Generic Name and Formulations:
Bismuth subcitrate potassium 140mg, metronidazole 125mg, tetracycline HCl 125mg; caps.
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).
Swallow whole 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).
Concomitant methoxyflurane. During or within 14 days of disulfiram. Alcohol or propylene-glycol containing products (during and for ≥3days after treatment). Severe renal impairment. Pregnancy.
Potential for carcinogenicity. May cause permanent teeth discoloration during 2nd/3rd trimester of pregnancy and children up to 8yrs of age; avoid. Discontinue if superinfection, skin erythema or cutaneous reaction occurs. Blood dyscrasias. Monitor CBC with differential before and after treatment. Avoid sun, UV light. Severe hepatic impairment: not recommended; monitor in mild to moderate. Children ≤8yrs: avoid. High tetracycline doses may cause hepatotoxicity in pregnancy. Nursing mothers: not recommended.
See Contraindications. May antagonize oral contraceptives (use non-hormonal backup method). Absorption reduced by antacids containing aluminum, magnesium, or calcium; and by iron, zinc, sodium bicarbonate, and dietary calcium (clinical significance unknown). Potentiated by CYP450 inhibitors (eg, cimetidine). Antagonized by CYP450 inducers (eg, phenytoin, phenobarbital); monitor phenytoin levels. Potentiates busulfan; avoid or monitor if clinically indicated. Monitor lithium, warfarin. Intracranial hypertension with concomitant isotretinoin; avoid. May interfere with GI X-rays, liver function tests, others.
Abnormal stool, diarrhea, nausea, headache; encephalopathy, peripheral neuropathy, aseptic meningitis, intracranial hypertension (monitor), neurotoxicity, tongue darkening, leukopenia, rash
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