Classes
DEA Class; Rx
Common Brand Names; Pylera
- H pylori Agents
Description
Combination product, with all 3 drugs contained in 1 capsule, used for eradication of H. pylori; FDA-approved regimen includes coadministration with omeprazole.
Indications
Indicated for Helicobacter pylori (H. pylori) eradication.
Contraindications
Hypersensitivity to bismuth subcitrate potassium, metronidazole or other nitroimidazole derivatives, or tetracycline
Coadministration with methoxyflurane; reports of fatal renal toxicity with concurrent use of tetracycline and methoxyflurane
Use of disulfiram within previous 2 weeks; psychotic reactions reported with concurrent use of metronidazole and disulfiram
Avoid alcohol or propylene glycol-containing products for at least 3 days after therapy with metronidazole-containing products are discontinued; disulfiram-like reaction may occur
Severe renal impairment; tetracyclines may increase BUN; higher tetracycline serum concentrations may lead to azotemia, hyperphosphatemia, and acidosis
Pregnancy
Adverse Effects
- Listed adverse drug reactions are of metronidazole/tetracycline/bismuth subcitrate potassium
- Abnormal feces (15.6%)
- Nausea (8.2%)
- Diarrhea (6.8%)
- Headache (5.4%)
- Abdominal pain (4.8%)
- Dysgeusia (4.1%)
- Asthenia (3.4%)
- Vaginal infection (2.7%)
- Dyspepsia (2.7%)
- Flatulence (2.6%)
- Dizziness (2.7%)
- Laboratory test abnormal (2%)
- Constipation (1.4%)
- Dry Mouth (1.4%)
- AST/ALT increased (1.4%)
- Urine abnormality (1.4%)
- Maculopapular rash (1.4%)
- Rash
Warnings
Metronidazole shown to be carcinogenic in mice and rats; tumors affecting the liver, lungs, mammary and lymphatic tissues detected in several studies of metronidazole in rats and mice; unknown whether metronidazole is associated with carcinogenicity in humans
Tetracycline can cause fetal harm when administered to a pregnant woman; tetracycline administered during pregnancy at high doses (>2 g IV) associated with rare but serious cases of maternal hepatotoxicity (see Pregnancy)
Use of tetracyclines during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown); this adverse reaction is more common during long-term use of the drug, but has been observed following repeated short-term courses
Known or previously unrecognized candidiasis may present more prominent symptoms during therapy with metronidazole that requires treatment with an antifungal agent
Photosensitivity, manifested by an exaggerated sunburn reaction, observed in patients taking tetracycline
Bismuth subcitrate potassium may cause temporary and harmless darkening of the tongue and/or black stools, generally reversible within several days after treatment is stopped
Metronidazole should be used with care in patients with evidence of or history of blood dyscrasias
Skin and subcutaneous disorders including Stevens-Johnson syndrome, toxic epidermal necrolysis and DRESS syndrome (drug rash with eosinophilia and systemic symptoms) reported
Cases of severe hepatotoxicity/acute hepatic failure, including cases with a fatal outcome with very rapid onset after treatment initiation in patients with Cockayne syndrome reported with products containing metronidazole for systemic use
Prescribing therapy in absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria
Metronidazole may interfere with certain types of determinations of serum chemistry values, such as AST, SGOT, ALT, SGPT, LDH, triglycerides, and hexokinase glucose
Bismuth absorbs x-rays and may interfere with x-ray diagnostic procedures of gastrointestinal tract
Pregnancy and Lactation
Contraindicated in women who are pregnant because treatment of H Pylori infection can be delayed in pregnant women
Tetracycline and metronidazole are present in human milk at concentrations similar to maternal serum levels
Maximum Dosage
3 Pylera capsules (420 mg bismuth subcitrate potassium; 375 mg metronidazole; 375 mg tetracycline) PO four times per day.
3 Pylera capsules (420 mg bismuth subcitrate potassium; 375 mg metronidazole; 375 mg tetracycline) PO four times per day.
Contraindicated.
Contraindicated.
Contraindicated.
How supplied
Metronidazole/Tetracycline/Bismuth subcitrate potassium
capsule
- 125mg/125mg/140mg
