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, USP in adults with normal renal function is shown in Table 1.
Table 1: Recommended Dosage and Duration of Famotidine for Oral SuspensionAfter preparation, the concentration of famotidine oral suspension, USP is 8 mg/mL
[See
Dosage and Administration (2.3)]
., USP in Adults with Normal Renal FunctionIndication Recommended Dosage Recommended Duration Active DU40 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 GU40 mg once daily. Up to 8 weeks Symptomatic nonerosive GERD20 mg twice daily. Up to 6 weeks Erosive esophagitis due to GERD, diagnosed by endoscopy20 mg twice daily; or 40 mg twice daily. 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 indicated Reduction of the risk of DU recurrence20 mg once daily. 1 year,or 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, USP in pediatric patients with normal renal function is shown in Table 2.
Table 2: Recommended Dosage and Duration of Famotidine for Oral Suspension, USP in Pediatric Patients with Normal Renal Function Indication Pediatric Age Range Recommended DosageAfter preparation, the concentration of famotidine oral suspension, USP is 8 mg/mL
[See
Dosage and Administration (2.3)]
.Duration Peptic Ulcer Disease1 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 weeksTreatment duration based on adult recommendations
(see
Table 1)
. Individualize the dose and duration based upon clinical response and/or pH determinations (gastric or esophageal) and endoscopy.GERDBirth to less than 3 months Starting dosage 0.5 mg/kg once daily. May increase to 1 mg/kg once daily. Up to 8 weeks,Use conservative measures (e.g., thickened feedings) concurrently
[see
Use in Specific Populations (8.4)]
.,After 4 weeks of treatment re-evaluate the patient. Consider an additional 4 weeks of treatment if treatment benefit outweighs potential risks.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 ulcerations1 year to less than 17 years 0.5 mg/kg twice daily
Maximum of 40 mg twice daily.6 to 12 weeks 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 dayGERD 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 dayGERD 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, USP in adults with normal renal function is shown in Table 1.
Table 1: Recommended Dosage and Duration of Famotidine for Oral SuspensionAfter preparation, the concentration of famotidine oral suspension, USP is 8 mg/mL
[See
Dosage and Administration (2.3)]
., USP in Adults with Normal Renal FunctionIndication Recommended Dosage Recommended Duration Active DU40 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 GU40 mg once daily. Up to 8 weeks Symptomatic nonerosive GERD20 mg twice daily. Up to 6 weeks Erosive esophagitis due to GERD, diagnosed by endoscopy20 mg twice daily; or 40 mg twice daily. 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 indicated Reduction of the risk of DU recurrence20 mg once daily. 1 year,or as clinically indicated ,2.2 Recommended Dosage in Pediatric PatientsThe recommended dosage and duration of famotidine for oral suspension, USP in pediatric patients with normal renal function is shown in Table 2.
Table 2: Recommended Dosage and Duration of Famotidine for Oral Suspension, USP in Pediatric Patients with Normal Renal Function Indication Pediatric Age Range Recommended DosageAfter preparation, the concentration of famotidine oral suspension, USP is 8 mg/mL
[See
Dosage and Administration (2.3)]
.Duration Peptic Ulcer Disease1 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 weeksTreatment duration based on adult recommendations
(see
Table 1)
. Individualize the dose and duration based upon clinical response and/or pH determinations (gastric or esophageal) and endoscopy.GERDBirth to less than 3 months Starting dosage 0.5 mg/kg once daily. May increase to 1 mg/kg once daily. Up to 8 weeks,Use conservative measures (e.g., thickened feedings) concurrently
[see
Use in Specific Populations (8.4)]
.,After 4 weeks of treatment re-evaluate the patient. Consider an additional 4 weeks of treatment if treatment benefit outweighs potential risks.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 ulcerations1 year to less than 17 years 0.5 mg/kg twice daily
Maximum of 40 mg twice daily.6 to 12 weeks )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 (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, USP in Adults 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 DU20 mg once daily; or 40 mg every other day 10 mg once daily; or 20 mg every other day Active GU20 mg once daily; or 40 mg every other day 10 mg once daily; or 20 mg every other day Symptomatic nonerosive GERD20 mg once daily 10 mg once daily; or 20 mg every other day Erosive esophagitis due to GERD, 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 dayThe 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, USP for pathological hypersecretory conditions is unknown. 10 mg once daily; or 20 mg every other day 40 mg once daily 20 mg once daily Pathological hypersecretory conditionsAvoid use Reduction of the risk of DU recurrence10 mg once daily; or 20 mg every other day 10 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.
| 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 endoscopy 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)] . | 20 mg once daily; or 40 mg every other dayThe 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, USP for pathological hypersecretory conditions is unknown. | 10 mg once daily; or 20 mg every other day |
| 40 mg once daily | 20 mg once daily | |
Pathological hypersecretory conditions | Avoid use | |
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.
