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PYLERA
Hyperacidity, GERD, and ulcers
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Drug Name:

PYLERA Rx

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

Company:
Allergan

Therapeutic Use:

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:

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.

Contraindications:

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.

Warnings/Precautions:

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.

Pharmacological Class:

Antimicrobial/antibiotics.

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. Intracranial hypertension with concomitant isotretinoin; avoid. May interfere with GI X-rays, liver function tests, others.

Adverse Reactions:

Abnormal stool, diarrhea, nausea, headache; encephalopathy, peripheral neuropathy, aseptic meningitis, intracranial hypertension (monitor), neurotoxicity, tongue darkening, leukopenia, rash

How Supplied:

Caps—120

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