Medication info
Withers Lafutidine Tablet 10 mg (Lafutidine)

Withers Lafutidine Tablet 10 mg (Lafutidine)

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

MFDS item code 202001488 · Approved 2020.03.03 · Insurance code 660703350

Summary

Main use
Treatment of gastrointestinal disorders (e.g., ulcers and gastritis); preanesthetic medication; combination treatment for Helicobacter pylori
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 in which treatment was given for up to 8 weeks, most ulcers healed within 8 weeks, although healing time may vary among 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 in which treatment was given for up to 6 weeks, most ulcers healed within 6 weeks, although healing time may vary among 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 in which treatment was given for up to 2 weeks, most lesions healed within 2 weeks, although healing time may vary among patients. 4. Combination antibiotic 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. Preanesthetic medication The usual dose is 10mg of lafutidine 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 orally twice daily.

Ingredients

Manufacturer
Withers Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Gastric ulcers
  • duodenal ulcers
  • acute gastritis
  • chronic gastritis
  • peptic ulcers
  • gastroesophageal reflux disease
View approved original text

This medication is used to treat peptic ulcers such as gastric ulcers and duodenal ulcers. It also has the effect of improving gastric mucosal damage caused by acute and chronic gastritis. For patients with peptic ulcers caused by Helicobacter pylori infection, it enhances treatment efficacy when combined with antibiotics. It is also used for pre-anesthetic medication prior to surgery or examinations. Additionally, it helps in the treatment of gastroesophageal reflux disease. Overall, it is used to effectively treat and improve diseases related to the stomach and esophagus.

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 in which treatment was given for up to 8 weeks, most ulcers healed within 8 weeks, although healing time may vary among 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 in which treatment was given for up to 6 weeks, most ulcers healed within 6 weeks, although healing time may vary among 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 in which treatment was given for up to 2 weeks, most lesions healed within 2 weeks, although healing time may vary among patients. 4. Combination antibiotic 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. Preanesthetic medication The usual dose is 10mg of lafutidine 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 orally twice daily.

Precautions

This medication should not be used in patients with allergies to specific components. Additionally, it contains lactose, so individuals with genetic disorders such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should avoid it. Patients allergic to soybean oil, soybeans, or peanuts should also not use this medication. Patients with a history of drug allergies, impaired liver or kidney function, those undergoing dialysis, the elderly, and those with disorders of fat metabolism or using lipid emulsions should take this medication with caution. This drug can rarely cause serious allergic reactions, liver dysfunction, or decreased blood cell counts; if any abnormal symptoms appear, discontinue use immediately and consult a physician. Various side effects have been reported in multiple body systems, including the gastrointestinal, central nervous, circulatory, blood, liver, and kidneys; thus, consulting healthcare professionals when experiencing symptoms is essential. When malignancy is suspected, this medication may delay diagnosis, so accurate diagnosis should be obtained through examinations such as gastroscopy, and treatment should be discontinued if confirmed as a malignant cancer. During treatment, regular blood tests, along with liver and kidney function assessments, should be conducted, and the minimum effective dose should be administered. The elderly should have careful dosage adjustments and intervals due to decreased bodily functions, and dialysis patients should cautiously start from a low dose due to potential increased drug concentration. Pregnant women should only take this medication under the physician's judgment if the benefits outweigh the risks, and breastfeeding women should avoid using this drug as it may be secreted in breast milk. Safety in pediatric patients has not yet been established, so administration should be done with caution. 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 carcinogenicity was not observed in animal experiments, some side effects have been reported at high doses, so it is important to adhere to the recommended dosage.

Side effects

  • Shock
  • anaphylactic symptoms
  • facial pallor
  • hypotension
  • generalized pruritus
  • respiratory distress
  • liver dysfunction
  • jaundice
  • agranulocytosis
  • pharyngitis
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  • general malaise
  • fever
  • thrombocytopenia
  • pancytopenia
  • aplastic anemia
  • seizures
  • interstitial nephritis
  • Stevens-Johnson syndrome
  • Reye's syndrome
  • rhabdomyolysis
  • heart block
  • heart failure
  • constipation
  • diarrhea
  • hard stool
  • nausea
  • vomiting
  • abdominal distention
  • anorexia
  • headache
  • insomnia
  • drowsiness
  • reversible confusional state
  • hallucinations
  • consciousness disturbances
  • dizziness
  • chills
  • heat sensation
  • 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 recovery
  • elevated Na
  • decreased K
  • gynecomastia
  • edema
  • lethargy
  • glossitis
  • headache
  • urticaria
  • skin rash
  • abdominal pain
  • dyspepsia
  • 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
  • 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 medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. It is advisable to maintain the storage temperature between 1 and 30 degrees Celsius. Doing so will help prolong the efficacy of the medication and ensure safe use.

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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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.