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 It is used to treat stomach /intestinal ulcers caused by the bacteria H. pylori and to prevent the ulcers from returning.Each capsule contains 3 medications: bismuth subcitrate, metronidazole, and. Do not administer methoxyflurane to patients taking PYLERA. Results of animal studies indicate that tetracycline crosses the placenta, is found in fetal tissues, and can have toxic effects on the developing fetus (often related to reversible retardation of skeletal development). 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. The clinical significance of metronidazole MIC values against H. pylori is unknown. Helicobacter pylori verursacht durchaus Magengeschwüre und Magenkrebs. 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]. In the North American study, pre-treatment metronidazole MIC values showed no correlation with clinical outcome in patients treated with PYLERA and omeprazole therapy. Immune system disorders: Urticaria, erythematous rash, Stevens - Johnson syndrome, toxic epidermal necrolysis, flushing, nasal congestion, and fever [See Contraindications (4.5)]. These highlights do not include all the information needed to use PYLERA safely and effectively. PYLERA is contraindicated in patients who have taken disulfiram within the last two weeks. 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. Blasers neue herausfordernde Bemerkung: Was passiert, wenn wir in ein oder zwei Generationen durch zu häufige Gabe von Antibiotika nicht nur den Helicobacter pylori, sondern auch viele andere Mikroben auslöschen. Although there are data on the separate components, there are no available data on the use of PYLERA in pregnant women. Monitor phenytoin concentrations during treatment with PYLERA. Der Zugriff oder die technische Speicherung ist unbedingt für den rechtmäßigen Zweck erforderlich, um die Nutzung eines bestimmten Dienstes zu ermöglichen, der vom Abonnenten oder Nutzer ausdrücklich angefordert wurde, oder für den alleinigen Zweck der Übertragung einer Nachricht über ein elektronisches Kommunikationsnetz. CNS lesions seen on MRI have also been described as reversible; Peripheral neuropathy, mainly of sensory type has been reported and is characterized by numbness or paresthesia of an extremity. Patients with severe hepatic disease metabolize metronidazole slowly, with resultant accumulation of metronidazole and its metabolites in plasma. 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. Food reduced the systemic absorption of all three PYLERA components, with AUC values for metronidazole, tetracycline hydrochloride and bismuth being reduced by 6%, 34% and 60%, respectively. Das Präparat muss zusammen mit dem Arzneimittel Omeprazol eingenommen werden. Women of child-bearing potential should use a different or additional form of contraception while taking PYLERA [see WARNINGS AND PRECAUTIONS]. The pharmacokinetics of the individual components of PYLERA, bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride are summarized below. One omeprazole 20 mg capsule should be taken twice a day with Pylera after the morning and evening meal for 10 days. PYLERA, a combination of bismuth subcitrate potassium, metronidazole and tetracycline hydrochloride has antibacterial activity. PYLERA is supplied as a white opaque capsule containing 140 mg bismuth subcitrate potassium, 125 mg metronidazole, and 125 mg tetracycline hydrochloride, with the Axcan Pharma logo printed on the body and “BMT” printed on the cap. Administer three PYLERA capsules 4 times a day (after meals and at bedtime) for 10 days. The average Pylera price is about $1,025 for a supply of 120, 140 mg-125 mg-125 mg capsules. All of the assays in which interference has been reported involve enzymatic coupling of the assay to oxidation-reduction of nicotinamide (NAD+ <=> NADH). The pharmacokinetic parameters for the individual drugs, when administered as separate capsule formulations or as PYLERA, are similar as shown in Table 3. February 3, 2011. There are no adequate and well-controlled studies of PYLERA in pregnant women. 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). Dosage Print Save Pylera Dosage Generic name: BISMUTH SUBCITRATE POTASSIUM 140mg, METRONIDAZOLE 125mg, TETRACYCLINE HYDROCHLORIDE 125mg Dosage form: capsule Drug class: H. pylori eradication agents Medically reviewed by Drugs.com. Encephalopathy has been reported in association with cerebellar toxicity characterized by ataxia, dizziness, and dysarthria. Fallbeispiel: Reizdarm – Diagnose und Behandlung (36j). What Is Exocrine Pancreatic Insufficiency? Patients with mild to moderate hepatic impairment should be monitored for metronidazole associated adverse events. . The molecular mass of the theoretical molecular formula of a single unit of bismuth subcitrate potassium is 834.71. The concurrent use of tetracycline hydrochloride, a component of PYLERA, with methoxyflurane has been reported to result in fatal renal toxicity [See Drug Interactions (7.1)]. Metronidazole and tetracycline are antibiotics that fight bacteria in the body. The metabolites that appear in the urine result primarily