Generic Name and Formulations:
Bismuth subcitrate potassium 140mg, metronidazole 125mg, tetracycline HCl 125mg; caps.

Company:
Aptalis Pharmaceutical Technologies

Indications for PYLERA:
To eradicate H. pylori, in combination with omeprazole, in patients with H. pylori infection and duodenal ulcer disease (active or history of).

Adult:
Take with 8 oz water. 3 caps 4 times daily after meals and at bedtime for 10 days (give with omeprazole 20mg twice daily with breakfast and dinner for 10 days).

Children:
See Contraindications.

Contraindications:
Renal or hepatic impairment. Pediatric patients. Pregnancy (Cat.D). Nursing mothers.

Warnings/Precautions:
Blood dyscrasias. CNS disease. Discontinue if abnormal neurological signs or skin erythema occurs. Avoid sun, UV light.

Interactions:
Avoid alcohol during and for at least 1 day after therapy. Recent (within 2 weeks) therapy with disulfiram: not recommended. May antagonize oral contraceptives (use non-hormonal backup method). May interfere with bactericidal anti-infectives (eg, penicillin). Tetracycline absorption reduced by antacids containing aluminum, magnesium, or calcium; and by iron, zinc, sodium bicarbonate, and dietary calcium (clinical significance unknown). Fatal renal toxicity with methoxyflurane. Metronidazole levels increased by cimetidine, others that inhibit hepatic microsomal enzymes. Metronidazole levels decreased by phenytoin, phenobarbital, other drugs that induce hepatic microsomal enzymes. Monitor phenytoin, lithium, anticoagulants. May interfere with GI X-rays, liver function tests, others.

Pharmacological Class:
Antimicrobial/antibiotics.

Adverse Reactions:
GI effects (diarrhea, dyspepsia, abdominal pain, nausea, gastritis, flatulence), darkening of tongue and/or stool, headache, flu syndrome, taste perversion, asthenia, superinfection (eg, vaginitis), dizziness, rash.

How Supplied:
Caps—120