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Pylera Generic Name & Formulations
Legal Class
Rx
General Description
Bismuth subcitrate potassium 140mg, metronidazole 125mg, tetracycline HCl 125mg; caps.
Pharmacological Class
Antimicrobial/antibiotics.
How Supplied
Caps—120
Manufacturer
Generic Availability
YES
Mechanism of Action
Tetracycline interacts with the 30S subunit of the bacterial ribosome and inhibits protein synthesis. Metronidazole’s antibacterial mechanism of action in an anaerobic environment is not fully understood but possibly includes reduction by intracellular electron transport proteins after entry into the organism. Because of this alteration to the metronidazole molecule, a concentration gradient is created and maintained which promotes the drug’s intracellular transport. Presumably, free radicals are formed which, in turn, react with cellular components resulting in death of bacteria. The antibacterial action of bismuth salts is not well understood.
Pylera Indications
Indications
To eradicate H. pylori, in combination with omeprazole, in patients with H. pylori infection and duodenal ulcer disease (active or history of).
Pylera Dosage and Administration
Adult
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).
Children
Not established.
Pylera Contraindications
Contraindications
Concomitant methoxyflurane. During or within 14 days of disulfiram. Alcohol or propylene-glycol containing products (during and for ≥3days after treatment). Cockayne syndrome. Severe renal impairment. Pregnancy.
Pylera Boxed Warnings
Boxed Warning
Potential for carcinogenicity.
Pylera Warnings/Precautions
Warnings/Precautions
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.
Pylera Pharmacokinetics
See Literature
Pylera Interactions
Interactions
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. QT prolongation esp. when concomitant drugs that prolong the QT interval. Intracranial hypertension with concomitant isotretinoin; avoid. May interfere with GI X-rays, liver function tests, others.
Pylera Adverse Reactions
Adverse Reactions
Abnormal stool, diarrhea, nausea, headache; encephalopathy, peripheral neuropathy, aseptic meningitis, intracranial hypertension (monitor), neurotoxicity, tongue darkening, leukopenia, rash.
Pylera Clinical Trials
See Literature
Pylera Note
Not Applicable
Pylera Patient Counseling
See Literature
