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

Warnings:

Oral route(Capsule)

Potential for CarcinogenicityMetronidazole has been shown to be carcinogenic in mice and rats. It is unknown whether metronidazole is associated with carcinogenicity in humans .

Classifications:

Therapeutic—

Antiulcer, Helicobacter Pylori

Chemical—

Nitroimidazole

Uses of This Medicine:

Bismuth subcitrate, metronidazole, and tetracycline combination is used together with omeprazole to treat a stomach infection caused by the H. pylori bacteria and duodenal ulcer. 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 geriatric-specific problems that would limit the usefulness of Pylera® in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

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
Bepridil
Cisapride
Disulfiram
Dronabinol
Dronedarone
Levoketoconazole
Mesoridazine
Methoxyflurane
Pimozide
Saquinavir
Sparfloxacin
Terfenadine
Thioridazine
Ziprasidone

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.

Adagrasib
Alfuzosin
Amiodarone
Amitriptyline
Amoxicillin
Ampicillin
Anagrelide
Apomorphine
Aripiprazole
Aripiprazole Lauroxil
Arsenic Trioxide
Asenapine
Astemizole
Atazanavir
Azithromycin
Bacampicillin
Bedaquiline
Bexarotene
Buprenorphine
Bupropion
Buserelin
Busulfan
Capecitabine
Ceritinib
Chloroquine
Chlorpromazine
Cholera Vaccine, Live
Ciprofloxacin
Citalopram
Clarithromycin
Clofazimine
Clomipramine
Clothiapine
Cloxacillin
Clozapine
Crizotinib
Cyclobenzaprine
Dabrafenib
Dasatinib
Degarelix
Delamanid
Desipramine
Deslorelin
Desogestrel
Deutetrabenazine
Dexmedetomidine
Dicloxacillin
Dienogest
Digoxin
Disopyramide
Dofetilide
Dolasetron
Domperidone
Donepezil
Doxepin
Doxifluridine
Droperidol
Drospirenone
Ebastine
Efavirenz
Encorafenib
Entrectinib
Eribulin
Erythromycin
Escitalopram
Estradiol
Ethinyl Estradiol
Ethynodiol
Etretinate
Famotidine
Felbamate
Fexinidazole
Fingolimod
Flecainide
Fluconazole
Fluorouracil
Fluoxetine
Formoterol
Foscarnet
Fosphenytoin
Galantamine
Gatifloxacin
Gemifloxacin
Gestodene
Glasdegib
Gonadorelin
Goserelin
Granisetron
Halofantrine
Haloperidol
Histrelin
Hydroquinidine
Hydroxychloroquine
Hydroxyzine
Ibutilide
Iloperidone
Imipramine
Inotuzumab Ozogamicin
Isotretinoin
Itraconazole
Ivabradine
Ivosidenib
Ketoconazole
Lapatinib
Leuprolide
Levofloxacin
Levonorgestrel
Lofexidine
Lumefantrine
Macimorelin
Magnesium Sulfate
Mebendazole
Mefloquine
Mestranol
Methadone
Methicillin
Methotrexate
Mifepristone
Mizolastine
Mobocertinib
Moxifloxacin
Mycophenolate Mofetil
Mycophenolic Acid
Nafarelin
Nafcillin
Nelfinavir
Nilotinib
Nomegestrol
Norethindrone
Norfloxacin
Norgestimate
Norgestrel
Octreotide
Ofloxacin
Olanzapine
Ondansetron
Osimertinib
Oxacillin
Oxaliplatin
Ozanimod
Pacritinib
Paliperidone
Palovarotene
Panobinostat
Papaverine Hydrochloride
Paroxetine
Pasireotide
Pazopanib
Penicillin G
Penicillin G Benzathine
Penicillin G Procaine
Penicillin V
Pentamidine
Perphenazine
Phenobarbital
Pimavanserin
Pipamperone
Piperacillin
Pitolisant
Pivampicillin
Ponesimod
Porfimer
Posaconazole
Primidone
Probucol
Procainamide
Prochlorperazine
Promethazine
Propafenone
Protriptyline
Quetiapine
Quinidine
Quinine
Ranolazine
Relugolix
Ribociclib
Risperidone
Ritonavir
Selpercatinib
Sertindole
Sertraline
Sevoflurane
Siponimod
Sodium Phosphate
Sodium Phosphate, Dibasic
Sodium Phosphate, Monobasic
Solifenacin
Sorafenib
Sotalol
Sulpiride
Sultamicillin
Sunitinib
Tacrolimus
Tamoxifen
Tegafur
Telaprevir
Telavancin
Telithromycin
Temocillin
Tetrabenazine
Tolterodine
Toremifene
Trazodone
Tretinoin
Trimipramine
Triptorelin
Vandetanib
Vardenafil
Vemurafenib
Venlafaxine
Vilanterol
Vinflunine
Voclosporin
Voriconazole
Vorinostat
Warfarin
Zuclopenthixol

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
Aminolevulinic Acid
Atovaquone
Calcium
Carbamazepine
Cholestyramine
Colestipol
Cyclosporine
Dihydroxyaluminum Aminoacetate
Dihydroxyaluminum Sodium Carbonate
Iron
Lithium
Magaldrate
Magnesium Carbonate
Magnesium Hydroxide
Magnesium Oxide
Magnesium Trisilicate
Milk Thistle
Quinine

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 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 (eg, leukopenia) or
Encephalopathy or
Fungal infection (eg, candidiasis) or
Peripheral neuropathy or
Seizures, history of—Use with caution. May make these conditions worse.

Cockayne Syndrome (genetic disorder) or
Kidney disease, severe or
Liver disease, severe—Should not be used in patients with these conditions.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

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 and duodenal ulcer (taken with omeprazole):
  - 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 4 doses of this medicine, check with your doctor right away.

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 your progress 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 your last dose.

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 (eg, condoms, diaphragm, or a contraceptive foam or jelly) 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, 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 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, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) can occur with this medicine. Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, painful or difficult urination, red irritated eyes, red skin lesions, severe acne or skin rash, sore throat, sores or ulcers or white spots in the mouth or on the lips, swollen glands, or unusual tiredness or weakness 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.

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: Belching; chills; cough; darkened urine; diarrhea; fever; general feeling of discomfort or illness; headache; heartburn; indigestion; joint pain; loss of appetite; muscle aches and pains; nausea; pains in the stomach, side, or abdomen, possibly radiating to the back; runny nose; shivering; sore or dry throat; stomach discomfort, upset, or pain; sweating; trouble sleeping; unusual tiredness or weakness; vomiting; yellow eyes or skin

Less common: Back pain; black, tarry stools; body aches or pain; burning feeling in the chest or stomach; burning while urinating; chest pain; dizziness; fast, irregular, pounding, or racing heartbeat or pulse; frequent urination; hoarseness; increased volume of pale, dilute urine; 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; pale skin; 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; unusual bleeding or bruising; voice changes

Rare: Bloated feeling; excess air or gas in the stomach or bowels; feeling of fullness; pain or tenderness around the eyes and cheekbones; passing gas; skin rash; tightness of the chest; trouble breathing

Incidence not known: Blistering, peeling, loosening of the skin; blurred or decreased vision; burning, numbness, tingling, or painful sensations; clumsiness; itching; pressure in the stomach; red irritated eyes; red skin lesions, often with a purple center; sores, ulcers, or white spots in the mouth or on the lips; swelling of the stomach area; unsteadiness or awkwardness; weakness in the arms, hands, legs, or feet; white patches in the mouth or throat or on the tongue

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: 11/16/2023

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