AUGMENTINXR- amoxicillin and clavulanate potassium tablet, film coated, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN - UNII:804826J2HU), CLAVULANATE POTASSIUM (UNII: Q42OMW3AT8) (CLAVULANIC ACID - UNII:23521W1S24)

Available from:

Physicians Total Care, Inc.

INN (International Name):

AMOXICILLIN

Composition:

AMOXICILLIN 1000 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

AUGMENTIN XR Extended Release Tablets are indicated for the treatment of patients with community-acquired pneumonia or acute bacterial sinusitis due to confirmed, or suspected β-lactamase−producing pathogens (i.e., H. influenzae , M. catarrhalis , H. parainfluenzae , K. pneumoniae , or methicillin-susceptible S. aureus ) and S. pneumoniae with reduced susceptibility to penicillin (i.e., penicillin MICs = 2 mcg/mL). AUGMENTIN XR is not indicated for the treatment of infections due to S. pneumoniae with penicillin MICs ≥ 4 mcg/mL. Data are limited with regard to infections due to S. pneumoniae with penicillin MICs ≥ 4 mcg/mL (see CLINICAL STUDIES). Of the common epidemiological risk factors for patients with resistant pneumococcal infections, only age > 65 years was studied. Patients with other common risk factors for resistant pneumococcal infections (e.g., alcoholism, immune-suppressive illness, and presence of multiple co-morbid conditions) were not studied. In patients with community-acquire

Product summary:

Each white, oval film-coated bilayer scored tablet, debossed with AUGMENTIN XR, contains amoxicillin trihydrate and amoxicillin sodium equivalent to a total of 1,000 mg of amoxicillin and clavulanate potassium equivalent to 62.5 mg of clavulanic acid. NDC 54868-4735-0     Bottles of 20 NDC 54868-4735-2     Bottles of 28 (7 day XR pack) NDC 54868-4735-1     Bottles of 40 (10 day XR pack)

Authorization status:

New Drug Application

Summary of Product characteristics

AUGMENTINXR - AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, FILM
COATED, EXTENDED RELEASE
PHYSICIANS TOTAL CARE, INC.
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To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
AUGMENTIN XR (amoxicillin/clavulanate potassium) and other
antibacterial drugs, AUGMENTIN XR
should be used only to treat or prevent infections that are proven or
strongly suspected to be caused by
bacteria.
DESCRIPTION
AUGMENTIN XR is an oral antibacterial combination consisting of the
semisynthetic antibiotic
amoxicillin (present as amoxicillin trihydrate and amoxicillin sodium)
and the β-lactamase inhibitor
clavulanate potassium (the potassium salt of clavulanic acid).
Amoxicillin is an analog of ampicillin,
derived from the basic penicillin nucleus 6-aminopenicillanic acid.
The amoxicillin trihydrate
molecular formula is C
H N O S•3H O, and the molecular weight is 419.45. Chemically,
amoxicillin trihydrate is (2_S_,5_R _,6_R_)-6-[(_R
_)-(-)-2-Amino-2-(_p_-hydroxyphenyl)acetamido]-3,3-dimethyl-
7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate
and may be represented
structurally as:
The amoxicillin sodium molecular formula is C
H N NaO S, and the molecular weight is 387.39.
Chemically, amoxicillin sodium is [2_S_-[2α,5α,6β(_S
_*)]]-6-[[Amino(4-hydroxyphenyl)acetyl]amino]-3,3-
dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid
monosodium salt and may be
represented structurally as:
Clavulanic acid is produced by the fermentation of _Streptomyces
clavuligerus_. It is a β-lactam structurally
related to the penicillins and possesses the ability to inactivate a
wide variety of β-lactamases by
blocking the active sites of these enzymes. Clavulanic acid is
particularly active against the clinically
important plasmid-mediated β-lactamases frequently responsible for
transferred drug resistance to
penicillins and cephalosporins. The clavulanate potassium molecular
formula is C H KNO , and the
molecular weight is 237.25. Chemically, clavulanate potassium is
potassiu