When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. The eradication of Helicobacter pylori has been shown to reduce the risk of duodenal ulcer recurrence. What is bismuth subcitrate potassium, metronidazole, and tetracycline (Pylera)? PYLERA capsules are a combination antimicrobial product containing bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride for oral administration. Nebenwirkungen führen, wie Übelkeit, Erbrechen, Magenschmerzen ( Bauchkrämpfe ), Hitzewallungen und Kopfschmerzen. Values of zero may be observed. 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. Anticoagulants: Potentiation of the anticoagulant effect; Prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests should be closely monitored. No interpretive criteria have been established for testing metronidazole against H. pylori. The rate of renal elimination appears to reach steady state 2 weeks after treatment discontinuation with similar rates of elimination at 6 weeks after discontinuation. 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). Encephalopathy has been reported in association with cerebellar toxicity characterized by ataxia, dizziness, and dysarthria. 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. Metronidazole significantly decreased testes and epididymides weight, decreased sperm viability, and increased the incidence of abnormal sperm. 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. 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. Administration of oral tetracycline to pregnant rats at various doses resulted in yellow fluorescence in teeth and bones in the newborn animals. 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 [see DOSAGE AND ADMINISTRATION]. Renal clearance of metronidazole is approximately 10 mL/min/1.73m2. However, tetracycline can cause fetal harm when administered to a pregnant women. Table 1: Daily Dosing Schedule for PYLERA. In additon, 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. The appearance of abnormal neurologic signs and symptoms demands the prompt evaluation of the benefit/risk ratio of the continuation of PYLERA therapy [See Adverse Reactions (6.3)]. Hypersensitivity reactions: Urticaria, angioedema, anaphylaxis, Henoch-Schonlein purpura, pericarditis, exacerbation of systemic lupus erythematosus, and serum sickness-like reactions. If PYLERA is used during pregnancy, or if the patient becomes pregnant while taking PYLERA, advise the patient of the potential risk to the fetus [see CONTRAINDICATIONS and Use In Specific Populations ]. Renal and urinary disorders: Dysuria, cystitis, polyuria, incontinence, darkened urine, and a sense of pelvic pressure. Die Gabe von Antibiotika hat auch immer einen Nachteil: sie zerstört auch wenig bekannten guten Seiten von Bakterien: man gebe Antibiotika also möglichst nur in wirklich medizinisch notwendigen Fällen. CNS lesions seen on MRI have also been described as reversible. Tell your doctor all medications and supplements you use. In the North American study, pre-treatment metronidazole MIC values showed no correlation with clinical outcome in patients treated with PYLERA and omeprazole therapy. Lithium: Increased lithium serum concentrations; measure serum lithium and serum creatinine concentrations during therapy. One omeprazole 20 mg capsule should be taken twice a day with PYLERA after the morning and evening meal for 10 days (Table 1). Each PYLERA capsule contains the following inactive ingredients: Magnesium Stearate NF, Lactose Monohydrate NF, Talc USP, Gelatin USP, and Titanium Dioxide NF. 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. Schwangerschaft und Stillzeit. In animals, no fetotoxicity was observed when metronidazole was orally administered to pregnant mice at approximately 5% of the indicated human dose. Bakterien haben mehr gesundheitlich stützende Bedeutung in unserem Körper, als uns eigentlich bisher bewusst war. 10 Things People With Depression Wish You Knew, *PYLERA given as a single dose of 3 capsules, *PYLERA given as 3 capsules four times daily for 6 days with or without 20 mg omeprazole twice daily. In patients with significantly impaired renal function, higher serum concentrations of tetracyclines may lead to azotemia, hyperphosphatemia, and acidosis. The effect of a reduced tetracycline hydrochloride systemic exposure, due to an interaction with bismuth, on the clinical efficacy of PYLERA is not thought to be clinically meaningful as the contribution of systemic, as compared to local, antimicrobial activity against Helicobacter pylori has not been established. 