PEPCID Oral suspension Ref.[10596] Active ingredients: Famotidine

Source: FDA, National Drug Code (US) Revision Year: 2019

1. Indications and Usage

PEPCID for oral suspension is indicated in adults for the treatment of:

active duodenal ulcer (DU).
active gastric ulcer (GU).
symptomatic nonerosive gastroesophageal reflux disease (GERD).
erosive esophagitis due to GERD, diagnosed by biopsy.
treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine
neoplasias).
reduction of the risk of duodenal ulcer recurrence.

PEPCID for oral suspension is indicated in pediatric patients 1 year of age and older for the treatment of:

peptic ulcer disease.
GERD with or without esophagitis and ulcerations.

PEPCID for oral suspension is indicated in pediatric patients from birth to less than 1 year of age for the treatment of:

GERD.

2. Dosage and Administration

2.1 Recommended Dosage in Adults

The recommended dosage and duration of PEPCID for oral suspension in adults with normal renal function is shown in Table 1.

Table 1. Recommended Dosage and Duration of PEPCID for Oral Suspension^* in Adults with Normal Renal Function:

Indication	Recommended Dosage	Recommended Duration
Active DU	40 mg once daily; or 20 mg twice daily^†	Up to 8 weeks^‡§
Active GU	40 mg once daily	Up to 8 weeks^§
Symptomatic nonerosive GERD	20 mg twice daily	Up to 6 weeks^§
Erosive esophagitis due to GERD, diagnosed by endoscopy	20 mg twice daily; or 40 mg twice daily^†	Up to 12 weeks
Pathological hypersecretory conditions	Starting dosage: 20 mg every 6 hours; adjust dosage to individual patient needs Maximum dosage 160 mg every 6 hours	As clinically indicated
Reduction of the risk of DU recurrence	20 mg once daily	1 year^‡§ or as clinically indicated

^* After preparation, the concentration of PEPCID oral suspension is 8 mg/mL [See Dosage and Administration (2.3)]
^† 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)].

2.2 Recommended Dosage in Pediatric Patients

The recommended dosage and duration of PEPCID for oral suspension in pediatric patients with normal renal function is shown in Table 2.

Table 2. Recommended Dosage and Duration of PEPCID for Oral Suspension^* in Pediatric Patients with Normal Renal Function:

Indication	Pediatric Age Range	Recommended Dosage^*	Duration
Peptic Ulcer Disease	1 year to less than 17 years	Starting dosage 0.5 mg/kg once daily; or 0.25 mg/kg twice daily. May increase to 1 mg/kg once daily at bedtime or 0.5 mg/kg twice dailyMaximum of 40 mg per day	8 weeks^†
GERD	Birth to less than 3 months	Starting dosage 0.5 mg/kg once daily. May increase to 1 mg/kg once daily^†	Up to 8 weeks^†‡§
GERD	3 months to less than 1 year	Starting dosage 0.5 mg/kg twice daily. May increase to 1 mg/kg twice daily^† Maximum of 40 mg per day	Up to 8 weeks^†‡§
GERD with or without esophagitis and ulcerations	1 year to less than 17 years	0.5 mg/kg twice daily Maximum of 40 mg twice daily	6 to 12 weeks^†

^* After preparation, the concentration of PEPCID oral suspension is 8 mg/mL [See Dosage and Administration (2.3)]
^† Treatment duration based on adult recommendations (see Table 1). Individualize the dose and duration based upon clinical response an/or pH determinations (gastric or esophageal) and endoscopy.
^‡ Use conservative measures (e.g., thickened feedings) concurrently [see Use in Specific Populations (8.4)].
^§ After 4 weeks of treatment re-evaluate the patient. Consider an additional 4 weeks of treatment if treatment benefit outweighs potential risks.

2.3 Recommended Dosage in Adults with Renal Impairment

Recommended dosage adjustments for adults with moderate to severe renal impairment (creatinine clearance less than 60 mL/min) by indication are shown in Table 4. Use the lowest effective dosage [see Use in Specific Populations (8.6)].

A safe and effective dosage has not been established in pediatric patients with renal impairment.

Table 3. Recommended Maximum Dosage of PEPCID for Oral Suspension in Adults with Moderate and Severe Renal Impairment:

Indication	Recommended Maximum Dosages
Indication	Creatinine clearance 30 to 60 mL/minute	Creatinine clearance less than 30 mL/minute
Active DU	20 mg once daily; or 40 mg every other day	10 mg once daily; or 20 mg every other day
Active GU	20 mg once daily; or 40 mg every other day	10 mg once daily; or 20 mg every other day
Symptomatic nonerosive GERD	20 mg once daily	10 mg once daily; or 20 mg every other day
Erosive esophagitis due to GERD, diagnosed by endoscopy^*	20 mg once daily; or 40 mg every other day	10 mg once daily; or 20 mg every other day^†
Erosive esophagitis due to GERD, diagnosed by endoscopy^*	40 mg once daily^†	20 mg once daily^†
Pathological hypersecretory conditions	Avoid use^†
Reduction of the risk of DU recurrence	10 mg once daily; or 20 mg every other day	10 mg every other day

^* Dosage adjustments for renal impairment are provided for both dosing regimens (20 mg twice daily and 4 0 mg twice daily) which showed effectiveness for the treatment of erosive esophagitis in clinical trials [see Clinical Studies (14.4)].
^† The dosage required to treat pathological hypersecretory conditions may exceed the maximum dosage evaluated in patients with impaired renal function. The risk for increased adverse reactions in renally impaired patients treated with PEPCID for oral suspension for pathological hypersecretory conditions is unknown.

2.4 Administration Instructions

Preparation of Constituted Suspension by a Healthcare Provider Prior to Dispensing

Prior to dispensing, constitute PEPCID for oral suspension by slowly adding 46 mL of Purified Water to the bottle.
Shake vigorously for 5 to 10 seconds immediately after adding the water.
The constituted suspension contains 40 mg of famotidine per 5 mL, and should be a smooth, mobile, off-white, and
homogeneous suspension.
Administration and Storage of Constituted Suspension
Shake the bottle of constituted PEPCID suspension vigorously for 5 to 10 seconds prior to each use.
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.
Store the constituted suspension at 25°C (77°F). Protect from freezing. Discard unused constituted suspension after 30 days.

10. Overdosage

The types of adverse reactions in overdosage of famotidine 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 famotidine overdosage.

16.2. Storage and Handling

Store PEPCID for oral suspension dry powder and constituted suspension at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Protect from freezing. Discard unused constituted suspension after 30 days.

Dispense in a USP tight, light-resistant container.

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