To request personally-delivered samples of PYLERA®, please complete the following information and e-mail or fax this form to the Aptalis Customer Service Department at (205) 991-8426.
IMPORTANT SAFETY INFORMATION
To reduce the development of drug-resistant bacteria and maintain the effectiveness of PYLERA® and other antibacterial drugs, PYLERA® should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
PYLERA® Capsules (bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride), in combination with omeprazole, are indicated for the treatment of patients with Helicobacter pylori (H. pylori) infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori
PYLERA® is contraindicated in:
Patients with renal impairment
Patients with known hypersensitivity to product components
WARNINGS AND PRECAUTIONS
Fetal Toxicity: Advise pregnant women of the risk for permanent discoloration of teeth with tetracycline if used during the second or third trimester
Maternal Toxicity: Risk of hepatotoxicity in pregnant women with high doses of intravenous tetracycline also resulting in stillborn or premature birth
Metronidazole is a nitroimidazole and should be used with caution in patients with evidence of, or history of, blood dyscrasia. A mild leukopenia has been observed; however, no persistent hematologic abnormalities attributable to metronidazole have been observed.
Central and Peripheral Nervous System Effects: Encephalopathy and peripheral neuropathy with metronidazole, pseudotumor cerebri with tetracycline and neurotoxicity with bismuth-containing products; monitor patients with CNS conditions closely and discontinue promptly if abnormal neurologic signs develop
Development of Superinfection: If superinfection occurs, discontinue PYLERA® and institute appropriate therapy
Photosensitivity: Avoid exposure to sun and sun lamps