Famotidine

FAMOTIDINE- famotidine tablet
Mckesson Corporation DBA SKY Packaginng

1 Indications and Usage

Famotidine tablets are indicated in adult and pediatric patients 40 kg and above for the treatment of:
• active duodenal ulcer.
• active gastric ulcer.
• symptomatic non-erosive 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

Duodenal Ulcer

Acute Therapy: The recommended adult oral dosage for active duodenal ulcer is 40 mg once a day at bedtime. Most patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks. A regimen of 20 mg b.i.d. is also effective.

Maintenance Therapy: The recommended adult oral dose is 20 mg once a day at bedtime.

Benign Gastric Ulcer

Acute Therapy: The recommended adult oral dosage for active benign gastric ulcer is 40 mg once a day at bedtime.

Gastroesophageal Reflux Disease (GERD)

The recommended oral dosage for treatment of adult patients with symptoms of GERD is 20 mg b.i.d. for up to 6 weeks. The recommended oral dosage for the treatment of adult patients with esophagitis including erosions and ulcerations and accompanying symptoms due to GERD is 20 or 40 mg b.i.d. for up to 12 weeks (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).

Dosage for Pediatric Patients <1 year of age Gastroesophageal Reflux Disease (GERD) See PRECAUTIONS , Pediatric Patients <1 year of age.

The studies described in PRECAUTIONS, Pediatric Patients <1 year of age suggest the following starting doses in pediatric patients <1 year of age: Gastroesophageal Reflux Disease (GERD) — 0.5 mg/kg/dose of famotidine oral suspension for the treatment of GERD for up to 8 weeks once daily in patients <3 months of age and 0.5 mg/kg/dose twice daily in patients 3 months to <1 year of age. Patients should also be receiving conservative measures (e.g., thickened feedings). The use of intravenous famotidine in pediatric patients <1 year of age with GERD has not been adequately studied.

Dosage for Pediatric Patients 1-16 years of age

See PRECAUTIONS , Pediatric Patients 1-16 years of age.

The studies described in PRECAUTIONS, Pediatric Patients 1-16 years of age suggest the following starting doses in pediatric patients 1-16 years of age:

Peptic ulcer — 0.5 mg/kg/day p.o. at bedtime or divided b.i.d. up to 40 mg/day.

Gastroesophageal Reflux Disease with or without esophagitis including erosions and ulcerations — 1.0 mg/kg/day p.o. divided b.i.d. up to 40 mg b.i.d.

While published uncontrolled studies suggest effectiveness of famotidine in the treatment of gastroesophageal reflux disease and peptic ulcer, data in pediatric patients are insufficient to establish percent response with dose and duration of therapy. Therefore, treatment duration (initially based on adult duration recommendations) and dose should be individualized based on clinical response and/or pH determination (gastric or esophageal) and endoscopy. Published uncontrolled clinical studies in pediatric patients 1-16 years of age have employed doses up to 1 mg/kg/day for peptic ulcer and 2 mg/kg/day for GERD with or without esophagitis including erosions and ulcerations.

Pathological Hypersecretory Conditions (e.g., Zollinger-Ellison Syndrome, Multiple Endocrine Adenomas)

The dosage of famotidine in patients with pathological hypersecretory conditions varies with the individual patient. The recommended adult oral starting dose for pathological hypersecretory conditions is 20 mg q 6 h. In some patients, a higher starting dose may be required. Doses should be adjusted to individual patient needs and should continue as long as clinically indicated. Doses up to 160 mg q 6 h have been administered to some adult patients with severe Zollinger-Ellison Syndrome.

Concomitant Use of Antacids

Antacids may be given concomitantly if needed.

Dosage Adjustment for Patients with Moderate or Severe Renal Insufficiency

In adult patients with moderate (creatinine clearance <50 mL/min) or severe (creatinine clearance <10 mL/min) renal insufficiency, the elimination half-life of famotidine is increased. For patients with severe renal insufficiency, it may exceed 20 hours, reaching approximately 24 hours in anuric patients. Since CNS adverse effects have been reported in patients with moderate and severe renal insufficiency, to avoid excess accumulation of the drug in patients with moderate or severe renal insufficiency, the dose of famotidine may be reduced to half the dose or the dosing interval may be prolonged to 36-48 hours as indicated by the patient’s clinical response.

Based on the comparison of pharmacokinetic parameters for famotidine in adults and pediatric patients, dosage adjustment in pediatric patients with moderate or severe renal insufficiency should be considered.

2.1 Recommended Dosage

Table 1 shows the recommended dosage of Famotidine 20 mg and 40 mg tablets in adults and pediatric patients weighing 40 kg or greater with normal renal function. The use of Famotidine 20 mg and 40 mg tablets is not recommended for use 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 Adults and Pediatric Patients 40 kg and Greater with Normal Renal Function
Indication Recommended Dosage Recommended Duration
Active duodenal ulcer (DU) 40mg once daily; or 20mg twice daily a Up to 8 weeks b,c
Active gastric ulcer 40mg once daily Up to 8 weeks
Symptomatic non-erosive GERD 20mg once daily Up to 6 weeks c
Erosive esophagitis diagnosed by endoscopy

20mg twice daily; or 40mg twice daily a

Up to 12 weeks
Pathological hypersecretory conditions d

Starting dosage: 20mg every 6 hours;

adjust dosage to individual patient needs

Maximum dosage 160mg every 6 hours 20mg once daily

As clinically indicated
Reduction of the risk of DU recurrence d 20mg once daily 1 year c or as clinically indicated

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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 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 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 Adults and Pediatric Patients 40 kg and Greater with Moderate and Severe Renal Impairment
Indication

Creatinine clearence

30 to 60mL/minute

Creatinine clearence

less than 30 mL/minute

Active duodenal ulcer (DU)

20mg once daily; or

40mg every other day

20mg every other day  a
Active gastric ulcer

20mg once daily; or

40mg every other day

20mg every other day a
Symptomatic non-erosive GERD 20mg once daily 20mg every other day  a

Erosive esophagitis diagnosed by

endoscopy  a

20mg once daily; or

40mg every other day b

20mg every other day  a,b
Pathological hypersecretory conditions  a Avoid use  d
Reduction of the risk of DU recurrence  c 20mg every other day a (see footnote)  e

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 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 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 alternative famotidine formulation.

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