Clinical Studies
Major North American Study of Eradication Treatment of Helicobacter pylori in Duodenal Ulcer Patients ...
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
Loren Laine, Richard Hunt, Hala El-Zimaity, Bich Nguyen, Michael Osato, Jean Spénard
Am J Gastroenterol 2003; 98:562-567.
Risk Factors for Helicobacter pylori Resistance in the United States: The Surveillance of H. pylori Antimicrobial Resistance Partnership (SHARP) Study, 1993-1999
Joette M. Meyer, Nancy P. Silliman, Wenjin Wang, Nancy Y. Siepman, Jennifer E. Sugg, David Morris, Jie Zhang, Helen Bhattacharyya, Eileen C. King, and Robert J. Hopkins
Ann Intern Med. 2002;136:13-24.
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.
C. O'Morain, T. Borody, A. Farley, W. A. De Boer, C. Dallaire, R. Schuman, J. Piotrowski, C. A. Fallone, G. Tytgat, F. Mégraud & J. Spérnard
Aliment Pharmacal Ther 2003; 17: 415-420.
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.
