Medication info
Napudy Tablet (Lafutidine)

Napudy Tablet (Lafutidine)

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

MFDS item code 201908602 · Approved 2019.12.24 · Insurance code 643704800

Summary

Main use
Treatment of gastrointestinal conditions (such as ulcers and gastritis), preanesthetic medication, and combination therapy for Helicobacter pylori
Who uses it
Adults
Adult dosage
1. Short-term treatment of gastric ulcers: The usual dose is lafutidine 10mg orally twice daily, in the morning and at bedtime. In clinical trials with treatment for up to 8 weeks, most ulcers healed within 8 weeks; however, healing time may occasionally vary among patients. 2. Short-term treatment of duodenal ulcers: The usual dose is lafutidine 10mg orally twice daily, in the morning and at bedtime. In clinical trials with treatment for up to 6 weeks, most ulcers healed within 6 weeks; however, healing time may occasionally vary among patients. 3. Improvement of gastric mucosal lesions in acute gastritis and chronic gastritis: The usual dose is lafutidine 10mg orally once daily at bedtime. In clinical trials with treatment for up to 2 weeks, most lesions healed within 2 weeks; however, healing time may occasionally vary among 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 lafutidine 10mg per dose, given twice orally (at bedtime on the day before surgery and 2 hours before anesthesia on the day of surgery). 6. Treatment of reflux esophagitis: Administer lafutidine 10mg per dose twice orally.

Ingredients

Manufacturer
International Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of gastrointestinal conditions (such as ulcers and gastritis), preanesthetic medication, and combination therapy for Helicobacter pylori

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

This medicine is used in the treatment of gastric ulcers and duodenal ulcers. It also helps improve damage to the gastric mucosa caused by acute and chronic gastritis. For patients with peptic ulcers associated with Helicobacter pylori infection, it is administered in combination with antibiotics to enhance treatment effectiveness. It is also given prior to anesthesia during surgery or procedures to control gastric acid secretion. Additionally, it is effective in treating gastroesophageal reflux disease. It is used for the treatment and improvement of various gastrointestinal disorders.

Dosage and Administration

Adult dosage

1. Short-term treatment of gastric ulcers: The usual dose is lafutidine 10mg orally twice daily, in the morning and at bedtime. In clinical trials with treatment for up to 8 weeks, most ulcers healed within 8 weeks; however, healing time may occasionally vary among patients. 2. Short-term treatment of duodenal ulcers: The usual dose is lafutidine 10mg orally twice daily, in the morning and at bedtime. In clinical trials with treatment for up to 6 weeks, most ulcers healed within 6 weeks; however, healing time may occasionally vary among patients. 3. Improvement of gastric mucosal lesions in acute gastritis and chronic gastritis: The usual dose is lafutidine 10mg orally once daily at bedtime. In clinical trials with treatment for up to 2 weeks, most lesions healed within 2 weeks; however, healing time may occasionally vary among 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 lafutidine 10mg per dose, given twice orally (at bedtime on the day before surgery and 2 hours before anesthesia on the day of surgery). 6. Treatment of reflux esophagitis: Administer lafutidine 10mg per dose twice orally.

Precautions

This medication should not be used in patients with a history of allergy to any of its components. This medication contains lactose; therefore, individuals with genetic conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take it. Patients with a history of allergic reactions to medications, those with impaired liver or kidney function, patients undergoing dialysis, and the elderly should exercise caution when using this medication. This medication can occasionally cause severe allergic reactions; if symptoms such as pallor, decreased blood pressure, red spots on the body, or difficulty breathing occur, stop taking the medication immediately and seek medical attention. Liver function abnormalities or jaundice symptoms may occur, so regular liver function tests are recommended, and if abnormalities are found, discontinue this medication. Severe hematological abnormalities such as agranulocytosis or thrombocytopenia may develop, prompting immediate notification of healthcare professionals if symptoms like pharyngitis, fatigue, or fever arise. Other serious adverse effects such as rare skin rashes, seizures, or cardiac rhythm disturbances have been reported; thus, any unusual symptoms should warrant immediate consultation with a specialist. Gastrointestinal symptoms may include constipation, diarrhea, nausea, vomiting, abdominal bloating, and loss of appetite, while central nervous system symptoms may include headache, insomnia, and drowsiness. The elderly may have reduced physical function, so it is necessary to adjust dosage and intervals while closely monitoring their condition. Dialysis patients may require careful dosing starting at low doses due to the potential for increased blood concentration of this medication. Pregnant women or those who could become pregnant should only take this medication if the physician determines that the benefits outweigh the risks; breastfeeding women are advised not to take this medication since it may be excreted in breast milk. Safety in children has not been established, and it is advisable not to use this medication in pediatric patients. This medication should be stored out of reach of children and in its original container to prevent misuse or degradation of quality. This medication may conceal symptoms of malignant tumors or delay diagnosis, so patients with or suspected of having gastric ulcers should verify the presence of malignancy. If there is no improvement during treatment, switching to an alternative therapy may be necessary, and regular monitoring of blood, liver, and kidney function is required.

Side effects

  • Shock
  • symptoms of anaphylaxis
  • pallor
  • hypotension
  • systemic rash
  • dyspnea
  • liver dysfunction
  • jaundice
  • agranulocytosis
  • pharyngitis
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  • general malaise
  • fever
  • thrombocytopenia
  • pancytopenia
  • aplastic anemia
  • seizures
  • interstitial nephritis
  • Stevens-Johnson syndrome
  • Riel 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
  • elevated ALT
  • elevated AST
  • elevated Al-P
  • elevated γ-GTP
  • elevated T-Bil
  • elevated LDH
  • elevated TTT
  • abnormal urine protein
  • elevated BUN
  • increased serum uric acid
  • elevated Cl
  • prolonged gestation
  • elevated Na
  • decreased K
  • gynecomastia
  • edema
  • fatigue
  • glossitis
  • headache
  • urticaria
  • skin rash
  • abdominal pain
  • dyspepsia
  • enteritis
  • gastric ulcer
  • erosive gastritis
  • duodenitis
  • bloating
  • nasopharyngitis
  • upper respiratory infection
  • bronchopneumonia
  • tinea
  • carotid stenosis
  • cough
  • oropharyngeal pain
  • oropharyngeal discomfort
  • wet cough
  • fatigue
  • chest pain
  • limb pain
  • joint pain
  • cervical pain
  • pruritus
  • acne
  • contusion
  • insomnia
  • non-alcoholic steatohepatitis

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

Storage

This medication may be sensitive to air or moisture; therefore, it should be stored in a tightly sealed container. It is advisable to maintain the storage temperature between 1 and 30 degrees Celsius to preserve the medication's efficacy and safety for a long time.

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.