In patients with decreased liver function, plasma clearance of metronidazole is decreased. Do not administer methoxyflurane to patients taking PYLERA. Renal and urinary disorders: Dysuria, cystitis, polyuria, incontinence, darkened urine, and a sense of pelvic pressure. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. Other: Dyspareunia, decrease of libido, proctitis, joint pains. Enamel hypoplasia has also been reported. RxList does not provide medical advice, diagnosis or treatment. Nervous system disorders: Pseudotumor cerebri (benign intracranial hypertension) in adults and bulging fontanels in infants. PYLERA (bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride- 140 mg/125 mg/125 mg capsule, To report SUSPECTED ADVERSE REACTIONS, contact AXCAN Pharma US, Inc. at 1-800-472-2634 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch, Table 1: Daily Dosing Schedule for PYLERA, Table 2: Adverse reactions with an incidence of ≥ 1% from North American trial, [n (%)], General disorders and administration site conditions, Table 3: Mean (%CV) Pharmacokinetic Parameters for Metronidazole, Tetracycline hydrochloride, and Bismuth Subcitrate Potassium in Healthy Volunteers (N=18), Table 4: Mean PYLERA Pharmacokinetic Parameters in Fasted and Fed States (N=18), Table 5: Mean Bismuth Pharmacokinetic Parameters following PYLERA Administration, Table 6: Helicobacter pylori Eradication at 8 Weeks after 10 Day Treatment Regimen Percent (%) of Patients Cured [95% Confidence Interval] (Number of Patients), for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically, bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride (140 mg/125 mg/125 mg) capsule, All Drug Bismuth subcitrate potassium has similar effects as bismuth subsalicylate; however, it does not carry the risks associated with the salicylate moiety found in other products. Die Arbeitsgruppe um Martin Blazer, Professor für Mikrobiologie in New York, forscht seit über zwanzig Jahren über die Bedeutung von Bakterien wie Helicobacter pylori und musste erfahren, dass viele Bakterien unseres Körpers nicht nur böse, sondern gerade auch wichtige und gute Signalgeber in unserem Körper sind.(3). PYLERA, a combination of bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride has antibacterial activity. Adverse drug reactions with an incidence of ≥ 5% in OAC group include diarrhea, dysgeusia, dyspepsia, nausea and headache. Nervous system disorders: The most serious adverse reactions reported in patients treated with metronidazole have been convulsive seizures, encephalopathy, aseptic meningitis, optic and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity. Metronidazole has shown mutagenic activity in in vitro assay systems including the Ames test. Because of this alteration to the metronidazole molecule, a concentration gradient is created and maintained which promotes the drug’s intracellular transport. The concurrent use of tetracycline hydrochloride, a component of PYLERA, with methoxyflurane has been reported to result in fatal renal toxicity [see CONTRAINDICATIONS]. Administer three PYLERA capsules 4 times a day (after meals and at bedtime) for 1 0 days. Inform patients of the risk of central and peripheral nervous system effects with PYELRA and to discontinue PYLERA and report immediately to their health-care provider if any neurologic symptoms occur [see WARNINGS AND PRECAUTIONS]. It is also not known whether bismuth subcitrate potassium can cause fetal harm when administered to a pregnant women or can affect reproduction capacity. Following oral administration, metronidazole is well absorbed, with peak plasma concentrations occurring between 1 and 2 hours after administration. Bismuth absorbs x-rays and may interfere with x-ray diagnostic procedures of the gastrointestinal tract. In patients stabilized on relatively high doses of lithium, short-term use of PYLERA may cause elevation of serum lithium concentrations and signs of lithium toxicity due to the interaction between metronidazole and lithium. Clarithromycin 500 mg plus 1000 mg amoxicillin plus 20 mg omeprazole twice a day before the morning and evening meals (OAC). Discontinue treatment at the first evidence of skin erythema. Malignant liver tumors were increased in male mice treated at approximately 1500 mg/m2 (similar to the maximum recommended daily dose, based on body surface area comparisons). & Articles, All Because elderly patients are more likely to have decreased renal function, additional monitoring may be required [see CONTRAINDICATIONS ]. Symptoms can occur within hours of dose adiminstration and generally resolve after metronidazole therapy is discontinued. A mild leukopenia has been observed during its administration; however, no persistent hematologic abnormalities attributable to metronidazole have been observed in clinical studies. Inform patients that PYLERA may cause allergic reactions and to discontinue PYLERA at the first sign of urticaria, erythematous rash, flushing, and fever or other symptoms of an allergic reaction [see CONTRAINDICATIONS ]. -. Tetracycline hydrochloride tends to localize in tumors, necrotic or ischemic tissue, liver and spleen and form tetracycline-calcium orthophosphate complexes at sites of new bone formation