Medication info

Mega Ito Tablet (Itopride Hydrochloride)

Prescription medicationTabletOralApproval withdrawn
Ingredient · strength
Itopride Hydrochloride›50mg / 1 tablet
Manufacturer / importer
LNC Bio Co., Ltd.
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 202000338 · Approved 2020.01.21

This product's status changed to Approval withdrawn on 2024.07.02. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

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

Ingredients

Manufacturer
LNC Bio Co., Ltd.

Efficacy & effects

Relief of symptoms of functional dyspepsia (including abdominal bloating, heartburn, and nausea)

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

This medication is used to alleviate gastrointestinal 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 itopride hydrochloride 50 mg orally 3 times daily before meals. Reduce the dose appropriately according to symptoms.

Precautions

This medication should not be used in patients who have a hypersensitivity reaction or have previously experienced an allergic reaction to this medication or its components. It should not be administered to patients for whom gastrointestinal motility stimulation may be risky, such as those with gastrointestinal bleeding, mechanical intestinal obstruction, or perforation. Since this medication contains lactose, it should be avoided in patients with lactose intolerance or specific genetic disorders. Serious allergic reactions such as shock or anaphylaxis may occur during treatment with this medication, so symptoms should be monitored carefully. Since liver dysfunction or jaundice symptoms may appear, liver health should be monitored regularly, and the medication should be discontinued immediately if any abnormal signs arise. Gastrointestinal symptoms such as nausea, diarrhea, constipation, abdominal pain, and increased salivation may occur; if discomfort persists, consult with medical personnel. Neurological symptoms such as headache, anxiety, sleep disturbances, and dizziness may also occur, so conditions should be observed carefully. Endocrine abnormalities such as gynecomastia or elevated prolactin levels may occur, so appropriate measures should be taken according to physician's instructions. Blood tests may reveal a decrease in platelet or white blood cell counts, hence regular blood tests are necessary, and the medication should be discontinued if abnormalities are found. It may affect kidney function, so blood BUN and creatinine levels should be monitored. Liver enzyme levels may increase, so liver conditions should be monitored consistently. Rarely, hypersensitivity reactions such as skin rash, redness, and itching may occur; if symptoms appear, the medication should be discontinued immediately. Extrapyramidal symptoms such as tremors may occur, and medical staff should be consulted if symptoms arise. Chest or back pain and fatigue may occur; if these symptoms persist, consulting a specialist is advisable. This medication enhances the action of acetylcholine, so care should be taken regarding interactions with other medications. If gastrointestinal symptoms do not improve, it should not be used for an extended period and should be taken strictly according to a physician's instructions. Co-administration with anticholinergic agents may reduce the effectiveness of this medication, so caution is required in adjusting the dosing intervals. Women who are pregnant or may become pregnant should use this medication only when the benefits of treatment outweigh the risks, as its safety has not been established. During breastfeeding, since this medication can be excreted in breast milk, it should be avoided if possible, and if unavoidable, breastfeeding should be discontinued. Safety for children has not been adequately confirmed, so it should be administered cautiously to children. Elderly patients should be monitored closely for adverse reactions due to decreased physical functions, and doses should be adjusted if necessary. This medication should be stored in a safe place out of the reach of children, and care should be taken not to transfer it to other containers as this may cause accidents or affect the quality.

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
  • increased salivation
  • headache
  • restlessness
  • 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 should be stored in a sealed container to protect it from air and moisture. It is advisable to maintain the storage temperature between 1 degree and 30 degrees Celsius to ensure the effectiveness of the medication and prevent deterioration.

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.