Medication info
Withus Famotidine Tablets 20mg

Withus Famotidine Tablets 20mg

Prescription medicationTablet
Ingredient · strength
Famotidine›20mg / 1 tablet
Manufacturer / importer
위더스제약(주)
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Active

MFDS item code 198802273 · Notified 1988.10.10 · Insurance code 660701370

Summary

Main use
Improvement of gastric ulcers and upper gastrointestinal bleeding (peptic ulcers, acute stress ulcers, etc.)
Who uses it
Adults
Adult dosage
For oral administration in the treatment of gastric and duodenal ulcers, anastomotic ulcers, upper gastrointestinal bleeding, gastroesophageal reflux disease, and Zollinger-Ellison syndrome: administer 20 mg twice daily after meals or at bedtime, or 40 mg once daily at bedtime. In cases of upper gastrointestinal bleeding, treatment is started with the injectable form and then switched to oral administration. For improvement of gastric mucosal lesions (acute gastritis, acute exacerbation of chronic gastritis): 10 mg orally, twice daily (after meals or at bedtime) or 20 mg orally, once daily (at bedtime). Adjust according to age and symptoms.

Ingredients

Manufacturer
위더스제약(주)

Efficacy & effects

Improvement of gastric ulcers and upper gastrointestinal bleeding (peptic ulcers, acute stress ulcers, etc.)

  • Gastric and duodenal ulcers
  • anastomotic ulcers
  • upper gastrointestinal bleeding
  • acute stress ulcers
  • hemorrhagic gastritis
  • gastroesophageal reflux disease
  • Zollinger-Ellison syndrome
  • gastric mucosal lesions
  • acute gastritis
  • acute exacerbations of chronic gastritis.
View approved original text

This medication is effective in the treatment of gastric and duodenal ulcers, anastomotic ulcers, and upper gastrointestinal bleeding associated with peptic ulcers. It is also used for improving conditions of excessive gastric acid secretion such as gastroesophageal reflux disease and Zollinger-Ellison syndrome. It alleviates gastric mucosal damage due to acute exacerbations of acute and chronic gastritis and helps treat lesions of the gastric mucosa such as erosion, bleeding, and swelling. As an injectable form, it is also utilized prior to anesthesia to reduce the risk of gastrointestinal bleeding. In summary, this drug is used for the treatment of various gastrointestinal diseases and for the protection of gastric mucosa.

Dosage and Administration

Adult dosage

For oral administration in the treatment of gastric and duodenal ulcers, anastomotic ulcers, upper gastrointestinal bleeding, gastroesophageal reflux disease, and Zollinger-Ellison syndrome: administer 20 mg twice daily after meals or at bedtime, or 40 mg once daily at bedtime. In cases of upper gastrointestinal bleeding, treatment is started with the injectable form and then switched to oral administration. For improvement of gastric mucosal lesions (acute gastritis, acute exacerbation of chronic gastritis): 10 mg orally, twice daily (after meals or at bedtime) or 20 mg orally, once daily (at bedtime). Adjust according to age and symptoms.

Precautions

This medication should not be used in patients who have previously shown allergic reactions to its ingredients or other H2 receptor antagonists. Patients with drug hypersensitivity, impaired renal function, heart disease, liver dysfunction, and elderly individuals should exercise special caution when using this drug. Particularly in cases of poor renal function, the drug may remain in the body longer, increasing the risk of side effects; thus, the dosage should be reduced or the administration interval extended. Rarely, this medication may cause serious side effects such as shock, severe allergic reactions, hematological abnormalities, severe skin diseases, hepatic dysfunction, muscle damage, heart rhythm abnormalities, altered consciousness, nephritis, and pneumonia. If any abnormal symptoms appear, the use of the medication should be discontinued immediately, and medical treatment should be sought. Additionally, various mild side effects such as constipation, diarrhea, nausea, vomiting, headache, drowsiness, insomnia, dizziness, and arthralgia may occur, so symptoms should be carefully monitored. During treatment, it is advisable to use the minimum effective dosage while closely observing changes in symptoms, and to switch to alternative treatment if no effect is observed. This medication dissolves in the oral cavity but is not absorbed through the oral mucosa, so it must be swallowed with saliva or water. Patients undergoing hemodialysis should be cautious as the efficacy of calcium supplements may be diminished when this drug is used together with phosphate binders. This medication may reduce the efficacy of certain antifungals or some anticancer agents when taken together; therefore, any other medications being used should be disclosed to the doctor or pharmacist. Elderly patients are more likely to have reduced kidney function, which can increase the blood concentration of this medication; hence, dosage adjustments or extended intervals may be necessary. Women who are pregnant or may become pregnant should use this medication only if the benefits outweigh the risks, as safety has not been fully established. Women who are breastfeeding are advised to discontinue breastfeeding as this medication can pass into breast milk. Safety in children has not been fully established, so caution should be exercised when administering to youngsters. Finally, this medication may mask symptoms of gastric cancer, making diagnosis difficult; therefore, it should only be used after confirming a non-malignant condition.

Side effects and when to seek care immediately

Serious side effects

Shock, hypersensitivity (anaphylaxis, difficulty breathing, systemic flushing, angioedema (facial swelling, pharyngeal edema, etc.), urticaria), pancytopenia, agranulocytosis, aplastic anemia, hemolytic anemia, thrombocytopenia, Stevens-Johnson syndrome, Lyell syndrome, hepatic dysfunction, jaundice, rhabdomyolysis, QT prolongation, ventricular tachycardia (including Torsades de Pointes), ventricular fibrillation, altered consciousness, seizures, interstitial nephritis, acute renal failure, interstitial pneumonia,

Mild side effects

  • Rash
  • urticaria (erythema)
  • facial swelling
  • leukopenia
  • eosinophilia
  • constipation
  • diarrhea
  • dry mouth
  • nausea
  • vomiting
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  • abdominal distension
  • loss of appetite
  • stomatitis
  • increased blood pressure
  • facial flushing
  • tinnitus
  • bradycardia
  • tachycardia
  • atrioventricular block
  • bronchospasm
  • elevation of AST (GOT)
  • ALT (GPT)
  • ALP
  • elevated total bilirubin
  • LDH
  • hepatic dysfunction
  • hepatitis
  • general fatigue
  • lethargy
  • headache
  • drowsiness
  • insomnia
  • hallucinations

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

Storage

This medication is light-sensitive and should be stored in a container that blocks light. It is also essential to store it at room temperature between 1 to 30 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 500 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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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.