Thursday, October 27, 2016

Bismuth Subcitrate/Metronidazole/Tetracycline


Pronunciation: BIZ-muth sub-SIT-rate/MET-roe-NYE-da-zole/TET-ra-SYE-kleen
Generic Name: Bismuth Subcitrate/Metronidazole/Tetracycline
Brand Name: Pylera

Bismuth Subcitrate/Metronidazole/Tetracycline should only be used for Helicobacter pylori (H. pylori) infections associated with ulcers. Do not use Bismuth Subcitrate/Metronidazole/Tetracycline to treat other conditions.





Bismuth Subcitrate/Metronidazole/Tetracycline is used for:

Treating H. pylori infections associated with ulcers. It is used along with certain proton pump inhibitors (eg, omeprazole).


Bismuth Subcitrate/Metronidazole/Tetracycline is an antimicrobial combination. It works by killing sensitive bacteria.


Do NOT use Bismuth Subcitrate/Metronidazole/Tetracycline if:


  • you are allergic to any ingredient in Bismuth Subcitrate/Metronidazole/Tetracycline

  • you are pregnant or breast-feeding

  • you have kidney or liver problems

  • you are taking acitretin, busulfan, an ergot alkaloid (eg, ergotamine), an HIV protease inhibitor oral solution (eg, amprenavir), isotretinoin, methoxyflurane, a penicillin antibiotic (eg, amoxicillin), ranolazine, or disulfiram, or if you have taken disulfiram within the past 14 days

  • you drink alcohol

Contact your doctor or health care provider right away if any of these apply to you.



Before using Bismuth Subcitrate/Metronidazole/Tetracycline:


Some medical conditions may interact with Bismuth Subcitrate/Metronidazole/Tetracycline. 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, anemia, low white blood cell levels, unusual bleeding or bruising)

  • if you have a seizure disorder (eg, epilepsy) or other nerve or brain problems

Some MEDICINES MAY INTERACT with Bismuth Subcitrate/Metronidazole/Tetracycline. 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

  • Methoxyflurane because serious, even fatal kidney problems may occur

  • Lithium because increased lithium blood levels and lithium toxicity could occur

  • Amiodarone, busulfan, disulfiram, or HIV protease inhibitor oral solutions (eg, amprenavir) because irregular heartbeat; serious liver, lung, or bladder problems; severe mood or mental problems; or stomach cramps, nausea, vomiting, headaches, and flushing may occur

  • Barbiturates (eg, phenobarbital), cimetidine, hydantoins (eg, phenytoin), or urinary alkalinizers (eg, sodium bicarbonate) because they may decrease Bismuth Subcitrate/Metronidazole/Tetracycline's effectiveness

  • Anticoagulants (eg, warfarin), cyclosporine, digoxin, ergot alkaloids (eg, ergotamine), macrolide immunosuppressants (eg, sirolimus), methotrexate, ranolazine, or valproic acid because the risk of their side effects may be increased by Bismuth Subcitrate/Metronidazole/Tetracycline

  • Atovaquone, hormonal contraceptives (eg, birth control pills, patches), penicillin antibiotics (eg, amoxicillin ), or sulfinpyrazone because their effectiveness may be decreased by Bismuth Subcitrate/Metronidazole/Tetracycline

This may not be a complete list of all interactions that may occur. Ask your health care provider if Bismuth Subcitrate/Metronidazole/Tetracycline 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 Bismuth Subcitrate/Metronidazole/Tetracycline:


Use Bismuth Subcitrate/Metronidazole/Tetracycline as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Take your dose of Bismuth Subcitrate/Metronidazole/Tetracycline 4 times a day, after meals and at bedtime, unless your doctor tells you otherwise.

  • Swallow Bismuth Subcitrate/Metronidazole/Tetracycline whole. Take it 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 Bismuth Subcitrate/Metronidazole/Tetracycline is recommended. Be sure to do this especially with the bedtime dose. Check with your doctor for instructions.

  • Do not take an antacid that has aluminum, calcium, or magnesium or any product that has iron or zinc in it within 2 hours of Bismuth Subcitrate/Metronidazole/Tetracycline.

  • Do not eat or drink dairy products within 2 hours of Bismuth Subcitrate/Metronidazole/Tetracycline.

  • To clear up your infection completely, take Bismuth Subcitrate/Metronidazole/Tetracycline for the full course of treatment. Keep taking it even if you feel better in a few days.

