Famotidine

Famotidine Injection is indicated for use in hospitalized adults, or as an alternative to oral famotidine 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 endoscopy. treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine neoplasias). reduction of the risk of duodenal ulcer recurrence.

Famotidine is a competitive inhibitor of histamine H 2 -receptors. The primary clinically important pharmacologic activity of famotidine is inhibition of gastric secretion. Both the acid concentration and volume of gastric secretion are suppressed by famotidine, while changes in pepsin secretion are proportional to volume output.

Administration Information. Famotidine Injection is intended for use in adult and pediatric hospitalized patients, or as an alternative to oral famotidine. Discontinue as soon as the patient is able to tolerate oral treatment and switch to an appropriate oral medication. Recommended Dosage. Adults: 20 mg every 12 hours. For pathological hypersecretory conditions titrate the dosage to individual patient needs. Pediatric Patients 1 year of age and older: 0.25 mg/kg every 12 hours, titrate to a maximum of 0.5 mg/kg every 12 hours (up to maximum of 20 mg every 12 hours) based on clinical response and/or gastric pH determination and endoscopy. Administer as an intravenous injection over at least 2 minutes or an intravenous infusion over 15 minutes to 30 minutes. Refer to the prescribing information for oral famotidine products for the recommended duration of famotidine treatment.

Famotidine Injection is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other H 2 -receptor antagonists. History of serious hypersensitivity reactions (e.g., anaphylaxis) to famotidine or other H 2 -receptor antagonists.

Central Nervous System (CNS) Adverse Reactions: Reported in elderly patients and patients with moderate and severe renal impairment, monitor elderly patients for CNS adverse reactions. Concurrent GI Malignancy: Absence of GI symptoms does not preclude the presence of gastric malignancy, evaluate prior to initiating therapy. Risk of Benzyl Alcohol Toxicity in Neonates: Famotidine Injection is not approved in neonates. Serious and fatal adverse reactions have been reported in low-birth weight and preterm neonates who received benzyl-alcohol-containing drugs intravenously. The minimum amount of benzyl alcohol at which these serious adverse reactions may occur is not known.

Most common adverse reactions (>1%) are: headache, dizziness, constipation, and diarrhea.

Drugs Dependent on Gastric pH for Absorption: Systemic exposure of the concomitant drug may be significantly reduced leading to loss of efficacy. See the prescribing information for other drugs dependent on gastric pH for absorption. Tizanidine (CYP1A2) Substrate: Potential for substantial increases in blood concentrations of tizanidine resulting in hypotension, bradycardia or excessive drowsiness, avoid concomitant use, if possible.

Store at room temperature between 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (59° and 86°F). Do not freeze. If not used immediately, store diluted solutions of Famotidine Injection between 2° and 8°C (36° and 46°F) for up to 48 hours. Protect from light.