packing Important safety information1

Omeclamox-Pak® is indicated for the treatment of patients with
H. pylori infection and duodenal ulcer disease (active or one-year history of duodenal ulcer) to eradicate H. pylori. Eradication of
H. pylori has been shown to reduce the risk of duodenal ulcer recurrence.

The most frequent adverse reactions observed in clinical trials using the combination therapy with omeprazole, clarithromycin and amoxicillin (n=274) were diarrhea (14%), taste perversion (10%) and headache (7%).

Omeclamox-Pak is contraindicated in patients with known hypersensitivity to omeprazole, any macrolide antibiotic, any penicillin or any component of the formulations.

Amoxicillin is contraindicated in patients who are allergic to penicillin.

Clarithromycin is contraindicated in patients taking ergotamine or dihydroergotamine and pimozide. Clarithromycin may elevate digoxin serum concentrations. Serum digoxin levels should be carefully monitored while digoxin and clarithromycin are taken concomitantly.

Clarithromycin should not be used in pregnant women except in circumstances where no alternative therapy is appropriate.

If clarithromycin resistance is demonstrated, a non-clarithromycin therapy is recommended. If possible, susceptibility testing should be done in patients who fail therapy.

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.

Exacerbation of symptoms and new onset of symptoms in patients with myasthenia gravis have been reported with clarithromycin. Monitor patients for symptoms.

Clostridium difficile-associated diarrhea has been reported with use of clarithromycin and amoxicillin; evaluate if diarrhea occurs. Symptomatic response to therapy with omeprazole does not preclude the presence of gastric malignancy.

Omeclamox-Pak® is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one-year history of duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. The most frequently reported adverse events with Omeclamox-Pak were diarrhea, headache, and taste perversion. No adverse events unique to triple therapy were observed. Adverse reactions were limited to those previously reported with omeprazole, clarithromycin or amoxicillin alone.

1. Omeclamox-Pak Complete Prescribing Information.
* 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.

 

 

© 2012 Pernix Therapeutics     All rights reserved     OME12-WS-00 6/2012     This information is intended only for residents of the United States.