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Bismuth subcitrate, metronidazole, and tetracycline (Oral route)

Pronunciation:

BIZ-muth sub-SIT-rate poe-TAS-ee-um, met-roe-NYE-da-zole, tet-ra-SYE-kleen hye-droe-KLOR-ide

Brand Names:

  • Pylera

Dosage Forms:

  • Capsule

Classifications:

Therapeutic—

Antiulcer, Helicobacter Pylori

Chemical—

Nitroimidazole

Uses of This Medicine:

Bismuth subcitrate, metronidazole, and tetracycline are combined in a single capsule that is used together with omeprazole to treat a stomach infection caused by the H. pylori bacteria. This bacteria can cause stomach ulcers if it is not treated. This medicine should not be used for any other infection .

This medicine is available only with your doctor's prescription .

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

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.

Children—

Because of tetracycline's toxicity, use in children younger than 8 years of age is not recommended. Tetracycline may cause permanent discoloration of the teeth. Safety and efficacy have not been established in this age group .

Older adults—

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of this combination of medicines in the elderly. However, elderly patients are more likely to have age-related kidney or liver problems, and this medicine should not be used in patients with these conditions .

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersDStudies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Acitretin
  • Amprenavir
  • Disulfiram
  • Methoxyflurane

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Amiodarone
  • Busulfan
  • Digoxin
  • Fluorouracil
  • Isotretinoin
  • Mycophenolate Mofetil
  • Tegafur
  • Tretinoin
  • Warfarin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Aluminum Carbonate, Basic
  • Aluminum Hydroxide
  • Aluminum Phosphate
  • Atovaquone
  • Calcium
  • Carbamazepine
  • Cholestyramine
  • Colestipol
  • Cyclosporine
  • Dihydroxyaluminum Aminoacetate
  • Dihydroxyaluminum Sodium Carbonate
  • Iron
  • Lithium
  • Magaldrate
  • Magnesium Carbonate
  • Magnesium Hydroxide
  • Magnesium Oxide
  • Magnesium Trisilicate
  • Milk Thistle
  • Penicillin G
  • Penicillin G Procaine
  • Penicillin V
  • Quinine
  • Tacrolimus

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is not recommended. Your doctor may decide not to treat you with this medication, change some of the other medicines you take, or give you special instructions about the use of food, alcohol, or tobacco.

  • Ethanol

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Dairy Food

Other medical problems—

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 .

Proper Use of This Medicine:

Your doctor will also prescribe another medicine called omeprazole that must be taken with this medicine .

Swallow the capsules whole and with a full glass (8 ounces) of water. Do not crush, break, or chew the capsules .

Drink extra fluids to help prevent irritation or ulcers in the esophagus (the tube between the throat and stomach) .

Keep using this medicine for the full treatment time, even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon .

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (capsules):
    • For the treatment of H. pylori infection:
      • Adults—3 capsules 4 times a day, after meals and at bedtime, for 10 days.
      • Children—Use and dose must be determined by your doctor .

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss more than four doses of this medicine, check with your doctor .

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

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 .

You should not use this medicine if you are pregnant. 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. Do not breastfeed while you take this medicine .

Oral contraceptives (birth control pills) may not work properly if you take them while you are using tetracycline. 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 .

The tetracycline in this medicine 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 .

Before you have any medical tests or x-rays, tell the medical doctor in charge that you are taking 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 one day after stopping it .

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

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
Acid or sour stomach
belching
chills
cough
diarrhea
fever
general feeling of discomfort or illness
headache
heartburn
indigestion
joint pain
loss of appetite
muscle aches and pains
nausea
runny nose
shivering
sore or dry throat
stomach discomfort, upset, or pain
sweating
trouble with sleeping
unusual tiredness or weakness
vomiting
Less common
Back pain
body aches or pain
burning feeling in the chest or stomach
chest pain
congestion
dizziness
fast, irregular, pounding, or racing heartbeat or pulse
hoarseness
itching of the vagina or genital area
lack or loss of strength
lower back or side pain
pain during sexual intercourse
painful or difficult urination
rash with flat lesions or small raised lesions on the skin
sneezing
stuffy nose
tender, swollen glands in the neck
tenderness in the stomach area
thick, white vaginal discharge with no odor or with a mild odor
trouble with swallowing
voice changes
Rare
Bloated
excess air or gas in the stomach or intestines
full feeling
pain or tenderness around the eyes and cheekbones
passing gas
shortness of breath or trouble with breathing
skin rash
tightness of the chest or wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
Black or dark tongue
black stools
Less common
Change in taste, or bad, unusual, or unpleasant aftertaste
dry mouth
fear or nervousness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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


Last Updated: 4/4/2014

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