Bismuth Subcitrate Potassium Metronidazole Tetracycline Brand Name– Pylera
What is Bismuth Subcitrate Potassium Metronidazole Tetracycline
Bismuth subcitrate potassium; metronidazole; tetracycline (Pylera™) capsules are indicated to eradicate Helicobacter pylori (H. pylori) in patients with H. pylori infection and duodenal ulcer disease (active or history of within the past 5 years); Pylera™ is FDA-approved for use only in combination with omeprazole.
Rates of H. pylori treatment failure have increased secondary to increased antibiotic resistance (primarily clarithromycin and metronidazole), poor patient compliance, inadequate treatment regimen or duration, and medication-related adverse effects.
H. pylori infection has been identified as a risk factor in the development of peptic ulcer, duodenal ulcer, atrophic gastritis, gastric cancer, and mucosal-associated lymphoid tissue (MALT) lymphoma, as well as, a possible risk factor for the development idiopathic thrombocytopenic purpura and anemia.
Eradication rates following treatment with Pylera™ plus omeprazole were found to be similar in patients with metronidazole-resistant H. pylori strains versus metronidazole-sensitive strains.
In another study, Pylera™ plus omeprazole therapy and triple therapy with omeprazole, amoxicillin, and clarithromycin were found to have similar efficacy in the eradication of H. pylori; regardless of metronidazole susceptibility.
Although the total number of capsules to be taken each day is reduced with the Pylera™ regimen, Pylera™ is administered four times/day, which may affect compliance.
Pylera™ received FDA approval on September 28, 2006.
Indications
- Helicobacter pylori
- Helicobacter pylori (H. pylori) eradication
Side Effects
- abdominal pain
- anaphylactic shock
- anaphylactoid reactions
- angioedema
- anorexia
- anxiety
- appetite stimulation
- aseptic meningitis
- asthenia
- ataxia
- azotemia
- back pain
- blurred vision
- candidiasis
- chest pain (unspecified)
- confusion
- constipation
- cystitis
- depression
- diarrhea
- diplopia
- dizziness
- drowsiness
- Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)
- dysarthria
- dysgeusia
- dyspareunia
- dyspepsia
- dysphagia
- dysuria
- elevated hepatic enzymes
- enamel hypoplasia
- encephalopathy
- eosinophilia
- eructation
- erythema
- esophageal ulceration
- esophagitis
- exfoliative dermatitis
- fatigue
- fever
- flatulence
- flushing
- gastritis
- glossitis
- headache
- hemolytic anemia
- hepatic failure
- hyperphosphatemia
- increased intracranial pressure
- insomnia
- irritability
- leukopenia
- libido decrease
- lupus-like symptoms
- maculopapular rash
- malaise
- metallic taste
- myalgia
- nail discoloration
- nausea
- neutropenia
- new primary malignancy
- onycholysis
- pancreatitis
- papilledema
- paresthesias
- pericarditis
- peripheral neuropathy
- photosensitivity
- polyuria
- proctitis
- pruritus
- pseudomembranous colitis
- pseudotumor cerebri
- purpura
- rash
- seizures
- serum sickness
- sinus tachycardia
- Stevens-Johnson syndrome
- stomatitis
- stool discoloration
- superinfection
- syncope
- thrombocytopenia
- thrombotic thrombocytopenic purpura (TTP)
- tinnitus
- tongue discoloration
- tooth discoloration
- toxic epidermal necrolysis
- urinary incontinence
- urine discoloration
- urticaria
- vaginitis
- vertigo
- vomiting
- weakness
- weight gain
- xerostomia
Monitoring Parameters
- LFTs
- serum creatinine/BUN
Contraindications
- alcoholism
- anticoagulant therapy
- bone marrow suppression
- breast-feeding
- children
