Medication info

Lubis D Tablet

Prescription medicationApproval withdrawn
Ingredient · strength
Tripotassium Bismuth Dicitrate›Strength being verifiedRanitidine Hydrochloride›Strength being verifiedSucralfate Hydrate›Strength being verified
Manufacturer / importer
한국휴텍스제약(주)
Appearance
Light green, rectangular film-coated tablets
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201905082 · Approved 2019.07.19

This product's status changed to Approval withdrawn on 2023.05.10. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of gastric and duodenal ulcers, gastritis, and other gastrointestinal disorders
Who uses it
Adults
Adult dosage
Generally administered orally as 1 tablet, twice daily before breakfast and bedtime, regardless of meals. 1) Gastric and duodenal ulcers Administer 1 tablet, twice daily, or 2 tablets, once daily before bedtime. Especially in patients with duodenal ulcers, administering 2 tablets, twice daily before breakfast and bedtime can yield a higher treatment rate. For ulcers due to NSAID use or long-term use of NSAIDs in combination therapy to prevent gastric and duodenal ulcer development, the dosage remains the same. Generally, diseases caused by NSAIDs resolve within 4 weeks, but healing time may occasionally be extended depending on the patient. For patients with recurrent ulcers who have had excellent results with short-term therapy, a maintenance dose of 1 tablet, once daily before bedtime is recommended. 2) Gastroesophageal reflux disease Administer 1 tablet, twice daily for 8 weeks, or 2 tablets, once daily before bedtime. However, in patients with severe gastroesophageal reflux disease, the dose may be increased to 2 tablets, four times daily. 3) Zollinger-Ellison syndrome Start treatment at an initial dose of 1 tablet, three times daily, increasing as necessary. In cases of severe disease, a total of up to 6 grams of ranitidine may be administered daily as directed by a physician. 4) Peptic ulcers, acute stress ulcers, and upper gastrointestinal bleeding due to acute gastric mucosal lesions Once oral administration is possible, switch from injection to oral administration of 1 tablet, twice daily. 5) Pre-anesthesia (prevention of Mendelson's syndrome) Administer 1 tablet 2 hours before induction of anesthesia. In this case, administering 1 tablet the night before surgery is advisable.

Ingredients

Manufacturer
한국휴텍스제약(주)

Efficacy & effects

Treatment of gastric and duodenal ulcers, gastritis, and other gastrointestinal disorders

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

This medication is used for gastrointestinal disorders such as gastric and duodenal ulcers, gastritis, and gastroesophageal reflux disease. It is also effective in cases of excessive gastric acid secretion, such as Zollinger-Ellison syndrome. It may be administered to prevent Mendelson's syndrome prior to anesthesia, and it helps treat ulcers that may occur post-surgery. It is also used for gastric and duodenal ulcers caused by nonsteroidal anti-inflammatory drugs (NSAIDs). This drug improves various symptoms and diseases related to excess gastric acid.

Dosage and Administration

Adult dosage

Generally administered orally as 1 tablet, twice daily before breakfast and bedtime, regardless of meals. 1) Gastric and duodenal ulcers Administer 1 tablet, twice daily, or 2 tablets, once daily before bedtime. Especially in patients with duodenal ulcers, administering 2 tablets, twice daily before breakfast and bedtime can yield a higher treatment rate. For ulcers due to NSAID use or long-term use of NSAIDs in combination therapy to prevent gastric and duodenal ulcer development, the dosage remains the same. Generally, diseases caused by NSAIDs resolve within 4 weeks, but healing time may occasionally be extended depending on the patient. For patients with recurrent ulcers who have had excellent results with short-term therapy, a maintenance dose of 1 tablet, once daily before bedtime is recommended. 2) Gastroesophageal reflux disease Administer 1 tablet, twice daily for 8 weeks, or 2 tablets, once daily before bedtime. However, in patients with severe gastroesophageal reflux disease, the dose may be increased to 2 tablets, four times daily. 3) Zollinger-Ellison syndrome Start treatment at an initial dose of 1 tablet, three times daily, increasing as necessary. In cases of severe disease, a total of up to 6 grams of ranitidine may be administered daily as directed by a physician. 4) Peptic ulcers, acute stress ulcers, and upper gastrointestinal bleeding due to acute gastric mucosal lesions Once oral administration is possible, switch from injection to oral administration of 1 tablet, twice daily. 5) Pre-anesthesia (prevention of Mendelson's syndrome) Administer 1 tablet 2 hours before induction of anesthesia. In this case, administering 1 tablet the night before surgery is advisable.