Famotidine for oral suspension 400 mg, 800 mg and 1,200 mg is a white to off-white powder containing 40 mg of famotidine per 5 mL. When constituted as directed, famotidine for oral suspension is a smooth, mobile, white to off-white, homogeneous suspension with a cherry-banana-mint flavor,
- 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, USP in pediatric patients with normal renal function is shown in Table 2.
Table 2: Recommended Dosage and Duration of Famotidine for Oral Suspension, USP in Pediatric Patients with Normal Renal Function Indication Pediatric Age Range Recommended DosageAfter preparation, the concentration of famotidine oral suspension, USP is 8 mg/mL
[See
Dosage and Administration (2.3)]
.Duration Peptic Ulcer Disease1 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 weeksTreatment duration based on adult recommendations
(see
Table 1)
. Individualize the dose and duration based upon clinical response and/or pH determinations (gastric or esophageal) and endoscopy.GERDBirth to less than 3 months Starting dosage 0.5 mg/kg once daily. May increase to 1 mg/kg once daily. Up to 8 weeks,Use conservative measures (e.g., thickened feedings) concurrently
[see
Use in Specific Populations (8.4)]
.,After 4 weeks of treatment re-evaluate the patient. Consider an additional 4 weeks of treatment if treatment benefit outweighs potential risks.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 ulcerations1 year to less than 17 years 0.5 mg/kg twice daily
Maximum of 40 mg twice daily.6 to 12 weeks ,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 (2.2), Clinical Pharmacology (12.3)].)8.5 Geriatric UseOf 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 post marketing 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 for oral suspension 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 oral suspension 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 in adults. (,
2.2 Recommended Dosage in Pediatric PatientsThe recommended dosage and duration of famotidine for oral suspension, USP in pediatric patients with normal renal function is shown in Table 2.
Table 2: Recommended Dosage and Duration of Famotidine for Oral Suspension, USP in Pediatric Patients with Normal Renal Function Indication Pediatric Age Range Recommended DosageAfter preparation, the concentration of famotidine oral suspension, USP is 8 mg/mL
[See
Dosage and Administration (2.3)]
.Duration Peptic Ulcer Disease1 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 weeksTreatment duration based on adult recommendations
(see
Table 1)
. Individualize the dose and duration based upon clinical response and/or pH determinations (gastric or esophageal) and endoscopy.GERDBirth to less than 3 months Starting dosage 0.5 mg/kg once daily. May increase to 1 mg/kg once daily. Up to 8 weeks,Use conservative measures (e.g., thickened feedings) concurrently
[see
Use in Specific Populations (8.4)]
.,After 4 weeks of treatment re-evaluate the patient. Consider an additional 4 weeks of treatment if treatment benefit outweighs potential risks.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 ulcerations1 year to less than 17 years 0.5 mg/kg twice daily
Maximum of 40 mg twice daily.6 to 12 weeks )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 (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 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 (2.3)]. 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 (H
2) 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, USP in pediatric patients with normal renal function is shown in Table 2.
Table 2: Recommended Dosage and Duration of Famotidine for Oral Suspension, USP in Pediatric Patients with Normal Renal Function Indication Pediatric Age Range Recommended DosageAfter preparation, the concentration of famotidine oral suspension, USP is 8 mg/mL
[See
Dosage and Administration (2.3)]
.Duration Peptic Ulcer Disease1 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 weeksTreatment duration based on adult recommendations
(see
Table 1)
. Individualize the dose and duration based upon clinical response and/or pH determinations (gastric or esophageal) and endoscopy.GERDBirth to less than 3 months Starting dosage 0.5 mg/kg once daily. May increase to 1 mg/kg once daily. Up to 8 weeks,Use conservative measures (e.g., thickened feedings) concurrently
[see
Use in Specific Populations (8.4)]
.,After 4 weeks of treatment re-evaluate the patient. Consider an additional 4 weeks of treatment if treatment benefit outweighs potential risks.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 ulcerations1 year to less than 17 years 0.5 mg/kg twice daily
Maximum of 40 mg twice daily.6 to 12 weeks ,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 (2.2), Clinical Pharmacology (12.3)].,8.5 Geriatric UseOf 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 post marketing 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 for oral suspension 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 oral suspension for an elderly patient and monitor renal function
[see Dosage and Administration (2.2)].)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 (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 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 (2.3)]. 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.