(FAMOTIDINE ORALLY DISINTEGRATING TABLETS)
FLUXID™ (famotidine orally disintegrating tablets) is a histamine H2-receptor antagonist. Famotidine is N′ -(aminosulfonyl)-3-[[[2-[(diaminomethylene)amino]-4-thiazolyl]methyl]thio] propanimidamide.
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).
Published Studies Related to Fluxid (Famotidine)
Esomeprazole Compared With Famotidine in the Prevention of Upper Gastrointestinal Bleeding in Patients With Acute Coronary Syndrome or Myocardial Infarction. [2011.11.22]
CONCLUSIONS:In patients with ACS or STEMI, esomeprazole is superior to famotidine in preventing upper gastrointestinal complications related to aspirin, clopidogrel, and enoxaparin or thrombolytics.Am J Gastroenterol advance online publication, 22 November 2011; doi:10.1038/ajg.2011.385.
Preventive effects of lansoprazole and famotidine on gastric mucosal injury induced by low-dose aspirin in Helicobacter pylori-negative healthy volunteers. [2011.07]
The preventive effects of lansoprazole and famotidine on low-dose aspirin-induced gastric mucosal injury in relation to gastric acidity were compared in healthy Japanese volunteers. Fifteen Helicobacter pylori-negative volunteers with different CYP2C19 genotypes were randomly administered aspirin 100 mg, aspirin plus famotidine 20 mg twice daily, or aspirin plus lansoprazole 15 mg once daily for 7 days each in a crossover fashion.
Comparison of the efficacy of irsogladine maleate and famotidine for the healing of gastric ulcers after Helicobacter pylori eradication therapy: a randomized, controlled, prospective study. [2011.03]
OBJECTIVE: Helicobacter pylori eradication therapy alone cannot heal gastric ulcers in Japanese patients. Irsogladine has previously been shown to accelerate the healing of gastric ulcers after H. pylori eradication therapy. And we previously reported that histamine H(2) receptor antagonists inhibit gastric ulcer relapse after H. pylori eradication therapy. We therefore compared the efficacy of irsogladine with famotidine as appropriate treatments for ulcers after eradication therapy... CONCLUSIONS: Irsogladine and famotidine are both acceptable in treatment after H. pylori eradication therapy in gastric ulcer patients. Findings also suggest that irsogladine is more beneficial than famotidine in patients who drink alcohol and smoke.
Efficacy of oral famotidine and 2 omeprazole formulations for the control of intragastric pH in dogs. [2011.01]
BACKGROUND: Little is known about the efficacy of commonly used acid suppressants on intragastric pH in dogs. OBJECTIVE: To compare the effect of oral famotidine, 2 formulations of omeprazole, and placebo on intragastric pH in dogs with a catheter-free, continuous pH monitoring system. ANIMALS: Six healthy adult mixed-breed colony dogs... CONCLUSION: Oral omeprazole tablet and RP provide superior gastric acid suppression to famotidine, and should therefore be considered more effective for the treatment of acid related disorders in dogs. Copyright (c) 2010 by the American College of Veterinary Internal Medicine.
A double-blind, controlled study comparing lafutidine with placebo and famotidine in Japanese patients with mild reflux esophagitis. [2010.12]
PURPOSE: This randomized, double-blind, controlled study examined whether lafutidine is superior to placebo and non-inferior to famotidine in terms of healing rates as assessed by endoscopy in Japanese patients with mild reflux esophagitis. Safety and improvement in symptoms of heartburn were also assessed... CONCLUSIONS: Lafutidine has a high endoscopic healing rate and improves symptoms of heartburn in patients with mild reflux esophagitis. Lafutidine is considered a promising treatment option for mild reflux esophagitis.
Clinical Trials Related to Fluxid (Famotidine)
Esomeprazole or Famotidine in the Management of Aspirin Related Non-Ulcer Dyspepsia [Recruiting]
Aspirin can prevent ischemic vascular disease but is commonly complicated by dyspepsia in
30% of patients. Patients, who have aspirin related dyspepsia, commonly underwent upper
endoscopy to exclude peptic ulcer disease or gastric cancers. For those without significant
lesions in the stomach and duodenum (non-ulcer dyspepsia), the best approach in the
management is unclear. The objective of this study is to compare the efficacy of
esomeprazole and famotidine in the control of dyspeptic symptom. After giving consent,
patients will be randomised to receive either esomeprazole 20 mg daily or famotidine 40 mg
daily in a double blinded manner. The patient will be followed-up at the 2nd and 4th week.
