Famotidine
Famotidine Prescribing Information
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.
- Recommended adult dosage by indication ():
2.1 Recommended Dosage in AdultsThe 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 Suspensionain Adults with Normal Renal Function aAfter preparation, the concentration of famotidine for oral suspension is 8 mg/mL [See Dosage and Administration ]
bBoth dosages demonstrated effectiveness in clinical trials[see Clinical Studies ].
cIn clinical trials, the majority of patients healed within 4 weeks. For patients who do not heal after 4 weeks, consider an additional 2 weeks to 4 weeks of treatment[see Clinical Studies ].
dLonger treatment durations have not been studied in clinical trials[see Clinical Studies ].IndicationRecommended DosageRecommendedDurationActive DU40 mg once daily; or 20 mg twice dailyb Up to 8 weeksc,d Active GU40 mg once daily Up to 8 weeksd Symptomatic nonerosive GERD20 mg twice daily Up to 6 weeksd Erosive esophagitis due to GERD, diagnosed by endoscopy20 mg twice daily; or 40 mg twice dailyb Up to 12 weeks Pathological hypersecretory conditionsStarting dosage: 20 mg every 6 hours; adjust dosage to individual patient needs
Maximum dosage 160 mg every 6 hours
As clinically indicatedReduction of the risk of DU recurrence20 mg once daily 1 yearc,dor as clinically indicated
| Active DU | 40 mg once daily; or 20 mg twice daily |
| Active GU | 40 mg once daily |
| Symptomatic Nonerosive GERD | 20 mg twice daily |
| Erosive Esophagitis due to GERD | 20 mg twice daily; or 40 mg twice daily |
| Pathological Hypersecretory Conditions | 20 mg every 6 hours; adjust to patient needs; maximum 160 mg every 6 hours |
| Risk Reduction of DU Recurrence | 20 mg once daily |
- Recommended pediatric dosage by indication ():
2.2 Recommended Dosage in Pediatric PatientsThe 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 Suspensionain Pediatric Patients with Normal Renal Function aAfter preparation, the concentration of famotidine for oral suspension is 8 mg/mL [See Dosage and Administration ]
bTreatment 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.
cUse conservative measures (e.g., thickened feedings) concurrently[see Use in Specific Populations ].
dAfter 4 weeks of treatment re-evaluate the patient. Consider an additional 4 weeks of treatment if treatment benefit outweighs potential risks.IndicationPediatric Age RangeRecommended DosageaDurationPeptic Ulcer Disease
1 year to less than 17 yearsStarting 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 weeksbGERDBirth 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 yearStarting dosage 0.5 mg/kg twice daily. May increase to 1 mg/kg twice dailyc
Maximum of 40 mg per dayGERD with or without esophagitisand ulcerations1 year to less than 17 years 0.5 mg/kg twice daily
Maximum of 40 mg twice daily
6 to 12 weeksb
| Peptic 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 |
| GERD | Birth to less than 3 months Starting dosage 0.5 mg/kg once daily; may increase to 1 mg/kg once daily |
| 3 months to less than 1 year Starting dosage 0.5 mg/kg twice daily; may increase to 1 mg/kg twice daily; 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 |
- See full prescribing information for complete dosing information in adults and pediatrics, recommended treatment duration by indication, and dosage adjustment for adult patients with renal impairment. (,
2.1 Recommended Dosage in AdultsThe 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 Suspensionain Adults with Normal Renal Function aAfter preparation, the concentration of famotidine for oral suspension is 8 mg/mL [See Dosage and Administration ]
bBoth dosages demonstrated effectiveness in clinical trials[see Clinical Studies ].
cIn clinical trials, the majority of patients healed within 4 weeks. For patients who do not heal after 4 weeks, consider an additional 2 weeks to 4 weeks of treatment[see Clinical Studies ].
dLonger treatment durations have not been studied in clinical trials[see Clinical Studies ].IndicationRecommended DosageRecommendedDurationActive DU40 mg once daily; or 20 mg twice dailyb Up to 8 weeksc,d Active GU40 mg once daily Up to 8 weeksd Symptomatic nonerosive GERD20 mg twice daily Up to 6 weeksd Erosive esophagitis due to GERD, diagnosed by endoscopy20 mg twice daily; or 40 mg twice dailyb Up to 12 weeks Pathological hypersecretory conditionsStarting dosage: 20 mg every 6 hours; adjust dosage to individual patient needs
Maximum dosage 160 mg every 6 hours
As clinically indicatedReduction of the risk of DU recurrence20 mg once daily 1 yearc,dor as clinically indicated ,2.2 Recommended Dosage in Pediatric PatientsThe 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 Suspensionain Pediatric Patients with Normal Renal Function aAfter preparation, the concentration of famotidine for oral suspension is 8 mg/mL [See Dosage and Administration ]
bTreatment 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.
