Advise patients to report to their health-care provider the use of any other medications while taking Pylera. The patient did not exhibit symptoms of neurotoxicity during the study. Pylera® is a registered trademark of Aptalis Pharma Canada ULC, an Allergan affiliate. Drugs that Prolong the QT interval Wenden Sie sich an Ihren Apotheker oder an Ihr örtliches Abfallbeseitigungsunternehmen, um weitere Informationen zur sicheren Entsorgung Ihres Produkts zu erhalten. Hypersensitivity Tumors affecting the liver, lungs, mammary and lymphatic tissues have been detected in several studies of metronidazole in rats and mice, but not hamsters [see Nonclinical Toxicology (13)]. Patients with severe hepatic disease metabolize metronidazole slowly, with resultant accumulation of metronidazole and its metabolites in plasma. pressure in the stomach. Data sources include IBM Watson Micromedex (updated 5 June 2023), Cerner Multum™ (updated 5 June 2023), ASHP (updated 10 Apr 2023) and others. Pylera may cause your tongue to become darker in color. Do not double the dose to catch up. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Pylera and other antibacterial drugs, Pylera should be used to treat only indicated infections that are proven or strongly suspected to be caused by susceptible bacteria. 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 (5.5)]. If no therapeutic alternatives to Pylera are available, and concomitant administration with busulfan is medically needed, monitor for busulfan toxicity and busulfan plasma concentrations and adjust the busulfan dose accordingly [see Warnings and Precautions (5.14)]. Kinder sollten dieses Produkt nicht einnehmen, da es Tetracyclin enthält. Wenn jemand eine Überdosierung hat und schwerwiegende Symptome hat, z. Pylera is not recommended in patients with severe hepatic impairment (Child-Pugh C) [see Clinical Pharmacology (12.3)]. Helicobacter pylori macht sich durch ständige Magenprobleme bemerkbar, etwa durch häufiges Aufstoßen, Bauchschmerzen und Blähungen. Denken Sie daran, dass Ihr Arzt Ihnen dieses Medikament verschrieben hat, weil er oder sie der Meinung ist, dass der Nutzen für Sie größer ist als das Risiko von Nebenwirkungen. 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. >/= 2 (n = 25) Therapieversagen. 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. 35 Patienten (70%) hatten einen auslandischen Hintergrund (mediterran, osteuropaisch . Do not use Pylera if you are pregnant. Do not use Pylera if you are pregnant or breastfeeding. Patients should also be monitored for evidence of bleeding [see Warnings and Precautions (5.14)]. Adverse drug reactions with an incidence of ≥ 5% in OAC group include diarrhea, dysgeusia, dyspepsia, nausea and headache. Dieses Produkt kann auch die Röntgenuntersuchung des Magens / Darms beeinträchtigen. 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. These effects were partially reversible. Administration with Fluids Take each dose (3 capsules) with a full glass of water (8 ounces or 240 milliliters) unless your doctor directs you otherwise. Metronidazole has shown mutagenic activity in in vitro assay systems including the Ames test. Verdoppeln Sie nicht die Dosis, um aufzuholen. There is no clinical evidence to suggest that short-term exposure to bismuth Cmax concentrations above 50 ng/mL is associated with neurotoxicity. Orally absorbed bismuth is distributed throughout the entire body. *Pylera given as a single dose of 3 capsules. Metronidazole has been reported to potentiate the anticoagulant effect of warfarin, and other oral coumarin anticoagulants, resulting in a prolongation of prothrombin time. Das Präparat ­Pylera ® enthält drei der vier Wirkstoffe in einer zweischichtigen Hartkapsel. Bismuth absorbs x-rays and may interfere with x-ray diagnostic procedures of the gastrointestinal tract. Concurrent use of Pylera with oral contraceptive may make oral contraceptives less effective due to an interaction with the tetracycline component of Pylera. However, the clinical significance of reduced tetracycline systemic exposure is unknown as the relative contribution of systemic versus local antimicrobial activity against Helicobacter pylori has not been established. Severe irreversible hepatotoxicity/acute liver failure with fatal outcomes have been reported after initiation of metronidazole in patients with Cockayne syndrome, General disorders and administration site conditions, smaller capsule (size 3) containing tetracycline hydrochloride, 125 mg, Bismuth subcitrate potassium is a white or almost white powder. -Helicobacter pylori eradication has been shown to reduce duodenal ulcer recurrence risk. Tell your doctor right away if you get sunburned or have skin blisters/redness. These are harmless and temporary side effects. Pylera is usually taken after meals and at bedtime. Evidence of embryotoxicity has also been noted in animals treated early in pregnancy. Metronidazole has been shown to be carcinogenic in mice and rats. Informieren Sie sofort Ihren Arzt, wenn Sie schwanger werden oder vermuten, schwanger zu sein. Begrenzen Sie Ihre Zeit in der Sonne. Avoid alcoholic beverages and products containing propylene glycol while taking this product and for at least 3 days after finishing this product because severe stomach upset/cramps, nausea, vomiting, headache, and flushing may occur. Anticoagulants They work by stopping the growth of bacteria.This product treats only bacterial infections. Rufen Sie andernfalls sofort ein Giftkontrollzentrum an. You should not breastfeed within 2 days after using Pylera. 