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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.

INDICATION

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

CONTRAINDICATIONS

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

DRUG INTERACTIONS

Drug interactions exist with PYLERA^®. Please refer to the full US Prescribing Information for complete details.

• Methoxyflurane: Risk of fatal renal toxicity; do not co-administer
• Disulfiram: Psychotic reactions can occur; do not take concurrently or within the last 2 weeks of disulfiram
• Alcohol: Abdominal cramps, nausea, vomiting, headaches, and flushing can occur; do not consume during therapy and for at least 3 days afterwards
• Oral Contraceptives: Decreased efficacy possibly resulting in pregnancy; use a different or additional form of contraception
• Anticoagulants: Potentiation of the anticoagulant effect; prothrombin time, international normalized ratio (lNR), or other suitable anticoagulation tests should be closely monitored
• Lithium: Increased lithium serum concentrations; measure serum lithium and serum creatinine concentrations during therapy
• Antacids, Multivitamins or Dairy Products: Decreased absorption of PYLERA^®; do not take concomitantly

USE IN SPECIAL POPULATIONS

• Nursing Mothers: Discontinue drug or nursing, taking into consideration the importance of the drug to the mother
• 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

ADVERSE REACTIONS

The most frequently reported adverse reactions (≥5%) during clinical trials were:

• Abnormal feces
• Diarrhea
• Nausea
• Headache

DOSAGE AND ADMINISTRATION

• Each dose of PYLERA^® includes 3 capsules
• Each dose of PYLERA^® should be taken 4 times a day, after meals and at bedtime for 10 days
• Administer PYLERA^® with omeprazole 20 mg twice daily, after morning and evening meals

DOSAGE FORMS AND STRENGTHS

Each capsule of PYLERA^® contains

• 140 mg of bismuth subcitrate potassium
• 125 mg of metronidazole
• 125 mg of tetracycline hydrochloride

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit http://www.fda.gov/medwatch/ or call 1-800-FDA-1088.