Blood abnormalities such as thrombocytopenia or leukopenia may occur, necessitating regular blood tests. Due to potential effects on kidney function, blood levels of BUN and creatinine should be monitored. Liver enzyme levels may rise, so regular liver function tests are recommended. Hypersensitivity reactions such as rash, erythema, and itching may occur rarely, so skin conditions should be monitored closely. Extrapyramidal symptoms like hand tremors may occur; if they appear, administration should be stopped, and medical advice should be sought. Chest or back pain and fatigue may occur, so if these symptoms persist, patients should consult their doctor. This medication enhances the action of acetylcholine, so this should be considered during its use. If digestive symptoms do not improve, long-term use should be avoided. When taken with anticholinergic drugs, the efficacy of this medication may decrease, so a cautious approach should be taken regarding dosing intervals when used together. Women who are pregnant or may become pregnant should only use this medication if the benefit outweighs the risks, as its safety has not been established. This medication may be excreted in breast milk, so breastfeeding should be avoided during treatment, or breastfeeding should be suspended if necessary. The safety for pediatric patients has not been sufficiently established and should be administered cautiously. Since elderly patients may easily exhibit abnormal reactions due to decreased physiological function, symptoms should be monitored closely, and doses should be adjusted as needed. Store this medication out of reach of children and avoid transferring it to another container, as this can cause accidents or compromise 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
  • increased 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 distension

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, avoid locations that are too hot or too cold, and it is best to store it at room temperature between 1 degree Celsius and 30 degrees Celsius.

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.