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)]. 5 Patienten werden in Kürze zur Kontrolle erwartet, 7 Patienten haben sich der Nachbeobachtung entzogen. If a dose is missed, patients should continue the normal dosing schedule until medication is gone. You should not use Pylera if you are allergic to bismuth subcitrate potassium, metronidazole, or tetracycline, or if: you regularly consume foods or medicines that contain propylene glycol; you took disulfiram (Antabuse) within the past 14 days; or. Discontinue treatment at the first evidence of a cutaneous reaction [see Adverse Reactions (6.2)]. Do not use it later for another infection unless your doctor tells you to. Alle Patienten wurden anhand eines standardisierten Flyers über die Therapie aufgeklärt. Because elderly patients are more likely to have decreased renal function, additional monitoring may be required [see Contraindications (4.5)]. Dairy products (such as milk, yogurt), calcium-enriched juice, sucralfate, iron, and zinc are also included. This condition may occur during treatment or weeks to months after treatment has stopped. Reduction in the absorption of all three Pylera components in the presence of food is not considered to be clinically significant. Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. Absorption and Distribution In general, elderly patients may have a greater frequency of decreased hepatic, renal, or cardiac function, and concomitant diseases or other drug therapies. Keep all medications away from children and pets. Zur Verkehrstüchtigkeit. Stellen Sie sicher, dass das Laborpersonal und alle Ihre Ärzte wissen, dass Sie dieses Medikament verwenden. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use. Starten, stoppen oder ändern Sie die Dosierung von Arzneimitteln nicht ohne die Zustimmung Ihres Arztes. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment. Bismuth subcitrate potassium Two lifetime tumorigenicity studies in hamsters have been performed and reported to be negative. However, you may not be able to tell this effect apart from blood in the stool, which could be a sign of a serious condition. Pylera is not recommended in patients with severe hepatic impairment [see Warnings and Precautions (5.10) and Clinical Pharmacology (12.3)]. Lithium Subscribe to Drugs.com newsletters for the latest medication news, new drug approvals, alerts and updates. 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 bismuth subcitrate potassium 140 mg / metronidazole 125 mg / tetracycline hydrochloride 125 mg (B M T AXCAN PHARMA), Metronidazole has been shown to be carcinogenic in mice and rats, . Informieren Sie sofort Ihren Arzt, wenn eine dieser unwahrscheinlichen, aber schwerwiegenden Nebenwirkungen auftritt: Taubheitsgefühl / Kribbeln der Arme / Beine, verfärbte Zähne, mentale / Stimmungsschwankungen (wie Verwirrung, Angstzustände, Reizbarkeit, Depressionen), schwieriges / schmerzhaftes Schlucken, Sodbrennen schneller / klopfender Herzschlag, Klingeln in den Ohren, häufiges / schmerzhaftes Wasserlassen. Pylera may alter the anticoagulant effects of warfarin and other oral coumarin anticoagulants. Some related antibiotics (oxytetracycline, minocycline) have shown evidence of oncogenic activity in rats. Tetracyclin kann selten einen schwerwiegenden Druckanstieg im Schädel verursachen (intrakranielle Hypertonie-IH). 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. 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. Absorption and Distribution Store at room temperature away from moisture and heat. Things to remember when you fill your prescription. Some products that may interact with this drug include: alcohol-containing products (such as cough and cold syrups, aftershave), atovaquone, digoxin, lithium, lopinavir/ritonavir solution, products containing propylene glycol, retinoid medications (such as acitretin, isotretinoin, tretinoin), strontium. One omeprazole 20 mg capsule should be taken twice a day with Pylera after the morning and evening meal for 10 days (Table 1). Metabolism and nutrition disorders: Pancreatitis. Pylera contains a combination of bismuth subcitrate potassium, metronidazole, and tetracycline. 