Famotidine

Famotidine is a histamine-2 (H
₂) receptor antagonist indicated (

In adult and pediatric patients 40 kg and greater for the treatment

• active duodenal ulcer (DU).
• active gastric ulcer.
• symptomatic nonerosive gastroesophageal reflux disease (GERD).
• erosive esophagitis due to GERD, diagnosed by biopsy.

In adults for the:

• treatment of pathological hypersecretory conditions (e.g., Zollinger- Ellison syndrome, multiple endocrine neoplasias).
• reduction of the risk of DU recurrence.

• See full prescribing information for complete dosing information, including dosing in renal impairment, and recommended treatment duration. (
  
  
  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 dailyBoth dosages demonstrated effectiveness in clinical trials [see Clinical Studies (14)].	Up to 8 weeksIn 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)] .
  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 conditionsIn 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)] .	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 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 dayAn 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.
  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 endoscopyDosage 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)] .	20 mg once daily; or 40 mg every other day	20 mg every other day ,
  	40 mg once daily	20 mg once daily
  Pathological hypersecretory conditionsIn 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)] .	Avoid useDoses 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.
  Reduction of the risk of DU recurrence	20 mg every other day	(see footnote)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 once daily before bedtime or twice daily in the morning and before bedtime with or without food.

Tablets: 20 mg, 40 mg (

• Geriatric Use
  : Use the lowest effective dose for an elderly patient and monitor renal function. (
  
  
  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 dayAn 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.
  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 endoscopyDosage 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)] .	20 mg once daily; or 40 mg every other day	20 mg every other day ,
  	40 mg once daily	20 mg once daily
  Pathological hypersecretory conditionsIn 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)] .	Avoid useDoses 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.
  Reduction of the risk of DU recurrence	20 mg every other day	(see footnote)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.
  ,
  
  
  5.1 Central Nervous System Adverse Reactions

  Central nervous system (CNS) adverse reactions, including confusion, delirium, hallucinations, disorientation, agitation, seizures, and lethargy, have been reported in elderly patients and patients with moderate and severe renal impairment treated with famotidine. Since famotidine blood levels are higher in patients with renal impairment than in patients with normal renal function, dosage adjustments are recommended in patients with renal impairment

  [see Dosage and Administration (2.2), Clinical Pharmacology (12.3)

  ].
  ,
  
  
  8.5 Geriatric Use

  Of the 1,442 famotidine-treated patients in clinical studies, approximately 10% were 65 and older. In these studies, no overall differences in safety or effectiveness were observed between elderly and younger patients. In postmarketing experience, CNS adverse reactions have been reported in elderly patients with and without renal impairment receiving famotidine [

  see Warnings and Precautions (5.1)

  ].

  Famotidine is known to be substantially excreted by the kidney, and the risk of adverse reactions to famotidine may be greater in elderly patients, particularly those with impaired renal function [

  see Use in Specific Populations (8.6)

  ].

  In general, use the lowest effective dose of famotidine for an elderly patient and monitor renal function [

  see Dosage and Administration (2.2)

  ].
  )
  
• Renal Impairment
  : Risk of CNS adverse reactions and QT prolongation in patients with moderate and severe renal impairment; reduce the dosage. (
  
  
  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 dayAn 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.
  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 endoscopyDosage 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)] .	20 mg once daily; or 40 mg every other day	20 mg every other day ,
  	40 mg once daily	20 mg once daily
  Pathological hypersecretory conditionsIn 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)] .	Avoid useDoses 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.
  Reduction of the risk of DU recurrence	20 mg every other day	(see footnote)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.
  ,
  
  
  8.6 Renal Impairment

  CNS adverse reactions and prolonged QT intervals have been reported in patients with moderate and severe renal impairment [

  see Warnings and Precautions (5.1)

  ]. The clearance of famotidine is reduced in adults with moderate and severe renal impairment compared to adults with normal renal function [

  see Clinical Pharmacology (12.3)

  ]. No dosage adjustment is needed in patients with mild renal impairment (creatinine clearance greater than or equal to 60 mL/minute). Dosage reduction is recommended in adult and pediatric patients greater than or equal to 40 kg with moderate or severe renal impairment (creatinine clearance less than 60 mL/minute) [

  see Dosage and Administration (2.2)

  ].
  )
  

• Central Nervous System (CNS) Adverse Reactions
  : Elderly patients and patients with renal impairment at increased risk; reduce the dosage. (
  
  
  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 dayAn 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.
  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 endoscopyDosage 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)] .	20 mg once daily; or 40 mg every other day	20 mg every other day ,
  	40 mg once daily	20 mg once daily
  Pathological hypersecretory conditionsIn 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)] .	Avoid useDoses 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.
  Reduction of the risk of DU recurrence	20 mg every other day	(see footnote)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.
  ,
  
  
  5.1 Central Nervous System Adverse Reactions

  Central nervous system (CNS) adverse reactions, including confusion, delirium, hallucinations, disorientation, agitation, seizures, and lethargy, have been reported in elderly patients and patients with moderate and severe renal impairment treated with famotidine. Since famotidine blood levels are higher in patients with renal impairment than in patients with normal renal function, dosage adjustments are recommended in patients with renal impairment

  [see Dosage and Administration (2.2), Clinical Pharmacology (12.3)

  ].
  ,
  
  
  8.5 Geriatric Use

  Of the 1,442 famotidine-treated patients in clinical studies, approximately 10% were 65 and older. In these studies, no overall differences in safety or effectiveness were observed between elderly and younger patients. In postmarketing experience, CNS adverse reactions have been reported in elderly patients with and without renal impairment receiving famotidine [

  see Warnings and Precautions (5.1)

  ].

  Famotidine is known to be substantially excreted by the kidney, and the risk of adverse reactions to famotidine may be greater in elderly patients, particularly those with impaired renal function [

  see Use in Specific Populations (8.6)

  ].

  In general, use the lowest effective dose of famotidine for an elderly patient and monitor renal function [

  see Dosage and Administration (2.2)

  ].
  ,
  
  
  8.6 Renal Impairment

  CNS adverse reactions and prolonged QT intervals have been reported in patients with moderate and severe renal impairment [

  see Warnings and Precautions (5.1)

  ]. The clearance of famotidine is reduced in adults with moderate and severe renal impairment compared to adults with normal renal function [

  see Clinical Pharmacology (12.3)

  ]. No dosage adjustment is needed in patients with mild renal impairment (creatinine clearance greater than or equal to 60 mL/minute). Dosage reduction is recommended in adult and pediatric patients greater than or equal to 40 kg with moderate or severe renal impairment (creatinine clearance less than 60 mL/minute) [

  see Dosage and Administration (2.2)

  ].
  )
  
• GI Malignancy
  : Absence of GI symptoms does not preclude the presence of gastric malignancy; evaluate prior to initiating therapy. (
  
  
  5.2 Concurrent Gastric Malignancy

  In adults, symptomatic response to therapy with famotidine does not preclude the presence of gastric malignancy. Consider evaluation for gastric malignancy in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with famotidine.
  )