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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 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.
Eradication of Helicobacter pylori in Patients with Active Duodenal Ulcer or History of Duodenal Ulcer Disease
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.
DOSAGE AND ADMINISTRATION
Each dose of PYLERA is 3 capsules. Each dose of all 3 capsules should be taken 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 evening meal||3||1|
Instruct patients to swallow the PYLERA apsules 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.
Dosage Forms And Strengths
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 APTALISTM logo printed on the body and “BMT” printed on the cap.
Storage And Handling
PYLERA is supplied as a white opaque capsule containing 140 mg bismuth subcitrate potassium, 125 mg metronidazole, and 125 mg tetracycline hydrochloride, with the APTALISTM logo printed on the body and “BMT” printed on the cap. PYLERA Capsules are supplied as bottles of 120 capsules and as the 10 day Therapy pack containing 10 blister cards, with each card containing 12 PYLERA capsules for a total of 120 capsules.
NDC Number: 58914-600-21, Bottles of 120.
NDC Number: 58914-600-20, Blister pack of 120.
Store at controlled room temperature [68° to 77°F or 20° to 25°C].
Manufactured for: Aptalis Pharma US, Inc., 200 Somerset Corporate Boulevard, Bridgewater, NJ 08807 USA. Revised 9/2012
Last reviewed on RxList: 2/6/2013
This monograph has been modified to include the generic and brand name in many instances.
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