from side-chain oxidation [1-(β-hydroxyethyl) 2-hydroxymethyl-5-nitroimidazole and 2-methyl5-nitroimidazole-1-yl-acetic acid] and glucuronide conjugation, with unchanged metronidazole accounting for approximately 20% of the total. Eligibility for the Allergan Pharma, Inc. program is based upon information you and your licensed practitioner provide on the application form. One omeprazole 20 mg capsule should be taken twice a day with PYLERA after the morning and evening meal for 10 days (Table 1). H. pylori ist ein Bakterium, das in der Magenschleimhaut vorkommt. Patients were randomized to one of the following 10-day treatment regimens: H. pylori eradication rates, defined as two negative 13C-urea breath tests performed at 4 and 8 weeks post-therapy are shown in Table 6 for OBMT and OAC. (1.1), Each dose of PYLERA includes 3 capsules. Files, All Mapping No long-term studies have been performed to evaluate the effect of PYLERA on carcinogenesis, mutagenesis, or impairment of fertility. Metronidazole crosses the placental barrier. 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. PYLERA is contraindicated during pregnancy [see Use In Specific Populations ]. Safety and effectiveness of PYLERA in pediatric patients infected with Helicobacter pylori have not been established. Get Label RSS Feed, Avoid exposure to sun or sun lamps while taking PYLERA [see WARNINGS AND PRECAUTIONS]. Bismuth subsalicylate did not show mutagenic potential in the NTP Salmonella plate assay. Gastrointestinal disorders: Furry tongue, glositis, stomatitis; these may be associated with a sudden overgrowth of candida which may occur during therapy[See Warnings and Precautions (5.1)]. PYLERA should not be used in children up to 8 years of age [See Warnings and Precautions (5.3)]. Indigenous microbes and the ecology of human diseases. PYLERA may alter the anticoagulant effects of warfarin and other oral coumarin anticoagulants. Evidence of embryotoxicity has also been noted in animals treated early in pregnancy. Advise women of child-bearing potential to use a different or additional form of contraception while taking PYLERA [see DRUG INTERACTIONS ]. Fertility studies have been conducted with male rates and mice with divergent results. The discoloration is more common during long-term use of the drug but has also been observed following repeated short-term courses. The effect resolved when the drug was discontinued. These products should not be consumed concomitantly with PYLERA. The antibacterial action of bismuth salts is not well understood. Visit the FDA MedWatch website or call 1-800-FDA-1088. Alternatively, a nursing mother may choose to pump and discard human milk for the duration of PYLERA therapy, and for 24 hours after therapy ends and feed her infant stored human milk or formula. No long-term studies have been performed to evaluate the effect of PYLERA on carcinogenesis, mutagenesis, or impairment of fertility. 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. I've already taken 2 courses of antibiotics and the bacteria was still resistant. The capsules are white and opaque, with the Axcan Pharma logo printed on the body and “BMT” printed on the cap. Animal reproductive studies have not been conducted with bismuth subcitrate potassium. Blaser et al. Psychotic reactions have been reported in alcoholic patients who are using metronidazole, a component of PYLERA and disulfiram concurrently. PYLERA is not recommended in patients with severe hepatic impairment (Child-Pugh C) [see CLINICAL PHARMACOLOGY ]. This syndrome may result in stillborn or premature birth due to maternal pathology [see WARNINGS AND PRECAUTIONS]. Pylera enthält eine Gruppe von Arzneimitteln zur Behandlung von erwachsenen Patienten mit einer Helicobacter pylori (H. pylori)-Infektion, die ein Magengeschwür haben oder hatten. Data indicate that oral absorption of tetracycline in infants is low due to the calcium binding in human milk. The usual clinical manifestations are headache and blurred vision. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. What Are Side Effects of Pylera? Original-Beipackzettel. Metronidazole also appears in cerebrospinal fluid, saliva, and breast milk in concentration similar to those found in plasma. 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 (4.4)]. The available human and animal data are summarized below for each of PYLERA's active ingredients: Published case reports have described the yellowing of bones and teeth in human infants exposed to tetracycline during the second and third trimester of pregnancy. Following oral administration, metronidazole is well absorbed, with peak plasma concentrations occurring between 1 and 2 hours after administration. View NDC Code(s)NEW! Discontinue treatment at the first evidence of skin erythema. PYLERA contains bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride. Renal clearance of metronidazole is approximately 10 mL/min/1.73m2. There is no clinical evidence to suggest that short-term exposure to bismuth Cmax concentrations above 50 ng/mL is associated with neurotoxicity. Das Trinken von Alkohol während der Behandlung mit Pylera kann zu