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. Development of Superinfection: If superinfection occurs, discontinue PYLERA and institute appropriate therapy. Pulmonary tumors have been observed in all six reported studies in the mouse, including one study in which the animals were dosed on an intermittent schedule (administration during every fourth week only). Each dose of PYLERA is 3 capsules. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus [See Use in Specific Populations (8.1)]. 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. Pylera is used to treat ulcers in the stomach caused by the bacteria H. pylori. In general, elderly patients may have a greater frequency of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapies. Metronidazole has been reported to potentiate the anticoagulant effect of warfarin, and other oral coumarin anticoagulants, resulting in a prolongation of prothrombin time. The safety of PYLERA plus omeprazole (OBMT) to eradicate Helicobacter pylori was assessed in an open-label, randomized, active-controlled clinical trial conducted in North America. Severe irreversible hepatotoxicity/acute liver failure with fatal outcomes have been reported after initiation of metronidazole in patients with Cockayne syndrome [see ADVERSE REACTIONS ]. If you are approved, you will receive a three-month supply of the product you require at no charge. Patients should not take double doses. These products should not be consumed concomitantly with PYLERA. Tetracycline hydrochloride is distributed into most body tissues and fluids. 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 [See Dosage and Administration (2)]. Each PYLERA capsule contains the following inactive ingredients: Magnesium Stearate NF, Lactose Monohydrate NF, Talc USP, Gelatin USP, and Titanium Dioxide NF, Printed in red ink. Interference is due to the similarity in absorbance peaks of NADH (340 nm) and metronidazole (322 nm) at pH 7. Bismuth-containing products: Cases of neurotoxicity associated with excessive doses of various bismuth-containing products have been reported. Patients with mild to moderate hepatic impairment should be monitored for metronidazole associated adverse events. Another fertility study was performed in male mice at oral doses of 500 mg/kg/day (approximately 2 times the indicated human dose based on mg/m2 for 14 days. Blood and lymphatic system disorders: Hemolytic anemia, thrombocytopenia, thrombocytopenic purpura, neutropenia, and eosinophilia. If visual disturbance occurs during treatment, prompt ophthalmologic evaluation is warranted. Also, the published results of one of the mouse studies indicate an increase in the incidence of malignant lymphomas as well as pulmonary neoplasms associated with lifetime feeding of the drug. Prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests should be closely monitored if PYLERA is administered concomitantly with warfarin. An open-label, parallel group, active-controlled, multicenter study in Helicobacter pylori positive patients with current duodenal ulcer or a history of duodenal ulcer disease was conducted in the United States and Canada (the North American Study). The antibacterial action of bismuth salts is not well understood. Bismuth subcitrate potassium is a mineral. Effects have been reversible with discontinuation of bismuth therapy. EMBO Report: 2006 Oct.; 7(10): 956-60: Review. Metronidazole is metabolized through reductive pathways into reactive intermediates that have cytotoxic action. Files, Presentations PYLERA capsules are a combination antimicrobial product containing bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride for oral administration. All these effects are statistically significant. This syndrome may result in stillborn or premature birth due to maternal pathology [See Warnings and Precautions (5.2)]. Each dose of all 3 capsules should be taken 4 times a day, after meals and at bedtime for 10 days. Metronidazole has been reported to increase plasma concentrations of busulfan, which can result in an increased risk for serious busulfan toxicity. Literatur: Total and differential leukocyte counts are recommended before and after therapy [see ADVERSE REACTIONS ]. PYLERA, therefore, should not be used in this age group unless other drugs are not likely to be effective or are contraindicated [See Use in Specific Populations (8.4)] Pylera® [(bismuth subcitrate (140 mg) / metronidazole (125 mg) / tetracycline (125 mg)] Voquezna™ Dual Pak [vonoprazan (20 mg) / amoxicillin (1000 mg)] Voquezna™ Triple Pak [vonoprazan (20 mg) / amoxicillin (1000 mg) / clarithromycin (500 mg)] Talicia® [(omeprazole (10 mg), amoxicillin (250 mg), rifabutin (12.5)] delayed-release In another study where rats were treated with up to 400 mg/kg/day for 8 weeks, there was severe degeneration of the seminiferous epithelium in the testes which was associated with a marked decrease in testicular spermatid