Medication info

Stona Tablet 10 mg (Lafutidine)

Prescription medicationTabletApproval withdrawn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Approval withdrawn

MFDS item code 202002138 · Approved 2020.03.27

This product's status changed to Approval withdrawn on 2024.02.07. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of gastrointestinal disorders (ulcers, gastritis, etc.), preanesthetic medication, and treatment in combination with antibiotics
Who uses it
Adults
Adult dosage
1. Short-term treatment of gastric ulcers: The usual dose is 10 mg of lafutidine orally twice daily, in the morning and before bedtime. Clinical trials of 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 10 mg of lafutidine orally twice daily, in the morning and before bedtime. Clinical trials of 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 10 mg of lafutidine orally once daily before bedtime. Clinical trials of 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 ulcers infected with Helicobacter pylori: Administer lafutidine 20mg, clarithromycin 500mg, and amoxicillin 1000mg twice daily for 7 days or 14 days. 5. Premedication for anesthesia: The usual dose is 10mg of lafutidine per dose, given orally twice (before 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
Daewoong Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of gastrointestinal disorders (ulcers, gastritis, etc.), preanesthetic medication, and treatment in combination with antibiotics

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

This medication is used to treat gastric ulcers and duodenal ulcers. It also has a beneficial effect in improving gastric mucosal damage caused by acute and chronic gastritis. For patients with peptic ulcers due to Helicobacter pylori infection, it is used in combination with antibiotics. It may be administered before anesthesia for safety, and helps relieve symptoms of gastroesophageal reflux disease. It is used for the treatment and symptom relief of various gastrointestinal disorders.

Dosage and Administration

Adult dosage

1. Short-term treatment of gastric ulcers: The usual dose is 10 mg of lafutidine orally twice daily, in the morning and before bedtime. Clinical trials of 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 10 mg of lafutidine orally twice daily, in the morning and before bedtime. Clinical trials of 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 10 mg of lafutidine orally once daily before bedtime. Clinical trials of 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 ulcers infected with Helicobacter pylori: Administer lafutidine 20mg, clarithromycin 500mg, and amoxicillin 1000mg twice daily for 7 days or 14 days. 5. Premedication for anesthesia: The usual dose is 10mg of lafutidine per dose, given orally twice (before 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 who have an allergic reaction to any of its components. It contains lactose, so patients with genetic issues such as lactose intolerance, lactase deficiency, or glucose-galactose malabsorption should avoid it. Individuals with hypersensitivity or a history of allergies to soybean oil, soybeans, or peanuts should also refrain from using this medication. Patients with a history of drug hypersensitivity, liver or kidney dysfunction, patients on dialysis, elderly patients, and patients with abnormal lipid metabolism should be particularly cautious when using this medication. This medication can cause serious allergic reactions such as anaphylaxis; thus, if symptoms such as facial pallor, decreased blood pressure, or difficulty breathing occur, use should be discontinued immediately and medical attention sought. Routine liver function testing is necessary as liver dysfunction or jaundice may occur, and if abnormalities are found, medication should be stopped. There is a potential for agranulocytosis or thrombocytopenia with decreased blood cell counts, so if symptoms such as fatigue, sore throat, or fever occur, patients should consult a doctor without delay. Rare side effects such as skin rash, convulsions, or cardiac issues have been reported, so patients should inform healthcare providers immediately if such symptoms occur. Gastrointestinal side effects may include constipation, diarrhea, nausea, vomiting, abdominal bloating, or loss of appetite, while central nervous system side effects may include headache, insomnia, drowsiness, or dizziness. This medication may relieve symptoms of malignant tumors, potentially delaying diagnosis; therefore, patients presenting with weight loss, recurrent vomiting, or hematemesis should undergo examination. Elderly patients may have deteriorated physical function, necessitating careful monitoring of dosage and administration intervals. Dialysis patients may have elevated blood drug concentrations, so it should be administered cautiously starting at a low dose. Pregnant women should only take this medication if the benefits justify the risks as determined by a physician, and breastfeeding women are advised not to use it as it may be excreted in breast milk. Safety in children has not been established, so it should be administered cautiously in pediatric patients. Keep this medication out of reach of children, store it in its original container, and avoid transferring it to other containers to safeguard the medication's quality and safety.

Side effects

  • Shock
  • anaphylaxis symptoms
  • facial pallor
  • hypotension
  • generalized rash
  • dyspnea
  • liver dysfunction
  • jaundice
  • agranulocytosis
  • pharyngitis
Show 80 more
  • generalized malaise
  • fever
  • thrombocytopenia
  • pancytopenia
  • aplastic anemia
  • seizures
  • interstitial nephritis
  • Stevens-Johnson syndrome
  • Riel syndrome
  • rhabdomyolysis
  • heart block
  • inadequate contractions
  • constipation
  • diarrhea
  • hard stools
  • nausea
  • vomiting
  • abdominal bloating
  • anorexia
  • headache
  • insomnia
  • drowsiness
  • reversible confusional state
  • hallucinations
  • consciousness disturbances
  • dizziness
  • fever
  • heat sensation
  • facial flushing
  • leukocytosis
  • eosinophilia
  • leukopenia
  • erythrocytopenia
  • reduced hematocrit
  • ALT elevation
  • AST elevation
  • Al-P elevation
  • γ-GTP elevation
  • T-Bil elevation
  • LDH elevation
  • TTT elevation
  • urinary protein abnormalities
  • BUN elevation
  • serum uric acid elevation
  • Cl elevation
  • life prolongation
  • Na elevation
  • K decrease
  • gynecomastia
  • edema
  • malaise
  • glossitis
  • headache
  • urticaria
  • skin rash
  • abdominal pain
  • dyspepsia
  • enteritis
  • gastric ulcer
  • erosive gastritis
  • duodenitis
  • bloating
  • nasopharyngitis
  • upper respiratory infection
  • bronchopneumonia
  • tinea
  • cough
  • pain in the oral pharynx
  • discomfort in the oral pharynx
  • wet cough
  • fatigue
  • chest pain
  • limb pain
  • joint pain
  • neck pain
  • itching
  • acne
  • contusion
  • insomnia
  • non-alcoholic fatty liver disease

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. It is important to maintain a storage 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.