- Cockayne syndrome
- colitis
- Crohn’s disease
- diarrhea
- ethanol intoxication
- fungal infection
- GI disease
- hematological disease
- hepatic disease
- infants
- inflammatory bowel disease
- laboratory test interference
- leukopenia
- neonates
- neurological disease
- neutropenia
- new primary malignancy
- peripheral neuropathy
- pregnancy
- pseudomembranous colitis
- renal disease
- renal failure
- renal impairment
- seizure disorder
- seizures
- sunlight (UV) exposure
- surgery
- tetracyclines hypersensitivity
- ulcerative colitis
Interactions
- Acitretin
- Alfuzosin
- Aluminum Hydroxide
- Aluminum Hydroxide; Magnesium Carbonate
- Aluminum Hydroxide; Magnesium Hydroxide
- Aluminum Hydroxide; Magnesium Hydroxide; Simethicone
- Aluminum Hydroxide; Magnesium Trisilicate
- Amiodarone
- Amitriptyline
- Amitriptyline; Chlordiazepoxide
- Amlodipine; Celecoxib
- Amoxicillin
- Amoxicillin; Clarithromycin; Lansoprazole
- Amoxicillin; Clarithromycin; Omeprazole
- Amoxicillin; Clavulanic Acid
- Ampicillin
- Ampicillin; Sulbactam
- Anagrelide
- Antacids
- Apomorphine
- Aripiprazole
- Arsenic Trioxide
- Artemether; Lumefantrine
- Asenapine
- Aspirin, ASA; Citric Acid; Sodium Bicarbonate
- Aspirin, ASA; Omeprazole
- Atomoxetine
- Atovaquone
- Atovaquone; Proguanil
- Atracurium
- Atropine; Difenoxin
- Atropine; Diphenoxylate
- Azithromycin
- Barbiturates
- Bedaquiline
- Belladonna Alkaloids; Ergotamine; Phenobarbital
- Bexarotene
- Bismuth Subsalicylate
- Bismuth Subsalicylate; Metronidazole; Tetracycline
- Bortezomib
- Bosentan
- Buprenorphine
- Buprenorphine; Naloxone
- Busulfan
- Caffeine; Ergotamine
- Calcium
- Calcium Acetate
- Calcium Carbonate
- Calcium Carbonate; Magnesium Hydroxide
- Calcium Carbonate; Risedronate
- Calcium Carbonate; Simethicone
- Calcium Chloride
- Calcium Gluconate
- Calcium; Vitamin D
- Carbamazepine
- Carbenicillin
- Carbetapentane; Guaifenesin; Phenylephrine
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- Carbidopa
- Carbidopa; Levodopa
- Carbidopa; Levodopa; Entacapone
- Celecoxib
- Ceritinib
- Chloroquine
- Chlorpheniramine; Pseudoephedrine
- Chlorpromazine
- Cholestyramine
- Chromium
- Cimetidine
- Ciprofloxacin
- Cisapride
- Cisatracurium
- Citalopram
- Clarithromycin
- Clofazimine
- Clomipramine
- Clozapine
- Codeine; Phenylephrine; Promethazine
- Codeine; Promethazine
- Colesevelam
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- Crizotinib
- Cyclophosphamide
- Cyclosporine
- Dasabuvir; Ombitasvir; Paritaprevir; Ritonavir
- Dasatinib
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- Digoxin
- Disopyramide
- Disulfiram
- Dofetilide
- Dolasetron
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- Entrectinib
- Ergonovine
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- Eribulin
- Erythromycin
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- Estradiol; Norgestimate
- Ethanol
- Ethinyl Estradiol
- Ethinyl Estradiol; Desogestrel
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- Ethinyl Estradiol; Levonorgestrel; Ferrous bisglycinate
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- Ethinyl Estradiol; Norelgestromin
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- Ethinyl Estradiol; Norethindrone Acetate
- Ethinyl Estradiol; Norethindrone Acetate; Ferrous fumarate
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- Ethinyl Estradiol; Norgestimate
- Ethinyl Estradiol; Norgestrel
- Ezogabine
- Fingolimod
- Flecainide
- Floxuridine
- Fluconazole
- Fluorouracil, 5-FU
- Fluoxetine
- Fluoxetine; Olanzapine
- Fluphenazine