or tooth development. The simultaneous administration of PYLERA and drugs that induce microsomal liver enzymes, such as phenytoin or phenobarbital, may accelerate the elimination of metronidazole, resulting in reduced plasma concentrations of metronidazole. It is a soluble, complex bismuth salt of citric acid. If a dose is missed, patients should continue the normal dosing schedule until medication is gone. If more than 4 doses are missed, the prescriber should be contacted. The relationship of these findings to the drug is unknown. The major route of elimination of metronidazole and its metabolites is via the urine (60% to 80% of the dose), with fecal excretion accounting for 6% to 15% of the dose. Each PYLERA capsule contains 140 mg of bismuth subcitrate potassium, 125 mg of metronidazole, and a smaller capsule inside containing 125 mg of tetracycline hydrochloride. The administration of any of the following drugs with PYLERA may result in clinically significant adverse reactions or insufficient drug efficacies [See Contraindications (4)] ;Drug Interactions (7)] : Inform patients that PYLERA may cause temporary and harmless darkening of the tongue and/or black stool generally reversible within several days after treatment is stopped. Report Adverse Severe irreversible hepatotoxicity/acute liver failure with fatal outcomes have been reported after initiation of metronidazole in patients with Cockayne syndrome [see ADVERSE REACTIONS ]. Pylera (bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride) is a combination of a mineral and two antibiotics used to treat stomach ulcers associated with H pylori infection. How should I take Pylera? February 3, 2011. 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. The viability of sperm was normal by 2 months after the start of the treatment. Original-Beipackzettel. Advise patients to report to their health-care provider the use of any other medications while taking PYLERA. No carcinogenicity or reproductive toxicity studies have been conducted with bismuth subcitrate potassium. Instruct patients to swallow the PYLERA capsules whole with a full glass of water (8 ounces). Enamel hypoplasia has also been reported. In addition, more than ten randomized, placebo-controlled clinical trials enrolled more than 5000 pregnant women to assess the use of antibiotic treatment (including metronidazole) for bacterial vaginosis on the incidence of preterm delivery. Methoxyflurane: Risk of fatal renal toxicity; do not co-administer. urticaria, erythematous rash, flushing, and fever) to bismuth subcitrate potassium, metronidazole or other nitroimidazole derivatives, or tetracycline [See Adverse Reactions (6.3)]. Aseptic meningitis symptoms may occur within hours of dose administration and generally resolve after metronidazole therapy is discontinued. One omeprazole 20 mg capsule should be taken twice a day with PYLERA after the morning and evening meal for 10 days. Store at controlled room temperature [68° to 77°F or 20° to 25°C]. Pill Identifier Tool Quick, Easy, Pill Identification, Drug Interaction Tool Check Potential Drug Interactions, Pharmacy Locator Tool Including 24 Hour, Pharmacies. The efficacy of the Pylera capsule was studied in a randomized control trial, in which a quadruple Pylera therapy (Pylera capsule and a PPI) was evaluated against the standard triple regimen. PYLERA contains bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride. Citations, 5.3 Tooth Enamel Discoloration and Hypoplasia, 5.4 Central and Peripheral Nervous System Effects, 5.7 Darkening of the Tongue and/or Black Stool, 5.8 Use in Patients with Blood Dyscrasias, 5.10 Development of Drug Resistant Bacteria, 6.3 Other Important Adverse Reactions from Labeling for the Individual Components of PYLERA, 7.7 Antacids, Multivitamins, or Dairy Products, 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility, 17.7 Darkening of the Tongue and/or Stool, Report Adverse The equivalent theoretical molecular formula is BiC12H14K5O17. When PYLERA is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests should be closely monitored if PYLERA is administered concomitantly with warfarin. Renal clearance of metronidazole is approximately 10 mL/min/1.73m2. In general, elderly patients may have a greater frequency of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapies. Das Trinken von Alkohol während der Behandlung mit Pylera kann zu unangenehmen. Total and differential leukocyte counts are recommended before and after therapy [see ADVERSE REACTIONS ]. Administration of oral tetracycline to pregnant rats at various doses resulted in yellow fluorescence in teeth and bones in newborn animals. This syndrome may result in stillborn or premature birth due to maternal pathology [See Warnings and Precautions (5.2)]. Reduction in the absorption of all three PYLERA components in the presence of food is not considered to be clinically significant. Metronidazole and tetracycline are antibiotics that fight bacteria in the body. Patients should also be monitored for evidence of bleeding. Use a SingleCare card to pay $250.43 for 120, 140-125-125mg Capsule of generic Pylera. The antibacterial action of bismuth salts is not well understood. PYLERA in combination with omeprazole are