Medication info
Rafudil Tablets (Rafutidine)

Rafudil Tablets (Rafutidine)

Prescription medicationTabletOral
Ingredient · strength
Lafutidine›10mg / 1 tablet
Manufacturer / importer
Nexpam Korea Co., Ltd.
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201302934 · Approved 2013.01.31 · Insurance code 662502800

Summary

Main use
Treatment of gastrointestinal disorders (ulcers, gastritis, etc.), pre-anesthetic medication, and combination therapy for Helicobacter pylori eradication
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 at bedtime. In clinical trials of up to 8 weeks, most ulcers healed within 8 weeks, although healing time may vary in some patients. 2. Short-term treatment of duodenal ulcers: The usual dose is 10mg of lafutidine orally twice daily, in the morning and at bedtime. In clinical trials of up to 6 weeks, most ulcers healed within 6 weeks, although healing time may vary in some patients. 3. Improvement of gastric mucosal lesions in acute and chronic gastritis: The usual dose is 10mg of lafutidine orally once daily at bedtime. In clinical trials of up to 2 weeks, most lesions healed within 2 weeks, although healing time may vary in some patients. 4. Combination therapy with antibiotics for patients with peptic ulcers infected with Helicobacter pylori: Administer lafutidine 20mg, clarithromycin 500mg, and amoxicillin 1000mg twice daily for 7 days or 14 days. 5. Premedication before anesthesia: The usual dose is 10mg of lafutidine per dose, given twice (at bedtime on the day before surgery and 2 hours before administration of anesthesia on the day of surgery). 6. Treatment of reflux esophagitis: Administer 10mg of lafutidine per dose orally twice daily.

Ingredients

Manufacturer
Nexpam Korea Co., Ltd.

Efficacy & effects

Treatment of gastrointestinal disorders (ulcers, gastritis, etc.), pre-anesthetic medication, and combination therapy for Helicobacter pylori eradication

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

This medication is used for the treatment of gastric ulcers and duodenal ulcers and helps improve gastric mucosal damage caused by acute and chronic gastritis. It also enhances the treatment effect when used in combination with antibiotics for patients with peptic ulcers caused by Helicobacter pylori infection. It is used as premedication and is effective in alleviating the symptoms of gastroesophageal reflux disease. It is widely used for various gastrointestinal diseases.

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

Precautions

This drug should not be used in patients with hypersensitivity to the ingredients. Furthermore, it contains lactose, so patients should avoid it if they have genetic problems such as lactose intolerance, deficiency of lactase, or glucose-galactose malabsorption. Patients with a history of hypersensitivity to medications, impaired liver or kidney function, dialysis patients, and the elderly should use this drug with caution. This drug can rarely cause severe allergic reactions such as anaphylaxis or shock, so if symptoms like shortness of breath, facial pallor, or low blood pressure occur, administration should be immediately discontinued and medical attention sought. Liver function abnormalities or jaundice may occur, so liver conditions should be monitored regularly, and if any abnormalities are found, medication should be discontinued. A decrease in blood cell count such as agranulocytosis or thrombocytopenia may occur, so if symptoms like sore throat, fever, or general malaise develop, immediate consultation with a doctor is recommended. Other reported side effects include constipation, diarrhea, hard stools, nausea, vomiting, abdominal bloating, loss of appetite, headache, insomnia, drowsiness, reversible confusion, hallucinations, altered consciousness, dizziness, chills, warmth, facial flushing, elevated white blood cell counts, increased eosinophils, decreased white blood cell counts, decreased red blood cell counts, decreased hematocrit, elevated ALT (GPT), elevated AST (GOT), elevated Al-P, elevated γ-GTP, elevated T-Bil, elevated LDH, increased TTT, abnormal urinary protein, BUN. In particular, if malignant tumors are suspected, this drug may alleviate symptoms and delay diagnosis, so if symptoms like weight loss, recurrent vomiting, or hematemesis occur, testing must be conducted. The elderly have decreased physical functions, so care must be taken regarding dosage and intervals, and they should be monitored closely during use. Dialysis patients may have elevated drug concentrations in the blood, so they should start with a lower dose initially. Pregnant women or women who may become pregnant should only take this under medical advice if the benefits outweigh the risks, and nursing mothers are advised against taking it as it may be excreted in breast milk. The safety in children has not been established, so its use is not recommended. This medication should be kept out of reach of children and stored in its original container; transferring it to another container poses a risk of misuse or degradation of quality.

Side effects

  • Shock
  • symptoms of anaphylaxis
  • facial pallor
  • hypotension
  • generalized rash
  • dyspnea
  • liver function impairment
  • jaundice
  • agranulocytosis
  • pharyngitis
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  • general malaise
  • fever
  • thrombocytopenia
  • pancytopenia
  • aplastic anemia
  • seizures
  • interstitial nephritis
  • Stevens-Johnson syndrome
  • Reilly syndrome
  • rhabdomyolysis
  • atrioventricular block
  • heart failure
  • constipation
  • diarrhea
  • hard stool
  • nausea
  • vomiting
  • abdominal distension
  • loss of appetite
  • headache
  • insomnia
  • drowsiness
  • reversible confusional state
  • hallucinations
  • altered consciousness
  • dizziness
  • chills
  • sensation of heat
  • facial flushing
  • leukocytosis
  • eosinophilia
  • leukopenia
  • erythrocytopenia
  • decreased hematocrit
  • ALT elevation
  • AST elevation
  • Al-P elevation
  • γ-GTP elevation
  • T-Bil elevation
  • LDH elevation
  • TTT elevation
  • abnormal urine protein
  • BUN elevation
  • elevated serum uric acid
  • Cl elevation
  • prolonged life span
  • Na elevation
  • K deficiency
  • gynecomastia
  • edema
  • fatigue
  • glossitis
  • headache
  • urticaria
  • skin rash
  • abdominal pain
  • dyspepsia
  • enteritis
  • gastric ulcer
  • erosive gastritis
  • duodenitis
  • distension
  • rhinitis
  • upper respiratory tract infection
  • bronchopneumonia
  • tinea
  • cough
  • oropharyngeal pain
  • oropharyngeal discomfort
  • wet cough
  • fatigue
  • chest pain
  • limb pain
  • arthralgia
  • cervical pain
  • pruritus
  • acne
  • contusion
  • insomnia
  • non-alcoholic steatohepatitis

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

Storage

This medication must be stored in a tightly sealed container to avoid exposure to air or moisture. Additionally, it is important to store it at a cool room temperature between 1 to 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.

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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.