metronidazole/tetracycline/bismuth subsalicylate (Rx)

Brand and Other Names:Pylera
  • Print

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

metronidazole/tetracycline/bismuth subsalicylate

capsule

  • 125mg/125mg/140mg
more...

Duodenal Ulcer

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

Administration

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

Contraindicated

Next:

Interactions

Interaction Checker

and metronidazole/tetracycline/bismuth subsalicylate

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 
            Previous
            Next:

            Adverse Effects

            >10%

            Nausea (12%)

            1-10%

            Diarrhea (7%)

            Abdominal pain (7%)

            Melena (3%)

            Upper respiratory infection (2%)

            Constipation (2%)

            Anorexia (2%)

            Vomiting (2%)

            Discolored tongue (2%)

            Headache (2%)

            Dyspepsia (2%)

            Dizziness (2%)

            Stool abnormality (1%)

            Duodenal ulcer (1%)

            Sinusitis (1%)

            Taste perversion (1%)

            Flatulence (1%)

            GI hemorrhage (1%)

            Pain (1%)

            Insomnia (1%)

            Anal discomfort (1%)

            Paresthesia (1%)

            <1%

            Acne

            Chest pain

            Hypertension

            Dysphagia

            Arthritis

            Rheumatoid arthritis

            Stomatitis

            Tendonitis

            Glossitis

            Bruising

            Cerebral ischemia

            Conjunctivitis

            Postmarketing Reports

            • 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)
            Previous
            Next:

            Warnings

            Contraindications

            Metronidazole

            • Hypersensitivity to metronidazole or other nitroimidazoles (although cautious desensitization has been applied)
            • Pregnancy 1st trimester (controversial)
            • Avoid during breastfeeding (see lactation)

            Bismuth Subsalicylate

            • 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)

            Tetracycline

            • Hypersensitivity to drug or formulation components

            Pylera

            • 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)

            Cautions

            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

            Metronidazole

            • 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)

            Tetracycline

            • IV/IM no longer commercially available
            • Psudomoter crebri reported (resolves with discontinuation)
            • Prolonged use may cause superinfection
            • May cause photosensitivity

            Bismuth Subsalicylate

            • 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
            Previous
            Next:

            Pregnancy & Lactation

            Pregnancy

            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

            Lactation

            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

            Pregnancy Categories

            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.

            more...
            Previous
            Next:

            Pharmacology

            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

            Pharmacokinetics

            Metronidazole

            • 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%

            Tetracycline

            • 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)

            Bismuth Subsalicylate

            • 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
            • Excretion:
            • Bismuth: Urine & feces
            • Salicylate: Urine
            Previous
            Next:

            Images

            Previous
            Next:

            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            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.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
            Additional Offers
            Email to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Email Forms to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Previous