OMECLAMOX-PAK- omeprazole, clarithromycin, amoxicillin kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cumberland Pharmaceuticals Inc.

INN (International Name):

OMEPRAZOLE

Composition:

OMEPRAZOLE 20 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

OMECLAMOX-PAK (Omeprazole delayed-release capsules, clarithromycin tablets, and amoxicillin capsules taken together) are indicated for the treatment of patients with Helicobacter pylori infection and duodenal ulcer disease (active or one-year history) to eradicate H. pylori in adults. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14.1) ]. 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 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. OMECLAMOX-PAK is contraindicated in the following patients: - Known history of h

Product summary:

OMECLAMOX-PAK is supplied in a carton containing ten individual daily administration cards. Each card contains the morning dose and the evening dose of the following three drugs: Omeprazole Delayed-Release Capsules, USP, 20 mg Clarithromycin Tablets, USP, 500 mg Amoxicillin Capsules, USP, 500 mg Store at controlled room temperature between 20°C and 25°C (68°F and 77°F). Protect from light and moisture.

Authorization status:

New Drug Application

Summary of Product characteristics

OMECLAMOX-PAK - OMEPRAZOLE, CLARITHROMYCIN, AMOXICILLIN
CUMBERLAND PHARMACEUTICALS INC.
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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.
OMECLAMOX-PAK (OMEPRAZOLE DELAYED-RELEASE CAPSULES; CLARITHROMYCIN
TABLETS, AMOXICILLIN
CAPSULES) CO-PACKAGED FOR ORAL USE
INITIAL U.S. APPROVAL: 2011
RECENT MAJOR CHANGES
Contraindications (4.2)
08/2023
INDICATIONS AND USAGE
OMECLAMOX-PAK, a co-packaged product containing omeprazole, a proton
pump inhibitor, clarithromycin,
a macrolide antimicrobial, and amoxicillin, 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)
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. (1.2)
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 (3):
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, lurasidone, ergotamine or
dihydroergotamine. (4.2, 7.2, 7.3)
WARNINGS AND PRECAUTIONS
Emb