FAMOTIDINE FOR ORAL SUSPENSION 40 MG / 5ML 50 MLCT
Generic: Famotidine
FAMOTIDINE FOR ORAL SUSPENSION 40 MG / 5ML 50 MLCT
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Identification
Famotidine
Famotidine
ANI Pharmaceuticals, Inc.
HUMAN PRESCRIPTION DRUG
Administration
POWDER, FOR SUSPENSION
ORAL
ANDA215043
Active Ingredients
| Ingredient | Strength |
|---|---|
| FAMOTIDINE | 40 mg/5mL |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
Wholesale compliance resources
Drug Resources
Clinical Drug Information
Indications & Usage
1 INDICATIONS & USAGE 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. Famotidine for oral suspension is a histamine-2 (H2) receptor antagonist indicated (1): 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 DU recurrence. In pediatric patients 1 year of age and older for the treatment of: peptic ulcer GERD with or without esophagitis and ulcerations In pediatric patients from birth to less than 1 year of age for the treatment of: GERD
Dosage & Administration
2 DOSAGE & 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 Indication Recommended Dosage Recommended 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 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)] . 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 Indication Pediatric Age Range Recommended Dosage a Duration 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 8 weeks b GERD 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 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 and/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. 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 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 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 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 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. 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, white to 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.
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions are: headache, dizziness, constipation, and diarrhea. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Novitium Pharma LLC at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of famotidine for oral suspension has been established based on adequate and well controlled studies of another oral famotidine product [see CLINICAL STUDIES (14)]. The following is a summary of the adverse reactions reported in those studies. Oral famotidine was studied in 7 US and international placebo- and active-controlled trials in approximately 2500 patients [see CLINICAL STUDIES (14)] . A total of 1442 patients were treated with famotidine, including 302 treated with 40 mg twice daily, 456 treated with 20 mg twice daily, 461 treated with 40 mg once daily, and 396 treated with 20 mg once daily. The population was 17 to 91 years old, fairly well distributed between sex and race; however, the predominant race was Caucasian. The following adverse reactions occurred in greater than or equal to 1% of famotidine-treated patients: headache, dizziness and constipation. The following other adverse reactions were reported in less than 1% of patients in clinical trials: Body as a Whole: fever, asthenia, fatigue Cardiovascular: palpitations Gastrointestinal: elevated liver enzymes, vomiting, nausea, abdominal discomfort, anorexia, dry mouth Hematologic: thrombocytopenia Hypersensitivity: orbital edema, rash, conjunctival injection, bronchospasm Musculoskeletal: musculoskeletal pain, arthralgia Nervous System/Psychiatric: seizure, hallucinations, depression, anxiety, decreased libido, insomnia, somnolence Skin: pruritus, dry skin, flushing Special Senses: tinnitus, taste disorder Other: impotence Pediatric Patients Less Than One Year of Age In a clinical study in 35 pediatric patients less than 1 year of age with GERD symptoms, two patients discontinued due to adverse reactions. Agitation observed in 5 patients resolved when famotidine was discontinued [see USE IN SPECIFIC POPULATIONS (8.4)] . 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of famotidine. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular: arrhythmia, AV block, prolonged QT interval Gastrointestinal: cholestatic jaundice, hepatitis Hematologic: agranulocytosis, pancytopenia, leukopenia Hypersensitivity: anaphylaxis, angioedema, facial edema, urticaria Musculoskeletal: rhabdomyolysis, muscle cramps Nervous System/Psychiatric: confusion, agitation, paresthesia Respiratory: interstitial pneumonia Skin: toxic epidermal necrolysis/Stevens-Johnson syndrome
Information for Patients
17 PATIENT COUNSELING INFORMATION Central Nervous System (CNS) Adverse Reactions Advise elderly patients and those with moderate and severe renal impairment of the risk of CNS adverse reactions; including confusion, delirium, hallucinations, disorientation, agitation, seizures, and lethargy [see WARNINGS AND PRECAUTIONS (5.1)] . Report symptoms immediately to a healthcare provider. QT Prolongation Advise patients with moderate and severe renal impairment of the risk of QT interval prolongation [see USE IN SPECIFIC POPULATIONS (8.6)] . Report new cardiac symptoms, such as palpitations, fainting and dizziness or light headedness immediately to a healthcare provider. Administration Advise patients to take and caregivers to administer: Famotidine for oral suspension once daily before bedtime or twice daily in the morning and before bedtime, as recommended. Advise patients and caregivers: Famotidine for oral suspension may be taken with or without food. Famotidine for oral suspension may be given with antacids. Manufactured by : Novitium Pharma LLC 70 Lake Drive, East Windsor New Jersey 08520 Issued: 09/2023 LB4367-01
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.