Medication info

Edis D Tablets

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Tripotassium Bismuth Dicitrate›200mg / 1 tabletRanitidine Hydrochloride›168mg / 1 tabletSucralfate Hydrate›600mg / 1 tablet
Manufacturer / importer
(주)이든파마
Appearance
Light green oblong film-coated tablets
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201508508 · Approved 2015.12.30

This product's status changed to Approval withdrawn on 2024.03.19. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of gastrointestinal diseases such as gastric ulcers and gastritis and prevention of Mendelson syndrome
Who takes it
Adults · Children
Adult dose
Generally, 1 tablet should be taken twice daily, regardless of meals, in the morning and before bedtime. 1) Gastric ulcers and duodenal ulcers: Administer 1 tablet twice a day or administer 2 tablets once daily before bedtime. Especially for patients with duodenal ulcers, administering 2 tablets twice a day in the morning and before bedtime can achieve a higher treatment rate. 2) Gastroesophageal reflux disease: Take 1 tablet twice daily for 8 weeks.
Child dose
For children aged 8-18 years, take 1 tablet (2 mg/kg of Ranitidine) twice a day.

Ingredients

Manufacturer
(주)이든파마

Efficacy & effects

Treatment of gastrointestinal diseases such as gastric ulcers and gastritis and prevention of Mendelson syndrome

  • Gastric ulcers
  • gastritis
  • duodenal ulcers
  • Zollinger-Ellison syndrome
  • gastroesophageal reflux disease
  • Mendelson syndrome
  • post-surgical ulcers
  • gastric and duodenal ulcers due to non-steroidal anti-inflammatory drugs (NSAIDs)
View approved original text

This medication is effectively used for gastrointestinal diseases such as gastric ulcers, gastritis, duodenal ulcers, and Zollinger-Ellison syndrome, as well as for gastroesophageal reflux disease. Additionally, it can prevent Mendelson syndrome when administered preoperatively and assists in the treatment of post-surgical ulcers. It is also applicable for treating ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). It helps improve symptoms and treat various gastrointestinal conditions.

How to take

Adult dose

Generally, 1 tablet should be taken twice daily, regardless of meals, in the morning and before bedtime. 1) Gastric ulcers and duodenal ulcers: Administer 1 tablet twice a day or administer 2 tablets once daily before bedtime. Especially for patients with duodenal ulcers, administering 2 tablets twice a day in the morning and before bedtime can achieve a higher treatment rate. 2) Gastroesophageal reflux disease: Take 1 tablet twice daily for 8 weeks.

Child dose

For children aged 8-18 years, take 1 tablet (2 mg/kg of Ranitidine) twice a day.

Precautions

This medication should not be used in patients undergoing dialysis or those allergic to Ranitidine Hydrochloride. Patients with impaired kidney function may require a reduced dosage or increased dosing interval due to prolonged retention of the medication in the body, and those with liver function issues should use it cautiously. Patients with a history of allergic reactions to this medication or the elderly should also take it with care. While using this medication, serious shock reactions may occur rarely; therefore, patients should be observed carefully, and if abnormal symptoms appear, the medication should be stopped immediately, and appropriate treatment should be sought. If allergic symptoms such as skin rash, urticaria, swelling, fever, respiratory distress, or low blood pressure develop, the administration of the drug must be stopped immediately. Blood tests may show a temporary decrease in white blood cells or platelets, and liver function tests may show a temporary increase or symptoms of hepatitis may appear. Arrhythmias or heart palpitations have been reported rarely, so caution is needed for patients with heart diseases. Gastrointestinal symptoms may include nausea, vomiting, constipation, diarrhea, abdominal bloating, and abdominal pain, and stool color may turn black, although this does not require special treatment. Nervous system side effects such as dizziness, drowsiness, confusion, seizures, insomnia, and headaches may occur infrequently. Cases of gynecomastia or sexual dysfunction have been reported, but direct correlation with this drug is not certain. Joint pain, skin rashes, hair loss, itching, inflammation of the tongue, and even blackening of the tongue can occur rarely, although it usually returns to normal after some time. Long-term use of this medication is not advisable, and patients with kidney disease should consult a doctor or pharmacist before taking it. Therapeutic effects should be confirmed while using the minimum effective dose, and if ineffective, alternative medications should be adopted. Pregnant women or those who may become pregnant should only use this medication if the therapeutic benefits outweigh the risks as its safety is not established. This medication is excreted in breast milk, so breastfeeding should be avoided while taking it. Safety for children has not been fully confirmed, so caution is necessary when using it. Some urine tests may yield false positive results, so it's advisable to use specific testing methods for accurate results. In case of overdose, emergency measures such as vomiting or gastric lavage may be necessary, and in some instances, blood dialysis may be performed to eliminate the drug. This medication can mask symptoms of gastric cancer, so it should only be used after confirming that it is not a malignant disease, and ocular health should be monitored through eye examinations during long-term use.

Side effects and when to seek care immediately

Serious side effects

Shock, bronchospasm, severe allergic reactions (urticaria, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor), severe skin adverse reactions (severe rashes, blisters, skin peeling, mucosal pain in the mouth/eyes), liver abnormalities (jaundice), severe edema or urination abnormalities (systemic severe edema, accompanied by increased blood pressure)

Mild side effects

Skin rash, hives, fever, angioedema, low blood pressure, blood abnormalities (reversible leukopenia, thrombocytopenia, elevated serum enzyme levels, agranulocytosis, pancytopenia, eosinophilia), liver dysfunction (temporary increases in S-GOT, S-GPT, r-GPT, ALP, icteric or non-icteric hepatitis), arrhythmias (tachycardia, bradycardia, heart block, premature ventricular contractions), nausea, vomiting, constipation, diarrhea, abdominal bloating, abdominal pain

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

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture ingress. It is important to maintain a storage temperature between 1 and 30 degrees Celsius to preserve the medication's efficacy and safety for an extended period.

Appearance and packaging

Appearance

Light green oblong film-coated tablets

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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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.