Medication info

Rafdin Tablet 10 mg (Lafutidine)

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

MFDS item code 201903128 · Approved 2019.05.15

This product's status changed to Expired on 2024.05.15. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of gastrointestinal conditions (such as ulcers and gastritis), preanesthetic medication, and adjunctive treatment for Helicobacter pylori eradication
Who uses it
Adults
Adult dosage
1. Short-term treatment of gastric ulcers: The usual dose is 10mg of lafutidine twice daily, orally in the morning and before bedtime. Clinical studies involving treatment for up to 8 weeks showed that most ulcers healed within 8 weeks, although the healing period may occasionally vary between patients. 2. Short-term treatment of duodenal ulcers: The usual dose is 10mg of lafutidine twice daily, orally in the morning and before bedtime. Clinical studies involving treatment for up to 6 weeks showed that most ulcers healed within 6 weeks, although the healing period may occasionally vary between patients. 3. Improvement of gastric mucosal lesions in acute and chronic gastritis: The usual dose is 10mg of lafutidine orally once daily before bedtime. Clinical studies involving treatment for up to 2 weeks showed that most lesions healed within 2 weeks, although the healing period may occasionally vary between 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 or 14 days. 5. Premedication for anesthesia: The usual dose is 10mg 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 10mg of lafutidine orally twice daily.

Ingredients

Manufacturer
Ahn-Gook New Pharm Co., Ltd.

Efficacy & effects

Treatment of gastrointestinal conditions (such as ulcers and gastritis), preanesthetic medication, and adjunctive treatment 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 effective for the treatment of gastric ulcers and duodenal ulcers, and is used to improve gastric mucosal lesions caused by acute and chronic gastritis. It also increases the treatment effect when combined with antibiotics for patients with peptic ulcers infected by Helicobacter pylori. It may also be utilized as premedication before surgery or procedures, and is helpful in treating gastroesophageal reflux disease. Thus, it effectively improves various gastrointestinal-related issues.

Dosage and Administration

Adult dosage

1. Short-term treatment of gastric ulcers: The usual dose is 10mg of lafutidine twice daily, orally in the morning and before bedtime. Clinical studies involving treatment for up to 8 weeks showed that most ulcers healed within 8 weeks, although the healing period may occasionally vary between patients. 2. Short-term treatment of duodenal ulcers: The usual dose is 10mg of lafutidine twice daily, orally in the morning and before bedtime. Clinical studies involving treatment for up to 6 weeks showed that most ulcers healed within 6 weeks, although the healing period may occasionally vary between patients. 3. Improvement of gastric mucosal lesions in acute and chronic gastritis: The usual dose is 10mg of lafutidine orally once daily before bedtime. Clinical studies involving treatment for up to 2 weeks showed that most lesions healed within 2 weeks, although the healing period may occasionally vary between 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 or 14 days. 5. Premedication for anesthesia: The usual dose is 10mg 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 10mg of lafutidine orally twice daily.

Precautions

This medication should not be used by patients who are allergic to certain ingredients. It contains lactose, so caution is needed for patients with lactose intolerance or genetic metabolic disorders. Patients with allergies to soybean oil, beans, peanuts, etc. should also refrain from taking this medication. Patients who have previously experienced hypersensitivity reactions to medications should use this product with caution. Patients with liver or kidney issues, especially those on dialysis or the elderly, should be particularly careful when taking this medication. Patients with lipid metabolism disorders or who use lipid emulsions should take this medication cautiously. Severe allergic reactions such as anaphylaxis may occur, so if any unusual symptoms appear, immediately discontinue use and inform medical personnel. Liver dysfunction or jaundice symptoms may occur, so it is important to regularly check liver status. If symptoms related to decreased blood cell counts such as sore throat, general fatigue, or fever appear, immediate consultation with a healthcare provider is necessary. Rarely, serious side effects have been reported, such as skin rash, seizures, nephritis, heart problems, so swift action is required if unusual symptoms occur. Gastrointestinal symptoms such as constipation, diarrhea, nausea, vomiting, abdominal bloating, and loss of appetite may occur. Central nervous system symptoms can include headache, insomnia, drowsiness, reversible disorientation, hallucinations, consciousness disturbance, and dizziness. Cardiovascular symptoms include palpitations, warmth, and facial flushing. Blood tests may reveal an increase or decrease in white blood cells, decreased red blood cell counts, and possible elevated liver function test results, thus periodic testing is necessary. Symptoms of kidney function abnormalities have also been reported, so kidney status should be monitored. This medication may mask or delay the diagnosis of malignant tumors; therefore, if symptoms like weight loss, recurrent vomiting, or hematemesis occur, testing is essential. If stomach cancer is suspected, treatment should be discontinued upon confirmation after initial testing. During treatment, the patient's condition should be continuously monitored, and if no effect is observed, it is advisable to switch to another therapy. Patients at risk for lipid overload should regularly check plasma lipid levels and adjust the dose if necessary. The elderly may have decreased physical function, thus dosage and intervals should be carefully monitored. Patients on dialysis may experience increased drug concentrations in the blood, so treatment should start at a low dose and be administered cautiously. Pregnant women should use the medication only if the benefits outweigh the risks as judged by a physician, and it is safest not to administer it to breastfeeding women. Safety for children has not been established, so caution is required for use. Store out of reach of children, and do not transfer the medication from its original container to another container.

Side effects

  • Shock
  • symptoms of anaphylaxis
  • pallor
  • hypotension
  • generalized rash
  • dyspnea
  • hepatic impairment
  • jaundice
  • agranulocytosis
  • pharyngitis
Show 82 more
  • generalized malaise
  • fever
  • thrombocytopenia
  • pancytopenia
  • aplastic anemia
  • seizures
  • interstitial nephritis
  • Stevens-Johnson syndrome
  • Reiter's syndrome
  • rhabdomyolysis
  • heart block
  • heart failure
  • constipation
  • diarrhea
  • hardened stools
  • nausea
  • vomiting
  • abdominal distension
  • loss of appetite
  • headache
  • insomnia
  • drowsiness
  • reversible confusional state
  • hallucinations
  • consciousness disturbance
  • dizziness
  • dysesthesia
  • warmth sensation
  • facial flushing
  • leukocytosis
  • eosinophilia
  • leukopenia
  • erythrocytopenia
  • reduced 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 maturation
  • elevated Na
  • decreased K
  • gynecomastia
  • edema
  • fatigue
  • glossitis
  • headache
  • chest pain
  • subdural hemorrhage
  • urticaria
  • skin rash
  • abdominal pain
  • dyspepsia
  • enteritis
  • gastric ulcer
  • erosive gastritis
  • duodenitis
  • distension
  • rhinopharyngitis
  • upper respiratory infection
  • bronchopneumonia
  • tinea
  • cough
  • oropharyngeal pain
  • oropharyngeal discomfort
  • wet cough
  • fatigue
  • chest pain
  • limb pain
  • arthralgia
  • cervical pain
  • pruritus
  • acne
  • contusions
  • insomnia
  • nonalcoholic fatty liver disease

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

Storage

This medication may be sensitive to air and moisture, so it must be stored in a tightly closed container. It is best to maintain room temperature between 1 to 30 degrees Celsius. Doing so will ensure the medication's efficacy and safety.

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.