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

Dosage and Administration

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.

2.3 Administration Instructions

• Take Famotidine 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: A white, round, film-coated tablet engraved with CTI 121 on one side.

4 Contraindications

Famotidine tablets are contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other 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 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.

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