cUse conservative measures (e.g., thickened feedings) concurrently[see Use in Specific Populations ].
dAfter 4 weeks of treatment re-evaluate the patient. Consider an additional 4 weeks of treatment if treatment benefit outweighs potential risks.IndicationPediatric Age RangeRecommended DosageaDurationPeptic Ulcer Disease
1 year to less than 17 yearsStarting 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 weeksbGERDBirth 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 yearStarting dosage 0.5 mg/kg twice daily. May increase to 1 mg/kg twice dailyc
Maximum of 40 mg per dayGERD with or without esophagitisand ulcerations1 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 ImpairmentRecommended dosage adjustments for adults with moderate to severe renal impairment (creatinine clearance less than 60 mL/min) by indication are shown in Table 3. Use the lowest effective dosage
[see Use in Specific Populations ].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 aDosage 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 ].
bThe 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.IndicationRecommended Maximum DosagesCreatinine clearance 30 to 60 mL/minuteCreatinine clearance less than 30 mL/minuteActive DU20 mg once daily; or
40 mg every other day10 mg once daily; or
20 mg every other dayActive GU20 mg once daily; or
40 mg every other day10 mg once daily; or
20 mg every other daySymptomatic nonerosive GERD20 mg once daily 10 mg once daily; or
20 mg every other dayErosive esophagitis due to GERD, diagnosed by endoscopya20 mg once daily; or
40 mg every other dayb10 mg once daily; or
20 mg every other dayb40 mg once dailyb 20 mg once dailyb Pathological hypersecretory conditionsAvoid useb Reduction of the risk of DU recurrence10 mg once daily; or
20 mg every other day10 mg every other day
Recommended dosage adjustments for adults with moderate to severe renal impairment (creatinine clearance less than 60 mL/min) by indication are shown in Table 3. Use the lowest effective dosage
A safe and effective dosage has not been established in pediatric patients with renal impairment.
| aDosage 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 ]. bThe 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 | Recommended 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 endoscopya | 20 mg once daily; or 40 mg every other dayb | 10 mg once daily; or 20 mg every other dayb | ||||||||||||||||||||||
| 40 mg once dailyb | 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 | ||||||||||||||||||||||
- Take once daily before bedtime or twice daily in the morning and before bedtime with or without food.
For Oral Suspension: 400 mg as a white to off-white granular powder. When constituted as directed, famotidine for oral suspension USP is a white to off-white smooth, homogeneous suspension with cherry-banana-mint flavour, containing 40 mg of famotidine per 5 mL.
- Geriatric Use:Use the lowest effective dose for an elderly patient and monitor renal function. (,
2.2 Recommended Dosage in Pediatric PatientsThe 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 Suspensionain Pediatric Patients with Normal Renal Function aAfter preparation, the concentration of famotidine for oral suspension is 8 mg/mL [See Dosage and Administration ]
bTreatment 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.
cUse conservative measures (e.g., thickened feedings) concurrently[see Use in Specific Populations ].
dAfter 4 weeks of treatment re-evaluate the patient. Consider an additional 4 weeks of treatment if treatment benefit outweighs potential risks.IndicationPediatric Age RangeRecommended DosageaDurationPeptic Ulcer Disease
1 year to less than 17 yearsStarting 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 weeksbGERDBirth 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 yearStarting dosage 0.5 mg/kg twice daily. May increase to 1 mg/kg twice dailyc
Maximum of 40 mg per dayGERD with or without esophagitisand ulcerations1 year to less than 17 years 0.5 mg/kg twice daily
Maximum of 40 mg twice daily
6 to 12 weeksb,5.1 Central Nervous System Adverse ReactionsCentral 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 , Clinical Pharmacology ].)8.5 Geriatric UseOf the 1442 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 ].Famotidine is known to be substantially excreted by the kidney, and the risk of adverse reactions to famotidine for oral suspension may be greater in elderly patients, particularly those with impaired renal function
[see Use in Specific Populations ].In general, use the lowest effective dose of famotidine for oral suspension for an elderly patient and monitor renal function
[see Dosage and Administration ]. - Renal Impairment:Risk of CNS adverse reactions and QT prolongation in patients with moderate and severe renal impairment; reduce the dosage in adults. (,
2.2 Recommended Dosage in Pediatric PatientsThe 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 Suspensionain Pediatric Patients with Normal Renal Function aAfter preparation, the concentration of famotidine for oral suspension is 8 mg/mL [See Dosage and Administration ]
bTreatment 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.