unangenehmen. Pill Identifier Tool Quick, Easy, Pill Identification, Drug Interaction Tool Check Potential Drug Interactions, Pharmacy Locator Tool Including 24 Hour, Pharmacies. If visual disturbance occurs during treatment, prompt ophthalmologic evaluation is warranted. Clinical Trials, While this is not a problem in those with normal renal function, in patients with severe renal impairment, higher serum concentrations of tetracycline may lead to azotemia, hyperphosphatemia, and acidosis [See Contraindications (4.4)]. Breakthrough bleeding has been reported. Metronidazole’s antibacterial mechanism of action in an anaerobic environment is not fully understood but a possible mechanism includes reduction by intracellular electron transport proteins after entry into the organism. PYLERA capsules are a combination antimicrobial product containing bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride for oral administration. PYLERA capsules are supplied as bottles of 120 capsules and as the 10 day Therapy pack containing 10 blister cards, with each card containing 12 PYLERA capsules for a total of 120 capsules. (current), bismuth subcitrate 140 MG / metroNIDAZOLE 125 MG / tetracycline HCl 125 MG Oral Capsule, bismuth subcitrate 140 MG / metronidazole 125 MG / tetracycline hydrochloride 125 MG Oral Capsule, PYLERA 140 MG / 125 MG / 125 MG Oral Capsule, bismuth subcitrate 140 MG / metronidazole 125 MG / tetracycline hydrochloride 125 MG Oral Capsule [Pylera], Pylera (bismuth subcitrate 140 MG / metronidazole 125 MG / tetracycline hydrochloride 125 MG) Oral Capsule. home Relabeling of "Additional Barcode" label by: Advise pregnant women that PYLERA capsules can cause fetal harm due to the tetracycline it contains. Die Magenkrebs-Erkrankungsrate ist hierdurch gesunken. Absorption, Distribution, Metabolism and Excretion. Medikament. It is a soluble, complex bismuth salt of citric acid. Less than 20% of the circulating metronidazole is bound to plasma proteins. Table 4: Mean PYLERA Pharmacokinetic Parameters in Fasted and Fed States (N=18)*. One omeprazole 20 mg capsule should be taken twice a day with PYLERA after the morning and evening meal for 10 days. 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 ]. Metronidazole 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. The duration of treatment was 10 days with 147 patients exposed to PYLERA plus omeprazole (OBMT) and 152 exposed to control, consisting of omeprazole, amoxicillin, and clarithromycin (OAC). See full prescribing information for PYLERA. Prominent among the effects in the mouse was an increased incidence of pulmonary tumorigenesis. 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. Oral Contraceptives: Decreased efficacy possibly resulting in pregnancy; use a different or additional form of contraception. Consumption of alcoholic beverages or administration of other products containing propylene glycol during treatment with PYLERA and for at least 3 days afterwards may cause a disulfiram-like reaction (abdominal cramps, nausea, vomiting, headaches, and flushing) due to the interaction between alcohol or propylene glycol and metronidazole, a component of PYLERA. Ohne Anwesenheit von Helicobacter pylori ist ein Signal des Nahrungsstop (Leptin) gehemmt: der Appetit kann steigen. Metronidazole has been reported to increase plasma concentrations of busulfan, which can result in an increased risk for serious busulfan toxicity. 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 presence of food, milk or cations may significantly decrease the extent of absorption. Pylera während der Schwangerschaft und Stillzeit. 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. Ihr Dr. med. Die technische Speicherung oder der Zugriff, der ausschließlich zu anonymen statistischen Zwecken verwendet wird. Adverse reactions with an incidence of <1% for OBMT group are: back pain, vomiting, tongue darkening [See Warnings and Precautions (5.7)]., anxiety, gastritis, gastroenteritis, myalgia, chest pain, increased appetite, blood creatine phosphokinase increased, malaise, somnolence, tachycardia, duodenal ulcer, visual disturbance, weight increased. See 17 for PATIENT COUNSELING INFORMATION. In addition, two studies on PYLERA were conducted to determine the effect of co-administration on the pharmacokinetics of the components. Tetracycline hydrochloride is distributed into most body tissues and fluids. Chronische Verstopfung: bis zu 15% der Bevölkerung betroffen! Tetracycline readily crosses the placenta and is excreted in high amounts in breast milk. (2), Each dose of PYLERA should be taken 4 times a day, after meals and at bedtime for 10 days. Tetracycline has been shown to depress plasma prothrombin activity. This syndrome may result in stillborn or premature birth due to maternal pathology [See Use in Specific Populations (8.3)]. Convulsive seizures, encephalopathy, aseptic meningitis and peripheral neuropathy (including optic neuropathy) have been reported. Tetracyklín a metronidazol patria do skupiny liekov nazývaných antibiotiká. 