bismuth subcitrate potassium/metronidazole/tetracycline hydrochloride (Rx)

Brand and Other Names:Pylera

Dosing & Uses


Dosage Forms & Strengths

metronidazole/tetracycline/bismuth subcitrate potassium


  • 125mg/125mg/140mg

Duodenal Ulcer

Indicated for eradication of H pylori infection in patients with duodenal ulcer disease (active or history of within the past 5 yr); use in combination with omeprazole

3 capsules (375 mg/375 mg/420 mg) PO q6hr for 10 days in combination with omeprazole

Refer to omeprazole prescribing information for dosing information

Dosage Modifications

Renal impairment

  • Antianabolic action of the tetracyclines may cause an increase in blood urea nitrogen (BUN)
  • Severe: Contraindicated

Hepatic impairment

  • Mild-to-moderate: Monitor for metronidazole-associated adverse events
  • Severe: Not recommended

Dosing Considerations

Only treat infections that are proven or strongly suspected to be caused by susceptible bacteria to reduce development of drug-resistant bacteria

Safety and efficacy not established



Interaction Checker

and bismuth subcitrate potassium/metronidazole/tetracycline hydrochloride

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                    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%)



                    Postmarketing Reports (Metronidazole)

                    Blood and lymphatic system disorders: Reversible neutropenia (leucopenia), reversible thrombocytopenia

                    Cardiac disorders: Flattening of the T-wave

                    Gastrointestinal disorders: Nausea, vomiting, diarrhea, abdominal pain, constipation, anorexia, metallic taste, furry tongue, glossitis, stomatitis and candida overgrowth

                    Hypersensitivity/immune system disorders: Urticaria, erythematous rash, flushing, nasal congestion, dryness of the mouth (or vagina or vulva), and fever

                    Metabolism and nutrition disorders: Pancreatitis

                    Nervous system disorders: Convulsive seizures, encephalopathy, aseptic meningitis, optic and peripheral neuropathy, headache, syncope, dizziness, vertigo, incoordination, ataxia, confusion, dysarthria, irritability, depression, weakness, and insomnia

                    Dermatologic disorders: Erythematous rash and pruritus

                    Renal and urinary disorders: Dysuria, cystitis, polyuria, incontinence, darkened urine, and a sense of pelvic pressure

                    Other: Dyspareunia, decrease of libido, proctitis, joint pains

                    Postmarketing Reports (Tetracycline)

                    Blood and lymphatic system disorders: Hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, neutropenia, and eosinophilia

                    Gastrointestinal disorders: Nausea, vomiting, diarrhea, anorexia, glossitis, black hairy tongue, dysphagia, enterocolitis, inflammatory lesions (with Candida overgrowth) in the anogenital region, esophagitis and esophageal ulceration

                    Nervous system disorders: Intracranial hypertension including pseudotumor cerebri, tinnitus, and myasthenic syndrome

                    Renal and urinary disorders: Increased BUN

                    Skin and subcutaneous tissue disorders: Maculopapular and erythematous rashes, onycholysis, discoloration of the nails, exfoliative dermatitis, photosensitivity

                    Liver: Hepatotoxicity, liver failure

                    Hypersensitivity reactions: Urticaria, angioedema, anaphylaxis, Henoch-SchÖnlein purpura, pericarditis, exacerbation of systemic lupus erythematosus, serum sickness-like reactions



                    Black Box Warnings

                    Metronidazole has been shown to be carcinogenic in mice and rats

                    Unknown whether metronidazole is associated with carcinogenicity in humans


                    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



                    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

                    Central and peripheral nervous system effects

                    • Metronidazole
                      • Convulsive seizures, encephalopathy, aseptic meningitis and peripheral neuropathy reported
                      • Encephalopathy reported in association with cerebellar toxicity characterized by ataxia, dizziness, and dysarthria; CNS lesions seen on MRI described in reports of encephalopathy
                      • CNS symptoms are generally reversible within days to weeks upon discontinuation of metronidazole
                    • Tetracycline
                      • Intracranial hypertension (IH), including pseudotumor cerebri, associated with the use of tetracyclines
                      • Clinical manifestations of IH include headache, blurred vision, diplopia, and vision loss; papilledema can be found on funduscopy
                      • Women of childbearing age who are overweight or have a history of IH are at greater risk for developing tetracycline associated IH
                    • Bismuth-containing products
                      • Cases of neurotoxicity associated with excessive doses of various bismuth-containing products reported
                      • Effects have been reversible with discontinuation of bismuth therapy
                      • Appearance of abnormal neurologic signs and symptoms demands the prompt evaluation of the benefit/risk ratio of the continuation of therapy

