Product Information
Discover the Power of 3-in-1 with PYLERA®
- PYLERA® Capsules (with BID omeprazole 20mg) achieve an overall eradication rate of 93% after 10 days of treatment2
- Eradication rates of clarithromycin-based regimens decrease to as low as 21.4% in resistant strains3
- PYLERA® is not a clarithromycin-based therapy and does not contain antibiotics of the macrolide class1
- PYLERA® Capsules have a well established safety and tolerability profile1,3
- Recommended as first-line therapy by ACG4
- Innovative 3-in-1 capsules taken with omeprazole reinvent quadruple therapy1
- Broad managed care coverage versus other brands6
- NDC 58914-600-21, bottle of 120 capsules
Convulsive seizures and peripheral neuropathy, the latter characterized mainly by numbness or paresthesia of an extremity, have been reported in patients treated with metronidazole. The prevalence and severity of the neuropathy are directly related to the cumulative dose and duration of therapy, being most prevalent in patients taking high doses for prolonged treatment periods. The appearance of abnormal neurologic signs demands the prompt discontinuation of metronidazole therapy.
References
1. PYLERA® Capsules Prescribing Information. 2. O’Morain C, et al . Efficacy and safety of single-triple capsules of bismuth biskalcitrate, metronidazole and tetracycline, given with omeprazole, for the eradication of Helicobacter pylori: an international multicentre study. Aliment Pharmacol Ther 2003; 17: 415-420. 3. Laine L, Hunt R, El-Zimaity H, Nguyen B, Osato M, Spenard J. Bismuth-based quadruple therapy using a single capsule of bismuth biskalcitrate, metronidazole, and tetracycline given with omeprazole versus omeprazole, amoxicillin, and clarithromycin for eradication of Helicobacter pylori in duodenal ulcer patients: A prospective, randomized, multicenter, North American trial. Am J Gastroenterol 2003; 98:562-567. 4. Chey WD, Wong BC. Practice Parameters Committee of the American College of Gastroenterology. American College of Gastroenterology Guideline on the Management of Helicobacter pylori Infection. Am J Gastroenterol. 2007 August; 102:1808-1825. 6. Wolters Kluwer Health TRx Report, April 2008.
PYLERA® is available by prescription only
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use PYLERA® safely and effectively. See full prescribing information for PYLERA®
PYLERA® (Bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride) CAPSULES for oral administration Initial U.S. Approval: 2006
INDICATIONS AND USAGE
PYLERA® Capsules (bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride), 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. The eradication of Helicobacter pylori has been shown to reduce the risk of duodenal ulcer recurrence. (See CLINICAL STUDIES and DOSAGE AND ADMINISTRATION)
DOSAGE AND ADMINISTRATION
Each dose of PYLERA® includes 3 capsules. Each dose of all 3 capsules should be taken 4 times a day, after meals and at bedtime, for 10 days in combination with BID omeprazole (20 mg).
DOSAGE FORMS AND STRENGTHS
Each capsule of PYLERA® contains:
- 125 mg of metronidazole
- 140 mg of bismuth subcitrate potassium
- 125 mg of tetracycline hydrochloride contained in inner capsule
CONTRAINDICATIONS
PYLERA® is contraindicated in:
- Pregnant or nursing women
- Pediatric patients up to 8 years of age
- Patients with renal or hepatic impairment
- Patients with known hypersensitivity to bismuth subcitrate potassium, metronidazole or other nitroimidazole derivatives, or tetracyclines.
WARNINGS AND PRECAUTIONS
- Development of drug-resistant bacteria: PYLERA® should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria..
- Neurotoxicity: rare reports associated with excessive doses of various bismuth-containing products with long term use..
- Convulsive seizures and peripheral neuropathy: reported in patients treated with metronidazole..
- The use of tetracycline during tooth development may cause permanent discoloration of the teeth..
- Caution must be taken in patients with evidence of or history of blood dyscrasia..
- Photosensitivity, manifested by an exaggerated sunburn reaction, has been observed in some individuals taking tetracycline.
DRUG INTERACTIONS
A large number of drug interactions exist with PYLERA® including alcohol, anticoagulants, anticonvulsants, and oral contraceptives. Also note that PYLERA® may interfere with x-ray diagnostic procedures of the gastrointestinal tract and with certain types of determinations of serum chemistry values. Please refer to Full US Prescribing Information for complete details.
USE IN SPECIAL POPULATIONS
- Pregnancy Category D.
- Pediatric use: should not be used in children less than 8 years of age.
- Geriatric use: there is insufficient data in elderly patients. Caution should be taken with these patients.
- Nursing mothers: Metronidazole and tetracycline are both excreted in human milk.
ADVERSE REACTIONS
The most frequently reported adverse reactions (>5%) during clinical trials were: diarrhea, dyspepsia, nausea, stool abnormality (excluding diarrhea), abdominal pain, headache, and flu syndrome.
You are encouraged to report negative side effects of prescription drugs to Aptalis or the FDA. Call Aptalis at 1-800-472-2634, visit
http://www.fda.gov/medwatch/ or call 1-800-FDA-1088.
