Medication info

Rafutil Tablet 10mg (Lafutidine)

Prescription medicationTabletExpired
Ingredient · strength
Lafutidine›10mg / 1 tablet
Manufacturer / importer
IQUR Co., Ltd.
Appearance
White round film-coated tablet
Packaging
For domestic use - 30 tablets/bottle, For domestic use - 300 tablets/bottle
Approval status
Expired

MFDS item code 202003573 · Approved 2020.05.18

This product's status changed to Expired on 2025.05.18. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Gastrointestinal disorders (e.g., ulcers and gastritis); preanesthetic medication; combination therapy with antibiotics for Helicobacter pylori infection
Who uses it
Adults
Adult dosage
1. Short-term treatment of gastric ulcers: The usual dose is lafutidine 10mg orally twice daily, in the morning and at bedtime. In clinical trials of up to 8 weeks of treatment, most ulcers healed within 8 weeks, although healing time may occasionally vary between patients. 2. Short-term treatment of duodenal ulcers: The usual dose is lafutidine 10mg orally twice daily, in the morning and at bedtime. In clinical trials of up to 6 weeks of treatment, most ulcers healed within 6 weeks, although healing time may occasionally vary between patients. 3. Improvement of gastric mucosal lesions in acute gastritis and chronic gastritis: The usual dose is lafutidine 10mg orally once daily at bedtime. In clinical trials of up to 2 weeks of treatment, most lesions healed within 2 weeks, although healing time may occasionally vary between patients. 4. Antibiotic combination therapy for 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 lafutidine 10mg per dose, administered orally twice (at bedtime on the day before surgery and 2 hours before anesthesia on the day of surgery). 6. Treatment of reflux esophagitis: Administer lafutidine 10mg per dose twice daily.

Ingredients

Manufacturer
IQUR Co., Ltd.

Efficacy & effects

Gastrointestinal disorders (e.g., ulcers and gastritis); preanesthetic medication; combination therapy with antibiotics for Helicobacter pylori infection

  • Gastric ulcer
  • duodenal ulcer
  • gastric mucosal lesions due to acute gastritis
  • chronic gastritis
  • peptic ulcer
  • gastroesophageal reflux disease
View approved original text

This medicine is used to treat gastric and duodenal ulcers and helps improve gastric mucosal damage caused by acute and chronic gastritis. It is also effective in increasing treatment efficacy when used with antibiotics in patients with peptic ulcers who have Helicobacter pylori infections. It is safely administered before anesthesia to control gastric acid secretion and alleviate the symptoms of gastroesophageal reflux disease. It effectively works on various gastrointestinal diseases to help improve patient symptoms.

Dosage and Administration

Adult dosage

1. Short-term treatment of gastric ulcers: The usual dose is lafutidine 10mg orally twice daily, in the morning and at bedtime. In clinical trials of up to 8 weeks of treatment, most ulcers healed within 8 weeks, although healing time may occasionally vary between patients. 2. Short-term treatment of duodenal ulcers: The usual dose is lafutidine 10mg orally twice daily, in the morning and at bedtime. In clinical trials of up to 6 weeks of treatment, most ulcers healed within 6 weeks, although healing time may occasionally vary between patients. 3. Improvement of gastric mucosal lesions in acute gastritis and chronic gastritis: The usual dose is lafutidine 10mg orally once daily at bedtime. In clinical trials of up to 2 weeks of treatment, most lesions healed within 2 weeks, although healing time may occasionally vary between patients. 4. Antibiotic combination therapy for 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 lafutidine 10mg per dose, administered orally twice (at bedtime on the day before surgery and 2 hours before anesthesia on the day of surgery). 6. Treatment of reflux esophagitis: Administer lafutidine 10mg per dose twice daily.

Precautions

This medicine should not be used in patients who are allergic to any component of this medicine. It contains lactose, so patients with lactose intolerance or specific metabolic disorders should not take it. Individuals allergic to soybean oil, soy, or peanuts should also avoid this medicine. Patients with a history of drug allergies, those with liver or kidney problems, patients undergoing dialysis, elderly patients, and those with lipid metabolism disorders should use this medicine with caution. It can rarely cause serious allergic reactions, liver function abnormalities, or reductions in blood cells, so if any symptoms occur, discontinue use immediately and seek medical attention. Various mild side effects have been reported in multiple systems including the gastrointestinal, central nervous, and circulatory systems, so one must carefully observe changes in their physical condition. Especially in cases where gastric cancer or malignant tumors are suspected, accurate examinations should be conducted before using this medicine, and it should be discontinued if cancer is confirmed. During treatment, blood, liver, and kidney function tests should be done regularly, and the condition should be closely monitored. Elderly patients or those on dialysis may experience increased blood concentrations of this medicine, so careful adjustments in dosage and intervals are necessary. Pregnant women should only take this medicine under a doctor's judgment if absolutely necessary, and breastfeeding women are advised to avoid this medicine as it may be excreted in breast milk. The safety in children has not been established, so use in pediatric patients is not recommended. This medicine should be kept out of the reach of children and stored in its original container to prevent misuse or degradation of quality.

Side effects

  • Shock
  • symptoms of anaphylaxis: facial pallor
  • low blood pressure
  • generalized rash
  • shortness of breath
  • liver function impairment
  • jaundice
  • agranulocytosis
  • pharyngitis
  • generalized malaise
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  • fever
  • thrombocytopenia
  • pancytopenia
  • aplastic anemia
  • convulsions
  • interstitial nephritis
  • Stevens-Johnson syndrome
  • Leal syndrome
  • rhabdomyolysis
  • heart block
  • contractile dysfunction
  • constipation
  • diarrhea
  • hard stools
  • nausea
  • vomiting
  • abdominal distension
  • loss of appetite
  • headache
  • insomnia
  • drowsiness
  • reversible confusional state
  • hallucinations
  • consciousness disturbance
  • dizziness
  • chills
  • hot flashes
  • facial flushing
  • leukocytosis
  • eosinophilia
  • leukopenia
  • anemia
  • decreased hematocrit
  • elevated ALT
  • elevated AST
  • elevated Al-P
  • elevated γ-GTP
  • elevated T-Bil
  • elevated LDH
  • elevated TTT
  • abnormal urine protein
  • elevated BUN
  • elevated serum uric acid
  • elevated Cl
  • delayed menstruation
  • elevated Na
  • decreased K
  • gynecomastia
  • edema
  • fatigue
  • glossitis
  • headache
  • urticaria
  • skin rash
  • abdominal pain
  • dyspepsia
  • enteritis
  • gastric ulcer
  • erosive gastritis
  • duodenitis
  • distension
  • nasopharyngitis
  • upper respiratory infection
  • bronchopneumonia
  • tinea
  • cough
  • oral pharyngitis pain
  • oral pharyngitis discomfort
  • productive cough
  • fatigue
  • chest pain
  • limb pain
  • joint pain
  • cervical pain
  • itching
  • acne
  • contusion
  • insomnia
  • non-alcoholic steatohepatitis

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

Storage

This medicine should be stored in a sealed container to prevent air or moisture intrusion, and it is safe to store at a temperature between 1 to 30 degrees Celsius. By storing it this way, the effectiveness of the medicine can be maintained, and degradation can be avoided.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

For domestic use - 30 tablets/bottle, For domestic use - 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.