Medication info
Rafugen 10 mg Tablets (Rafutidine)

Rafugen 10 mg Tablets (Rafutidine)

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

MFDS item code 201405104 · Approved 2014.10.31 · Insurance code 640902860

Summary

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

Ingredients

Manufacturer
Ilhwa Co., Ltd.

Efficacy & effects

Treatment of gastrointestinal disorders (e.g., ulcers, gastritis); preanesthetic medication; adjunctive treatment for Helicobacter pylori eradication

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

This medication is used for the treatment of gastric ulcers and duodenal ulcers. Additionally, it helps to improve gastric mucosal damage caused by acute and chronic gastritis. For patients with peptic ulcers infected with Helicobacter pylori, it is used in combination with antibiotics to enhance therapeutic effects. It is also used for pre-anesthetic medication before surgery or procedures. Furthermore, it is effective in relieving and treating the symptoms of gastroesophageal reflux disease. Overall, it is widely used to improve related diseases of the stomach and esophagus.

How to take

Adult dose

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

Precautions

This medication should not be used in patients who are allergic to any of its components. Furthermore, this medicine contains lactose, so patients with a genetic disorder that prevents proper digestion of lactose should avoid taking it. Patients with a history of drug allergies, liver or kidney function problems, those undergoing dialysis, and the elderly should use this medication cautiously. This drug can rarely cause serious allergic reactions, so if you experience facial pallor, a drop in blood pressure, or difficulty breathing, stop using it immediately and seek medical attention. It can affect liver function; if liver enzyme levels increase or jaundice symptoms appear, stop taking the medication and consult a doctor. There may be a decrease in blood cell counts, so if you experience symptoms like sore throat, fatigue, or fever, consult your doctor immediately. Rarely, symptoms such as skin rash, convulsions, and heart rhythm abnormalities have been reported; notify medical personnel if any unusual symptoms occur. Side effects such as abdominal pain, constipation, diarrhea, headache, dizziness, insomnia, and others may occur, so caution is advised. This drug may conceal symptoms of malignant tumors such as gastric cancer; therefore, if symptoms like weight loss, persistent vomiting, or hematemesis occur, you must get checked. Especially if gastric cancer is suspected, an early endoscopy and accurate diagnosis should be performed, and if confirmed as a malignant tumor, this medication should be discontinued. During treatment, the patient's condition should be carefully monitored, and if there is no effect, a different treatment method should be considered. The elderly should be cautious regarding dosage and administration intervals due to weakened physical function and should take it carefully. Dialysis patients may have higher blood concentrations of the drug, so they should start with a low dose and take it carefully. Pregnant women or women who may become pregnant should take this drug only if the benefits exceed the risks, as determined by a doctor, and breastfeeding women are advised not to take this medicine. Safety in children has not been established, so it is preferable to avoid use. This medication should be kept out of reach of children, and stored in its original container to prevent misuse or deterioration in quality.

Side effects

  • Shock
  • symptoms of anaphylaxis
  • pallor
  • hypotension
  • generalized pruritus
  • dyspnea
  • liver dysfunction
  • jaundice
  • agranulocytosis
  • pharyngitis
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  • generalized fatigue
  • fever
  • thrombocytopenia
  • pancytopenia
  • aplastic anemia
  • seizures
  • interstitial nephritis
  • Stevens-Johnson syndrome
  • Liell syndrome
  • rhabdomyolysis
  • atrioventricular block
  • impaired contractility
  • constipation
  • diarrhea
  • hard stools
  • nausea
  • vomiting
  • abdominal bloating
  • loss of appetite
  • headache
  • insomnia
  • drowsiness
  • reversible confusional state
  • hallucinations
  • consciousness disturbance
  • dizziness
  • temperature sensation
  • feeling of heat
  • 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 rehabilitation
  • elevated Na
  • reduced K
  • gynecomastia
  • edema
  • lethargy
  • glossitis
  • headache
  • urticaria
  • skin rash
  • abdominal pain
  • dyspepsia
  • enteritis
  • gastric ulcer
  • erosive gastritis
  • duodenitis
  • bloating
  • rhinopharyngitis
  • upper respiratory infection
  • bronchopneumonia
  • tinea
  • carotid artery stenosis
  • cough
  • oropharyngeal pain
  • oropharyngeal discomfort
  • wet cough
  • fatigue
  • chest pain
  • limb pain
  • joint pain
  • neck pain
  • pruritus
  • acne
  • contusion
  • insomnia
  • non-alcoholic fatty liver disease

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

Storage

This drug should be stored in a tightly closed container to protect it from air and moisture, at a temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the medication's efficacy for a longer period.

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.