AMOXICILLIN AND CLAVULANATE POTASSIUM- amoxicillin and clavulanate potassium tablet, film coated

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:

State of Florida DOH Central Pharmacy

INN (International Name):

AMOXICILLIN

Composition:

AMOXICILLIN 875 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amoxicillin/clavulanate potassium is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the conditions listed below: Lower Respiratory Tract Infections - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Otitis Media - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Sinusitis - caused by β-lactamase-producing strains of H. influenzae and M. catarrhalis. Skin and Skin Structure Infections - caused by β-lactamase-producing strains of S. aureus, E. coli and Klebsiella spp. Urinary Tract Infections - caused by β-lactamase-producing strains of E. coli , Klebsiella spp. and Enterobacter spp. While amoxicillin/clavulanate potassium is indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to amoxicillin/clavulanate potassium treatment due to its amoxicillin content, therefore, mixed infections caused by ampicillin-susceptible orga

Product summary:

Amoxicillin and Clavulanate Potassium Tablets, USP 500/125 mg  are white to off-white, oblong film coated tablets with beveled edges, debossed with 500/125 on one side and AMC on the other side. Amoxicillin and Clavulanate Potassium Tablets, USP 875/125 mg  are white to off-white, oblong film coated tablets with beveled edges, scored and debossed with 875/125 on one side and AMC on the other side. They are supplied by State of Florida DOH Central Pharmacy as follows: Store tablets at 20 - 25°C (68 - 77°F) [See USP Controlled Room Temperature]. Dispense in tightly closed, moisture-proof containers.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMOXICILLIN AND CLAVULANATE POTASSIUM - AMOXICILLIN AND CLAVULANATE
POTASSIUM TABLET, FILM COATED
STATE OF FLORIDA DOH CENTRAL PHARMACY
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AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS, USP
AMOXICILLIN, 500 mg, as the trihydrate and CLAVULANIC ACID, 125 mg, as
clavulanate potassium;
or
AMOXICILLIN, 875 mg, as the trihydrate and CLAVULANIC ACID, 125 mg, as
clavulanate potassium
Rx only
PRESCRIBING
INFORMATION
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of Amoxicillin and
Clavulanate Potassium Tablets, USP and other antibacterial drugs,
Amoxicillin and Clavulanate
Potassium Tablets, USP should be used only to treat or prevent
infections that are proven or strongly
suspected to be caused by bacteria.
DESCRIPTION
Amoxicillin and Clavulanate Potassium Tablet USP 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 _(2S, 5R,
6R)_-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-
hydroxyethyliden