Precautions

It is not safe to use this medication in patients undergoing dialysis or with impaired kidney function. Patients who have had allergic reactions to this drug or its components, a history of acute porphyria, have undergone upper gastrointestinal surgery, are pregnant or potentially pregnant, premature infants, and neonates should also not be administered this medication, as well as patients adhering to a potassium-restricted diet. Care should be taken in patients with compromised liver function, a history of drug allergies, elderly patients, patients with kidney issues, and those taking nonsteroidal anti-inflammatory drugs when using this medication. Especially, as this drug may mask symptoms of gastric cancer, patients with gastric ulcers or middle-aged patients recently experiencing new dyspeptic symptoms should confirm that it is not a malignant condition before treatment. Patients with Helicobacter pylori infection and gastric or duodenal ulcers require treatment to eradicate the bacteria. Patients in severe intensive care units, patients with hypophosphatemia, and those with swallowing difficulties also need to be cautious when administered this medication. During treatment with this medication, rare cases of allergic reactions or shock, skin rash, decreased blood cell counts, liver dysfunction, arrhythmias, gastrointestinal symptoms, neurological symptoms, muscle pain, and hair loss may occur, so if any of these symptoms arise, immediate consultation with medical staff is advised. Long-term use should be avoided, and if the treatment effect is absent, it is advisable to switch to another medication. Elderly patients, patients with chronic lung disease, and patients with diabetes may have an increased risk of pneumonia and should be monitored closely. Avoid driving or operating dangerous machinery if dizziness or drowsiness occurs while taking this medication. This drug may interact with other medications, so it is essential to inform the healthcare provider of any other medications being taken. It is safest for women who are pregnant or breastfeeding to avoid using this drug, and its safety for children has not been established, so administration is not recommended. This medication may affect certain clinical test results, so caution is needed during tests. In case of overdose, treatment such as vomiting or gastric lavage may be necessary, and in severe cases, blood dialysis can be performed. Finally, since this drug decreases gastric acid secretion and can promote bacterial growth in the stomach, regular check-ups, including eye exams, are necessary for long-term use.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, bronchospasm, shock (anaphylactic shock), blood vessel swelling, hypotension, chest pain, agranulocytosis, pancytopenia, bone marrow depression, aplastic anemia, acquired immune hemolytic anemia, jaundice, hepatitis, liver dysfunction, abnormal heart rate (tachycardia, bradycardia, heart block, premature ventricular contractions), vasculitis, convulsions, altered consciousness, myoclonus, rhabdomyolysis, erythema multiforme, alopecia

Mild side effects

  • Skin rash
  • fever
  • hypotension
  • chest pain
  • elevated serum enzyme levels
  • nausea
  • vomiting
  • constipation
  • diarrhea
  • abdominal bloating
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  • abdominal pain
  • loss of appetite
  • dizziness
  • drowsiness
  • confusion
  • agitation
  • insomnia
  • headache
  • heaviness in the head
  • malaise
  • anxiety
  • depression
  • hallucinations
  • blurred vision
  • involuntary movement disorders
  • gynecomastia
  • galactorrhea
  • erectile dysfunction
  • decreased libido
  • joint pain
  • muscle pain
  • skin itching
  • glossitis
  • blackening of the tongue

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

Storage

Store this medication in a tightly sealed container to prevent exposure to air or moisture, preferably at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness over time.

Appearance and packaging

Appearance

Light green, rectangular 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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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.