DOSAGE AND ADMINISTRATION
Duodenal Ulcer
Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use PEPCID at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.
Maintenance Therapy: The recommended oral dose is 20 mg once a day at bedtime.
Benign Gastric Ulcer Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.
Gastroesophageal Reflux Disease (GERD)
The recommended oral dosage for treatment of patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks.
Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas) The dosage of PEPCID in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some patients with severe Zollinger-Ellison Syndrome.
Oral Suspension PEPCID for Oral Suspension may be substituted for PEPCID Tablets in any of the above indications. Each five mL contains 40 mg of famotidine after constitution of the powder with 46 mL of Purified Water as directed.
Directions for Preparing PEPCID for Oral Suspension
Prepare suspension at time of dispensing. Slowly add 46 mL of Purified Water. Shake vigorously for 5-10 seconds immediately after adding the water and immediately before use.
Stability of PEPCID for Oral Suspension
Unused constituted oral suspension should be discarded after 30 days.
Orally Disintegrating Tablets
PEPCID RPD Orally Disintegrating Tablets may be substituted for PEPCID Tablets in any of the above indications at the same recommended dosages.
PEPCID RPD Orally Disintegrating Tablets rapidly disintegrate on the tongue. No water is needed for taking the tablet. Patients should be instructed to open the tablet blister pack with dry hands, place the tablet on the tongue to disintegrate and be swallowed with saliva.
Concomitant Use of Antacids
Antacids may be given concomitantly if needed.
Dosage Adjustment for Patients with Severe Renal Insufficiency
In patients with severe renal insufficiency, i.e., with a creatinine clearance less than 10 mL/min, the elimination half-life of PEPCID may exceed 20 hours, reaching approximately 24 hours in anuric patients. Although no relationship of adverse effects to high plasma levels has been established, to avoid excess accumulation of the drug, the dose of PEPCID may be reduced to 20 mg h.s. or the dosing interval may be prolonged to 36-48 hours as indicated by the patient's clinical response.
OVERDOSAGE
There is no experience to date with deliberate overdosage. Oral doses of up to 640 mg/day have been given to patients with pathological hypersecretory conditions with no serious adverse effects. In the event of overdosage, treatment should be symptomatic and supportive. Unabsorbed material should be removed from the gastrointestinal tract, the patient should be monitored, and supportive therapy should be employed.
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