Famotidine

FAMOTIDINE- famotidine powder, for suspension
Lupin Pharmaceuticals, Inc.

1 INDICATIONS AND USAGE

Famotidine 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.

Famotidine 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.

Famotidine 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 Famotidine for oral suspension in adults with normal renal function is shown in Table 1.

Table 1: Recommended Dosage and Duration of Famotidine for Oral Suspensiona in Adults with Normal Renal Function

a After preparation, the concentration of famotidine oral suspension is 8 mg/mL [see DOSAGE AND ADMINISTRATION (2.3)]

b Both dosages demonstrated effectiveness in clinical trials [see CLINICAL STUDIES (14)].

c 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)].

d Longer treatment durations have not been studied in clinical trials [see CLINICAL STUDIES (14.1, 14.2, 14.3)].

Indication Recommended Dosage Rec ommended Duration
Active DU 40 mg once daily; or 20 mg twice dailyb Up to 8 weeksc,d
Active GU 40 mg once daily Up to 8 weeksd
Symptomatic nonerosive GERD 20 mg twice daily Up to 6 weeksd
Erosive esophagitis due to GERD, diagnosed by endoscopy 20 mg twice daily; or 40 mg twice dailyb 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 yearc,d or as clinically indicated

2.2 Recommended Dosage in Pediatric Patients

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

Table 2: Recommended Dosage and Duration of Famotidine for Oral Suspensiona in Pediatric Patients with Normal Renal Function

a After preparation, the concentration of famotidine oral suspension is 8 mg/mL [see DOSAGE AND ADMINISTRATION (2.3)]

b 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.

c Use conservative measures (e.g., thickened feedings) concurrently [see USE IN SPECIFIC POPULATIONS (8.4)].

d After 4 weeks of treatment re-evaluate the patient. Consider an additional 4 weeks of treatment if treatment benefit outweighs potential risks.

Indication Pediatric Age Range Recommended Dosagea Duration
Pepti c 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 daily Maximum of 40 mg per day 8 weeksb
GE RD Birth to less than 3 months Starting dosage 0.5 mg/kg once daily. May increase to 1 mg/kg once dailyb Up to 8 weeksb,c,d
3 months to less than 1 year Starting dosage 0.5 mg/kg twice daily. May increase to 1 mg/kg twice dailyc Maximum of 40 mg per day
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 weeksb

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 Famotidine for Oral Suspension in Adults with Moderate and Severe Renal Impairment

a 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)].

b 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 famotidine for oral suspension for pathological hypersecretory conditions is unknown.

Indication Rec o m mended Maximum Dosages
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 a 20 mg once daily; or 40 mg every other dayb 40 mg once dailyb 10 mg once daily; or 20 mg every other dayb 20 mg once dailyb
Pathological hypersecretory conditions Avoid useb
Reduction of the risk of DU recurrence 10 mg once daily; or 20 mg every other day 10 mg every other day

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