Famotidine: Package Insert and Label Information

FAMOTIDINE- famotidine powder, for suspension
Lupin Pharmaceuticals, Inc.

1 INDICATIONS AND 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.

2 DOSAGE AND ADMINISTRATION

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 Suspensiona 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 dailyb Up to 8 weeksc,d
Active GU 40 mg once daily Up to 8 weeksd
Symptomatic nonerosive GERD 20 mg twice daily Up to 6 weeksd
Erosive esophagitis due to GERD, diagnosed by endoscopy 20 mg twice daily; or 40 mg twice dailyb 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 yearc,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 Suspensiona 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 Dosagea 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 weeksb
GE RD Birth 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 year Starting dosage 0.5 mg/kg twice daily. May increase to 1 mg/kg twice dailyc 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 weeksb

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 dayb 40 mg once dailyb 10 mg once daily; or 20 mg every other dayb 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

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.

3 DOSAGE FORMS AND STRENGTHS

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 granular powder forming an off-white suspension with characteristic odor, containing 40 mg of famotidine per 5 mL.

4 CONTRAINDICATIONS

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.

5 WARNINGS AND PRECAUTIONS

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)].

5.2 Concurrent Gastric Malignancy

In 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.

6 ADVERSE REACTIONS

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

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