Pylera Prescribing Information
Metronidazole, a component of PYLERA, has been shown to be carcinogenic in mice and rats. Tumors affecting the liver, lungs, mammary and lymphatic tissues have been detected in several studies of metronidazole in rats and mice, but not hamsters
Warnings and Precautions, Severe Cutaneous Adverse Reactions (Metronidazole : Severe cutaneous adverse reactions (SCARs) including toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with the use of metronidazole. Symptoms can be serious and potentially life threatening. If symptoms or signs of SCARs develop, discontinue PYLERA capsules immediately and institute appropriate therapy.Tetracycline : Fixed drug eruptions have occurred with tetracycline and have been associated with worsening severity upon subsequentadministrations, including generalize bullous fixed drug eruption [see Adverse Reactions (6.3)] . If severe skin reactions occur,discontinue PYLERA immediately, and institute appropriate therapy. | 3/2025 |
Contraindications, Methoxyflurane (PYLERA is contraindicated in patients who have taken disulfiram within the last two weeks. Psychotic reactions have been reported in alcoholic patients who are using metronidazole, a component of PYLERA, and disulfiram concurrently [see Drug Interactions (7.1)] . | Removed 3/2025 |
PYLERA is a combination of metronidazole, a nitroimidazole antimicrobial, tetracycline,- a tetracycline class antimicrobial and bismuth subcitrate potassium, indicated for use, in combination with omeprazole, for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or history of within the past 5 years) to eradicate H. pylori. (
PYLERA in combination with omeprazole are indicated for the treatment of patients with
To reduce the development of drug-resistant bacteria and maintain the effectiveness of PYLERA and other antibacterial drugs, PYLERA should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. (
To reduce the development of drug-resistant bacteria and maintain the effectiveness of PYLERA and other antibacterial drugs, PYLERA should be used to treat only indicated infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Administer three PYLERA capsules 4 times a day (after meals and at bedtime) for 10 days. One omeprazole 20 mg capsule should be taken twice a day with PYLERA after the morning and evening meal for 10 days (
| Time of dose | Number of capsules of PYLERA | Number of capsules of omeprazole 20 mg |
|---|---|---|
| After morning meal | 3 | 1 |
| After lunch | 3 | 0 |
| After evening meal | 3 | 1 |
| At bedtime | 3 | 0 |
Instruct patients to swallow the PYLERA capsules whole with a full glass of water (8 ounces). Ingestion of adequate amounts of fluid, particularly with the bedtime dose, is recommended to reduce the risk of esophageal irritation and ulceration by tetracycline hydrochloride.
If a dose is missed, patients should continue the normal dosing schedule until medication is gone. Patients should not take double doses. If more than 4 doses are missed, the prescriber should be contacted.
Each PYLERA capsule contains 140 mg of bismuth subcitrate potassium, 125 mg of metronidazole, and a smaller capsule inside containing 125 mg of tetracycline hydrochloride. The capsules are white and opaque, with the APTALIS™ logo printed on the body and "BMT" printed on the cap.
- Lactation: A woman should pump and discard human milk for the duration of PYLERA therapy, and for 2 days after therapy ends. ()
8.2 LactationRisk SummaryTwo of the individual components of PYLERA, tetracycline and metronidazole, are present in human milk at concentrations similar to maternal serum levels. It is not known whether bismuth subcitrate, the third component of PYLERA is present in human milk. It is not known what effect metronidazole, tetracycline or bismuth has on the breastfed infant or on milk production. Tetracycline binds with calcium in human milk
[see Clinical Pharmacology (12.3)].Data indicate that oral absorption of tetracycline in infants is low due to the calcium binding in human milk. Metronidazole transfers to human milk, and infant serum levels can be close to or comparable to infant therapeutic levels. Because of the potential risk of tumorigenicity shown in animal studies with metronidazole, a woman should pump and discard human milk for the duration of PYLERA therapy, and for 2 days after therapy ends, and feed her infant stored human milk (collected prior to therapy) or formula. - Pediatric Use: Tetracycline may cause permanent discoloration of the teeth. Enamel hypoplasia has also been reported. Do not use in children less than 8 years of age. (,
5.4 Tooth Enamel Discoloration and HypoplasiaThe use of drugs of the tetracycline class during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years) may cause permanent discoloration of the teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the drug, but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. PYLERA, therefore, should not be used in this age group unless other drugs are not likely to be effective or are contraindicated
[see Use in Specific Populations (8.4)].)8.4 Pediatric UseSafety and effectiveness of PYLERA in pediatric patients infected with
Helicobacter pylorihave not been established.Tetracycline use in children may cause permanent discoloration of the teeth. Enamel hypoplasia has also been reported. PYLERA should not be used in children up to 8 years of age
[see Warnings and Precaution (5.4)].