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 FLUXID™ 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.
FLUXID™ is indicated in:1.
Short term treatment of active duodenal ulcer.
Most adult patients heal within 4 weeks; there is rarely reason to use famotidine at full dosage for longer than 6 to 8 weeks.
Studies have not assessed the safety of famotidine in uncomplicated active duodenal ulcer for periods of more than eight weeks.2.
Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of an active ulcer.
Controlled studies in adults have not extended beyond one year.3.
Short term treatment of active benign gastric ulcer.
Most adult patients heal within 6 weeks.
Studies have not assessed the safety or efficacy of famotidine in uncomplicated active benign gastric ulcer for periods of more than 8 weeks.4.
Short term treatment of gastroesophageal reflux disease (GERD).
FLUXID™ is indicated for short term treatment of patients with symptoms of GERD (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).FLUXID™ is also indicated for the short term treatment of esophagitis due to GERD including erosive or ulcerative disease diagnosed by endoscopy (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).5.Treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison Syndrome, multiple endocrine adenomas) (see CLINICAL PHARMACOLOGY IN ADULTS, Clinical Studies).
Hypersensitivity to any component of this product.
Cross sensitivity in this class of compounds has been observed.Therefore, FLUXID™ should not be administered to patients with a history of hypersensitivity to other H2-receptor antagonists.