PYLERA is a combination antibacterial 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. (1.1)

• Each dose of PYLERA includes 3 capsules. (2)

• Each dose of PYLERA should be taken 4 times a day, after meals and at bedtime for 10 days. (2)

• Administer PYLERA with omeprazole 20 mg twice daily (after the morning and evening meals). (2)

DOSAGE FORMS AND STRENGTHS

• Patients with renal impairment. (4.4)
• Patients with known hypersensitivity to product components. (4.5)

• Fetal Toxicity: Advise pregnant women of the risk for permanent discoloration of teeth with tetracycline if used during the second or third trimester (5.1, 8.1)
• Maternal Toxicity: Risk of hepatotoxicity in pregnant women with high doses of intravenous tetracycline also resulting in stillborn or premature birth (5.2, 8.1)
• 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. (5.4)
• Development of Superinfection: If superinfection occurs, discontinue PYLERA and institute appropriate therapy. (5.5)
• Photosensitivity: avoid exposure to sun and sun lamps. (5.6)

Most frequently reported adverse reactions (≥5%); abnormal feces, diarrhea, nausea, and headache. (6.1)

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.

• Methoxyflurane: Risk of fatal renal toxicity; do not co-administer.  (4.1, 7.1)
• Disulfiram: Psychotic reactions can occur; do not take concurrently or within the last 2 weeks of disulfiram.  (4.2, 7.2)
• Alcohol: Abdominal cramps, nausea, vomiting, headaches, and flushing can occur; do no consume during therapy and for at least 3 days afterwards.  (7.3)
• Oral Contraceptives: Decreased efficacy possibly resulting in pregnancy; use a different or additional form of contraception.  (7.4)
• Anticoagulants: Potentiation of the anticoagulant effect; Prothrombin time, International Normalized Ratio (INR), or other suitable anticoagulation tests should be closely monitored. (7.5)
• Lithium: Increased lithium serum concentrations; measure serum lithium and serum creatinine concentrations during therapy. (7.6)
• Antacids, Multivitamins or Dairy Products: Decreased absorption of PYLERA; do not take concomitantly.  (7.7)

• Nursing Mothers: Discontinue drug or nursing taking into consideration the importance of the drug to the mother. (8.3)
• Pediatric Use: Tetracycline may cause permanent discoloration of the teeth.  Enamel hypoplasia has also been reported.  Do not use in children less than 8 years of age.