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).

Clinical Trials:

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])

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:


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.

Drug Elimination:

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.

Tetracycline Hydrochloride

  • Renal, fecal.

Generic Drug Availability:


How Supplied: