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).
The approval was based on an open-label, parallel-group, active-controlled, multicenter study in Helicobacter pylori positive patients with current duodenal ulcer or a history of duodenal ulcer disease was conducted in the United States and Canada (the North American Study).
Patients were randomly assigned to receive 1 of the following 10-day treatment regimens:
Three Pylera capsules four times daily, after meals and at bedtime plus 20 mg omeprazole twice a day after the morning and evening meals (OBMT).
Clarithromycin 500 mg plus 1000 mg amoxicillin plus 20 mg omeprazole twice a day before the morning and evening meals (OAC).
Results showed the following H. pylori eradication rates for OBMT vs OAC at 8 weeks after the 10-day treatment regimen, respectively:
Per Protocol: 92.5% vs 85.7% (difference, 6.8% [95% CI, -0.9, 14.5])
Modified Intent-to-Treat: 87.7% vs 83.2% (difference, 4.5% [95% CI, -3.9, 12.8])
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). Cockayne syndrome. 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. 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.
Abnormal stool, diarrhea, nausea, headache; encephalopathy, peripheral neuropathy, aseptic meningitis, intracranial hypertension (monitor), neurotoxicity, tongue darkening, leukopenia, rash.
Bismuth Subcitrate Potassium (Bismuth)
Elimination half-life: ~5 days in both blood and urine.
Elimination half-life: 8 hours. Renal (60–80%), fecal (6–15%). Renal clearance: ~10 mL/min/1.73m2.
Generic Drug Availability: