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bismuth subcit K-metronidazole-tetracycline

COMMON BRAND NAME(S): Pylera

GENERIC NAME(S): COLLOIDAL BISMUTH SUBCITRATE/METRONIDAZOLE/TETRACYCLINE HCL

Uses

This combination medication is used with an acid blocker (e.g., a proton pump inhibitor such as omeprazole). It is used to treat stomach/intestinal ulcers caused by the bacteria H. pylori and to prevent the ulcers from returning.

Each capsule contains 3 medications: bismuth subcitrate, metronidazole, and tetracycline. Bismuth subcitrate is often used to treat upset stomach, but it is used in this combination to help stop the growth of bacteria. Metronidazole and tetracycline are antibiotics used to treat a wide variety of bacterial infections. They work by stopping the growth of bacteria.

This product treats only bacterial infections. It will not work for viral infections (e.g., common cold, flu). Unnecessary use or misuse of any antibiotic can lead to its decreased effectiveness.

This product is not recommended for use in children.

How to use bismuth subcit K-metronidazole-tetracycline

Take this medication by mouth 4 times daily (after meals and at bedtime) for 10 days. Take each dose (3 capsules) with a full glass of water (8 ounces or 240 milliliters) unless your doctor directs you otherwise. Swallow the capsules whole. Do not crush or chew the capsules. Do not lie down for 10 minutes after taking this medication.

Follow your doctor's instructions on how to correctly take an acid blocker with this medication.

Take this medication 2 to 3 hours before or after taking any products containing magnesium, aluminum, or calcium. These products bind with tetracycline, preventing its full absorption. Some examples include quinapril, certain forms of didanosine (e.g., chewable/dispersible buffered tablets or pediatric oral solution), vitamins/minerals, and antacids. Dairy products (e.g., milk, yogurt), calcium-enriched juice, sucralfate, iron, and zinc are also included.

Take this medication regularly in order to get the most benefit from it. Continue to take this medication and the acid blocker until the full prescribed amount is finished, even if symptoms disappear after a few days. Stopping the medication too early may result in a return of the infection/ulcer.

Tell your doctor if your condition persists or worsens.

Side Effects

Nausea, diarrhea, upset stomach, abdominal pain, changes in taste, headache, or dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Your tongue may turn dark in color while you are taking this medication. This is harmless, and the effect will disappear when you stop the medication.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: numbness/tingling of arms/legs, discolored teeth, mental/mood changes (such as confusion, anxiety, irritability, depression), difficult/painful swallowing, heartburn, fast/pounding heartbeat, ringing in the ears, frequent/painful urination.

Tell your doctor immediately if any of these rare but very serious side effects occur: severe headache, stiff/painful neck, change in the amount of urine, signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding, dark urine, yellowing eyes/skin, persistent nausea/vomiting, severe stomach/abdominal pain, unusual weakness/tiredness, seizures, chest pain.

This product commonly causes dark stools that are usually not serious. However, you may not be able to tell this effect apart from blood in the stool, which could be a sign of a serious condition. Therefore, tell your doctor immediately if you have dark stools.

Tetracycline may rarely cause a serious increase in pressure inside the skull (intracranial hypertension-IH). The risk of this side effect is greater for women of childbearing age who are overweight or who have had IH in the past. If IH develops, it usually goes away after tetracycline is stopped; however, there is a chance of permanent vision loss or blindness. Get medical help right away if you have: persistent/severe headache, vision changes (such as blurred/double vision, decreased vision, sudden blindness), persistent nausea/vomiting.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

Use of this medication for prolonged or repeated periods may result in oral thrush or a new yeast infection. Contact your doctor if you notice white patches in your mouth, a change in vaginal discharge, or other new symptoms.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

See also Side Effects section.

Before taking this product, tell your doctor or pharmacist if you are allergic to bismuth subcitrate, metronidazole, or tetracycline; or to other nitroimidazoles (e.g., tinidazole); or to other tetracyclines (e.g., doxycycline); or to other bismuth products (e.g., bismuth subsalicylate); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: kidney disease, liver disease.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood disorders, brain/spinal cord disorders (e.g., seizures), trouble swallowing, esophagus problems (e.g., hiatal hernia, reflux disease-GERD).

Before having surgery, tell your doctor or dentist that you are using this product.

Tetracycline may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.

This product may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages and products that contain alcohol (e.g., certain cough-and-cold products) while taking this product and for at least 1 day afterward. Alcohol may increase dizziness or cause a severe reaction with metronidazole (including abdominal cramping, nausea, vomiting, headache, and flushing).

The elderly may be at greater risk for side effects while using this product.

Children should not take this product because it contains tetracycline. Tetracycline may cause permanent tooth discoloration and other problems in children younger than 8 years. Tooth discoloration has also occurred in older children and young adults. Consult the doctor for more information.

This product is not recommended for use during pregnancy because it may harm an unborn baby. Women who could become pregnant should use effective, non-hormonal birth control (e.g., condom, diaphragm with spermicide) while taking this medication. Consult your doctor for more details. See also Drug Interactions.

This combination product contains drugs that may pass into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

Interactions

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

This drug should not be used with the following medications because very serious interactions may occur: retinoid medications taken by mouth (such as acitretin, isotretinoin), strontium.

Avoid disulfiram for 2 weeks before and during treatment with this medication.

If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting this product.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: atovaquone, "blood thinners" (e.g., warfarin, heparin), busulfan, digoxin, drugs affecting liver enzymes that remove metronidazole from your body (such as cimetidine, certain anti-seizure medicines including phenytoin, phenobarbital), fluorouracil, lithium, live bacterial vaccines (e.g., typhoid vaccine), methoxyflurane, penicillins (e.g., amoxicillin, dicloxacillin), tretinoin applied to the skin.

Although most antibiotics probably do not affect hormonal birth control such as pills, patch, or ring, some antibiotics may decrease their effectiveness. This could cause pregnancy. Examples include rifamycins such as rifampin or rifabutin. Be sure to ask your doctor or pharmacist if you should use additional reliable birth control methods while using this antibiotic.

This product may interfere with certain laboratory tests (including liver function tests, triglycerides, hexokinase glucose, lactate dehydrogenase), possibly causing false test results. This product may also interfere with X-ray exams of the stomach/intestines. Make sure laboratory personnel and all your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: seizures.

Notes

Do not share this medication with others.

Laboratory and/or medical tests may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

This medication has been prescribed for your current condition only. Do not use it later for another infection unless told to do so by your doctor. A different medication may be necessary in that case.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up. Contact your doctor if you miss more than 4 doses.

Storage

Store at room temperature between 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Taking outdated tetracycline can result in serious illness. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised December 2013. Copyright(c) 2013 First Databank, Inc.

Images

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PYLERA CAPSULE
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PYLERA CAPSULE
PYLERA CAPSULE

Identification

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This medicine is a white, oblong capsule imprinted with "logo" and "B M T".

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, expect as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

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