Generic Name: bismuth subcitrate/metronidazole/tetracycline (BIZ-muth sub-SI-trate/MET-roe-NYE-da-zole/TET-ra-SYE-kleen)
Brand Name: Pylera
Metronidazole, a component of Pylera, has caused cancer in mice and rats. Discuss any questions or concerns with your doctor. Do not use Pylera for a condition other than the one for which it was prescribed.
Pylera is used for:
Treating Helicobacter pylori infections associated with ulcers. It is used along with certain proton pump inhibitors (eg, omeprazole).
Pylera is an antimicrobial combination. It works by killing sensitive bacteria.
Do NOT use Pylera if:
- you are allergic to any ingredient in Pylera, to bismuth subcitrate potassium, or to other tetracycline antibiotics (eg, doxycycline)
- you are allergic to any medicines similar to metronidazole (eg, tinidazole)
- you have severe kidney problems
- you consume alcohol or other products that contain propylene glycol
- you are taking acitretin, busulfan, isotretinoin, or a penicillin antibiotic (eg, amoxicillin)
- you are taking disulfiram or have taken it within the past 14 days
Contact your doctor or health care provider right away if any of these apply to you.
Before using Pylera:
Some medical conditions may interact with Pylera. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have a history of blood problems (eg, low white blood cell or platelet levels) or liver or kidney problems
- if you have a seizure disorder (eg, epilepsy), nerve or brain problems, stomach or bowel problems (eg, inflammation, Crohn disease), or lupus
Some MEDICINES MAY INTERACT with Pylera. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Acitretin or isotretinoin because the risk of high pressure in the brain may be increased
- Disulfiram because the risk of severe side effects, such as mental or mood changes, may be increased
- Barbiturates (eg, phenobarbital), cimetidine, hydantoins (eg, phenytoin), or urinary alkalinizers (eg, sodium bicarbonate) because they may decrease Pylera's effectiveness
- Amiodarone, anticoagulants (eg, warfarin), busulfan, lithium, medicines for diabetes (eg, glipizide), methotrexate, or valproic acid because the risk of their side effects may be increased by Pylera
- Atovaquone, hormonal contraceptives (eg, birth control pills), penicillin antibiotics (eg, amoxicillin), or sulfinpyrazone because their effectiveness may be decreased by Pylera
This may not be a complete list of all interactions that may occur. Ask your health care provider if Pylera may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
How to use Pylera:
Use Pylera as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Take your dose of Pylera 4 times a day, after meals and at bedtime, unless your doctor tells you otherwise.
- Swallow Pylera whole with a full glass of water (8 oz/240 mL). Do not break, crush, or chew before swallowing.
- Drinking extra fluids while you are taking Pylera is recommended. Be sure to do this, especially with the bedtime dose. Check with your doctor for instructions.
- If you take an antacid that has aluminum, calcium, or magnesium in it; a product that has iron, zinc, or sodium bicarbonate in it; or a multivitamin; ask your doctor or pharmacist how to take it with Pylera.
- Do not eat or drink calcium-rich foods (eg, milk, dairy products, calcium-enriched juices) within 2 hours of taking Pylera.
- To clear up your infection completely, take Pylera for the full course of treatment. Keep taking it even if you feel better in a few days.
- If you miss a dose of Pylera, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. If you miss more than 4 doses of Pylera, contact your doctor.
Ask your health care provider any questions you may have about how to use Pylera.
Important safety information:
- Pylera may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Pylera with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
- Do not consume alcohol or other products that contain propylene glycol while you are using Pylera and for at least 3 days after you have stopped taking Pylera. Stomach cramps, nausea, vomiting, headaches, and flushing may occur.
- Pylera combination should only be used to treat H. pylori infections associated with ulcers. It is not effective for treating viral infections (eg, the common cold).
- Be sure to use Pylera for the full course of treatment. If you do not, the medicine may not clear up your infection completely. This could cause your ulcer to recur.
- Long-term or repeated use of Pylera may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
- Some patients have developed persistent nerve problems (peripheral neuropathy) after taking Pylera for a long period of time. Tell your doctor right away if you develop signs of nerve problems (eg, numbness; tingling; burning of the arms, hands, legs, feet). Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
- Do not receive a live vaccine (eg, typhoid) while you are taking Pylera. Talk with your doctor before you receive any vaccine.
- Hormonal birth control (eg, birth control pills) may not work as well while you are using Pylera. To prevent pregnancy, use an extra form of birth control (eg, condoms).
- Pylera may temporarily discolor or darken the tongue or stools. This is normal and not a cause for concern.
- Pylera may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Pylera. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
- Tell your doctor or dentist that you take Pylera before you receive any medical or dental care, emergency care, or surgery.
- Pylera may interfere with certain lab tests, including x-rays and blood, liver function, and triglyceride tests. Be sure your doctor and lab personnel know you are taking Pylera.
- Use Pylera with caution in the ELDERLY; they may be more sensitive to its effects.
- Pylera should not be used in CHILDREN younger than 8 years old; permanent yellow, gray, or brown discoloration of the teeth may occur.
- PREGNANCY and BREAST-FEEDING: Pylera has been shown to cause harm to the fetus. If you think you may be pregnant, contact your doctor right away. Pylera is found in breast milk. Do not breast-feed while taking Pylera and for 24 hours after your last dose.
Possible side effects of Pylera:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Seek medical attention right away if any of these SEVERE side effects occur:
Constipation; darkening of the tongue or stools; diarrhea; dizziness; headache; indigestion; loss of appetite; metallic taste; mild stomach pain; nausea; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; flushing); black, hairy tongue or sore tongue; bloody or black, tarry stools; blurred vision, vision loss, or other vision changes; changes in the amount of urine produced; chest pain; confusion; dark urine; decreased coordination; depression; difficult or painful urination; numbness, tingling, or burning of the arms, hands, legs, or feet; one-sided weakness; pale stools; red, swollen, peeling, or blistered skin; seizures; severe diarrhea; severe or persistent dizziness, headache, or stomach pain or cramps; signs of infection (eg, fever, chills, or persistent sore throat); speech problems; stiff neck; swelling or soreness of the mouth or tongue; unusual bruising or bleeding; unusual tiredness or weakness; vaginal odor or discharge; vomit that looks like coffee grounds; white patches in the mouth or on the tongue; yellowing of the eyes or skin.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include decreased coordination; severe or persistent diarrhea, nausea, or vomiting.Proper storage of Pylera:
Store Pylera at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Pylera out of the reach of children and away from pets.
- If you have any questions about Pylera, please talk with your doctor, pharmacist, or other health care provider.
- Pylera is to be used only by the patient for whom it is prescribed. Do not share it with other people.
- If your symptoms do not improve or if they become worse, check with your doctor.
- Check with your pharmacist about how to dispose of unused medicine.
This information should not be used to decide whether or not to take Pylera or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Pylera. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Pylera. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Pylera.
Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.