Medication info
Samsung Lafutidine Tablet 10 mg

Samsung Lafutidine Tablet 10 mg

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

MFDS item code 201903334 · Approved 2019.05.22 · Insurance code 642307810

Summary

Main use
Treatment of gastrointestinal disorders (e.g., ulcers and gastritis), preanesthetic medication, and combination therapy for Helicobacter pylori eradication
Who uses it
Adults
Adult dosage
1. Short-term treatment of gastric ulcers: The usual dose is 10mg of lafutidine orally twice daily, in the morning and at bedtime. Clinical trials of treatment for up to 8 weeks showed that 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. Clinical trials of treatment for up to 6 weeks showed that 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. Clinical trials of treatment for up to 2 weeks showed that most lesions healed within 2 weeks, although healing time may vary in some patients. 4. Antibiotic combination therapy for patients with peptic ulcer disease infected with Helicobacter pylori: Administer lafutidine 20mg, clarithromycin 500mg, and amoxicillin 1000mg twice daily for 7 or 14 days. 5. Premedication before anesthesia: The usual dose is 10mg of lafutidine 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 10mg of lafutidine per dose orally twice daily.

Ingredients

Manufacturer
Samsung Pharm Co., Ltd.

Efficacy & effects

Treatment of gastrointestinal disorders (e.g., ulcers and gastritis), preanesthetic medication, and combination therapy for Helicobacter pylori eradication

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

This medication is used for the treatment of gastric ulcers and duodenal ulcers, and it improves gastric mucosal damage caused by acute and chronic gastritis. Additionally, it can be effectively used in combination with antibiotics for patients with peptic ulcers infected with Helicobacter pylori. It helps to prepare patients safely for anesthesia before surgery or other procedures. It is also used for the relief and treatment of symptoms of gastroesophageal reflux disease. Thus, it is widely used in the treatment and symptom improvement of various gastrointestinal-related diseases.

Dosage and Administration

Adult dosage

1. Short-term treatment of gastric ulcers: The usual dose is 10mg of lafutidine orally twice daily, in the morning and at bedtime. Clinical trials of treatment for up to 8 weeks showed that 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. Clinical trials of treatment for up to 6 weeks showed that 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. Clinical trials of treatment for up to 2 weeks showed that most lesions healed within 2 weeks, although healing time may vary in some patients. 4. Antibiotic combination therapy for patients with peptic ulcer disease infected with Helicobacter pylori: Administer lafutidine 20mg, clarithromycin 500mg, and amoxicillin 1000mg twice daily for 7 or 14 days. 5. Premedication before anesthesia: The usual dose is 10mg of lafutidine 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 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 lactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take it. Patients with a history of drug hypersensitivity, impaired liver or kidney function, those undergoing dialysis, and the elderly should use this medication cautiously. This medication can cause serious allergic reactions such as anaphylaxis or shock; therefore, if there is facial pallor, drop in blood pressure, widespread rash, or difficulty breathing during administration, treatment should be immediately halted, and appropriate medical help should be sought. Liver function impairment or jaundice may occur, so regular liver function tests should be conducted, and if abnormalities are found, discontinuation of the medication is necessary. Blood-related abnormal symptoms such as agranulocytosis or thrombocytopenia may occur, so if there are symptoms such as sore throat, fatigue, or fever, immediate consultation with a doctor is essential. Additionally, rare side effects such as skin rash, convulsions, and heart rhythm irregularities have been reported; hence, any unusual symptoms should be promptly reported to healthcare providers. Constipation, diarrhea, nausea, headache, insomnia, dizziness, warmth, facial flushing, elevated leukocyte count, increased eosinophils, decreased leukocyte count, decreased red blood cell count, decreased hematocrit, elevated ALT(GPT), elevated AST(GOT), elevated Al-P, elevated γ-GTP, elevated T-Bil, elevated LDH, elevated TTT, abnormal urinary protein, elevated BUN, and elevated serum uric acid may occur during administration, so it is important to consult a professional if symptoms are severe or persistent. This medication can mask symptoms of malignant tumors and delay diagnosis; therefore, if there are unintentional weight loss, repeated vomiting, hemoptysis, or other concerning symptoms, necessary examinations must be conducted. If gastric cancer is suspected and malignancy is confirmed after initial examinations, the medication should be discontinued, and if there is no therapeutic effect, other treatment options should be considered. Elderly patients should be closely monitored for dosage adjustments and intervals, as their physical functions may decline. Dialysis patients should start taking this medication cautiously from a low dose, as blood drug concentrations may increase. Pregnant women or women who may become pregnant should take this medication only when the benefits outweigh the risks, as determined by a physician, and breastfeeding women are advised not to take this medication due to possible secretion into breast milk. The safety in children has not been adequately established, so caution is needed in usage. This medication should be stored out of the reach of children and kept in its original container to prevent misuse or deterioration of quality. Lastly, although no carcinogenic effects were found in animal tests, some side effects have been reported at high doses; therefore, adherence to prescribed dosages and administration instructions is important.

Side effects

  • Shock
  • symptoms of anaphylaxis
  • facial pallor
  • hypotension
  • generalized rash
  • dyspnea
  • hepatic dysfunction
  • jaundice
  • agranulocytosis
  • pharyngodynia
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  • systemic fatigue
  • fever
  • thrombocytopenia
  • pancytopenia
  • aplastic anemia
  • seizures
  • interstitial nephritis
  • Stevens-Johnson syndrome
  • Riele syndrome
  • rhabdomyolysis
  • heart block
  • heart failure
  • constipation
  • diarrhea
  • hard stools
  • nausea
  • vomiting
  • abdominal distension
  • loss of appetite
  • headache
  • insomnia
  • drowsiness
  • reversible confusional state
  • hallucinations
  • consciousness disturbance
  • dizziness
  • chills
  • heat sensation
  • facial flushing
  • leukocytosis
  • eosinophilia
  • leukopenia
  • erythrocytopenia
  • decreased hematocrit
  • increased ALT
  • increased AST
  • increased Al-P
  • increased γ-GTP
  • increased T-Bil
  • increased LDH
  • increased TTT
  • abnormal urinary protein
  • increased BUN
  • elevated serum uric acid
  • increased Cl
  • delayed metabolism
  • increased Na
  • decreased K
  • gynecomastia
  • edema
  • fatigue
  • glossitis
  • headache
  • urticaria
  • skin rash
  • abdominal pain
  • indigestion
  • enteritis
  • gastric ulcer
  • erosive gastritis
  • duodenitis
  • bloating
  • nasopharyngitis
  • upper respiratory infection
  • bronchopneumonia
  • tinea
  • cough
  • oropharyngeal pain
  • oropharyngeal discomfort
  • wet cough
  • fatigue
  • chest pain
  • limb pain
  • arthralgia
  • cervical pain
  • pruritus
  • acne
  • contusion
  • insomnia
  • non-alcoholic fatty liver disease

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

Storage

This medication must be stored in a tightly closed container to prevent exposure to air or moisture. Additionally, it is safest to store the drug at room temperature, between 1°C and 30°C, not in excessively hot or cold conditions.

Appearance and packaging

Appearance

White circular 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.