Generic drug: bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride
Brand name: Pylera
What is Pylera, and how does it work?
Pylera (bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride) is a combination of a mineral and two antibiotics used to treat stomach ulcers associated with H pylori infection. Pylera is usually used together with omeprazole (Prilosec).
What are the side effects of Pylera?
POTENTIAL FOR CARCINOGENICITY
Metronidazole has been shown to be carcinogenic in mice and rats. It is unknown whether metronidazole is associated with carcinogenicity in humans.
Common side effects of Pylera include:
- upset stomach,
- abdominal pain,
- changes in taste,
- vaginal itching or discharge, or
- diarrhea or other changes in your stools.
Tell your doctor if you have unlikely but serious side effects of Pylera including:
- numbness and tingling of arms or legs,
- discolored teeth,
- mental/mood changes (such as confusion, anxiety, irritability, depression),
- difficult or painful swallowing, heartburn,
- fast or pounding heartbeat,
- ringing in the ears, or
- frequent or painful urination.
What is the dosage for Pylera?
Administer three Pylera capsules 4 times a day (after meals and at bedtime) for 10 days. One omeprazole 20 mg capsule should be taken twice a day with Pylera after the morning and evening meal for 10 days (Table 1).
Table 1: Daily Dosing Schedule for Pylera
|Time of dose||Number of capsules of Pylera||Number of capsules of omeprazole 20 mg|
|After morning meal||3||1|
|After evening meal||3||1|
Instruct patients to swallow the Pylera capsules whole with a full glass of water (8 ounces). Ingestion of adequate amounts of fluid, particularly with the bedtime dose, is recommended to reduce the risk of esophageal irritation and ulceration by tetracycline hydrochloride.
If a dose is missed, patients should continue the normal dosing schedule until medication is gone. Patients should not take double doses. If more than 4 doses are missed, the prescriber should be contacted.
What drugs interact with Pylera?
- Do not administer methoxyflurane to patients taking Pylera. The concurrent use of tetracycline hydrochloride, a component of Pylera, with methoxyflurane has been reported to result in fatal renal toxicity.
- Psychotic reactions have been reported in alcoholic patients who are using metronidazole, a component of Pylera and disulfiram concurrently.
- Pylera should not be given to patients who have taken disulfiram within the last two weeks.
- Consumption of alcoholic beverages or administration of other products containing propylene glycol during treatment with Pylera and for at least 3 days afterwards may cause a disulfiram-like reaction (abdominal cramps, nausea, vomiting, headaches, and flushing) due to the interaction between alcohol or propylene glycol and metronidazole, a component of Pylera.
- Discontinue alcoholic beverage or other products containing propylene glycol during and for at least 3 days after therapy with Pylera.
- Concurrent use of Pylera with oral contraceptive may make oral contraceptives less effective due to an interaction with the tetracycline component of Pylera. Breakthrough bleeding has been reported.
- Women of child-bearing potential should use a different or additional form of contraception while taking Pylera.
- Pylera may alter the anticoagulant effects of warfarin and other oral coumarin anticoagulants.
- Metronidazole has been reported to potentiate the anticoagulant effect of warfarin, and other oral coumarin anticoagulants, resulting in a prolongation of prothrombin time.
- Tetracycline has been shown to depress plasma prothrombin activity.
- Prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests should be closely monitored if Pylera is administered concomitantly with warfarin. Patients should also be monitored for evidence of bleeding.
- In patients stabilized on relatively high doses of lithium, short-term use of Pylera may cause elevation of serum lithium concentrations and signs of lithium toxicity due to the interaction between metronidazole and lithium.
- Serum lithium and serum creatinine concentrations should be monitored several days after beginning treatment with Pylera to detect any increase that may precede clinical symptoms of lithium toxicity.
Antacids, Multivitamins, Or Dairy Products
- The absorption of Pylera may be reduced if administered with antacids containing aluminium, calcium, or magnesium; preparations containing iron, zinc, or sodium bicarbonate; or milk or dairy products due to the interaction between these products and tetracycline.
- These products should not be consumed concomitantly with Pylera. However, the clinical significance of reduced tetracycline systemic exposure is unknown as the relative contribution of systemic versus local antimicrobial activity against Helicobacter pylori has not been established.
- Metronidazole has been reported to increase plasma concentrations of busulfan, which can result in an increased risk for serious busulfan toxicity.
- Do not administer Pylera concomitantly with busulfan unless the benefit outweighs the risk.
- If no therapeutic alternatives to Pylera are available, and concomitant administration with busulfan is medically needed, monitor for busulfan toxicity and busulfan plasma concentrations and adjust the busulfan dose accordingly.