  • If you miss a dose of Bismuth Subcitrate/Metronidazole/Tetracycline, take it as soon as possible. If it is almost time for your next dose, 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 Bismuth Subcitrate/Metronidazole/Tetracycline, contact your doctor.

Ask your health care provider any questions you may have about how to use Bismuth Subcitrate/Metronidazole/Tetracycline.



Important safety information:


  • Bismuth Subcitrate/Metronidazole/Tetracycline may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Bismuth Subcitrate/Metronidazole/Tetracycline with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Do not drink alcohol while you are using Bismuth Subcitrate/Metronidazole/Tetracycline and for at least 1 day after you have stopped taking Bismuth Subcitrate/Metronidazole/Tetracycline. Stomach cramps, nausea, vomiting, headaches, and flushing may occur.

  • Bismuth Subcitrate/Metronidazole/Tetracycline 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 Bismuth Subcitrate/Metronidazole/Tetracycline 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 Bismuth Subcitrate/Metronidazole/Tetracycline may cause a second infection. Your doctor may want to change your medicine to treat the second infection. Contact your doctor if signs of a second infection occur.

  • Some patients have developed persistent nerve problems (peripheral neuropathy) after taking Bismuth Subcitrate/Metronidazole/Tetracycline 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 receive a live vaccine (eg, typhoid) while you are taking Bismuth Subcitrate/Metronidazole/Tetracycline. 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 Bismuth Subcitrate/Metronidazole/Tetracycline. To prevent pregnancy, use an extra form of birth control (eg, condoms).

  • Bismuth Subcitrate/Metronidazole/Tetracycline may temporarily discolor or darken the tongue or stools. This is normal and not a cause for concern.

  • Bismuth Subcitrate/Metronidazole/Tetracycline may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Bismuth Subcitrate/Metronidazole/Tetracycline. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

  • Bismuth Subcitrate/Metronidazole/Tetracycline may interfere with certain lab tests, including x-ray, blood, liver function, and triglyceride tests. Be sure your doctor and lab personnel know you are taking Bismuth Subcitrate/Metronidazole/Tetracycline.

  • Use Bismuth Subcitrate/Metronidazole/Tetracycline with caution in the ELDERLY; they may be more sensitive to its effects.

  • Bismuth Subcitrate/Metronidazole/Tetracycline should not be used in CHILDREN; safety and effectiveness in children have not been confirmed. Use of tetracycline in CHILDREN younger than 8 years old may cause serious tooth problems, including softening of the tooth enamel and permanent yellow, gray, or brown discoloration of the teeth.

  • PREGNANCY and BREAST-FEEDING: Do not use Bismuth Subcitrate/Metronidazole/Tetracycline if you are pregnant. It may cause harm to the fetus. Avoid becoming pregnant while taking it. If you think you may be pregnant, contact your doctor right away. Bismuth Subcitrate/Metronidazole/Tetracycline is found in breast milk. Do not breast-feed while taking Bismuth Subcitrate/Metronidazole/Tetracycline.


Possible side effects of Bismuth Subcitrate/Metronidazole/Tetracycline:


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:



Constipation; darkening of the tongue and black stools; diarrhea; dizziness; headache; indigestion; loss of appetite; metallic taste; nausea; stomach pain; vomiting; weakness.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black, hairy tongue or sore tongue; bloody stools; blurred vision, vision loss, or other vision changes; dark urine; depression; increased or decreased urination; loss of coordination; numbness, tingling, or burning of the arms, hands, legs, or feet; pale stools; red, swollen, peeling, or blistered skin; seizures; severe or persistent dizziness or headache; severe stomach pain/cramps; signs of infection (eg, fever, chills, or persistent sore throat); sore mouth; speech problems; stiff neck; unusual bruising or bleeding; vaginal odor or discharge; 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.


Proper storage of Bismuth Subcitrate/Metronidazole/Tetracycline:

Store Bismuth Subcitrate/Metronidazole/Tetracycline 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 Bismuth Subcitrate/Metronidazole/Tetracycline out of the reach of children and away from pets.


General information:


  • If you have any questions about Bismuth Subcitrate/Metronidazole/Tetracycline, please talk with your doctor, pharmacist, or other health care provider.

  • Bismuth Subcitrate/Metronidazole/Tetracycline 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.

This information is a summary only. It does not contain all information about Bismuth Subcitrate/Metronidazole/Tetracycline. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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