FAMOTIDINE — famotidine tablet, film coated
Ascend Laboratories, LLC
Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater 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.
Famotidine tablets are indicated in adults for the:
- treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias).
- reduction of the risk of duodenal ulcer recurrence.
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 hypersecretory conditionsd||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)].
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.
- Take famotidine tablets once daily before bedtime or twice daily in the morning and before bedtime, as recommended.
- Famotidine tablets may be taken with or without food [see Clinical Pharmacology (12.3)].
- Famotidine tablets may be given with antacids.
- 20 mg tablets: round, white to off-white film-coated tablets, debossed with “V” on one side and “15” on the other side.
- 40 mg tablets: round, white to off-white film-coated tablets, debossed with “V” on one side and “16” on the other side.
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