The study will be completed at the 4th week. The primary analysis will be the efficacy in
the control of dyspepsia symptom between the two groups.
Drug Interaction Study With Famotidine, Atazanavir, and Atazanavir/Ritonavir/Tenofovir [Completed]
The purpose of this clinical research study is to assess the pharmacokinetics of atazanavir,
identifying one or more dosing regimens of atazanavir/ritonavir/tenofovir when dosed with
famotidine results in atazanavir exposures similar to those when
atazanavir/ritonavir/tenofovir 300/100/300 mg is dosed without famotidine in healthy
Comparison of Esomeprazole and Famotidine for Stress Ulcer Prophylaxis in Neurosurgical Intensive Care Unit [Recruiting]
Although stress ulcer is a complication that can cause mortality and morbidity in critical
patients, there is still lack of consensus about its prophylaxis. There is also few data
available from Taiwan. H2 blockers are commonly used due to convenience. Some prefer
sucralfate (a mucosal protective agent) for the sake of less associated nosocomial
pneumonia. Recently, proton pump inhibitors were shown to have good prophylactic effects for
stress ulcer. Esomeprazole, an isoform of omeprazole, has good acid suppression effect and
the tablets are soluble for the use of tube feeding. Our previous study showed that there
was no difference for the efficacy of stress ulcer prophylaxis between esomeprazole and
sucralfate in patients admitted to medical ICU with at least one risk factor. The prevalence
of nosocomial pneumonia was also similar.
We will enroll those patients that have received intracranial surgery and admitted to
neurosurgical ICU. After obtaining the consent, we will give them prophylactic drugs for 7
days within 24 hours. They are randomly allocated to 2 groups. Group I: esomeprazole 40 mg
qd from NG route or orally; Group II: famotidine 20 mg iv bolus q12h. We will monitor the
following data: Glasgow coma scale, APACHE II score, CBC, CXR, stool character and OB test,
NG aspirate. If clinical evidence of UGI bleeding occurs, endoscopy will be performed. We
define the end point as overt bleeding, death or transfer out of ICU. We will compare the
prevalence of UGI bleeding and nosocomial pneumonia in these 2 groups.
Comparison of Intravenous Pantoprazole and Famotidine for Stress Ulcer Prophylaxis [Recruiting]
Although stress ulcer is a complication that can cause significant mortality and morbidity
in critical patients with risk factors, there is still lack of consensus about its
prophylaxis. There are also few data available from Taiwan. H2 blockers are commonly used
due to convenience. Some prefer sucralfate (a mucosal protective agent) for the sake of less
association with nosocomial pneumonia. Recently, proton pump inhibitors were shown to have
good prophylactic effects for stress ulcer. Pantoprazole (iv) is the first intravenous form
of proton pump inhibitor that was approved by FDA. There are some reports about its
application for treatment of peptic ulcer bleeding. It also has good acid suppression effect
in patients under critical care. We expect that intravenous pantoprazole will have a role in
stress ulcer prophylaxis.
We will enroll those patients that have received major abdominal surgery and admitted to
surgical ICU. After obtaining the consent, we will give them prophylactic drugs for 7 days
within 24 hours. They are randomly allocated to 2 groups. Group I: pantoprazole 40 mg iv
bolus stat and then qd ; Group II: famotidine 20 mg iv bolus stat and then q12h. We will
monitor the following data: operation type & time, APACHE II score, CBC, CXR, stool
character and OB test, NG aspirate. If clinical evidence of UGI bleeding occurs, endoscopic
examination will be performed. We define the end point as overt bleeding, death or transfer
out of ICU. We will compare the prevalence of UGI bleeding and ventilator associated
pneumonia in these 2 groups
Drug Interaction Study of Famotidine and Atazanavir With Ritonavir in HIV-Infected Patients [Completed]
The purpose of this clinical research study is to assess the effect of Famotidine given twice
daily on Atazanavir administered with Ritonavir in HIV-Infected subjects.
Page last updated: 2011-12-09