Medication info
Samik Famotidine Tablets (Famotidine)

Samik Famotidine Tablets (Famotidine)

Prescription medicationTablet
Ingredient · strength
Famotidine›20mg / 1 tablet
Manufacturer / importer
삼익제약(주)
Appearance
White round film-coated tablets
Packaging
30 tablets/bottle, 1000 tablets/bottle
Approval status
Active

MFDS item code 200403434 · Notified 2004.09.20 · Insurance code 644000900

Summary

Main use
Improvement of gastric ulcers and upper gastrointestinal bleeding (peptic ulcers, acute stress ulcers, etc.)
Who uses it
Adults
Adult dosage
Oral administration: 1) For gastric and duodenal ulcers, anastomotic ulcers, upper gastrointestinal bleeding, gastroesophageal reflux disease, and Zollinger-Ellison syndrome, take 20 mg orally twice a day (after breakfast, after dinner, or at bedtime) or 40 mg orally once daily (at bedtime). In cases of upper gastrointestinal bleeding, treatment is generally initiated with injection until oral administration becomes possible, at which point you can switch to oral medication. 2) For improvement of gastric mucosal lesions (acute gastritis, acute exacerbation of chronic gastritis), adults should take 10 mg orally twice a day (after breakfast, after dinner, or at bedtime) or 20 mg orally once daily (at bedtime). Adjust according to age and symptoms.

Ingredients

Manufacturer
삼익제약(주)

Efficacy & effects

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

  • Gastric ulcer
  • duodenal ulcer
  • anastomotic ulcer
  • upper gastrointestinal bleeding
  • acute stress ulcer
  • hemorrhagic gastritis
  • gastroesophageal reflux disease
  • Zollinger-Ellison syndrome
  • gastric mucosal erosion
  • gastric mucosal bleeding
  • gastric mucosal reddening
  • gastric mucosal swelling
View approved original text

This medication is used for the treatment of ulcers in the stomach and duodenum, anastomotic ulcers, and for upper gastrointestinal bleeding due to peptic ulcers or acute stress ulcers and hemorrhagic gastritis. It is also effective in conditions of increased gastric acid such as gastroesophageal reflux disease and Zollinger-Ellison syndrome. It assists in the improvement of lesions such as erosion, bleeding, reddening, and swelling of the gastric mucosa that occur during acute exacerbations of both acute and chronic gastritis. It is also used in injectable form for upper gastrointestinal bleeding, Zollinger-Ellison syndrome, and for pre-anesthetic medication. Overall, this drug is effectively used for the treatment of various gastrointestinal disorders and symptom relief.

Dosage and Administration

Adult dosage

Oral administration: 1) For gastric and duodenal ulcers, anastomotic ulcers, upper gastrointestinal bleeding, gastroesophageal reflux disease, and Zollinger-Ellison syndrome, take 20 mg orally twice a day (after breakfast, after dinner, or at bedtime) or 40 mg orally once daily (at bedtime). In cases of upper gastrointestinal bleeding, treatment is generally initiated with injection until oral administration becomes possible, at which point you can switch to oral medication. 2) For improvement of gastric mucosal lesions (acute gastritis, acute exacerbation of chronic gastritis), adults should take 10 mg orally twice a day (after breakfast, after dinner, 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 with a history of allergic reactions to this drug or to other H2 receptor antagonists. This drug contains lactose, so individuals with genetic issues such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take it. Patients with a history of drug allergy should use this medication cautiously, and those with decreased renal function may need to reduce the dosage or extend the dosing interval due to increased drug concentrations. Patients with heart disease should be cautious as cardiovascular side effects may occur, and those with compromised liver function should also be careful as symptoms may worsen. Elderly patients may have impaired kidney function and require dosage adjustments when using this drug. Serious side effects may include shock, severe allergic reactions, decrease in blood cell count, severe adverse skin and mucosal reactions, liver dysfunction, muscle breakdown, heart rhythm disorders, altered consciousness, nephritis, and pneumonia, so if any unusual symptoms occur, discontinue use immediately and inform healthcare professionals. Common side effects may include skin rash, indigestion, blood pressure changes, respiratory problems, liver function abnormalities, mental and neurological symptoms, so careful observation is necessary if symptoms arise. During treatment, patients' conditions should be closely monitored, using the minimum effective dose necessary, and if no efficacy is observed, it is advisable to switch to another treatment method. This medication dissolves in the mouth but is not absorbed through the oral mucosa, so it must be swallowed with water or saliva. Patients undergoing hemodialysis should be cautious when using this drug with phosphate binders, as the drug's effectiveness may be reduced. There may be drug interactions, particularly with certain antifungals or anticancer drugs, as the efficacy of this drug or those medications may be reduced; hence, it is essential to inform healthcare personnel. Women who are pregnant or may become pregnant should carefully consider the benefits and risks of using this drug, and nursing mothers are advised to discontinue breastfeeding as the medication may be transmitted through breast milk. Safety in pediatric patients has not been sufficiently established, so this drug should be used cautiously in children. Finally, this drug may mask signs of gastric cancer; therefore, it should only be used after confirming that it is not gastric cancer.

Side effects and when to seek care immediately

Serious side effects

Shock, hypersensitivity (anaphylaxis, respiratory distress, generalized flushing, angioedema, urticaria), Stevens-Johnson syndrome, Lyell's syndrome, liver dysfunction, jaundice, rhabdomyolysis, QT prolongation, ventricular tachycardia, ventricular fibrillation, altered consciousness, seizures, interstitial nephritis, acute renal failure, interstitial pneumonia, failure of contraction

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
  • flushing
  • tinnitus
  • bradycardia
  • tachycardia
  • atrioventricular block
  • bronchospasm
  • elevation of AST (GOT)
  • ALT (GPT)
  • ALP
  • increase in total bilirubin and LDH
  • liver function abnormalities
  • hepatitis
  • generalized malaise
  • lethargy
  • headache
  • drowsiness
  • insomnia
  • hallucinations
  • agitation

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

Storage

This medication should be stored in a tightly sealed container to prevent air from entering, and ideally kept at room temperature between 1°C and 30°C. This helps maintain the drug's efficacy and prevents deterioration.

Appearance and packaging

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 1000 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.