2 DOSAGE AND ADMINISTRATION Recommended adult dosage by indication ( 2.1 ): 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 ): 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 , 2.2 , 2.3 ) Administration ( 2.3 ): Take once daily before bedtime or twice daily in the morning and before bedtime with or without food. 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 Suspension a 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 daily b Up to 8 weeks c,d Active GU 40 mg once daily Up to 8 weeks d Symptomatic nonerosive GERD 20 mg twice daily Up to 6 weeks d Erosive esophagitis due to GERD, diagnosed by endoscopy 20 mg twice daily; or 40 mg twice daily b 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 year c,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 Suspension a 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 Dosage a 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 weeks b GE RD Birth to less than 3 months Starting dosage 0.5 mg/kg once daily. May increase to 1 mg/kg once daily b Up to 8 weeks b,c,d 3 months to less than 1 year Starting dosage 0.5 mg/kg twice daily. May increase to 1 mg/kg twice daily c 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 weeks b 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 day b 40 mg once daily b 10 mg once daily; or 20 mg every other day b 20 mg once daily b Pathological hypersecretory conditions Avoid use b Reduction of the risk of DU recurrence 10 mg once daily; or 20 mg every other day 10 mg every other day 2.4 Administration Instructions Preparation of Constituted Suspension by a Healthcare Provider Prior to Dispensing Prior to dispensing, constitute famotidine for oral suspension by slowly adding 46 mL of Purified Water to the bottle. Shake vigorously for 5 to 10 seconds immediately after adding the water. The constituted suspension contains 40 mg of famotidine per 5 mL, and should be a smooth, mobile, off-white, and homogeneous suspension. Administration and Storage of Constituted Suspension Shake the bottle of constituted famotidine for oral suspension vigorously for 5 to 10 seconds prior to each use. Take famotidine for oral suspension once daily before bedtime or twice daily in the morning and before bedtime, as recommended. Famotidine for oral suspension may be taken with or without food [see CLINICAL PHARMACOLOGY ( 12.3 )] . Famotidine for oral suspension may be given with antacids. Store the constituted suspension at 25°C (77°F). Protect from freezing. Discard unused constituted suspension after 30 days.