metronidazole/tetracycline/bismuth subsalicylate (Rx)

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Brand and Other Names:Pylera

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

metronidazole/tetracycline/bismuth subsalicylate

capsule

  • 125mg/125mg/140mg
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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

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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

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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

  • 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
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Pregnancy & Lactation

Pregnancy category: D

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.

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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
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Images

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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.
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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.
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