AUGMENTIN- amoxicillin and clavulante potassium tablet, film coated AUGMENTIN- amoxicillin and clavulante potassium tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9), CLAVULANATE POTASSIUM (UNII: Q42OMW3AT8) (CLAVULANIC ACID - UNII:23521W1S24)

Available from:

Physicians Total Care, Inc.

INN (International Name):

AMOXICILLIN

Composition:

AMOXICILLIN 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

AUGMENTIN is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: − caused by β-lactamase−producing strains of H. influenzae and M. catarrhalis . − caused by β-lactamase−producing strains of H. influenzae and M. catarrhalis . − caused by β-lactamase−producing strains of H. influenzae and M. catarrhalis . − caused by β-lactamase−producing strains of S. aureus , E. coli , and Klebsiella spp. − caused by β-lactamase−producing strains of E. coli , Klebsiella  spp., and Enterobacter spp. While AUGMENTIN is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with AUGMENTIN due to its amoxicillin content; therefore, mixed infections caused by ampicillin-susceptible organisms and β-lactamase−producing organisms susceptible to AUGMENTIN should not require the addition of another antibiotic. Because amoxicillin has greater in vitro activity again

Product summary:

Each white oval filmcoated tablet, debossed with AUGMENTIN on 1 side and 250/125 on the other side, contains 250  mg amoxicillin as the trihydrate and 125  mg clavulanic acid as the potassium salt. Store tablets at or below 25°C (77°F). Dispense in original container.

Authorization status:

New Drug Application

Summary of Product characteristics

AUGMENTIN - AMOXICILLIN AND CLAVULANTE POTASSIUM TABLET, FILM COATED
AUGMENTIN - AMOXICILLIN AND CLAVULANTE POTASSIUM TABLET
PHYSICIANS TOTAL CARE, INC.
----------
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of AUGMENTIN
(amoxicillin/clavulanate potassium) and other antibacterial drugs,
AUGMENTIN should be used only to
treat or prevent infections that are proven or strongly suspected to
be caused by bacteria.
DESCRIPTION
AUGMENTIN is an oral antibacterial combination consisting of the
semisynthetic antibiotic amoxicillin
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 molecular formula is C
H N O S•3H O, and the molecular weight is 419.46.
Chemically, amoxicillin 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:
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
potassium (_Z_)-(2_R, _5_R_)-3-(2-
hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]-heptane-2-carboxylate,
and may be represented
structurally as:
Inactive Ingredients
Colloidal silicon dioxide, hypromellose, magnesium stearate,
microcrystalline cellulose, polyethylene
glycol, sodium starch glycolate, and titanium dioxide.
Each tablet of AUGMENTIN contains 0.63 mEq potassium.
CLINICA