PEPCID Film-coated tablet Ref.[10595] Active ingredients: Famotidine

2.1 Recommended Dosage

Table 1 shows the recommended dosage of PEPCID 20 mg and 40 mg tablets in adult and pediatric patients weighing 40 kg and greater with normal renal function. The use of PEPCID 20 mg and 40 mg tablets is not recommended in pediatric patients weighing less than 40 kg because the lowest available strength (20 mg) exceeds the recommended dose for these patients. Use another famotidine formulation for pediatric patients weighing less than 40 kg.

Table 1. Recommended Dosage and Duration of PEPCID Tablets in Adult and Pediatric Patients 40 kg and Greater with Normal Renal Function:

^* Both dosages demonstrated effectiveness in clinical trials [see Clinical Studies (14)].
^† In clinical trials, the majority of patients healed within 4 weeks. For patients who do not heal after 4 weeks, consider an additional 2 to 4 weeks of treatment [see Clinical Studies (14.1)].
^‡ Longer treatment durations have not been studied in clinical trials [see Clinical Studies (14.1, 14.2, 14.3)].
^§ In pediatric patients, the safety and effectiveness of PEPCID have not been established for the reduction of the risk of duodenal ulcer recurrence or for treatment of pathological hypersecretory conditions [see Use in Specific Populations (8.4)].

2.2 Dosage in Renal Impairment

Dosage adjustments of PEPCID are recommended for patients with moderate to severe renal impairment (creatinine clearance less than 60 mL/min) [see Use in Specific Populations (8.6)]. Table 2 shows the recommended maximum dosage of PEPCID 20 mg or 40 mg tablets for patients with renal impairment, by indication. Use the lowest effective dose. Some dosage adjustments may require switching to other formulations of famotidine (e.g., oral suspension, lower dose tablet).

Table 2. Recommended Maximum Dosage of PEPCID Tablets in Adult and Pediatric Patients 40 kg and Greater with Moderate and Severe Renal Impairment:

^* An alternate dosage regimen is 10 mg once daily. Since 20 mg or 4 0 mg tablet strength cannot be used for this dosage regimen, use an alternate famotidine formulation.
^† Dosage adjustments for renal impairment are provided for both dosing regimens (20 mg twice daily and 0 mg twice daily) which showed effectiveness for the treatment of erosive esophagitis in clinical trials [see Clinical Studies (14.4)].
^‡ In pediatric patients, the safety and effectiveness of PEPCID have not been established for the reduction of the risk of duodenal ulcer recurrence or for treatment of pathological hypersecretory conditions see Use in Specific Populations (8.4)].
^§ Doses required to treat pathological hypersecretory conditions may exceed the maximum doses evaluated in patients with impaired renal function. The risk for increased adverse reactions in renally impaired patients treated with PEPCID for pathological hypersecretory conditions is unknown.
^¶ Recommended dosage regimen is 10 mg every other day. Since 20 mg or 4 0 mg strength cannot be used for this dosage regimen, use an alternate famotidine formulation.

2.3 Administration Instructions

• Take PEPCID once daily before bedtime or twice daily in the morning and before bedtime, as recommended.
• PEPCID may be taken with or without food [see Clinical Pharmacology (12.3)].

PEPCID may be given with antacids.

The types of adverse reactions in overdosage of PEPCID are similar to the adverse reactions encountered with use of recommended dosages [see Adverse Reactions (6.1)].

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.

Due to low binding to plasma proteins, famotidine is eliminated by hemodialysis. There is limited experience on the usefulness of hemodialysis as a treatment for PEPCID overdosage.

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Dispense in a USP tight, light-resistant container.