When is Pepcid (famotidine) indicated for use?

Indications for Pepcid (Famotidine) Use

Famotidine is indicated for the treatment of active duodenal ulcer, active gastric ulcer, symptomatic non-erosive gastroesophageal reflux disease (GERD), erosive esophagitis due to GERD, pathological hypersecretory conditions, and for the reduction of risk of duodenal ulcer recurrence. 1

FDA-Approved Indications

• Famotidine is indicated for the treatment of active duodenal ulcer, with most adult patients healing within 4 weeks 1, 2
• Treatment of active benign gastric ulcer, with most patients healing within 6 weeks 2
• Management of symptomatic non-erosive gastroesophageal reflux disease (GERD) 1
• Treatment of erosive esophagitis due to GERD, diagnosed by biopsy or endoscopy 1, 2
• Treatment of pathological hypersecretory conditions such as Zollinger-Ellison Syndrome and multiple endocrine neoplasias 1, 2
• Reduction of the risk of duodenal ulcer recurrence (maintenance therapy) 1, 2

Dosing and Administration

• For duodenal ulcer: 40 mg at bedtime has shown remarkable reduction of gastric acidity, with antisecretory action lasting for 12 hours 3
• For GERD: Twice daily dosing is necessary for achieving adequate results based on intraesophageal pH monitoring and clinical studies 4
• For prevention of NSAID-induced ulcers: 40 mg twice daily has been shown to significantly reduce the cumulative incidence of both gastric and duodenal ulcers in patients receiving long-term NSAID therapy 5

Special Clinical Situations

Prevention of GI Bleeding in Patients on Antiplatelet Therapy

• Famotidine may be considered as an alternative to proton pump inhibitors (PPIs) in patients on dual antiplatelet therapy, particularly with clopidogrel 6
• The FDA notes there is no evidence that H2 blockers like famotidine interfere with the antiplatelet activity of clopidogrel, unlike some PPIs which may inhibit CYP2C19 activity 6
• The FAMOUS trial demonstrated that famotidine 20 mg twice daily was beneficial in reducing the incidence of peptic ulcer in patients taking low-dose aspirin, with gastric ulcer rates of 3.4% versus 15% with placebo 6

NSAID-Induced Ulcer Prevention

• Double-dose famotidine has shown efficacy against NSAID-related duodenal and gastric ulcers, particularly in patients with a history of prior ulcers 6
• High-dose famotidine (40 mg twice daily) significantly reduces the cumulative incidence of both gastric ulcers (8% vs 20% with placebo) and duodenal ulcers (2% vs 13% with placebo) in patients receiving long-term NSAID therapy 5

Advantages and Limitations

Advantages

• Famotidine is very well tolerated and is free of the antiandrogenic effects occasionally reported with cimetidine 7, 8
• Unlike cimetidine, famotidine does not notably bind to cytochrome P-450 and therefore has not been associated with clinically significant drug interactions 8
• Famotidine is generally well tolerated in patients with cardiovascular, renal, or hepatic dysfunction 8

Limitations

• H2 receptor antagonists like famotidine suppress gastric acid production by only 37% to 68% over 24 hours, which is less effective than PPIs 6
• Tachyphylaxis can develop within 6 weeks of initiation of treatment, limiting its potential for long-term use 6
• H2 receptor antagonists have been shown to be less effective than PPIs in symptom relief and healing rates of erosive esophagitis 6

Pediatric Use

• Famotidine is indicated in pediatric patients 40 kg and above for the treatment of active duodenal ulcer, active gastric ulcer, symptomatic non-erosive GERD, and erosive esophagitis due to GERD 1
• For children, famotidine is available as a cherry-banana-mint-flavored oral suspension at a dose of 1 mg/kg/day divided in 2 doses for ages 1-16 years 6

Common Pitfalls and Caveats

• When considering famotidine for ulcer prevention in patients on antiplatelet therapy, remember that while H2 blockers don't interfere with clopidogrel activity, they "cannot be relied on to protect as well as PPIs" 6
• The benefit of famotidine for NSAID-related ulcer prevention may be limited primarily to those with H. pylori infection 6
• For optimal acid suppression in GERD, twice daily dosing is necessary rather than once daily 4