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

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

Do not drink alcohol or consume foods or medicines that contain propylene glycol while you are taking Pylera and for at least 3 days after you stop taking it.

Metronidazole has caused cancer in animal studies. It is not known whether this would occur in humans taking Pylera.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take your medicine with a full glass (8 ounces) of water. Swallow the capsule whole. Do not take with milk.

Pylera is usually taken after meals and at bedtime. If you also take omeprazole (Prilosec), take it after your morning and evening meals.

Keep using bismuth subcitrate potassium, metronidazole, and tetracycline even if your symptoms quickly improve. Skipping doses could make your infection resistant to medication. Pylera will not treat a viral infection (flu or a common cold).

Bismuth can affect the results of certain x-rays or 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.

Usual Adult Dose for Helicobacter pylori Infection:

Bismuth subcitrate potassium 420 mg-metronidazole 375 mg-tetracycline 375 mg orally 4 times a day (after meals and at bedtime)
-Duration of therapy: 10 days

Comments:
-Omeprazole 20 mg should be given orally 2 times a day during treatment (after morning and evening meals).
-Helicobacter pylori eradication has been shown to reduce duodenal ulcer recurrence risk.

Use: Eradication of H pylori infection in patients with active or a history (e.g., within 5 years) of duodenal ulcer infection and/or disease

You should not use Pylera if you are allergic to bismuth subcitrate potassium, metronidazole, or tetracycline, or if:

• you have severe kidney disease;

• you drink alcohol daily;

• you regularly consume foods or medicines that contain propylene glycol;

• you took disulfiram (Antabuse) within the past 14 days; or

• you also use methoxyflurane.

Tell your doctor if you have ever had:

• kidney disease;

• liver disease;

• Cockayne syndrome (a rare genetic disorder);

• a blood cell disorder; or

• any type of infection.

Metronidazole has caused cancer in animal studies. It is not known whether this would occur in humans taking Pylera. Ask your doctor about your risk.

Do not use Pylera if you are pregnant. Tetracycline can cause permanent tooth discoloration and affect growth in the baby.

Pylera can make birth control pills less effective. Ask your doctor about other birth control options such as an injection, implant, skin patch, vaginal ring, condom, diaphragm, cervical cap, or contraceptive sponge.

You should not breastfeed within 2 days after using Pylera. If you use a breast pump during this time, throw out any milk you collect. Do not feed it to your baby.

Not approved for use by anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

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

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

While taking Pylera and for 3 days after your last dose: Do not drink alcohol or consume foods, medicines, or other products that contain alcohol or propylene glycol. You may have unpleasant effects such as headaches, nausea, vomiting, stomach cramps, and warmth or tingling under your skin.

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

Antibiotic medicines can cause diarrhea. Tell your doctor if you have diarrhea that is watery or bloody.

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

Stop taking Pylera and get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Bismuth subcitrate potassium, metronidazole, and tetracycline may cause serious side effects. Call your doctor at once if you have:

• severe stomach pain, diarrhea that is watery or bloody (even if it occurs months after your last dose);

• dizziness, problems with speech or coordination;

• fever, neck stiffness, increased sensitivity to light, nausea, vomiting.

• a seizure;

• vaginal itching or discharge;

• numbness or tingling in your arms and legs; or

• increased pressure inside the skull--severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes.

If you have Cockayne syndrome, stop taking Pylera and call your doctor right away if you have signs of liver problems such as stomach pain, nausea, clay-colored stools, or yellowing of your skin or eyes.

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.

Common side effects of bismuth subcitrate potassium, metronidazole, and tetracycline may include:

• 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.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Tell your doctor about all your current medicines. Many drugs can affect Pylera, especially:

• cimetidine;

• an antidepressant;

• asthma medication;

• busulfan or other cancer medicine;

• heart or blood pressure medication;

• lithium or other antipsychotic medicine;

• medicine to treat malaria, HIV, or other infection;

• a blood thinner--warfarin, Coumadin, Jantoven; or

• seizure medicine--phenytoin or phenobarbital.

This list is not complete and many other drugs may affect Pylera. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.