Bismuth subcitrate, metronidazole, and tetracycline

Generic name: Bismuth Subcitrate, Metronidazole, And Tetracycline
Drug class: H. pylori eradication agents

Usage of Bismuth subcitrate, metronidazole, and tetracycline

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.

Bismuth subcitrate, metronidazole, and tetracycline side effects

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.

Before taking Bismuth subcitrate, metronidazole, and tetracycline

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.

Pediatric

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.

Geriatric

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.

Interactions with 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.

Acenocoumarol

Adagrasib

Alfuzosin

Amiodarone

Amitriptyline

Amoxicillin

Ampicillin

Anagrelide

Apomorphine

Aripiprazole

Aripiprazole Lauroxil

Arsenic Trioxide

Asenapine

Astemizole

Atazanavir

Azithromycin

Bacampicillin

Bexarotene

Buserelin

Chlorpromazine

Cholera Vaccine, Live

Cimetidine

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

Lithium

Lofexidine

Lumefantrine

Macimorelin

Magnesium Sulfate

Mebendazole

Mefloquine

Mestranol

Methadone

Methicillin

Methotrexate

Methotrimeprazine

Mifepristone

Mizolastine

Mobocertinib

Moricizine

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

Phenprocoumon

Phenytoin

Pimavanserin

Pipamperone

Piperacillin

Piperaquine

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

Sultopride

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

Zotepine

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

Magaldrate

Magnesium Carbonate

Magnesium Hydroxide

Magnesium Oxide

Magnesium Trisilicate

Milk Thistle

Quinine

Interactions with Food/Tobacco/Alcohol

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

Relate drugs

How to use Bismuth subcitrate, metronidazole, and tetracycline

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.

Warnings

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.

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