Which treatment would your H. pylori patients prefer?
This comparison refers to pill count and days of therapy and does not compare safety or efficacy.
*Calculation based on maximum duration of therapy recommended in prescribing information for each product.
In the United States, the recommended primary therapies for H. pylori infection include: a PPI, clarithromycin, and amoxicillin, or metronidazole (clarithromycin-based triple therapy) for 14 days or a PPI or H2RA, bismuth, metronidazole, and tetracycline (bismuth quadruple therapy) for 10-14 days. Chey W., Wong B., American Journal of Gastroenterology 2007;102:1808-1825.
The recommended adult oral 10 day regimen is given twice daily in the morning and evening before eating a meal
Each daily dose card contains:
- Two 20 mg omeprazole delayed-release capsules
- Two 500 mg clarithromycin tablets
- Four 500 mg amoxicillin capsules
Swallow each tablet and capsule whole; do not crush
For information on use of the individual components when dispensed as individual medications outside this combined use for treating Helicobacter pylori, please see the package inserts for each individual product.
For information on use of the individual components when dispensed as individual medications outside this combined use for treating Helicobacter pylori, please see the package inserts for each individual product.
INDICATION
OMECLAMOX-PAK, a co-packaged product containing a omeprazole, a proton pump inhibitor, clarithromycin, a macrolide antimicrobial, and amoxicillin, a penicillin class antibacterial, is indicated for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or up to one-year history) to eradicate H. pylori.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Known hypersensitivity to omeprazole, any macrolide antibiotic, any penicillin, or any component of the formulations. Coadministration with pimozide, ergotamine or dihydroergotamine.
WARNINGS & PRECAUTIONS
Embryo-Fetal Toxicity: Based on animal findings for omeprazole and clarithromycin, OMECLAMOX-PAK is not recommended for use in pregnant women except in clinical circumstances when there is no appropriate alternative. Colchicine interaction: Concomitant use of clarithromycin and colchicine has resulted in deaths, especially in the elderly with renal insufficiency. Monitor patients for clinical symptoms of colchicine toxicity. Myasthenia gravis: Exacerbation of symptoms and new onset of symptoms reported with clarithromycin. Monitor patients for symptoms. Clostridioides difficile- associated diarrhea: Reported with use of clarithromycin and amoxicillin; evaluate continued use if diarrhea occurs. Risk of gastric malignancy: Symptomatic response does not preclude concomitant underlying malignancy. Acute interstitial nephritis has been observed in patients taking proton pump inhibitors. Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue OMECLAMOX-PAK and evaluate.
ADVERSE REACTIONS The most frequent adverse reactions (>7%) with triple therapy were diarrhea, taste perversion, and headache.
†Omeclamox®-Pak is a registered trademark of GastroEntero-Logic, LLC.
װPrevPac® is a registered trademark of Takeda Pharmaceuticals U. S. A. Inc.
¶Pylera® is a registered trademark of Aptalis Pharma Canada Inc., an affiliate of Aptalis Pharma US, Inc.
1. Omeclamox®-Pak complete prescribing information. 03/2017
2. PrevPac® complete prescribing information. Available at: http://general.takedapharm.com/content/file/pi.pdf?filetypecode=PREVPACPI. Retrieved March 1, 2017.
3. Pylera® complete prescribing information. Available at: https://www.allergan.com/assets/pdf/pylera_pi. Retrieved March 1, 2017.
Omeclamox®-Pak is a registered trademark of Cumberland Pharmaceuticals Inc.
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