Pylera

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood problems, history of (e.g., leukopenia) or
• Seizures, history of—Use with caution. This medicine may cause these conditions to become worse .

• Fungal infection (e.g., candidiasis)—May cause symptoms of the infection to be worse .

• Kidney disease or
• Liver disease—Should not use in patients with these conditions .

It is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by this medicine.

Do not use this medicine if you are also using methoxyflurane or have used disulfiram in the last 2 weeks. Do not drink alcohol while you are using this medicine and for at least 3 days after you stop taking it.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

Birth control pills may not work properly if you take them while you are using this medicine. You should use a different or additional means of birth control while you are using this medicine. If you have any questions about this, check with your doctor.

Bismuth subcitrate may cause your tongue to become a darker color or even black. It may also make your stools (bowel movements) black. This is only temporary and will not hurt you. Your tongue and stools will go back to normal when you stop using this medicine. Ask your doctor about this if you have any concerns.

Do not drink milk or eat dairy products with this medicine.

Check with your doctor right away if you start to have a stiff neck, drowsiness, fever, severe headache, nausea or vomiting, painful eye movements, or eye sensitivity to light. These could be symptoms of a serious condition called aseptic meningitis syndrome (AMS).

Check with your doctor right away if you are having burning, numbness, tingling, or painful sensations in the arms, hands, legs, or feet. These could be symptoms of a condition called peripheral neuropathy.

Tetracycline may make your skin more sensitive to sunlight. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loose skin, red skin lesions, severe acne or skin rash, sores or ulcers on the skin, or fever or chills while you are using this medicine.

Before you have any medical tests or x-rays, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

You should not drink alcoholic beverages or take other alcohol-containing preparations while you are using this medicine, and for at least 1 day after stopping it.

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

• Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid alcohol and products that have alcohol or propylene glycol in them while taking Pylera and for at least 72 hours after your last dose. Drinking alcohol or taking products that have alcohol or propylene glycol in them, like some cough syrups, may cause cramps, upset stomach, headaches, and flushing.
• You may get sunburned more easily. Avoid sun, sunlamps, and tanning beds. Use sunscreen and wear clothing and eyewear that protects you from the sun.
• Do not use longer than you have been told. A second infection may happen.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
• This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking Pylera with your other drugs.
• A very bad and sometimes deadly reaction has happened with this medicine. Most of the time, this reaction has signs like fever, rash, or swollen glands with problems in body organs like the liver, kidney, blood, heart, muscles and joints, or lungs. Talk with the doctor.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
• Do not give to children and teenagers who have or are getting better from flu signs, chickenpox, or other viral infections due to the chance of Reye's syndrome. Reye's syndrome causes very bad problems to the brain and liver.
• This medicine may cause a change in tooth color to yellow-gray-brown in children younger than 8 years old. If this change of tooth color happens, it will not go away. Talk with the doctor.
• Most of the time, Pylera is not for use in children younger than 8 years old. However, there may be times when these children may need to take this medicine. Talk with the doctor.
• Birth control pills and other hormone-based birth control may not work as well to prevent pregnancy. Use some other kind of birth control also like a condom when taking Pylera.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking this medicine, call your doctor right away.

1. Clinical and Laboratory Standards Institute, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically; Approved Standard–Tenth Edition. CLSI Document M7-A9 [2015], Clinical and Laboratory Standards Institute, 950 West Valley Rd., Suite 2500, Wayne, PA, 19087-1898.
2. Clinical and Laboratory Standards Institute, Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria; Approved Guideline–Third Edition. CLSI Document M45- A3 [2016]. Clinical and Laboratory Standards Institute, 950 West Valley Rd., Suite 2500, Wayne, PA. 19087- 1898.

Pylera contains a combination of bismuth subcitrate potassium, metronidazole, and tetracycline. Bismuth subcitrate potassium is a mineral. Metronidazole and tetracycline are antibiotics that fight bacteria in the body.

Pylera is used to treat peptic ulcer (duodenal ulcer) with Helicobacter pylori infection.

Pylera is usually given together with omeprazole (Prilosec).

You should not use Pylera if you have severe liver or kidney disease, if you are pregnant or breast-feeding, or if you drink alcohol daily. You should not take Pylera 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.

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

You should not use Pylera if:

• you have severe liver or 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 Pylera 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.

Take Pylera exactly as prescribed by your doctor. 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 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.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time that you are using Pylera. You may need to stop using the medicine for a short time.

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

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.