                    Drug interactions overview

                    • Avoid use with isotretinoin; both tetracycline and isotretinoin are known to cause intracranial hypertension
                    • Tetracyclines may decrease effectiveness of oral contraceptives; instruct women to use backup contraception during treatment
                    • Coadministration with anticoagulants may alter the effects of warfarin and other oral coumarin anticoagulants; metronidazole reported to potentiate the anticoagulant effect of warfarin, and other oral coumarin anticoagulants, resulting in a prolongation of prothrombin time; tetracycline shown to depress plasma prothrombin activity
                    • In patients stabilized on relatively high doses of lithium, short-term use of metronidazole may cause elevation of serum lithium concentrations and signs of lithium toxicity
                    • Metronidazole reported to increase plasma concentrations of busulfan, which can result in an increased risk for serious busulfan toxicity; do not administer concomitantly with busulfan unless the benefit outweighs the risk
                    • Coadministration with drugs that inhibit CYP450 liver enzymes (eg, cimetidine) may result in a prolonged half-life and decreased plasma clearance of metronidazole
                    • Coadministration with drugs that induce CYP450 liver enzymes (eg, phenytoin, phenobarbital) may accelerate the elimination of metronidazole, resulting in reduced plasma concentrations of metronidazole
                    • QT prolongation reported, particularly when metronidazole administered with drugs with potential for prolonging QT interval; flattening of T-wave may be seen in electrocardiographic tracings

                    Pregnancy & Lactation


                    Contraindicated in women who are pregnant because treatment of H Pylori infection can be delayed in pregnant women

                    Use of tetracyclines during the second and third trimester pregnancy can cause permanent discoloration of the teeth (yellow-gray brown) and possibly inhibit bone development in infant

                    Administration of oral tetracycline to pregnant rats at various doses resulted in yellow fluorescence in teeth and bones in the newborn animals; maternal risks with high IV doses of tetracycline reported

                    Metronidazole usage in pregnancy associated with certain congenital anomalies

                    Tetracycline administered during pregnancy at high doses (>2 g IV) was associated with rare but serious cases of maternal hepatotoxicity; syndrome may result in stillborn or premature birth due to maternal pathology


                    Tetracycline and metronidazole are present in human milk at concentrations similar to maternal serum levels

                    It is unknown whether bismuth subcitrate is present in human milk

                    It is unknown of the effect of therapy have the breastfed infant or on milk production

                    Tetracycline binds with calcium in human milk

                    Data indicate that oral absorption of tetracycline in infants is low due to the calcium binding in human milk

                    Metronidazole transfers to human milk, and infant serum levels can be close to or comparable to infant therapeutic levels

                    Because of the potential risk of tumorigenicity shown in animal studies with metronidazole, breastfeeding women should pump and discard human milk for the duration of therapy, and for 2 days after therapy ends, and feed her infant stored human milk (collected prior to therapy) or formula

                    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.



                    Mechanism of Action

                    Metronidazole, tetracycline: Inhibits nucleic acid synthesis by disrupting DNA

                    Bismuth Subcitrate: Antisecretory effect by salicylate, antimicrobial action by bismuth

                    Tetracycline: Binds to the 30S and possibly 50S ribosomal subunits of susceptible bacteria to inhibit protein synthesis

                    With omeprazole, therapy shown to be active against most isolates of H pylori both in vitro and in clinical infections


                    Peak plasma time

                    • Fed: 3 hr (metronidazole); 4 hr (tetracycline); 3.5 hr (bismuth subcitrate)
                    • Fasted: 0.75 hr (metronidazole); 3.3 hr (tetracycline); 0.6 hr (bismuth subcitrate)

                    Peak plasma concentration

                    • Fed: 6835 ng/mL (metronidazole); 515.8 ng/mL (tetracycline); 1.7 ng/mL (bismuth subcitrate)
                    • Fasted: 8666.3 ng/mL (metronidazole); 773.8 ng/mL (tetracycline); 16.7 ng/mL (bismuth subcitrate)


                    • Fed: 6,835 ng·hr/mL (metronidazole); 5,840.1 ng·hr/mL (tetracycline); 18.4 ng·hr/mL (bismuth subcitrate)
                    • Fasted: 84,413.6 ng·hr/mL (metronidazole); 9,986.7 ng·hr/mL (tetracycline); 56.5 ng·hr/mL (bismuth subcitrate)


                    Protein bound: >90% (bismuth subcitrate); <20% (metronidazole)

                    Metronidazole also appears in cerebrospinal fluid, saliva, and breast milk in concentration similar to those found in plasma

                    Tetracycline is absorbed (60-90%) in the stomach and upper small intestine

                    Tetracycline is distributed into most body tissues and fluids; distributed into the bile and undergoes varying degrees of enterohepatic recirculation; readily crosses the placenta and is excreted in high amounts in breast milk


                    Metronidazole: Side-chain oxidation and glucuronide oxidation


                    Half-life: ~5 days (bismuth subcitrate); 8 hr (metronidazole)

                    Clearance: 10 mL/min/1.73²


                    • Bismuth subcitrate: Urine (2.6% per day); feces
                    • Metronidazole and metabolites: Urine (60-80%); feces (6-15%)


                    Oral Administration

                    Administer 3 capsules after meals and at bedtime for 10 days

                    Take omeprazole 20 mg PO BID with Pylera after the morning and evening meal for 10 days

                    Swallow capsules whole with a full glass of water (8 ounces)

                    Ingestion of adequate amounts of fluid, particularly with the bedtime dose, is recommended to reduce the risk of esophageal irritation and ulceration by tetracycline hydrochloride

                    Missed dose: Continue normal dosing schedule until medication is gone; do not take double doses; if >4 doses are missed, contact prescriber


                    Capsules: Store at room temperature (20-25°C [68-77°F])



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