Pepcid
PEPCID- famotidine tablet, film coated
Bausch Health US LLC
1 INDICATIONS AND USAGE
PEPCID tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of:
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- active duodenal ulcer (DU).
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- active gastric ulcer (GU).
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- symptomatic nonerosive gastroesophageal reflux disease (GERD).
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- erosive esophagitis due to GERD, diagnosed by biopsy.
PEPCID tablets are indicated in adults for the:
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- treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias).
reduction of the risk of duodenal ulcer recurrence.
2 DOSAGE AND ADMINISTRATION
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.
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Indication | Recommended Dosage | Recommended Duration |
Active duodenal ulcer (DU) | 40 mg once daily; or 20 mg twice daily * | |
Active gastric ulcer | 40 mg once daily | Up to 8 weeks ‡ |
Symptomatic nonerosive GERD | 20 mg twice daily | Up to 6 weeks ‡ |
Erosive esophagitis 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 |
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).
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Indication | Recommended Maximum Dosages | |
Creatinine clearance 30 to 60 mL/minute | Creatinine clearance less than 30 mL/minute | |
Active duodenal ulcer (DU) | 20 mg once daily; or 40 mg every other day | 20 mg every other day * |
Active gastric ulcer | 20 mg once daily; or 40 mg every other day | 20 mg every other day * |
Symptomatic nonerosive GERD | 20 mg once daily | 20 mg every other day * |
Erosive esophagitis diagnosed by endoscopy † | 20 mg once daily; or 40 mg every other day | |
40 mg once daily † | 20 mg once daily † | |
Pathological hypersecretory conditions ‡ | Avoid use § | |
Reduction of the risk of DU reccurrence ‡ | 20 mg every other day * | (see footnote)¶ |
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