counts and epididymal sperm counts and a marked decrease in fecundity. Less than 20% of the circulating metronidazole is bound to plasma proteins. Stool darkening should not be confused with melena (blood in the stool) [See Warnings and Precautions (5.7)]. Two of the individual components of PYLERA, tetracycline and metronidazole, are present in human milk at concentrations similar to maternal serum levels. Metronizadole may interfere with certain types of determinations of serum chemistry values, such as aspartate aminotransferase (AST, SGOT), alanine aminotransferase (ALT, SGPT), lactate dehydrogenase (LDH), triglycerides, and hexokinase glucose. One study showed an increased risk of cleft lip, with or without cleft palate, in infants exposed to metronidazole in-utero; however, these findings were not confirmed. 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. At the highest dose levels, (approximately 500 mg/kg/day, which is approximately 1.6 times the indicated human dose for a 60 kg adult based on body surface area), there was a statistically significant increase in the incidence of malignant liver tumors in male mice. 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. Store at controlled room temperature [68° to 77°F or 20° to 25°C]. Each dose of all 3 capsules should be taken 4 times a day, after meals and at bedtime for 10 days. Each size 0 elongated capsule contains: Tetracycline hydrochloride is encapsulated within a smaller capsule to create a barrier to avoid contact with bismuth subcitrate potassium. Metronidazole usage in pregnancy has been associated with certain congenital anomalies [see Data]. Instruct patients to swallow the PYLERA capsules whole with a full glass of water (8 ounces). 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. No long-term studies have been performed to evaluate the effect of PYLERA on carcinogenesis, mutagenesis, or impairment of fertility. The use of drugs of the tetracycline class 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). Missed doses can be made up by continuing the normal dosing schedule until the medication is gone. They should not take double doses. There was evidence of mutagenicity by tetracycline hydrochloride in two in vitro mammalian cell assay systems (L51784y mouse lymphoma and Chinese hamster lung cells). Do not administer methoxyflurane to patients taking PYLERA. There is an anticipated reduction in tetracycline hydrochloride systemic absorption due to an interaction with bismuth. As with other antibacterial drugs, use of tetracycline hydrochloride may result in overgrowth of nonsusceptible organisms, including fungi. Danach fiel die Gewichtszunahme bei Personen, die wegen einer H. pylori Infektion antibiotisch behandelt wurden, deutlich stärker aus als bei Probanden einer Vergleichsgruppe, die statt . PYLERA should not be given to patients who have taken disulfiram within the last 2 weeks [See Contraindications (4.2)]. Do not use in children less than 8 years of age. Metronidazole crosses the placental barrier and its effects on the human fetal organogenesis are not known. https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=7fe5d2db-c59d-4e15-acd7-f9df8eca45aa, https://dailymed.nlm.nih.gov/dailymed/rss.cfm. Metronidazole transfers to human milk, and infant serum levels can be close to or comparable to infant therapeutic levels. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs. It is not known whether bismuth subcitrate potassium is excreted in human milk. . Inform patients of the risk of central and peripheral nervous system effects with PYLERA and to discontinue PYLERA and report immediately to their health-care provider if any neurologic symptoms occur [See Warnings and Precautions (5.4)]. 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. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by PYLERA or other antibacterial drugs in the future. 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. In case of an overdose, patients should contact a physician, poison control center, or emergency room. drugs a-z list While this condition and related symptoms usually resolve soon after discontinuation of the tetracycline, the possibility for permanent sequelae exists. The capsules are white . this version. avoid: sun exposure. The concurrent use of tetracycline hydrochloride, a component of PYLERA, with methoxyflurane has been reported to result in fatal renal toxicity [see DRUG INTERACTIONS ]. Because of the potential for tumorigenicity shown for metronidazole in animal studies, a decision should be made whether to discontinue nursing or to discontinue metronidazole, taking into account the importance of the therapy to the mother.
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