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How does H. pylori cause ulcers and how is it detected?
H. pylori weakens the protective mucous coating of the stomach and duodenum, allowing acid to penetrate to the sensitive lining underneath, causing chronic inflammation and ulceration.4 Together, the acid and bacteria irritate the lining and cause ulcers.3 Another cause of ulcer disease is the use of non-steroidal anti-inflammatory medications (also called NSAIDs) used for pain such as aspirin.3 Certain risk factors may make this more likely.
When ulcers are suspected, the physician will likely test for the presence of H. pylori organisms. Testing is important because treatment for an ulcer caused by H. pylori is different from treatment for an ulcer resulting from other causes.3 Tests that may be used to confirm the presence of H. pylori are blood tests, breath tests or an endoscopy (a scope used by physicians to view the stomach, visualize the duodenum, and obtain tissue samples).1,2 Breath tests may also be used to confirm treatment has been successful.
Precautions
- PYLERA® may cause a temporary and harmless darkening of the tongue and/or black stool because it contains bismuth. Stool darkening must not be confused with blood in stool.
- Notify your doctor if you have a blood condition or an infection prior to taking PYLERA® or develop an infection while taking PYLERA®.
- Use of tetracyclines may render oral contraceptives less effective. A different or additional form of birth control should be used while taking PYLERA®.
Information on this website is not intended to replace the advice of your physician(s). Please consider what you learn here a starting point for a conversation with your physician. PYLERA® is a prescription drug; please ask your physician if PYLERA® is right for you.
References:
1. Helicobacter pylori and Peptic Ulcer Disease. Centers for Disease Control and Prevention Website, Division of Bacterial Diseases. Available at: http://www.cdc.gov/ulcer/consumer.htm. Accessed 12/3/09 2. Helicobacter pylori and Peptic Ulcer Disease: the Key to Cure. Centers for Disease Control and Prevention Website, Division of Bacterial Diseases. Available at: http://www.cdc.gov/ulcer/keytocure.htm. Accessed 12/3/09 3. What I need to know about Peptic Ulcers. National Institute of Health Consumer Website. Available at: http://digestive.niddk.nih.gov/ddiseases/pubs/pepticulcers_ez/ Accessed 12/3/09 4. Ulcers and stress: Is there a connection? Mayo Clinic Website. Available at http://www.mayoclinic.com/health/peptic-ulcer/DS00242 Accessed 2/3/09
PYLERA® is a prescription medication.
PYLERA® capsules, (bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride) in combination with omeprazole are indicated for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori.
WHO SHOULD NOT TAKE PYLERA®?
- pregnant* or nursing women
- pediatric patients under the age of 8
- patients with kidney or liver problems
- patients with hypersensitivity to bismuth subcitrate potassium, metronidazole or other nitroimidazole derivatives, or tetra-cyclines
* Notify your doctor immediately if you become pregnant while taking PYLERA®
WHAT SHOULD I BE AWARE OF WHILE TAKING PYLERA®?
Warnings
- Metronidazole, one of the active ingredients in PYLERA®, has been shown to cause cancer in mice and rats. Unnecessary use should be avoided.
- Rarely some components of PYLERA® can affect the nervous system. Symptoms may include numbness or tingling of arms and legs, headache, blurred vision, and convulsive seizures.
Tell your doctor immediately if you experience any of these symptoms. - An exaggerated sunburn reaction has been seen in some individuals taking tetracycline. Avoid exposure to sun or tanning beds while taking PYLERA®.
Precautions
- PYLERA® may cause a temporary and harmless darkening of the tongue and/or black stool because it contains bismuth. Stool darkening must not be confused with blood in stool.
- Notify your doctor if you have a blood condition or an infection prior to taking PYLERA® or develop an infection while taking PYLERA®.
- Use of tetracyclines may render oral contraceptives less effective. A different or additional form of birth control should be used while taking PYLERA®.
WHAT ARE THE MOST COMMON SIDE EFFECTS OF PYLERA®?
The most commonly reported adverse events for PYLERA® include:
- change in the color, shape, consistency of stool
- diarrhea
- indigestion
- abdominal pain
- nausea
- headache
IS THERE ANYTHING I SHOULD AVOID WHILE TAKING PYLERA®?
Do not drink alcohol while taking this medication and for at least 1 day afterward because abdominal cramps, nausea, vomiting, headaches and flushing may occur.
Before taking PYLERA®, speak with your physician if you are taking lithium, anticoagulants (blood thinners), cimetidine, phenytoin, phenobarital, methoxyflurane, and penicillin.
HOW SHOULD I TAKE PYLERA®?
It is extremely important to follow your PYLERA® treatment regimen exactly as directed:
Each dose of PYLERA® includes 3 capsules. Each dose of all 3 capsules should be taken 4 times a day, after meals and at bedtime for 10 days. You should swallow the PYLERA® capsules whole with a full glass of water (8 ounces). One omeprazole 20 mg capsule should be taken twice a day with PYLERA® after the morning and evening meal for 10 days.
Daily Dosing Schedule for PYLERA® and Omeprazole:
| Time of dose |
Number of capsules of PYLERA® |
Number of capsules of Omeprazole 20 mg |
| After morning meal | 3 | 1 |
| After lunch | 3 | 0 |
| After evening meal | 3 | 1 |
| At bedtime | 3 | 0 |
Administration of adequate amounts of fluid, particularly with the bedtime dose of PYLERA®, is recommended to reduce the risk of esophageal irritation and ulceration, which can be associated with tetracycline hydrochloride.
It's essential to finish the medication, even if you start to feel better. Every dose counts toward helping you get rid of H. pylori. If you miss a dose just continue taking the medication until you have none left.
If you have any questions or concerns about your PYLERA® regimen including omeprazole, please ask your physician.
You are encouraged to report negative side effects of prescription drugs to AXCAN PHARMA US, Inc. or the FDA. Call Axcan Pharma US, Inc. at 1-800-472-2634, visit http://www.fda.gov/medwatch/ or call 1-800-FDA-1088.
