Source: FDA, National Drug Code (US) Revision Year: 2021
PYLERA in combination with omeprazole are indicated 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. The eradication of Helicobacter pylori has been shown to reduce the risk of duodenal ulcer recurrence.
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 (Table 1).
Table 1. Daily Dosing Schedule for PYLERA:
| 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.
In case of an overdose, patients should contact a physician, poison control center, or emergency room. The available overdosage information for each of the individual components in PYLERA (Metronidazole, Tetracycline and Bismuth subcitrate potassium) are summarized below:
Metronidazole:
Single oral doses of metronidazole, up to 15 g, have been reported in suicide attempts and accidental overdoses. Symptoms reported include nausea, vomiting, and ataxia. Metronidazole is dialyzable.
Neurotoxic effects, including seizures and peripheral neuropathy, have been reported after 5 to 7 days of doses of 6 to 10.4 g every other day.
There is no specific antidote for metronidazole overdose; therefore, management of the patient should consist of symptomatic and supportive therapy.
Tetracycline:
In case of overdosage, discontinue medication, treat symptomatically and institute supportive measures. Dialysis does not alter serum half-life and thus would not be of benefit in treating cases of overdosage.
Bismuth subcitrate potassium:
Symptoms of a bismuth subcitrate potassium overdosage are not known.
Store at controlled room temperature [68° to 77°F or 20° to 25°C].
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