Inhibitors Of CYP450 Liver Enzymes
- The simultaneous administration of Pylera and drugs that inhibit microsomal liver enzymes, such as cimetidine, may result in a prolonged half-life and decreased plasma clearance of metronidazole.
Inducers Of CYP450 Liver Enzymes
- The simultaneous administration of Pylera and drugs that induce microsomal liver enzymes, such as phenytoin or phenobarbital, may accelerate the elimination of metronidazole, resulting in reduced plasma concentrations of metronidazole.
- Impaired clearance of phenytoin has also been reported in this situation. Monitor phenytoin concentrations during treatment with Pylera.
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Is Pylera safe to use while pregnant or breastfeeding?
- Pylera is contraindicated in women who are pregnant because treatment of Helicobacter pylori infection can be delayed in pregnant women, and the use of drugs of the tetracycline class during the second and third trimester pregnancy can also cause permanent discoloration of the teeth (yellow-gray brown) and possibly inhibit bone development.
- Two of the individual components of Pylera, tetracycline and metronidazole, are present in human milk at concentrations similar to maternal serum levels.
- It is not known whether bismuth subcitrate, the third component of Pylera is present in human milk.
- It is not known what effect metronidazole, tetracycline or bismuth has on the breastfed infant or on milk production. Tetracycline binds with calcium in human milk.
- Data indicate that oral absorption of tetracycline in infants is low due to the calcium binding in human milk.
- Metronidazole transfers to human milk, and infant serum levels can be close to or comparable to infant therapeutic levels.
- Because of the potential risk of tumorigenicity shown in animal studies with metronidazole, a woman should pump and discard human milk for the duration of Pylera therapy, and for 2 days after therapy ends, and feed her infant stored human milk (collected prior to therapy) or formula.
Pylera (bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride) is a combination of a mineral and two antibiotics used to treat stomach ulcers associated with H pylori infection. Pylera is usually used together with omeprazole (Prilosec). Common side effects of Pylera include nausea, diarrhea, upset stomach, abdominal pain, changes in taste, headache, dizziness, vaginal itching or discharge, or diarrhea or other changes in your stools.
Multimedia: Slideshows, Images & Quizzes
Digestive Disorders: Visual Guide to Stomach Ulcers
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Picture of Peptic Ulcer
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Related Disease Conditions
Peptic Ulcer (Stomach Ulcer)
Peptic or stomach ulcers are ulcers are an ulcer in the lining of the stomach, duodenum, or esophagus. Ulcer formation is related to H. pylori bacteria in the stomach, use of anti-inflammatory medications, and cigarette smoking. Symptoms of peptic or stomach ulcers include abdominal burning or hunger pain, indigestion, and abdominal discomfort after meals. Treatment for stomach ulcers depends upon the cause.
Ulcerative Colitis Diet Plan
An ulcerative colitis diet plan can help a person with the disease avoid foods and drinks that trigger flares. There also are foods that can soothe ulcerative colitis symptoms during a flare. Types of ulcerative colitis plans include a high-calorie diet, a lactose-free diet, a low-fat diet, a low-fiber diet (low-residue diet), or a low-salt diet. Self-management of ulcerative colitis using healthy lifestyle habits and a nutrient rich diet can be effective in management of the disease. Learn what foods to avoid that aggravate, and what foods help symptoms of the disease and increase bowel inflammation.
Ulcerative colitis is a chronic inflammation of the colon. Symptoms include abdominal pain, diarrhea, and rectal bleeding. Ulcerative colitis is closely related to Crohn's disease, and together they are referred to as inflammatory bowel disease. Treatment depends upon the type of ulcerative colitis diagnosed.
Crohn's Disease vs. Ulcerative Colitis (UC)
Crohn's disease and ulcerative colitis are diseases that cause inflammation of part of or the entire digestive tract (GI). Crohn's affects the entire GI tract (from the mouth to the anus), while ulcerative colitis or ulcerative colitis only affects the large and small intestine and ilium. Researchers do not know the exact cause of either disease. About 20% of people with Crohn's disease also have a family member with the disease. Researchers believe that certain factors may play a role in causing UC. Both Crohn's disease and ulcerative colitis are a type of inflammatory bowel disease, or IBD. Crohn's disease and ulcerative colitis both have similar symptoms and signs, for example, nausea, loss of appetite, fatigue, weight loss, episodic and/or persistent diarrhea, fever, abdominal pain and cramping, rectal bleeding, bloody stools, joint pain and soreness, eye redness, or pain. Symptoms unique to Crohn’s disease include anemia and skin changes. Symptoms of unique to ulcerative colitis include, certain rashes, an urgency to defecate (have a bowel movement). Doctors diagnose both diseases with similar tests and procedures. While there is no cure for either disease, doctors and other health care professionals can help you treat disease flares, and manage your Crohn's or ulcerative colitis with medication, diet, nutritional supplements, and/or surgery.
