PYLERA (bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride- 140 mg/125 mg/125 mg capsule

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

Bismuth subcitrate potassium (UNII: R3O80H60KX) (BISMUTH - UNII:U015TT5I8H), Metronidazole (UNII: 140QMO216E) (Metronidazole - UNII:140QMO216E), Tetracycline hydrochloride (UNII: P6R62377KV) (Tetracycline - UNII:F8VB5M810T)

Saadav alates:

Physicians Total Care, Inc.

INN (Rahvusvaheline Nimetus):

Bismuth subcitrate potassium

Koostis:

Bismuth subcitrate potassium 140 mg

Manustamisviis:

ORAL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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. 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. Do not administer methoxyflurane to patients taking PYLERA. The concurrent use of tetracycline hydrochloride, a component of PYLERA, with methoxyflurane has been reported to resu

Toote kokkuvõte:

PYLERA is supplied as a white opaque capsule containing 140 mg bismuth subcitrate potassium, 125 mg metronidazole, and 125 mg tetracycline hydrochloride, with the Axcan Pharma logo printed on the body and “BMT” printed on the cap. PYLERA is supplied in: Storage Store at controlled room temperature [68° to 77°F or 20° to 25°C] Relabeling of "Additional Barcode" label by: Physicians Total Care, Inc. Tulsa, OK        74146

Volitamisolek:

New Drug Application

Toote omadused

PYLERA - BISMUTH SUBCITRATE POTASSIUM, METRONIDAZOLE, TETRACYCLINE
HYDROCHLORIDE (140 MG/125
MG/125 MG) CAPSULE
PHYSICIANS TOTAL CARE, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
PYLERA SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR PYLERA. INITIAL U.S. APPROVAL: 2006
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. (1)
INDICATIONS AND USAGE
PYLERA is a combination antibacterial 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_. (1.1)
DOSAGE AND ADMINISTRATION
Each dose of PYLERA includes 3 capsules. (2)
Each dose of PYLERA should be taken 4 times a day, after meals and at
bedtime for 10 days. (2)
Administer PYLERA with omeprazole 20 mg twice daily (after the morning
and evening meals). (2)
DOSAGE FORMS AND STRENGTHS
Each capsule of PYLERA contains: (3)
140 mg of bismuth subcitrate potassium
125 mg of metronidazole
125 mg of tetracycline hydrochloride
CONTRAINDICATIONS
Patients with renal impairment. (4.4)
Patients with known hypersensitivity to product components. (4.5)
WARNINGS AND PRECAUTIONS
Fetal Toxicity: Advise pregnant women of the risk for permanent
discoloration of teeth with tetracycline if used during
the second or third trimester (5.1, 8.1)
Maternal Toxicity: Risk of hepatotoxicity in pregnant women with high
doses of intravenous tetracycline also resulting
in stillborn or premature birth (5.2, 8.1)
Central and Peripheral Nervous System Effects: encephalopathy and
peripheral neuropathy with metronidazole,
pseudotumor cerebri with tetracycline and neurotoxicity with
bismuth-containing products; Monitor patients with CNS
conditions closely and discontinue promptly if abnormal neurologic
signs dev