Dosing & Uses
Dosage Forms & Strengths
Indicated for eradication of Helicobacter pylori in patients with duodenal ulcer disease (active or a history of duodenal ulcer), gastric ulcer, dyspepsia, or gastric mucosa associated lymphoid tissue (MALT) lymphoma
3 capsules (375 mg/375 mg/420 mg) PO q6hr for 10 days
Administer with omeprazole 20 mg PO q12hr for 10 days with 8 ounces of water
Contraindicated in elderly with renal or hepatic impairment, in hemodialysis patients, and in renal impairment
Serious - Use Alternative
Significant - Monitor Closely
Abdominal pain (7%)
Upper respiratory infection (2%)
Discolored tongue (2%)
Stool abnormality (1%)
Duodenal ulcer (1%)
Taste perversion (1%)
GI hemorrhage (1%)
Anal discomfort (1%)
- Infections and infestations: Candidiasis, pseudomembranous colitis (Clostridium difficile colitis)
- Nervous Systems: Peripheral neuropathy
- Skin and subcutaneous disorders: Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS syndrome (drug rash with eosinophilia and systemic symptoms)
- Hypersensitivity to metronidazole or other nitroimidazoles (although cautious desensitization has been applied)
- Pregnancy 1st trimester (controversial)
- Avoid during breastfeeding (see lactation)
- Hypersensitivity to bismuth, aspirin, other salicylates
- Infectious diarrhea, high fever, von Willebrand's disease, hemorrhage, GI bleeding, hemophilia
- Chicken pox or influenza in Peds (risk of Reye's synd)
- Hypersensitivity to drug or formulation components
- Coadministration with methoxyflurane, severe renal impairment; disulfiram (within the past 2 weeks), or ethanol or other products containing propylene glycol (during and for at least 3 days following therapy with Pylera)
Skin and subcutaneous disorders including Stevens-Johnson syndrome, toxic epidermal necrolysis and DRESS syndrome (drug rash with eosinophilia and systemic symptoms) reported; discontinue treatment at first evidence of cutaneous reaction
Metronidazole has been shown to be carcinogenic in mice and rats; it is unknown whether metronidazole is associated with carcinogenicity in humans
- Caution in CNS disease, history of blood dyscrasias
- Avoid alcohol
- May result in candidiasis
- Intravaginal: avoid vaginal intercourse or use of vaginal douches during course of treatment
- Antiandrogen: May cause gynecomastia
- Patients with hepatic impairment metabolize metronidazole slowly, with resultant accumulation of metronidazole in plasma; use with caution in patients with mild to moderate hepatic impairment; therapy may not be appropriate for patients with severe hepatic impairment (Child-Pugh C)
- IV/IM no longer commercially available
- Psudomoter crebri reported (resolves with discontinuation)
- Prolonged use may cause superinfection
- May cause photosensitivity
- May cause black tongue &/or black stool
- May interfere with GI radiographic tests
Central and Peripheral Nervous System Effects
- Metronidazole: Convulsive seizures, encephalopathy, aseptic meningitis and peripheral neuropathy (including optic neuropathy) have been reported
- Tetracycline: Intracranial hypertension (IH), including pseudotumor cerebri, associated with use of tetracyclines; women of childbearing age who are overweight or have a history of IH are at greater risk for developing tetracycline associated IH; avoid concomitant use of isotretinoin because isotretinoin is also known to cause IH; although IH typically resolves after discontinuation of treatment, possibility for permanent visual loss exists; if visual disturbance occurs during treatment, prompt ophthalmologic evaluation is warranted; since intracranial pressure can remain elevated for weeks after drug cessation, patients should be monitored until they stabilize
Pregnancy & Lactation
Contraindicated in women who are pregnant because treatment of Helicobacter pylori infection can be delayed in pregnant women, and use of drugs of the tetracycline class during second and third trimester pregnancy can also cause permanent discoloration of teeth (yellow-gray brown) and possibly inhibit bone development; tetracycline administered during pregnancy at high doses (> 2 g IV) has been associated with rare but serious cases of maternal hepatotoxicity; this syndrome may result in stillborn or premature birth due to maternal pathology
There are no human or animal data on the use of bismuth subcitrate potassium during pregnancy; although there are data on separate components, there are no available data on use of metronidazole/ tetracycline/ bismuth subsalicylate combination in pregnant women
There are no human data on use of bismuth subcitrate potassium during pregnancy
Two of the individual components, tetracycline and metronidazole, are present in human milk at concentrations similar to maternal serum levels; not known whether bismuth subcitrate, the third component of this drug combination is present in human milk; it is not known what effect metronidazole, tetracycline or bismuth has on breastfed infant or on milk production; metronidazole transfers to human milk, and infant serum levels can be close to or comparable to infant therapeutic levels; because of potential risk of tumorigenicity shown in animal studies with metronidazole, a woman should pump and discard human milk for duration of therapy, and for 2 days after therapy ends, and feed her infant stored human milk (collected prior to therapy) or formula
Lactation: Not recommended
A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA:Information not available.
Mechanism of Action
Metronidazole, tetracycline: Inhibits nucleic acid synthesis by disrupting DNA
Bismuth Subsalicylate: Antisecretory effect by salicylate, antimicrobial action by bismuth
Tetracycline: Binds to the 30S and possibly 50S ribosomal subunits of susceptbible bacteria to inhibit proteain synthesis
- Absorption: 80% from GI tract
- Distribution: Widely distributed; 13-43% (normal meningers); 100% (inflamed meninges)
- Metabolism: Liver (30-60%)
- Protein binding: < 20%
- Peak plasma time: 1-2 hr
- Half-life: 25-75 hr (neonates); 6-8 hr (others); 21 hr (end stage renal disease)
- Enzymes inhibited: hepatic CYP2C9
- Excretion: Urine: 77%; feces: 14%
- Absorption: 75%
- Distribution: Small amount appears in bile; relative diffusion from blood into CSF
- Protein bound: 65%
- Half-life: 8-11 hr (normal renal function); 57-108 hr (end-stage renal disease)
- Peak Plasma Time: 2-4 hr
- Excretion: Urine (60% as unchanged drug); feces (as active form)
- Half-Life: highly variable
- Peak Plasma Time: Bismuth: 1.8-5 hr
- Bioavailability: Bismuth: <1%; Salicylate: >90%
- Onset: 4 hr
- Protein Bound: 90% (bismuth);>90% (salicylate)
- Metabolism: Stomach: bismuth subsalicylate is hydrolyzed in stomach to form the slightly soluble bismuth oxychloride (BiOCl) and salicylic acid
- Metabolites: salicylate (active), [BiOCl, bismuth subcarbonate, bismuth phosphate] (activity unknown); unchanged bismuth subsalicylate passes into duodenum and reacts with other anions (eg, bicarbonate, phosphate) to form bismuth subcarbonate and bismuth phosphate salts; BiOCl, bismuth subcarbonate, bismuth phosphate, and undissociated bismuth subsalicylate react with hydrogen sulfide; salicylate is extensively metabolized in liver
- Clearance: Bismuth: 50 mL/min
- Bismuth: Urine & feces
- Salicylate: Urine
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|1||This drug is available at the lowest co-pay. Most commonly, these are generic drugs.|
|2||This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.|
|3||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.|
|4||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|5||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|6||This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.|
|NC||NOT COVERED – Drugs that are not covered by the plan.|
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