PREVPAC (lansoprazole, clarithromycin, and amoxicillin), PYLERA ...
Transcript of PREVPAC (lansoprazole, clarithromycin, and amoxicillin), PYLERA ...
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PREVPAC (lansoprazole, clarithromycin, and amoxicillin), PYLERA (bismuth subcitrate, metronidazole, tetracycline), OMECLAMOX-PAK (omeprazole, clarithromycin, and amoxicillin)
RATIONALE FOR INCLUSION IN PA PROGRAM
Background
Prevpac and Omeclamox-Pak are a copackaged product containing a proton pump inhibitor, a
macrolide antimicrobial, and a penicillin class antibacterial that, when taken together, is indicated
for the eradication of Heliobacter pylori infection in patients with duodenal ulcer disease that is
active or up to a one year history. Pylera is a copackaged product containing two antimicrobials;
metronidazole, tetracycline and bismuth subcitrate potassium. Pylera is also used to eradicate
Helicobacter pylori (H. pylori) in patients with H. pylori infection and duodenal ulcer disease; Pylera
is FDA-approved for use only in combination with omeprazole. Eradication of H. pylori has been
shown to reduce the risk of duodenal ulcer recurrence (1-3). It is important to treat H. pylori infection because it has been identified as a risk factor in the
development of peptic ulcer, duodenal ulcer, atrophic gastritis, gastric cancer, and mucosal-
associated lymphoid tissue (MALT) lymphoma, as well as, a possible risk factor for the
development idiopathic thrombocytopenic purpura and anemia (1-3). Regulatory Status
The components in Prevpac, Pylera and Omeclamox-Pak are indicated for the treatment of
patients with H. pylori infection and duodenal ulcer disease (active or one-year history of a
duodenal ulcer) to eradicate H. pylori (1-3). Summary
Prevpac, Pylera and Omeclamox-Pak are indicated for the treatment of patients with Heliobacter
pylori infection and duodenal ulcer disease (active one-year history) to eradicate H. pylori. They
should be used only to treat or prevent infections that are proven or strongly suspected to be
caused by bacteria. Prevpac and Omeclamox-Pak should only be used in patients with no
clarithromycin resistance. Patients taking Pylera will need to be co-administered with omeprazole
(1-3).
Prior approval is required to ensure the safe, clinically appropriate and cost effective use of Prevpac
and Omeclamox while maintaining optimal therapeutic outcomes.
Prevpack Pylera Omeclamox FEP Clinical Rationale
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PREVPAC (lansoprazole, clarithromycin, and amoxicillin), PYLERA (bismuth subcitrate, metronidazole, tetracycline), OMECLAMOX-PAK (omeprazole, clarithromycin, and amoxicillin)
References
1. Omeclamox-Pak [package insert]. Nashville, TN: Cumberland Pharmaceuticals Inc; October
2016.
2. PrevPac package insert. Deerfield, IL: Takeda Pharmaceuticals America Inc.; October 2016.
3. Pylera [package insert]. Bridgewater, NJ: Aptalis Pharma US, Inc.; May 2013.
Prevpack Pylera Omeclamox FEP Clinical Rationale