Hyperacidity, GERD, and ulcers:
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 Dosage:
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 Dosage:
Not established.
PYLERA 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.
Boxed Warning:
Potential for carcinogenicity.
PYLERA 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 Classification:
Antimicrobial/antibiotics.
PYLERA 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.
Adverse Reactions:
Abnormal stool, diarrhea, nausea, headache; encephalopathy, peripheral neuropathy, aseptic meningitis, intracranial hypertension (monitor), neurotoxicity, tongue darkening, leukopenia, rash.
Generic Drug Availability:
YES
How Supplied:
Caps—120