cUse conservative measures (e.g., thickened feedings) concurrently[see Use in Specific Populations ].
dAfter 4 weeks of treatment re-evaluate the patient. Consider an additional 4 weeks of treatment if treatment benefit outweighs potential risks.IndicationPediatric Age RangeRecommended DosageaDurationPeptic Ulcer Disease
1 year to less than 17 yearsStarting 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 weeksbGERDBirth 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 yearStarting dosage 0.5 mg/kg twice daily. May increase to 1 mg/kg twice dailyc
Maximum of 40 mg per dayGERD with or without esophagitisand ulcerations1 year to less than 17 years 0.5 mg/kg twice daily
Maximum of 40 mg twice daily
6 to 12 weeksb)8.6 Renal ImpairmentCNS adverse reactions and prolonged QT intervals have been reported in patients with moderate and severe renal impairment
[see Warnings and Precautions ]. The clearance of famotidine is reduced in adults with moderate and severe renal impairment compared to adults with normal renal function[see Clinical Pharmacology ]. No dosage adjustment is needed in adults with mild renal impairment (creatinine clearance greater than or equal to 60 mL/minute). Dosage reduction is recommended in adults with moderate or severe renal impairment (creatinine clearance less than 60 mL/minute)[see Dosage and Administration ]. Data are not available to establish a safe and effective dosage in pediatric patients with renal impairment.
Famotidine for oral suspension is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other histamine-2 (H2) receptor antagonists.
- Central Nervous System (CNS) Adverse Reactions: Elderly patients and patients with renal impairment at increased risk; reduce the dosage. (,
2.2 Recommended Dosage in Pediatric PatientsThe 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 Suspensionain Pediatric Patients with Normal Renal Function aAfter preparation, the concentration of famotidine for oral suspension is 8 mg/mL [See Dosage and Administration ]
bTreatment 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.
cUse conservative measures (e.g., thickened feedings) concurrently[see Use in Specific Populations ].
dAfter 4 weeks of treatment re-evaluate the patient. Consider an additional 4 weeks of treatment if treatment benefit outweighs potential risks.IndicationPediatric Age RangeRecommended DosageaDurationPeptic Ulcer Disease
1 year to less than 17 yearsStarting 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 weeksbGERDBirth 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 yearStarting dosage 0.5 mg/kg twice daily. May increase to 1 mg/kg twice dailyc
Maximum of 40 mg per dayGERD with or without esophagitisand ulcerations1 year to less than 17 years 0.5 mg/kg twice daily
Maximum of 40 mg twice daily
6 to 12 weeksb,5.1 Central Nervous System Adverse ReactionsCentral 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 , Clinical Pharmacology ].,8.5 Geriatric UseOf the 1442 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 ].Famotidine is known to be substantially excreted by the kidney, and the risk of adverse reactions to famotidine for oral suspension may be greater in elderly patients, particularly those with impaired renal function
[see Use in Specific Populations ].In general, use the lowest effective dose of famotidine for oral suspension for an elderly patient and monitor renal function
[see Dosage and Administration ].)8.6 Renal ImpairmentCNS adverse reactions and prolonged QT intervals have been reported in patients with moderate and severe renal impairment
[see Warnings and Precautions ]. The clearance of famotidine is reduced in adults with moderate and severe renal impairment compared to adults with normal renal function[see Clinical Pharmacology ]. No dosage adjustment is needed in adults with mild renal impairment (creatinine clearance greater than or equal to 60 mL/minute). Dosage reduction is recommended in adults with moderate or severe renal impairment (creatinine clearance less than 60 mL/minute)[see Dosage and Administration ]. Data are not available to establish a safe and effective dosage in pediatric patients with renal impairment. - GI Malignancy: Absence of GI symptoms does not preclude the presence of gastric malignancy; evaluate prior to initiating therapy. ()
5.2 Concurrent Gastric MalignancyIn adults, symptomatic response to therapy with famotidine for oral suspension 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 for oral suspension.