Nonsteroidal Anti-inflammatory Drugs and Ulcers
Nonsteroidal anti-inflammatory drugs (NSAIDs) are prescribed medications for the treatment of inflammatory conditions. Examples of NSAIDs include aspirin, ibuprofen, naproxen, and more. One common side effect of NSAIDs is peptic ulcer (ulcers of the esophagus, stomach, or duodenum). Side effects, drug interactions, warnings and precautions, and patient safety information should be reviewed prior to taking NSAIDs.
Is H. pylori Contagious?
H. pylori (Helicobacter pylori) infection: Is it contagious? H. pylori infection is caused by fecal contamination in either food or water, and by poor hygiene practices such as not washing the hands often. Common symptoms of H. pylori are a discomfort or pain in the area of the stomach. Some individuals describe the pain as gnawing or burning. Treatment of H. pylori infection is antibiotic therapy.
How Do You Know if You Have a Stomach Ulcer?
Stomach ulcer or gastric ulcer is a painful open sore that develops on the lining of your stomach due to the damage to the inner stomach lining. This is a type of peptic ulcer disease. Stomach ulcers often can be easily cured; however, it can be fatal if not treated properly. It occurs mostly in men are than in women.
What Is the Life Expectancy of Someone With Ulcerative Colitis?
Ulcerative colitis (UC) is an inflammatory bowel disease (IBD) that affects the inner lining of the large intestine (large bowel) leading to erosion and ulcers. It is a lifelong illness with no specific cause or cure.
What Are the Best Foods To Eat When You Have a Stomach Ulcer?
What Is a Stomach Ulcer? Learn what foods you should eat to relieve your symptoms.
How Do You Know if You Have an Ulcer?
In the past, it was difficult to know if you had an ulcer. Today, doctors know what causes it, how to diagnose and treat peptic ulcers. Learn more about peptic ulcers and when to see the doctor about them.
Is Ulcerative Colitis Curable?
Ulcerative colitis is an inflammatory bowel disease (IBD) that affects the inner lining of the large intestine (large bowel or colon) leading to erosion and ulcers. It is also associated with various manifestations outside of the colon, such as inflammation of the eyes, joints, skin, and lungs. Ulcerative colitis is a lifelong illness with no specific cause or cure. Patients have repeated cycles of flare-ups and disappearance of the disease.
Helicobacter Pylori (H Pylori) Infection Causes
Helicobacter pylori (H pylori) is a bacterium that is present in approximately half of the people in the world. However, not everybody infected with H pylori develops the signs and symptoms of the H pylori infection.
What Are the Most Common Causes of Stomach Ulcers?
What causes stomach ulcers? Learn about what causes this common stomach problem and how to treat it.
How Serious Is Ulcerative Colitis?
Ulcerative colitis (UC) is a lifelong disease with constant periods of flare-ups and remissions (periods without symptoms, which may last for weeks or years). Presently, there is no permanent medical cure for it, but there are various medications that can provide symptomatic relief, reduce inflammation and manage flare-ups.
Can Ulcerative Colitis Be Cured With Surgery?
Ulcerative colitis is a chronic inflammatory condition of the colon (the large bowel) characterized by frequent bloody diarrhea (10 to 30 episodes) throughout the day. Medicines can only reduce the intensity of its symptoms and surgery is the only option to cure it.
Peptic Ulcer Disease
Peptic ulcers are sores that develop on the inner lining of your stomach and the upper portion of your small bowel (duodenum). Peptic ulcers cause symptoms like heartburn, nausea, vomiting, weight loss and other symptoms. Ulcers are treated with lifestyle modification and medications.
What Is the Best Treatment for Ulcerative Colitis?
Ulcerative colitis (UC) is an inflammatory bowel disease (IBD) that affects the inner lining of the large intestine (large bowel) leading to erosion and ulcers. It is a lifelong illness with no specific cause or cure. Patients have repeated cycles of flare-ups and remission with potential extraintestinal (beyond the bowel) manifestations, such as joint pain, eye pain, and skin rashes.
Treatment & Diagnosis
Medications & Supplements
- Flagyl (metronidazole) Side Effects, Warnings, and Interactions
- tetracycline - oral, Sumycin
- Doxycycline vs. Tetracycline
- tetracycline (Sumycin)
- Metrogel (metronidazole) Side Effects, Warnings, and Interactions
- bismuth subsalicylate/metronidazole/tetracycline - oral, Helidac
- Side Effects of Sumycin (tetracycline)
- Side Effects of Noritate (metronidazole)
- Helidac (bismuth subsalicylate/metronidazole/tetracycline hydrochloride)
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