Medication info

Gladitin Tablets (Rafutidine)

Prescription medicationTabletOralExpired
Ingredient · strength
Lafutidine›10mg / 1 tablet
Manufacturer / importer
Kips Biopharma Co., Ltd.
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Expired

MFDS item code 202002003 · Approved 2020.03.20

This product's status changed to Expired on 2025.03.20. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of gastrointestinal disorders (ulcers, gastritis, etc.); preanesthetic medication; combination therapy for Helicobacter pylori
Who takes it
Adults
Adult dose
1. Short-term treatment of gastric ulcers The usual dose is 10mg of lafutidine orally twice daily, in the morning and before bedtime. In clinical trials with treatment for up to 8 weeks, most ulcers healed within 8 weeks, although healing time may vary occasionally among patients. 2. Short-term treatment of duodenal ulcers The usual dose is 10mg of lafutidine orally twice daily, in the morning and before bedtime. In clinical trials with treatment for up to 6 weeks, most ulcers healed within 6 weeks, although healing time may vary occasionally among patients. 3. Improvement of gastric mucosal lesions in acute and chronic gastritis The usual dose is 10mg of lafutidine orally once daily before bedtime. In clinical trials with treatment for up to 2 weeks, most lesions healed within 2 weeks, although healing time may vary occasionally among patients. 4. Concomitant antibiotic therapy in patients with peptic ulcers infected with Helicobacter pylori Administer lafutidine 20mg, clarithromycin 500mg, and amoxicillin 1000mg twice daily for 7 or 14 days. 5. Premedication for anesthesia The usual dose is 10mg of lafutidine per dose, administered orally twice (before bedtime on the day before surgery and 2 hours before anesthesia on the day of surgery). 6. Treatment of reflux esophagitis Administer 10mg of lafutidine per dose orally twice daily.

Ingredients

Manufacturer
Kips Biopharma Co., Ltd.

Efficacy & effects

Treatment of gastrointestinal disorders (ulcers, gastritis, etc.); preanesthetic medication; combination therapy for Helicobacter pylori

  • Gastric ulcers
  • duodenal ulcers
  • acute gastritis
  • chronic gastritis
  • gastric mucosal lesions
  • Helicobacter pylori infection
  • peptic ulcers
  • gastroesophageal reflux disease
View approved original text

This medication is effective for the treatment of gastric ulcers and duodenal ulcers, and improves gastric mucosal damage caused by acute and chronic gastritis. Additionally, it helps treat infections in peptic ulcer patients infected with Helicobacter pylori when used in conjunction with antibiotics. It is also utilized as pre-anesthetic medication and is useful in treating gastroesophageal reflux disease. Overall, it is used to alleviate symptoms associated with various gastrointestinal disorders and aids in recovery.

How to take

Adult dose

1. Short-term treatment of gastric ulcers The usual dose is 10mg of lafutidine orally twice daily, in the morning and before bedtime. In clinical trials with treatment for up to 8 weeks, most ulcers healed within 8 weeks, although healing time may vary occasionally among patients. 2. Short-term treatment of duodenal ulcers The usual dose is 10mg of lafutidine orally twice daily, in the morning and before bedtime. In clinical trials with treatment for up to 6 weeks, most ulcers healed within 6 weeks, although healing time may vary occasionally among patients. 3. Improvement of gastric mucosal lesions in acute and chronic gastritis The usual dose is 10mg of lafutidine orally once daily before bedtime. In clinical trials with treatment for up to 2 weeks, most lesions healed within 2 weeks, although healing time may vary occasionally among patients. 4. Concomitant antibiotic therapy in patients with peptic ulcers infected with Helicobacter pylori Administer lafutidine 20mg, clarithromycin 500mg, and amoxicillin 1000mg twice daily for 7 or 14 days. 5. Premedication for anesthesia The usual dose is 10mg of lafutidine per dose, administered orally twice (before bedtime on the day before surgery and 2 hours before anesthesia on the day of surgery). 6. Treatment of reflux esophagitis Administer 10mg of lafutidine per dose orally twice daily.

