See Supplemental Patient Information
- Metronidazole has been shown to be carcinogenic in mice and rats; avoid unnecessary use and reserve for approved conditions [US Black Box Warning]
- Excessive doses of bismuth subcitrate may cause neurotoxicity; effects have been reversible with suspension of therapy
- Metronidazole may cause convulsive seizures and peripheral neuropathy during therapy. Promptly discontinue metronidazole therapy on appearance of abnormal neurologic signs
- Metronidazole should be administered with caution to patients with central nervous system diseases
- Tetracycline may cause permanent discoloration of the teeth during long-term use or following repeated short-term courses when used during last half of pregnancy, infancy or childhood up to the age of 8 years. Do not use during pregnancy
- Tetracycline may cause photosensitivity manifested by an exaggerated sunburn reaction. Discontinue tetracycline at the first evidence of skin erythema
- Tetracyclines may cause an increase in blood urea nitrogen (BUN). When administered in patients with significantly impaired renal function, higher serum levels of tetracycline may lead to azotemia, hyperphosphatemia, and acidosis
- Prescribing therapy in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of development of drug-resistant bacteria
- Bismuth subcitrate may cause a temporary and harmless darkening of the tongue and/or black stool. Do not confuse stool darkening with melena
- Patients with severe hepatic disease metabolize metronidazole slowly, with resultant accumulation of metronidazole and its metabolites in plasma. Use with caution in patients with evidence of, or history of, blood dyscrasia. Metronidazole may cause mild leukopenia
- Known or previously unrecognized candidiasis may present more prominent symptoms during metronidazole use and requires treatment with an antifungal agent
- Tetracycline use may result in overgrowth of nonsusceptible organisms, including fungi. Discontinue therapy if superinfection occurs and institute appropriate therapy
- Tetracycline may cause pseudotumor cerebri, manifested by headache and blurred vision. Although this condition usually resolves soon after therapy discontinuation, the possibility for permanent sequelae exists
Supplemental Patient Information
- Advise patients to use a different or additional form of contraception as concurrent use of tetracyclines may render oral contraceptives less effective
- Caution patients receiving therapy to avoid exposure to sun or sun lamps
- Instruct patients to avoid alcoholic beverages during therapy and for at least one day afterward
Pregnancy Category:D
Breastfeeding: Metronidazole is excreted in breastmilk. With maternal intravenous and oral therapy, breastfed infants receive metronidazole in doses that are less than those used to treat infections in infants. Candidal infections and diarrhea have been reported in breastfed infants. Oral and rectal colonization with Candida might be more common in infants exposed to metronidazole. Most sources consider that tetracyclines are contraindicated during breastfeeding due to possible staining of infants' dental enamel or bone deposition of tetracyclines. However, short-term use of tetracyclines would not adversely affect the breastfed infant. Avoid prolonged or repeated courses of therapy during nursing. Monitor the infant for adverse events such as rash, diarrhea, or candidiasis. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 30 June 2011). Due to the potential for serious adverse reactions in nursing infants from tetracyclines, manufacturer recommends discontinuation of nursing or discontinuation of the drug, taking into account the importance of the drug to the mother.
US Trade Name(s)
US Availability
Pylera (bismuth subcitrate/metronidazole/tetracycline)
- CAPS: 140 mg/125 mg/125 mg
Canadian Trade Name(s)
Canadian Availability
UK Trade Name(s)
UK Availability
Australian Trade Name(s)
Australian Availability
[Outline]
