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U.S. Department of Health and Human Services


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Pepcid (famotidine) Labeling Changes Summary – 03/23/2001

Audience: Healthcare Professionals, particularly those caring for elderly patients in nursing home settings

Product: PEPCID [tablets, oral suspension, orally disintegrating tablets, injection, injection Pre-mixed]


Reason for Notice: clinically important safety labeling change

What’s Changed: Dosage adjustment in the case of moderate or severe renal impairment is necessary (see PRECAUTIONS, Patients with Moderate or Severe Renal Insufficiency and DOSAGE AND ADMINISTRATION, Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

What’s New: The need for dosage adjustments for patients with moderate renal insufficiency [creatinine clearance <50ml/minute] has been identified. The previous labeling recommended adjustments for severe insufficiency only [creatinine clearance <10ml/minute].

What is the Scientific Evidence Supporting this Change: This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. There is a close relationship between creatinine clearance values and the elimination half-life of PEPCID. In patients with severe renal insufficiency, i.e., creatinine clearance less than 10 mL/min, the elimination half-life of PEPCID may exceed 20 hours and adjustment of dose or dosing intervals in moderate and severe renal insufficiency may be necessary.

What Action Should be Considered: Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, 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.


Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.