Medication info

Famotidine Tablets 20 mg (Famotidine)

Prescription medicationApproval revoked
Ingredient · strength
Famotidine›Strength being verified
Manufacturer / importer
한국신텍스제약(주)
Appearance
White round film-coated tablets
Packaging
30 tablets/bottle, 500 tablets/bottle, 1000 tablets/bottle
Approval status
Approval revoked

MFDS item code 201906337 · Approved 2019.09.06

This product's status changed to Approval revoked on 2023.08.08. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of gastric ulcers and upper gastrointestinal bleeding, improvement of gastric mucosal lesions
Who uses it
Adults
Adult dosage
For gastric and duodenal ulcers, anastomotic ulcers, upper gastrointestinal bleeding, gastroesophageal reflux disease, and Zollinger-Ellison syndrome: As famotidine, take 20 mg orally twice a day (after breakfast, after dinner, or at bedtime) or 40 mg orally once a day (at bedtime). In cases of upper gastrointestinal bleeding, treatment typically starts with injections and is switched to oral administration once feasible. For acute gastritis and acute exacerbation of chronic gastritis.

Ingredients

Manufacturer
한국신텍스제약(주)

Efficacy & effects

Improvement of gastric ulcers and upper gastrointestinal bleeding, improvement of gastric mucosal lesions

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

This medication helps to treat ulcers of the stomach and duodenum and prevents bleeding in the ulcerated area. It also alleviates bleeding caused by acute stress ulcers and hemorrhagic gastritis, and improves symptoms of gastroesophageal reflux disease. It regulates excessive gastric acid secretion due to Zollinger-Ellison syndrome and improves lesions such as erosion, bleeding, redness, and swelling of the damaged gastric mucosa during acute exacerbation of acute and chronic gastritis. This drug is used to protect the gastric mucosa and effectively alleviate symptoms of gastrointestinal diseases.

Dosage and Administration

Adult dosage

For gastric and duodenal ulcers, anastomotic ulcers, upper gastrointestinal bleeding, gastroesophageal reflux disease, and Zollinger-Ellison syndrome: As famotidine, take 20 mg orally twice a day (after breakfast, after dinner, or at bedtime) or 40 mg orally once a day (at bedtime). In cases of upper gastrointestinal bleeding, treatment typically starts with injections and is switched to oral administration once feasible. For acute gastritis and acute exacerbation of chronic gastritis.

Precautions

This medication should not be used by patients who have had allergic reactions to this drug’s ingredients or similar medications. Additionally, it should not be taken by patients with a genetic disorder that prevents the digestion of lactose, as it contains lactose. Those with a history of drug allergies should use this medication cautiously, and patients with impaired kidney function may need to reduce the dosage or extend the dosing interval, as drug concentration can increase. Patients with heart disease, impaired liver function, and the elderly should also use this medication with caution. This drug can rarely cause serious allergic reactions, blood disorders, skin diseases, liver dysfunction, muscle damage, cardiac arrhythmias, consciousness disturbances, kidney problems, pulmonary diseases, and other side effects. Therefore, if any unusual symptoms occur, use should be stopped immediately and a doctor should be consulted. Furthermore, various side effects such as vomiting, diarrhea, headache, drowsiness, dizziness, cough, and blood pressure changes have been reported, so monitoring body condition is crucial. It is important to use the minimum dose necessary while confirming the therapeutic effect and to undergo regular blood tests or liver and kidney function tests. This medication dissolves in the mouth but is not absorbed through the mucosa, so it must be swallowed with water. Patients undergoing hemodialysis should be cautious, as interactions with other medications may reduce efficacy. Taking this drug with certain antifungal agents can diminish each other's effects, so consultation with a doctor is necessary. Elderly patients with reduced kidney function may retain the medication longer, necessitating dosage adjustment. Women who are pregnant or may become pregnant should only take this medication if the benefits outweigh the risks, as safety has not been fully established. Breastfeeding women are advised to discontinue breastfeeding, as this drug may be transferred into breast milk. Safety in children has not been sufficiently verified, so its use is not recommended. Finally, this medication can mask symptoms of gastric cancer, so 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, dyspnea, generalized flushing, angioedema, urticaria), pancytopenia, agranulocytosis, aplastic anemia, hemolytic anemia, thrombocytopenia, Stevens-Johnson syndrome, Lyell's syndrome, liver dysfunction, jaundice, rhabdomyolysis, QT prolongation, ventricular tachycardia, ventricular fibrillation, consciousness disturbance, seizures, interstitial nephritis, acute renal failure, interstitial pneumonia, contraction failure

Mild side effects

  • Hypersensitivity
  • rash
  • urticaria
  • facial edema
  • leukopenia
  • eosinophilia
  • constipation
  • diarrhea
  • thirst
  • nausea
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  • vomiting
  • abdominal distension
  • loss of appetite
  • stomatitis
  • elevated blood pressure
  • facial flushing
  • tinnitus
  • bradycardia
  • tachycardia
  • atrioventricular block
  • bronchospasm
  • increased AST(GOT)
  • ALT(GTP)
  • ALP
  • elevated total bilirubin
  • LDH
  • liver dysfunction
  • 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 that does not allow air entry and kept at a temperature between 1 and 30 degrees Celsius. Storing it this way maintains the drug's effectiveness for a longer period.

Appearance and packaging

Appearance

White round film-coated tablets

Package unit

30 tablets/bottle, 500 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.