indicated for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. PYLERA is supplied in: Store at controlled room temperature [68° to 77°F or 20° to 25°C]. Trikáliumdicitrát bizmutitý pomáha antibiotikám pri liečbe infekcie. The presence of food, milk or cations may significantly decrease the extent of absorption. While this condition and related symptoms usually resolve soon after discontinuation of the tetracycline, the possibility for permanent sequelae exists. Metronidazole is present in human milk at concentrations similar to maternal serum levels, and infant serum levels can be close to or comparable to infant therapeutic levels. Alcoholic beverages or other products containing propylene glycol should not be consumed during and for at least 3 days after therapy with PYLERA. Women who could become pregnant should use non-hormonal birth control (e.g., condom, diaphragm with spermicide) while taking Pylera. It is concentrated by the liver in the bile and excreted in the urine and feces at high concentrations in biologically active form. There has been no evidence of carcinogenicity for tetracycline hydrochloride in studies conducted with rats and mice. Patients with severe hepatic disease metabolize metronidazole slowly, with resultant accumulation of metronidazole and its metabolites in plasma. Patients with severe hepatic disease metabolize metronidazole slowly, with resultant accumulation of metronidazole and its metabolites in plasma. The pharmacokinetics of the individual components of PYLERA, bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride are summarized below. All 3 capsules should be taken 4 times a day (after meals and at bedtime) for 10 days. Plasma concentrations of metronidazole are proportional to the administered dose, with oral administration of 500 mg producing a peak plasma concentration of 12 mcg/mL. Get Label RSS Feed, Renal clearance of metronidazole is approximately 10 mL/min/1.73m2. Die technische Speicherung oder der Zugriff, der ausschließlich zu anonymen statistischen Zwecken verwendet wird. PYLERA is contraindicated in patients with known hypersensitivity (e.g. View NDC Code(s)NEW! Bakterien haben mehr gesundheitlich stützende Bedeutung in unserem Körper, als uns eigentlich bisher bewusst war. PYLERA plus omeprazole therapy has been shown to be active against most isolates of Helicobacter pylori both in vitro and in clinical infections [see Clinical Studies ]. These highlights do not include all the information needed to use PYLERA safely and effectively. Monitor phenytoin concentrations during treatment with PYLERA. Copyright © 2023 by RxList Inc. An Internet Brands company. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs. Gastrointestinal disorders: Nausea, vomiting, diarrhea, abdominal pain, constipation, anorexia, metallic taste, furry tongue, glossitis, stomatitis and candida overgrowth. Effects have been reversible with discontinuation of bismuth therapy. Pylera combines the antimicrobial agent, bismuth subcitrate potassium, with two antibiotics, metronidazole and tetracycline. Magen-Darm Probleme ganzheitlich behandeln, Hormonersatztherapie in den Wechseljahren. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Closely monitor prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests if PYLERA is administered concomitantly with warfarin. Neurotoxic effects, including seizures and peripheral neuropathy, have been reported after 5 to 7 days of doses of 6 to 10.4 g every other day. Although metronidazole has shown mutagenic activity in a number of in vitro assay systems, studies in mammals (in vivo) have failed to demonstrate a potential for genetic damage. However, tetracycline can cause fetal harm when administered to a pregnant women. Aseptic meningitis: Cases of aseptic meningitis have been reported with metronidazole. One omeprazole 20 mg capsule should be taken twice a day with Pylera after the morning and evening meal for 10 days. In the presence of omeprazole, the extent of absorption of bismuth from PYLERA was significantly increased, compared to when no omeprazole was given (Table 5). Pylera is used to treat ulcers in the stomach caused by the bacteria H. pylori. Who are we? Ihr Dr. med. Patients should not take double doses. In patients stabilized on relatively high doses of lithium, short-term use of PYLERA may cause elevation of serum lithium concentrations and signs of lithium toxicity due to the interaction between metronidazole and lithium. Tetracycline hydrochloride is absorbed (60%-90%) in the stomach and upper small intestine. Die vorübergehende Gabe von Antibiotika ist wichtig, steigert dann aber auch den Appetit und als Nachteil die Gewichtszunahme. PYLERA is a combination of antibacterial agents (metronidazole and tetracycline hydrochloride) and bismuth subcitrate potassium. The capsules are white . Other reported clinical experience has not identified differences in responses between the elderly and younger patients. Revised: Dec 2021. Metabolism and nutrition disorders: Pancreatitis. The concurrent use of tetracycline hydrochloride, a component of PYLERA, with methoxyflurane has been reported to result in fatal renal toxicity [See Contraindications (4.1)]. The viability of sperm was normal by 2 months