bismuth subcitrate potassium, metronidazole, and tetracycline

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Pronunciation: BIZ muth sub SIT rate poe TASS ee um, MET roe NYE da zole, TET ra SYE kleen

Brand: Pylera

What is the most important information I should know about bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera)?

You should not use this medicine if you have severe kidney disease, if you are pregnant or breast-feeding, or if you drink alcohol daily. You should not take Pylera if you are also using methoxyflurane or if you have taken disulfiram (Antabuse) in the past 14 days.

Using tetracycline during pregnancy could harm the unborn baby or cause permanent tooth discoloration later in the baby's life.

What is bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera)?

Bismuth subcitrate potassium is a mineral.

Metronidazole and tetracycline are antibiotics that fight bacteria in the body.

Bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera) is a combination medicine used to treat peptic ulcer (duodenal ulcer) with H pylori infection. Pylera is usually given together with omeprazole (Prilosec).

This medication may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking Pylera?

You should not use this medicine if:

  • you have severe kidney disease;
  • you are pregnant or breast-feeding;
  • you drink alcohol daily;
  • you have taken disulfiram (Antabuse) in the past 14 days; or
  • you are allergic to bismuth subcitrate potassium, metronidazole, or tetracycline.

To make sure Pylera is safe for you, tell your doctor if you have:

  • kidney disease;
  • liver disease;
  • a blood cell disorder; or
  • any type of infection.

Metronidazole has caused cancer in animal studies. However, it is not known whether this would occur in humans. Ask your doctor about your risk.

Taking this medicine during pregnancy may affect tooth and bone development in the unborn baby. Taking tetracycline during the last half of pregnancy can cause permanent tooth discoloration later in the baby's life. Tell your doctor if you are pregnant or if you become pregnant while using this medicine.

Tetracycline can make birth control pills less effective. Ask your doctor about using a non-hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy.

Metronidazole and tetracycline can pass into breast milk and may harm a nursing baby. Do not breast-feed within 24 hours after taking Pylera. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

Do not give this medication to a child younger than 8 years old. Tetracycline can cause permanent yellowing or graying of the teeth, and it can affect a child's growth. Pylera is not approved for use by anyone younger than 18 years old.

How should I take Pylera?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

The usual dose of Pylera is 3 capsules taken 4 times per day (after meals and at bedtime), while taking omeprazole 2 times per day (after breakfast and dinner). Follow your doctor's instructions.

Take your medicine with a full glass (8 ounces) of water. Swallow the capsule whole.

Pylera may cause your tongue to become darker in color. It may also cause your stools to appear black in color. These are harmless and temporary side effects.

Take this medicine for the full prescribed length of time, usually 10 days. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics. Pylera will not treat a viral infection such as the common cold or flu.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Pylera.

Store at room temperature away from moisture and heat. If you use the 10-day Pylera package, keep each capsule in the blister pack until you are ready to take a dose.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

If you miss more than 4 doses, call your doctor for instructions.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Pylera?

Do not drink alcohol while you are taking Pylera and for at least 1 day after you stop taking it. Drinking alcohol while taking Pylera may cause nausea, vomiting, headache, or flushing (warmth, redness, tingly feeling).

Certain food additives may also cause unwanted symptoms while you are taking Pylera. You may need to avoid products such as baking mixes, baked desserts, salad dressings, sauces, modified food starch, and gel capsule medicines or vitamins. Check all food and beverage labels, and avoid products that contain alcohol or propylene glycol.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Avoid taking Pylera with milk or other dairy products. Also avoid taking Pylera at the same time you take any multivitamins, mineral supplements, or antacids. These products can make it harder for your body to absorb the medicine.

Avoid exposure to sunlight or tanning beds. Pylera can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

What are the possible side effects of Pylera?

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • dizziness, problems with speech or coordination;
  • severe stomach pain, diarrhea that is watery or bloody;
  • neck stiffness, increased sensitivity to light, purple spots on the skin;
  • a seizure (convulsions);
  • fever, chills, sore throat, flu symptoms;
  • numbness or tingling in your arms and legs;
  • increased pressure inside the skull --severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes; or
  • severe skin reaction --fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • vaginal itching or discharge;
  • diarrhea or other changes in your stools;
  • nausea; or
  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Pylera?

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • busulfan;
  • cimetidine;
  • lithium;
  • a blood thinner (warfarin, Coumadin, Jantoven); or
  • seizure medication such as phenobarbital or phenytoin.

This list is not complete. Other drugs may interact with Pylera, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your pharmacist can provide more information about bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera).

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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