Precautions

This medication should not be used in patients with hypersensitivity to its ingredients. It also contains lactose, so patients with genetic issues such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should avoid it. Patients with a history of drug hypersensitivity, liver or kidney dysfunction, patients undergoing dialysis, and elderly individuals should use this medication with caution. While taking this medication, severe symptoms such as allergic reactions or anaphylaxis may occur. If symptoms like pale face, low blood pressure, and difficulty breathing appear, discontinue the medication immediately and seek medical attention. Liver dysfunction or jaundice symptoms may arise, so liver function tests should be checked regularly; if abnormalities are found, the medication should be discontinued. Initial symptoms of agranulocytosis or thrombocytopenia such as sore throat, general malaise, and fever may occur, so consult a healthcare provider immediately if these symptoms arise. Serious side effects such as seizures, skin rash, or heart problems may occur infrequently; seek immediate medical assistance if these symptoms occur. Gastrointestinal symptoms may include constipation, diarrhea, nausea, vomiting, abdominal distension, and loss of appetite. Central nervous system effects can include headache, insomnia, drowsiness, and dizziness. Blood tests may show an increase or decrease in white blood cell count, anemia, or elevated liver enzyme levels; regular testing is necessary. Elderly patients may have decreased physical function; therefore, drug dosage and administration intervals should be adjusted, and their condition should be closely monitored. Dialysis patients may have increased blood concentrations of the drug; therefore, it should be started at a low dose and taken cautiously. Pregnant women or those who may become pregnant should decide whether to take this drug based on medical advice, and breastfeeding women should avoid it as it may be secreted in breast milk. Safety in pediatric patients has not been sufficiently confirmed, so it should be avoided in children. Keep the medication out of reach of children and store it in the original container; transferring it to another container poses a risk of misuse or degradation of quality. This medication may relieve symptoms of malignant tumors or delay diagnosis; thus, if gastric ulcers are present or suspected, malignant tumor status should be confirmed, and the medication should be discontinued if diagnosed with malignant gastric cancer. During treatment, closely monitor the patient's condition and administer the minimum effective dose. If no improvement is seen, alternative treatments should be considered.

Side effects

  • Shock
  • symptoms of anaphylaxis
  • facial pallor
  • hypotension
  • generalized urticaria
  • dyspnea
  • liver dysfunction
  • jaundice
  • agranulocytosis
  • pharyngitis
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  • general malaise
  • fever
  • thrombocytopenia
  • pancytopenia
  • aplastic anemia
  • convulsions
  • interstitial nephritis
  • Stevens-Johnson syndrome
  • Reiter's syndrome
  • rhabdomyolysis
  • heart block
  • heart failure
  • constipation
  • diarrhea
  • hard stools
  • nausea
  • vomiting
  • abdominal distention
  • loss of appetite
  • headache
  • insomnia
  • drowsiness
  • reversible confusional state
  • hallucinations
  • consciousness disturbances
  • dizziness
  • temperature
  • warmth sensation
  • facial flushing
  • leukocytosis
  • eosinophilia
  • leukopenia
  • erythrocytopenia
  • decreased hematocrit
  • elevated ALT
  • elevated AST
  • elevated Al-P
  • elevated γ-GTP
  • elevated T-Bil
  • elevated LDH
  • elevated TTT
  • abnormal urinary protein
  • elevated BUN
  • elevated serum uric acid
  • elevated Cl
  • delayed healing
  • elevated Na
  • decreased K
  • gynecomastia
  • edema
  • malaise
  • glossitis
  • headache
  • urticaria
  • skin rash
  • abdominal pain
  • dyspepsia
  • enteritis
  • gastric ulcer
  • erosive gastritis
  • duodenitis
  • bloating
  • infection
  • rhinitis
  • upper respiratory infection
  • bronchopneumonia
  • tinea
  • carotid stenosis
  • cough
  • oropharyngeal pain
  • oropharyngeal discomfort
  • wet cough
  • fatigue
  • chest pain
  • limb pain
  • joint pain
  • neck pain
  • pruritus
  • acne
  • contusion
  • insomnia
  • non-alcoholic steatohepatitis

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. The recommended storage temperature is room temperature between 1 degree 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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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.