after the start of the treatment. The available overdosage information for each of the individual components in PYLERA (Metronidazole, Tetracycline and Bismuth subcitrate potassium) are summarized below: Single oral doses of metronidazole, up to 15 g, have been reported in suicide attempts and accidental overdoses. If more than 4 doses are missed, advise the patient to contact their health-care provider [see DOSAGE AND ADMINISTRATION]. Metronidazole has been reported to increase plasma concentrations of busulfan, which can result in an increased risk for serious busulfan toxicity. The yellowing is caused by the direct deposition of tetracycline during the mineralization process. Although IH typically resolves after discontinuation of treatment, the possibility for permanent visual loss exists. Bismuth subsalicylate did not show mutagenic potential in the NTP Salmonella plate assay. Tetracycline hydrochloride had no effect on fertility when administered in the diet to male and female rats at a daily intake of 25 times the human dose. Elimination of bismuth is primarily through urinary and biliary routes. PPI, clarithromycin (500 mg) plus either metronidazole or tinidazole (500 mg) for an additional 5 days. It is distributed into the bile and undergoes varying degrees of enterohepatic recirculation. A comparative bioavailability study of metronidazole (375 mg), tetracycline hydrochloride (375 mg) and bismuth subcitrate potassium (420 mg, equivalent to 120 mg Bi2O3) administered as PYLERA or as 3 separate capsule formulations administered simultaneously was conducted in healthy male volunteers. PYLERA is supplied as a white opaque capsule containing 140 mg bismuth subcitrate potassium, 125 mg metronidazole, and 125 mg tetracycline hydrochloride, with the APTALISTM logo printed on the body and “BMT” printed on the cap. In patients with significantly impaired renal function, higher serum concentrations of tetracyclines may lead to azotemia, hyperphosphatemia, and acidosis. Table 2 lists adverse reactions with an incidence of ≥ 1%, in either groups (OBMT vs OAC) and in order of decreasing incidence for the OBMT group. The effect of H. pylori eradication on meal-associated changes in plasma ghrelin and leptin.BMC Gastroenterol. Effect of Bismuth on the Bioavailability of Tetracycline Hydrochloride. No fetotoxicity was observed when metronidazole was administered orally to pregnant mice at 10 mg/kg/day, approximately 5 percent of the indicated human dose (1500 mg/day) based on body surface area; however in a single small study where the drug was administered intraperitoneally, some intrauterine deaths were observed. Bismuth subcitrate potassium, a component of PYLERA, is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. One omeprazole 20 mg capsule should be taken twice a day with PYLERA after the morning and evening meal for 10 days (Table 1). Immune system disorders: Urticaria, erythematous rash, Stevens - Johnson syndrome, toxic epidermal necrolysis, flushing, nasal congestion, and fever [See Contraindications (4.5)]. Bismuth absorbs x-rays and may interfere with x-ray diagnostic procedures of the gastrointestinal tract. Use PYLERA with caution in patients with hepatic impairment. avoid: breastfeeding during tx and x2 days after D/C. Indigenous microbes and the ecology of human diseases. In patients stabilized on relatively high doses of lithium, short-term use of PYLERA may cause elevation of serum lithium concentrations and signs of lithium toxicity due to the interaction between metronidazole and lithium. Patients with hepatic impairment metabolize metronidazole slowly, with resultant accumulation of metronidazole in the plasma. Prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests should be closely monitored if PYLERA is administered concomitantly with warfarin. Visit the FDA MedWatch website or call 1-800-FDA-1088. Bismuth subcitrate potassium may cause a temporary and harmless darkening of the stool. Monitor serum lithium and serum creatinine concentrations daily for several days after beginning treatment with PYLERA to detect any increase that may precede clinical symptoms of lithium toxicity [see DRUG INTERACTIONS ]. The average Pylera price is about $1,025 for a supply of 120, 140 mg-125 mg-125 mg capsules. Children. (2), Administer PYLERA with omeprazole 20 mg twice daily (after the morning and evening meals). Metronidazole is 2-methyl-5-nitroimidazole-1-ethanol, with a molecular formula of C6H9N3O3 and the following structural formula: Tetracycline hydrochloride is a yellow, odorless, crystalline powder. : Who are we? Administration of oral tetracycline to pregnant rats at various doses resulted in yellow fluorescence in teeth and bones in the newborn animals. Advise women of child-bearing potential to use a different or additional form of contraception while taking PYLERA [see DRUG INTERACTIONS ]. Tetracycline is present in human milk at concentrations similar to maternal serum levels; however, it binds with calcium in human milk. Instruct patients to swallow the PYLERA capsules whole with a full glass of water (8 ounces). Tetracycline administered during pregnancy at high doses (> 2 g IV) was associated with rare but serious cases of maternal hepatotoxicity.