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Drug Details

Famotidine (Generic)

• Drug Class Description
  H2 -antagonists (H2 -receptor antagonists / H 2 -blockers).
• Generic Name
  Generic
• Presentation
  Film-coated tablets. Beige, round-cornered square tablets, marked 'MSD 963' on one side and plain on the other. Brown, round-cornered square tablets, marked 'MSD 964' on one side and plain on the other.
• Description
  'Pepcid' 20 mg, each tablet contains 20 mg of famotidine. 'Pepcid' 40 mg, each tablet contains 40 mg of famotidine.
• Indications
  Duodenal ulcer. Prevention of relapses of duodenal ulceration. Benign gastric ulcer. Hypersecretory conditions such as ZollingerEllison syndrome. Treatment of gastro-oesophageal reflux disease. Prevention of relapse of symptoms and erosions or ulcerations associated with gastrooesophageal reflux disease.
• Adult Dosage
  

  In benign gastric and duodenal ulceration, the dose of 'Pepcid' is one 40 mg tablet at night.

  Duodenal ulcer

  The recommended initial dose is one 40 mg tablet of 'Pepcid' at night. Treatment should continue for four to eight weeks. In most patients, healing occurs on this regimen within four weeks. In those patients whose ulcers have not healed completely after four weeks, a further fourweek period of treatment is recommended.

  Maintenance therapy: For preventing the recurrence of duodenal ulceration, the reduced dose of 20 mg of 'Pepcid' at night is recommended.

  Benign gastric ulcer

  The recommended dose is one 40 mg tablet of 'Pepcid' at night. Treatment should continue for four to eight weeks unless endoscopy reveals earlier healing.

  ZollingerEllison syndrome

  Patients without prior antisecretory therapy should be started on 20 mg of 'Pepcid' every six hours. Dosage should then be adjusted to individual response: doses up to 800 mg daily have been used up to one year without the development of significant adverse effects or tachyphylaxis. Patients who have been receiving another H₂ antagonist may be switched directly to 'Pepcid' at a dose higher than that recommended for new cases. This starting dose will depend on the severity of the condition and the last dose of H₂ antagonist previously used.

  Gastrooesophageal reflux disease

  The recommended dosage for the symptomatic relief of gastrooesophageal reflux disease is 20 mg of famotidine twice daily, which may be given for six to twelve weeks. Most patients experience improvement after two weeks.

  Where gastro-oesophageal reflux disease is associated with the presence of oesophageal erosion or ulceration, the recommended dosage is 40 mg of famotidine twice daily, which may be given for six to twelve weeks.

  Maintenance therapy: For the prevention of recurrence of symptoms and erosions or ulcerations associated with gastrooesophageal reflux disease, the recommended dosage is 20 mg of famotidine twice daily.

  Use in the elderly: The recommended dosage in most elderly patients is the same as in younger patients for all indications (see above).

  Use in impaired renal function: To avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of PEPCID may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.

  Paediatric use

  The efficacy and safety of 'Pepcid' in children have not been established.

• Child Dosage
  Not recommended.
• Contra Indications
  

  Hypersensitivity to any component of this product. Cross sensitivity in this class of compounds has been observed. Therefore 'Pepcid' should not be administered to patients with a history of hypersensitivity to other H₂-receptor antagonists.

• Special Precautions
  

  Gastric carcinoma

  Gastric malignancy should be excluded prior to initiation of therapy of gastric ulcer with 'Pepcid'. Symptomatic response of gastric ulcer to therapy with 'Pepcid' does not preclude the presence of gastric malignancy.

  Impaired renal function

  Since 'Pepcid' is primarily excreted via the kidney, caution should be exercised when treating patients with impaired renal function. The dose should be reduced to 20 mg nocte when creatinine clearance falls below 10 ml/min.

• Interactions
  

  'Pepcid' does not inhibit the hepatic cytochrome P450 enzyme system. Furthermore, clinical studies have shown that famotidine does not potentiate the actions of warfarin, theophylline, phenytoin, diazepam, propranolol, aminopyrine and antipyrine, which are inactivated by this system.

  Probenecid

  The administration of probenecid can delay the elimination of famotidine. Concomitant use of probenecid and famotidine tablets should be used with caution.

  Antacids

  Bioavailability may be slightly increased by food, or slightly decreased by antacids; however, these effects are of no clinical consequence.

  Ketonconazole / Itraconazole

  During concomitant use of substances whose absorption is affected by gastric acid levels, a possible change in the absorption of these substances should be considered. The absorption of ketoconazole or itraconazole can be reduced; ketoconazole should be administered two hours before administering famotidine.

• Adverse Drug Reactions
  

  General disorders and administration site conditions :

  Very rare: fatigue

  Nervous system disorders:

  Rare: headache, dizziness,

  Very rare: epileptic seizures/convulsions (in patients with impaired renal function), paraesthesia

  Gastrointestinal disorders:

  Rare: constipation, diarrhoea

  Very rare: dry mouth, dysgeusia, nausea and/or vomiting, abdominal discomfort of distension, anorexia

  Hepatobiliary disorders:

  Very rare: liver enzyme abnormalities, cholestatic jaundice

  Isolated cases: worsening of hepatic disease however a causal relationship to therapy with 'Pepcid' has not been established.

  Skin and subcutaneous tissue disorders:

  Very rare: rash, pruritus, Stevens Johnson Syndrome/toxic epidermal necrolysis

  Immune system disorders:

  Very rare: urticaria, anaphylaxis, angioedema

  Musculoskeletal and connective tissue disorders:

  Very rare: arthralgia, muscle cramps

  Psychiatric disorders:

  Very rare: reversible psychic disturbances including depression, anxiety disorders, agitation, confusion and hallucinations, reduced libido, insomnia

  Hematologic:

  Very rare: pancytopenia, leucopenia; thrombocytopenia, agranulocytosis, neutropenia.

  Reproductive system and breast disorders:

  Rare: impotence, reversible gynaecomastia

  Cardic disorders:

  Very rare: A-V block, interstitial pneumonia.