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. B. Anfälle), Schluckbeschwerden, Probleme mit der Speiseröhre (z. Psychotic reactions have been reported in alcoholic patients who are using metronidazole, a component of Pylera, and disulfiram concurrently [see Drug Interactions (7.2)]. Metronidazole is 2-methyl-5-nitroimidazole-1-ethanol, with a molecular. Schlucken Sie die Kapseln im Ganzen. Informieren Sie sofort Ihren Arzt, wenn Sie einen Sonnenbrand bekommen oder Hautbläschen / -rötungen haben. It is a soluble, complex bismuth salt of citric acid. Einwohner Kanadas können ein Giftkontrollzentrum der Provinz anrufen. Das Risiko dieser Nebenwirkung ist bei Frauen im gebärfähigen Alter, die übergewichtig sind oder in der Vergangenheit unter IH leiden, größer. Renal and urinary disorders: Increased BUN. In der Leitlinie von 2016 wurden die Triple-Therapien als First-Linie-Therapie aufgeführt, aktuell wird hingegen die Bismut-Quadrupeltherapie empfohlen. Einwohner der USA können ihr örtliches Giftkontrollzentrum unter 1-800-222-1222 anrufen. Blood and Lymphatic system disorders: Reversible neutropenia (leucopenia) in cases of prolonged treatment; rarely reversible thrombocytopenia however no persistent hematological abnormalities attributable to metronidazole have been observed [see Warnings and Precautions (5.9)]. Wenn Sie eine Dosis vergessen haben, überspringen Sie die vergessene Dosis. Metronidazole also appears in cerebrospinal fluid, saliva, and breast milk in concentration similar to those found in plasma. Hepatic: Cases of severe irreversible hepatotoxicity/acute liver failure, including cases with fatal outcomes with very rapid onset after initiation of systemic use of metronidazole, have been reported in patients with Cockayne Syndrome (latency from drug start to signs of liver failure as short as 2 days) [see Contraindications (4.4)]. While taking Pylera and for 3 days after your last dose: Do not drink alcohol or consume foods, medicines, or other products that contain alcohol or propylene glycol. Bräunungskabinen und Sonnenlampen vermeiden. The antibacterial action of bismuth salts is not well understood. If visual disturbance occurs during treatment, prompt ophthalmologic evaluation is warranted. Patients should be counseled that antibacterial drugs including Pylera should only be used to treat bacterial infections. Do not administer Pylera concomitantly with busulfan unless the benefit outweighs the risk. All 3 capsules should be taken 4 times a day (after meals and at bedtime) for 10 days. Manage and view all your plans together – even plans in different states. Entsorgen Sie dieses Produkt ordnungsgemäß, wenn es abgelaufen ist oder nicht mehr benötigt wird. Instruct patients taking Pylera to avoid exposure to the sun or sun lamps. Tetracycline hydrochloride is (4S,4aS,5aS,6S,12aS)-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,6,10,12,12a-penta-hydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide hydrochloride, with a molecular formula of C22H24N2O8●HCl and the following structural formula: Pylera is a combination of antibacterial agents (metronidazole and tetracycline hydrochloride) and bismuth subcitrate potassium [see Microbiology (12.4)]. Because of this alteration to the metronidazole molecule, a concentration gradient is created and maintained which promotes the drug’s intracellular transport. Tetracycline has been shown to depress plasma prothrombin activity. Pylera is used to treat peptic ulcer (duodenal ulcer) with Helicobacter pylori infection. Data indicate that oral absorption of tetracycline in infants is low due to the calcium binding in human milk. formula of C6H9N3O3 and the following structural formula: Tetracycline hydrochloride is a yellow, odorless, crystalline powder. Psychotic reactions have been reported in alcoholic patients who are using metronidazole, a component of Pylera and disulfiram concurrently. Do not take this product if you are also taking disulfiram or if you have taken disulfiram within the last 2 weeks. unsteadiness or awkwardness. 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. Metronidazole has been reported to increase plasma concentrations of busulfan, which can result in an increased risk for serious busulfan toxicity. Use sunscreen and wear protective clothing when outdoors. Sodbrennen, Gastritis und Magen- bzw. Ergebnisse: Bis 3/2014 wurde bei 50 Patienten eine Therapie mit Pylera® verordnet. Tell your doctor if you have unlikely but serious side effects of Pylera including: numbness and tingling of arms or legs, discolored teeth, mental/mood changes (such as confusion, anxiety, irritability, depression), difficult or painful swallowing, heartburn, Risk Summary Metronidazole usage in pregnancy has been associated with certain congenital anomalies [see Data]. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. Nicht im Badezimmer aufbewahren. Fertility studies have been performed in male mice at doses up to six times the maximum recommended human dose based upon mg/m2 and have revealed no evidence of impaired fertility. Antimicrobial Activity Tetracycline readily crosses the placenta and is excreted in high amounts in breast milk. The eradication rates for both groups were found to be similar using either the Per Protocol (PP) or Modified Intent-to-Treat (MITT) populations. Hartkapseln Hersteller LABORATOIRES JUVISE PHARMACEUTICALS Produktdetails & Pflichtangaben verschreibungspflichtiges Arzneimittel Arzneimittelservice Beipackzettel PYLERA® 140 mg/125 mg/125 mg Wirkstoffe & Hilfsstoffe
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