OMEPRAZOLE, CLARITHROMYCIN, AMOXICILLIN (Omeclamox-Pak) Nursing Considerations

What is the generic name?

OMEPRAZOLE, CLARITHROMYCIN, AMOXICILLIN

What is the Trade Name for OMEPRAZOLE, CLARITHROMYCIN, AMOXICILLIN?

Omeclamox-Pak

What are the Indications for OMEPRAZOLE, CLARITHROMYCIN, AMOXICILLIN?

• 1 INDICATIONS AND USAGE OMECLAMOX-PAK, a co-packaged product containing 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 . ( 1 ) 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. ( 1.2 ) 1.1 Eradication of Helicobacter pylori in Patients with Active Duodenal Ulcer or History of Duodenal Ulcer Disease OMECLAMOX-PAK (Omeprazole delayed-release capsules, clarithromycin tablets, and amoxicillin capsules taken together) are indicated for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or one-year history) to eradicate H. pylori in adults. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [ see Clinical Studies ( 14.1 ) ]. 1.2 Usage 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 susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

References: https://open.fda.gov/