Famotidine

FAMOTIDINE- famotidine tablet, film coated
Legacy Pharmaceutical Packaging, LLC

1 INDICATIONS AND USAGE

Famotidine tablets are indicated in adult and pediatric patients 40 kg and greater for the treatment of: active duodenal ulcer (DU).

• active gastric ulcer (GU).
• active gastric ulcer (GU).
• symptomatic nonerosive gastroesophageal reflux disease (GERD).
• erosive esophagitis due to GERD, diagnosed by biopsy.

Famotidine tablets are indicated in adults for the:

• treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias).
• reduction of the risk of duodenal ulcer recurrence.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

Table 1 shows the recommended dosage of famotidine 20 mg and 40 mg tablets in adult and pediatric patients weighing 40 kg and greater with normal renal function. The use of famotidine 20 mg and 40 mg tablets is not recommended in pediatric patients weighing less than 40 kg because the lowest available strength (20 mg) exceeds the recommended dose for these patients . Use another famotidine formulation for pediatric patients weighing less than 40 kg.

Table 1: Recommended Dosage and Duration of Famotidine Tablets in Adult and Pediatric Patients 40 kg and Greater with Normal Renal Function

^a Both dosages demonstrated effectiveness in clinical trials [see Clinical Studies (14)].

^b 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)].

^c Longer treatment durations have not been studied in clinical trials [see Clinical Studies (14.1, 14.2, 14.3)].

^d In pediatric patients, the safety and effectiveness of famotidine tablets have not been established for the reduction of the risk of duodenal ulcer recurrence or for treatment of pathological hypersecretory conditions [see Use in Specific Populations (8.4)].

2.2 Dosage in Renal Impairment

Dosage adjustments of famotidine tablets are recommended for patients with moderate to severe renal impairment (creatinine clearance less than 60 mL/min) [see Use in Specific Populations (8.6)]. Table 2 shows the recommended maximum dosage of famotidine 20 mg or 40 mg tablets for patients with renal impairment, by indication. Use the lowest effective dose. Some dosage adjustments may require switching to other formulations of famotidine (e.g., oral suspension, lower dose tablet).

Table 2: Recommended Maximum Dosage of Famotidine Tablets in Adult and Pediatric Patients 40 kg and Greater with Moderate and Severe Renal Impairment

^a An alternate dosage regimen is 10 mg once daily. Since 20 mg or 40 mg tablet strength cannot be used for this dosage regimen, use an alternate famotidine formulation.

^b 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)].

^c In pediatric patients, the safety and effectiveness of famotidine tablets have not been established for the reduction of the risk of duodenal ulcer recurrence or for treatment of pathological hypersecretory conditions [see Use in Specific Populations (8.4)].

^d Doses required to treat pathological hypersecretory conditions may exceed the maximum doses evaluated in patients with impaired renal function. The risk for increased adverse reactions in renally impaired patients treated with famotidine tablets for pathological hypersecretory conditions is unknown.

^e Recommended dosage regimen is 10 mg every other day. Since 20 mg or 40 mg tablet strength cannot be used for this dosage regimen, use an alternate famotidine formulation.

2.3 Administration Instructions

• Take famotidine tablets once daily before bedtime or twice daily in the morning and before bedtime, as recommended.
• Famotidine tablets may be taken with or without food [see Clinical Pharmacology (12.3)].
• Famotidine tablets may be given with antacids.

3 DOSAGE FORMS AND STRENGTHS

20 mg tablets: beige, round, unscored, film-coated tablets, debossed with “5728” on one side and “TEVA” on the other side.

4 CONTRAINDICATIONS

Famotidine tablets are 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 tablets. 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 tablets 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 tablets.

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.

Famotidine tablets 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 tablets, 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 17-91 years old, fairly well distributed between gender and race; however, the predominant race treated was Caucasian.

The following adverse reactions occurred in greater than or equal to 1% of famotidine tablets-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