Famotidine 40 mg Tablets — Generic For Pepcid — Aurobindo

These highlights do not include all the information needed to use FAMOTIDINE TABLETS safely and effectively. See full prescribing information for FAMOTIDINE TABLETS.

FAMOTIDINE tablets, for oral use

Initial U.S. Approval: 1986

Indications And Usage

Famotidine is a histamine-2 (H2) receptor antagonist indicated (1):

In adult and pediatric patients 40 kg and greater for the treatment of:

active duodenal ulcer (DU).

active gastric ulcer.

symptomatic nonerosive gastroesophageal reflux disease (GERD).

erosive esophagitis due to GERD, diagnosed by biopsy.

In adults for the:

treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias).

reduction of the risk of DU recurrence.

Dosage And Administration

Indication

Recommended Dosage (2.1)

Adult and Pediatric Patients 40 kg and greater

Active DU

40 mg once daily; or

20 mg twice daily

Active Gastric Ulcer

40 mg once daily

Gerd

20 mg twice daily

Erosive Esophagitis

20 mg twice daily; or

40 mg twice daily

Adults

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

See full prescribing information for complete dosing information, including dosing in renal impairment, and recommended treatment duration. (2.1, 2.2)

Administration (2.3):

Take once daily before bedtime or twice daily in the morning and before bedtime with or without food.

Dosage Forms And Strengths

Tablets: 20 mg, 40 mg (3)

Contraindications

History of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other H2 receptor antagonists. (4)

Warnings And Precautions

• Central Nervous System (CNS)

• Central Nervous System (CNS)

Central Nervous System (CNS) Adverse Reactions: Elderly patients and patients with renal impairment at increased risk; reduce the dosage. (2.2, 5.1, 8.5, 8.6)

GI Malignancy: Absence of GI symptoms does not preclude the presence of gastric malignancy; evaluate prior to initiating therapy.(5.2)

Adverse Reactions

The most common adverse reactions are: headache, dizziness, constipation, and diarrhea. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions

Drugs Dependent on Gastric pH for Absorption: Systemic exposure of the concomitant drug may be significantly reduced leading to loss of efficacy. See full prescribing information for a list of interacting drugs. (7.1)

Tizanidine (CYP1A2) Substrate: Potential for substantial increases in blood concentrations of tizanidine resulting in hypotension, bradycardia or excessive drowsiness; avoid concomitant use, if possible. (7.2)

Use In Specific Populations

Geriatric Use: Use the lowest effective dose for an elderly patient and monitor renal function. (2.2, 5.1, 8.5)

Renal Impairment: Risk of CNS adverse reactions and QT prolongation in patients with moderate and severe renal impairment; reduce the dosage. (2.2, 8.6)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 4/2022