Why did my doctor prescribe Omeclamox®-Pak?
Omeclamox-Pak (oh-mec-la-mox pack) is a treatment for an infection in the stomach and gastrointestinal tract by a bacteria called Helicobacter pylori (hel-i-co-bac-ter pie-lor-e).1 The “nickname” for this bacteria is H. pylori. The medications in Omeclamox-Pak are proven to help get rid of H. pylori infection.
What are the medications in Omeclamox-Pak?
Omeclamox-Pak contains three well-known and trusted medications that have been prescribed by doctors for many years. Omeprazole (oh-mep-ra-zol) works to decrease the amount of acid the stomach produces. Omeclamox-Pak also contains two commonly prescribed antibiotics – clarithromycin (clar-ith-ro-my-cin) and amoxicillin (amox-i-cil-in). These antibiotics hinder the growth of H. pylori and help heal the damage caused by H. pylori. Omeclamox-Pak packages these three effective medications together for the first time, making it convenient and simple for patients to take.
Can you tell me more about H. pylori?
H. pylori is a bacteria that is commonly found in the stomach and gastrointestinal tract in an estimated 50% of the world’s population.2 H. pylori most likely spreads by consuming food or water contaminated with the bacteria. It does not always cause problems, but if left untreated, H. pylori can damage the stomach and gastrointestinal tract. Symptoms of H. pylori infection can include burning pain in the abdomen, nausea, loss of appetite, bloating and weight loss.3
Does Omeclamox-Pak work?
Studies have shown that the medications in Omeclamox-Pak effectively get rid of
H. pylori in up to 90% of patients in just 10 days.1*
How is Omeclamox-Pak different from other H. pylori therapies?
Omeclamox-Pak is designed to make it very simple and convenient for you to take. The medications are packaged together on convenient daily dosing cards with easy-to-follow instructions to help you complete the full 10-day course of therapy. The 10-day treatment is shorter than most other H. pylori treatments.1
What does Omeclamox-Pak look like?
Omeclamox-Pak comes in a simple-to-use box that contains a full 10-day course of treatment. Inside each box, there are 10 individual cards — one card for each day of treatment. Omeclamox-Pak is taken twice a day for 10 days. On each card, you will see the clearly marked morning (AM) and evening (PM) doses that should be taken before meals.
How should I take the medicines in Omeclamox-Pak?
Each Omeclamox-Pak daily dose card is clearly marked with the AM and PM doses. You should take the medications before meals to help avoid side effects patients sometimes experience with antibiotics like the ones in Omeclamox-Pak. Each morning and evening dose includes:
- One 20 mg Omeprazole delayed-release capsule
- One 500 mg Clarithromycin tablet
- Two 500 mg Amoxicillin capsules
Are there side effects with Omeclamox-Pak?
In studies done with Omeclamox-Pak, 14% of patients reported diarrhea, 10% reported temporary changes in their sense of taste and 7% reported getting a headache. These were the most common side effects with Omeclamox-Pak. These side effects occurred no more frequently than they did in studies with the individual medications. Please see the Omeclamox-Pak Complete Prescribing Information for more information. If you experience any troublesome side effects, it is important for you to contact your doctor. These are not all the possible side effects of Omeclamox-Pak. Call your doctor for medical advice about side effects. You may report side effects to Cumberland Pharmaceuticals at 1-800-484-2700.
What should I know about safely using Omeclamox-Pak?
As with any prescription medication, you should be aware of some important safety issues. Contact your doctor or pharmacist with any questions or concerns you may have.
Always follow the instructions for taking your medication as directed by your doctor.
Do not take Omeclamox-Pak if you:
- Are known to be over-sensitive to any of the medications in Omeclamox-Pak
- Are allergic to penicillin
- Are taking any of these medications:
- Ergotamine (er-got-amine)
- Dihydroergotamine (di-hy-dro-er-got-amine)
- Pimozide (pi-mo-zide)
- Are taking the medication digoxin (di-gox-in) — when digoxin and clarithromycin are taken at the same time, you should be monitored carefully
- Are pregnant or are planning to become pregnant while taking Omeclamox-Pak
- Are taking the medication colchicine (kol-chi-cine)
- Have been diagnosed with the disease, myasthenia gravis (my-uhs-thee-ne-uh gra-vis) – an increase in current symptoms and the start of new symptoms have been reported in patients taking clarithromycin, one of the medications in Omeclamox-Pak
Where can I get more information about Omeclamox-Pak?
If you have questions about treatment with Omeclamox-Pak, talk to your doctor. Pharmacists may also be helpful answering questions you may have about taking Omeclamox-Pak.
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.
1. Omeclamox®-Pak complete prescribing information. 03/2017
2. Mitchell HM. The common bacterium Helicobacter pylori, a spiral-shaped pathogenic bacterium found on the human epidemiology of Helicobacter pylori. Curr Top Microbiol Immunol. 1999;241:11-30.
3. H. pylori infection. Symptoms. Available at: http://www.mayoclinic.com/health/h-pylori/DS00958/DSECTION=symptoms. Accessed March 1, 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.
Omeclamox®-Pak is a registered trademark of Cumberland Pharmaceuticals Inc.
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