- Fluvoxamine
- food
- Foscarnet
- Fosphenytoin
- Gemifloxacin
- Gemtuzumab Ozogamicin
- Gilteritinib
- Glasdegib
- Goserelin
- Granisetron
- Halobetasol; Tazarotene
- Halogenated Anesthetics
- Haloperidol
- Halothane
- Heparin
- Hetastarch; Dextrose; Electrolytes
- Histrelin
- Hydrochlorothiazide, HCTZ; Quinapril
- Hydroxychloroquine
- Hydroxyzine
- Ibutilide
- Iloperidone
- Imipramine
- Inotuzumab Ozogamicin
- Insoluble Prussian Blue
- Iron
- Iron Salts
- Iron Sucrose, Sucroferric Oxyhydroxide
- Isoflurane
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- Ivosidenib
- Ixabepilone
- Ketoconazole
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- Lapatinib
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- Lenvatinib
- Leuprolide
- Leuprolide; Norethindrone
- Levofloxacin
- Levonorgestrel
- Lithium
- Lofexidine
- Lomitapide
- Long-acting beta-agonists
- Loperamide
- Loperamide; Simethicone
- Lopinavir; Ritonavir
- Macimorelin
- Magnesium
- Magnesium Citrate
- Magnesium Hydroxide
- Magnesium Salts
- Maprotiline
- Mebendazole
- Mefloquine
- Meperidine; Promethazine
- Mestranol; Norethindrone
- Methadone
- Methotrexate
- Methoxsalen
- Methylergonovine
- Methysergide
- Metoclopramide
- Midostaurin
- Mifepristone
- Mipomersen
- Mirtazapine
- Mivacurium
- Molindone
- Moxifloxacin
- Mycophenolate
- Nafcillin
- Neuromuscular blockers
- Nilotinib
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- Norgestrel
- Nortriptyline
- Octreotide
- Ofloxacin
- Olanzapine
- Ombitasvir; Paritaprevir; Ritonavir
- Omeprazole
- Omeprazole; Amoxicillin; Rifabutin
- Omeprazole; Sodium Bicarbonate
- Ondansetron
- Opiate Agonists
- Oral Contraceptives
- Osilodrostat
- Osimertinib
- Oxacillin
- Oxaliplatin
- Paclitaxel
- Paliperidone
- Pancuronium
- Panobinostat
- Pasireotide
- Pazopanib
- Penicillin G
- Penicillin G Benzathine
- Penicillin G Benzathine; Penicillin G Procaine
- Penicillin G Procaine
- Penicillin V
- Penicillins
- Pentamidine
- Perphenazine
- Perphenazine; Amitriptyline
- Phenylephrine; Promethazine
- Phenytoin
- Photosensitizing agents (topical)
- Pimavanserin
- Pimozide
- Piperacillin
- Piperacillin; Tazobactam
- Pitolisant
- Polycarbophil
- Polysaccharide-Iron Complex
- Porfimer
- Posaconazole
- Primaquine
- Procainamide
- Prochlorperazine
- Promethazine
- Propafenone
- Protriptyline
- Pyridostigmine
- Quetiapine
- Quinapril
- Quinidine
- Quinine
- Ramelteon
- Ranolazine
- Rapacuronium
- Ribociclib
- Ribociclib; Letrozole
- Rilpivirine
- Risperidone
- Ritonavir
- Rocuronium
- Romidepsin
- Saquinavir
- Segesterone Acetate; Ethinyl Estradiol
- Sertraline
- Sevoflurane
- Short-acting beta-agonists
- Siponimod
- Sirolimus
- Sodium Bicarbonate
- Sodium Ferric Gluconate Complex; ferric pyrophosphate citrate
- Sodium picosulfate; Magnesium oxide; Anhydrous citric acid
- Solifenacin
- Sorafenib
- Sotalol
- St. John’s Wort, Hypericum perforatum
- Succinylcholine
- Sucralfate
- Sulfamethoxazole; Trimethoprim, SMX-TMP, Cotrimoxazole
- Sulfonylureas
- Sunitinib
- Tacrolimus
- Tamoxifen
- Tazarotene
- Telavancin
- Telithromycin
- Tetrabenazine
- Tetracyclines
- Thalidomide
- Thioridazine
- Ticarcillin
- Ticarcillin; Clavulanic Acid
- Tipranavir
- Tolterodine
- Toremifene
- Trazodone
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- Trifluoperazine
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- Triptorelin
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- Venlafaxine
- Verteporfin
- Voriconazole
- Vorinostat
- Warfarin
- Zalcitabine, ddC
- Zinc
- Zinc Salts
- Ziprasidone
