Medication info

Ranibis Tablets

Prescription medicationApproval withdrawn
Ingredient · strength
Ranitidine Hydrochloride›Strength being verifiedSucralfate Hydrate›Strength being verifiedTripotassium Bismuth Dicitrate›Strength being verified
Manufacturer / importer
구주제약(주)
Appearance
White round film-coated tablets
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201403919 · Approved 2014.08.22

This product's status changed to Approval withdrawn on 2023.06.02. 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 and duodenal ulcers, gastritis
Who uses it
Adults
Adult dosage
Typically, administer 2 tablets orally, twice a day before meals and at bedtime, regardless of meals. 1) Gastric and duodenal ulcers: Administer either 2 tablets twice a day or 4 tablets once a day at bedtime. For duodenal ulcer patients, 4 tablets can be given twice a day, morning and at bedtime. 2) Gastroesophageal reflux disease: Administer 2 tablets twice a day for 8 weeks or 4 tablets once a day at bedtime.

Ingredients

Manufacturer
구주제약(주)

Efficacy & effects

Treatment of gastrointestinal diseases such as gastric and duodenal ulcers, gastritis

  • Gastric and duodenal ulcers
  • gastritis
  • Zollinger-Ellison syndrome
  • gastroesophageal reflux disease
  • Mendelson's syndrome
  • post-operative ulcers
  • gastric and duodenal ulcers caused by non-steroidal anti-inflammatory drugs
View approved original text

This medication is used to treat gastrointestinal diseases such as gastric and duodenal ulcers, gastritis, Zollinger-Ellison syndrome, and gastroesophageal reflux disease. It is particularly effective in preventing and treating gastric and duodenal ulcers caused by NSAIDs (non-steroidal anti-inflammatory drugs). Additionally, it is used to prevent Mendelson's syndrome when administered prior to anesthesia and to treat ulcers that may occur post-surgery. This medication regulates gastric acid secretion, protects the digestive tract, and improves symptoms, helping to maintain and improve the patient's gastric health.

Dosage and Administration

Adult dosage

Typically, administer 2 tablets orally, twice a day before meals and at bedtime, regardless of meals. 1) Gastric and duodenal ulcers: Administer either 2 tablets twice a day or 4 tablets once a day at bedtime. For duodenal ulcer patients, 4 tablets can be given twice a day, morning and at bedtime. 2) Gastroesophageal reflux disease: Administer 2 tablets twice a day for 8 weeks or 4 tablets once a day at bedtime.

Precautions

This medication should not be used in patients undergoing dialysis or in those with kidney function issues. Additionally, it should not be administered to patients who have had allergic reactions to this medication or its components, have a history of acute porphyria, have undergone upper gastrointestinal surgery, are pregnant or may become pregnant, are premature infants or newborns, or are on a dietary regimen that restricts potassium intake. Caution should be taken when administering this medication to patients with liver dysfunction, a history of drug allergies, the elderly, those with a history of kidney disease, and patients taking non-steroidal anti-inflammatory drugs concurrently. Particularly, since it may mask symptoms of gastric cancer, it should be used in patients with gastric ulcers or new digestive symptoms occurring in those aged 40 and above only after malignancy has been ruled out. Patients with helicobacter pylori infections need bacterial eradication therapy, and caution should be exercised when using this medication in patients in severe intensive care or with hypophosphatemia and dysphagia. Rarely, anaphylactic shock, skin rash, urticaria, or angioedema may occur, and if symptoms appear, administration should be stopped immediately, and appropriate treatment should be received. Blood tests may reveal leukopenia, thrombocytopenia, or hepatic dysfunction; if abnormal symptoms arise, administration should be halted, and testing should be done. Symptoms such as cardiac arrhythmias, nausea, vomiting, constipation, diarrhea, headache, dizziness, drowsiness, confusion, agitation, insomnia, and headache may occur, and medical consultation should be sought if these symptoms appear. Avoid long-term use, and if treatment effects are not observed, consider switching to another medication, especially in the elderly or chronically ill patients, as there may be an increased risk of pneumonia. It is advisable to avoid driving or operating dangerous machinery while taking this medication. Additionally, this medication can interact with other medications, so if there are other concomitant drugs, be sure to inform healthcare professionals, paying particular attention to anticoagulants or certain antibiotics. Pregnant or breastfeeding women should not take this medication, and its safety in children has not been established, so it is best not to administer it to them. In cases of overdose, treatments such as vomiting or gastric lavage may be necessary, and regular check-ups, including ophthalmologic examinations, are recommended for long-term users.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (including angioedema), tightness in the chest, difficulty breathing, shock (anaphylactic shock), severe allergic reactions, severe skin reactions (including mild erythema multiforme), jaundice hepatitis, non-jaundice hepatitis, hepatic dysfunction (including jaundice), sudden and severe headaches, seizures, altered consciousness, visual disturbances, paralysis, rhabdomyolysis, severe swelling of the body accompanied by increased blood pressure.

Mild side effects

  • Skin rash
  • angioedema
  • fever
  • bronchospasm
  • low blood pressure
  • chest pain
  • granulocytopenia
  • leukopenia
  • thrombocytopenia
  • elevated serum enzyme levels
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  • agranulocytosis
  • pancytopenia
  • eosinophilia
  • elevated AST
  • ALT
  • r-GTP
  • ALP
  • tachycardia
  • bradycardia
  • AV block
  • premature ventricular contractions
  • vasculitis
  • nausea
  • vomiting
  • constipation
  • diarrhea
  • abdominal bloating
  • abdominal pain
  • loss of appetite
  • dizziness
  • drowsiness
  • confusion
  • agitation
  • insomnia
  • headache

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

Storage

Store this medication in a tightly closed container to prevent air from entering, ideally at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication.

Appearance and packaging

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 500 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.