Omeclamox®-Pak

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Refer to the Omeclamox-Pak Complete Prescribing Information

For professional medical information:
For all questions concerning adverse events associated with the use of this product, please contact Cumberland Pharmaceuticals by phone at (877) 484-2700 or by email at omeclamox@cumberlandpharma.com

For customer service information:
Cumberland Pharmaceuticals offers a toll-free Customer Service number for orders and other inquiries concerning Omeclamox-Pak. Call (877) 274-7200

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Cumberland Pharmaceuticals Inc.
2525 West End Avenue, Suite 950
Nashville, TN 37203
Phone: (615) 255-0068
Fax: (615) 255-0094
info@cumberlandpharma.com
www.cumberlandpharma.com

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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.

Limitations of Use: To reduce the development of drug-resistant bacteria and maintain the effectiveness of OMECLAMOX-PAK and other antibacterial drugs, OMECLAMOX-PAK should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

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.

1. Omeclamox®-Pak complete prescribing information. 03/2017

* Three U.S., randomized, double-blind clinical studies in patients with H. pylori infection and duodenal ulcer disease (n = 558) compared omeprazole plus clarithromycin plus amoxicillin with clarithromycin plus amoxicillin. Two studies (1 and 2) were conducted in patients with an active duodenal ulcer, and the other study (3) was conducted in patients with a history of a duodenal ulcer in the past 5 years but without an ulcer present at the time of enrollment. The combination of omeprazole plus clarithromycin plus amoxicillin was effective in eradicating H. pylori.