Famotidine

FAMOTIDINE- famotidine tablet, film coated
Proficient Rx LP

1 INDICATIONS AND USAGE

Famotidine 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.

Famotidine 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 famotidine 20 mg and 40 mg tablets in adult and pediatric patients weighing 40 kg and greater with normal renal function. The use of famotidine 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 Famotidine Tablets in Adult and Pediatric Patients 40 kg and Greater with Normal Renal Function

Indication	Recommended Dosage	Recommended Duration
Active duodenal ulcer (DU)	40 mg once daily; or 20 mg twice dailya	Up to 8 weeksb,c
Active gastric ulcer	40 mg once daily	Up to 8 weeksc
Symptomatic nonerosive GERD	20 mg twice daily	Up to 6 weeksc
Erosive esophagitis diagnosed by endoscopy	20 mg twice daily; or 40 mg twice dailya	Up to 12 weeks
Pathological hypersecretoryconditionsd	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 recurrenced	20 mg once daily	1 yearc or as clinicallyindicated

^a Both dosages demonstrated effectiveness in clinical trials [see Clinical Studies (14)].

^b 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)].

^c Longer treatment durations have not been studied in clinical trials [see Clinical Studies (14.1, 14.2, 14.3)].

^d In pediatric patients, the safety and effectiveness of famotidine tablets 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 famotidine tablets 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 famotidine 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 Famotidine Tablets in Adult and Pediatric Patients 40 kg and Greater with Moderate and Severe Renal Impairment

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 daya
Active gastric ulcer	20 mg once daily; or 40 mg every other day	20 mg every other daya
Symptomatic nonerosive GERD	20 mg once daily	20 mg every other daya
Erosive esophagitis diagnosed by endoscopyb	20 mg once daily; or 40 mg every other dayb	20 mg every other daya,b
	40 mg once dailyb	20 mg once dailyb
Pathological hypersecretory conditionsc	Avoid used
Reduction of the risk of DU recurrencec	20 mg every other daya	(see footnote)e

^a An alternate dosage regimen is 10 mg once daily. Since 20 mg or 40 mg tablet strength cannot be used for this dosage regimen, use an alternate famotidine formulation.

^b Dosage adjustments for renal impairment are provided for both dosing regimens (20 mg twice daily and 40 mg twice daily) which showed effectiveness for the treatment of erosive esophagitis in clinical trials [see Clinical Studies (14.4)].

^c In pediatric patients, the safety and effectiveness of famotidine tablets 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)].

^d 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 famotidine tablets for pathological hypersecretory conditions is unknown.

^e Recommended dosage regimen is 10 mg every other day. Since 20 mg or 40 mg tablet strength cannot be used for this dosage regimen, use an alternate famotidine formulation.