OMECLAMOX-PAK omeprazole clarithromycin amoxicillin

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

OMEPRAZOLE (UNII: KG60484QX9) (OMEPRAZOLE - UNII:KG60484QX9)

Beszerezhető a:

Pernix Therapeutics, LLC

INN (nemzetközi neve):

OMEPRAZOLE

Összetétel:

OMEPRAZOLE 20 mg

Recept típusa:

PRESCRIPTION DRUG

Engedélyezési státusz:

New Drug Application

Termékjellemzők

OMECLAMOX-PAK- OMEPRAZOLE, CLARITHROMYCIN, AMOXICILLIN
PERNIX THERAPEUTICS, LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
OMECLAMOX-PAK™ SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING INFORMATION FOR OMECLAMOX-PAK™.
OMECLAMO X-PAK™
INITIAL U.S. APPROVAL: 2011
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Omeclamox-Pak™ and other
antibacterial drugs, Omeclamox-Pak™ should be used only to treat or
prevent infections that are proven or strongly
suspected to be caused by bacteria. (1)
RECENT MAJOR CHANGES
Acute Interstitial Nephritis (5.6)
12/2014
INDICATIONS AND USAGE
Omeclamox-Pak™, a copackaged product containing a proton pump
inhibitor, a macrolide antimicrobial, and a penicillin
class antibacterial, is indicated for the treatment of patients with
_Helicobacter pylori_ infection and duodenal ulcer disease
(active or up to one-year history) to eradicate _H. pylori._ (1.1)
DOSAGE AND ADMINISTRATION
Adult regimen: omeprazole 20 mg plus clarithromycin 500 mg plus
amoxicillin 1000 mg, each given twice daily for 10
days in the morning and evening before eating a meal. (2)
Advise patients to swallow all tablets and capsules whole. (2)
In patients with an ulcer present at initiation of therapy, an
additional 18 days of omeprazole 20 mg once daily is
recommended. (2)
DOSAGE FORMS AND STRENGTHS
Pack of 10 daily administration cards for morning and evening dosing,
each containing: (4)
Two omeprazole delayed-release capsules, USP, 20 mg.
Two clarithromycin tablets, USP, 500 mg.
Four amoxicillin capsules, USP, 500 mg.
CONTRAINDICATIONS
Known hypersensitivity to omeprazole, any macrolide antibiotic, any
penicillin, or any component of the formulations.
(4.1)
Coadministration with pimozide, ergotamine or dihydroergotamine. (4.2,
7.2, 7.3)
WARNINGS AND PRECAUTIONS
Fetal risk and clarithromycin: Based on animal data, may cause fetal
harm. Use in pregnancy only when there is no
appropriate alternative therapy