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. Metronidazole significantly decreased testes and epididymides weight, decreased sperm viability, and increased the incidence of abnormal sperm. You are encouraged to report negative side effects of prescription drugs to the FDA. PYLERA 140 mg/125 mg/125 mg Hartkapseln für Helicobacter-pylori-Gastritis mit Schwindel, Depressionen, Kopfschmerzen, Antriebslosigkeit, Benommenheit, Gangstörung, Gedächtnisprobleme, schwarzer Stuhl. Skin and subcutaneous tissue disorders: Maculopapular and erythematous rashes, onycholysis, discoloration of the nails, exfoliative dermatitis and photosensitivity have been rarely reported [see WARNINGS AND PRECAUTIONS]. If more than 4 doses are missed, advise the patient to contact their health-care provider [see DOSAGE AND ADMINISTRATION]. Dieses Arzneimittel kann die Reaktionsfähigkeit, die Fahrtüchtigkeit und die Fähigkeit, Werkzeuge oder Maschinen zu bedienen, beeinträchtigen! What should I discuss with my healthcare provider before taking Pylera? Völlegefühl. 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]. Each PYLERA capsule contains the following inactive ingredients: Magnesium Stearate NF, Lactose Monohydrate NF, Talc USP, Gelatin USP, and Titanium Dioxide NF. 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. Pylera ® (bismuth subcitrate potassium;lm, metronidazole, and tetracycline hydrochloride) Capsules. Susceptibility testing of Helicobacter pylori for metronidazole has not been standardized. The use of drugs of the tetracycline class during the second and third trimester pregnancy can also cause permanent discoloration of the teeth (yellow-gray brown) and possibly inhibit bone development [See Warnings and Precautions (5.3)]. In patients with significantly impaired renal function, higher serum concentrations of tetracyclines may lead to azotemia, hyperphosphatemia, and acidosis. They do not treat viral infections (e.g., the common cold). 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 Use a SingleCare card to pay $250.43 for 120, 140-125-125mg Capsule of generic Pylera. Clarithromycin 500 mg plus 1000 mg amoxicillin plus 20 mg omeprazole twice a day before the morning and evening meals (OAC). Evidence of embryotoxicity has also been noted in animals treated early in pregnancy. The average urinary elimination of bismuth is 2.6% per day in the first two weeks after discontinuation (urine drug concentrations 24 to 250 mcg/mL) suggesting tissue accumulation and slow elimination. The yellowing is caused by the direct deposition of tetracycline during the mineralization process. Metronidazole has been reported to increase plasma concentrations of busulfan, which can result in an increased risk for serious busulfan toxicity. Reduction in the absorption of all three PYLERA components in the presence of food is not considered to be clinically significant. 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 presence of food, milk or cations may significantly decrease the extent of absorption. Effects have been reversible with discontinuation of bismuth therapy. Metronidazole appears in the plasma mainly as unchanged compound with lesser quantities of the 2-hydroxymethyl metabolite also present. It is distributed into the bile and undergoes varying degrees of enterohepatic recirculation. Effect of Omeprazole on the Bioavailability of Bismuth. Most of the patients who experienced esophageal irritation took the medication immediately before going to bed. Tetracycline readily crosses the placenta and is excreted in high amounts in breast milk. Nursing Mothers: Discontinue drug or nursing taking into consideration the importance of the drug to the mother. Concurrent use of PYLERA with oral contraceptive may make oral contraceptives less effective due to an interaction with the tetracycline component of PYLERA. Photosensitivity, manifested by an exaggerated sunburn reaction, has been observed in patients taking tetracycline [See Adverse Reactions (6.3)]. The schematized empirical molecular formula of bismuth subcitrate potassium is Bi (Citrate)2K5●3 H2O. 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. One long-term follow-up study in children exposed to tetracycline in-utero showed no adverse effects on bone growth and development. (2), Most frequently reported adverse reactions (≥5%); abnormal feces, diarrhea, nausea, and headache. Pylera is a combination product that contains drugs that may pass into breast milk and could have undesirable effects on a nursing infant. Metronidazole, at doses up to 400 mg/kg/day (approximately 3 times the indicated human dose based on mg/m2) for 28 days, failed to produce any adverse effects on fertility and testicular function in male rats. No carcinogenicity or reproductive toxicity studies have been conducted with bismuth subcitrate potassium. avoid: sun exposure. 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. PYLERA plus omeprazole therapy has been shown to be active against most strains of Helicobacter pylori both in vitro and in clinical infections. es kann einem Fötus schaden. Tetracycline hydrochloride is stable in air, but exposure to strong sunlight causes it to darken.
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