AMOXICILLIN AND CLAVULANATE POTASSIUM tablet, film coated

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:

H.J. Harkins Company, Inc.

INN (International Name):

AMOXICILLIN

Composition:

AMOXICILLIN ANHYDROUS 500 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Amoxicillin and clavulanate potassium tablets are 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 amoxicillin and clavulanate potassium tablets are indicated only for the conditions listed above, infections caused by ampicillin-susceptible organisms are also amenable to treatment with amoxicillin and clavulanate potassium tablets due to their amoxicillin content; therefore, mixed infections caused by ampicillin-susceptible organisms and β-lactamase-producing organisms susceptible to amoxicillin and clavulanate po

Product summary:

Amoxicillin and clavulanate potassium tablets USP, 500 mg/125 mg are available as white, oblong-shaped, biconvex, film-coated tablets, debossed “93” on one side and “2274” on the other side. Each tablet contains 500 mg amoxicillin as the trihydrate and 125 mg of clavulanic acid as the potassium salt. They are available in bottles of 20. Amoxicillin and clavulanate potassium tablets USP, 875 mg/125 mg are available as white, capsule-shaped, biconvex, film-coated tablets, debossed “93” on one side and “22”, score, “75” on the other side. Each tablet contains 875 mg amoxicillin as the trihydrate and 125 mg clavulanic acid as the potassium salt. They are available in bottles of 20. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Advise patients to keep in a closed container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

AMOXICILLIN AND CLAVULANATE POTASSIUM - AMOXICILLIN AND CLAVULANATE
POTASSIUM TABLET, FILM COATED
H.J. HARKINS COMPANY, INC.
----------
AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP, 500 MG/125 MG AND
875
MG/125 MG
2274
2275
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of amoxicillin and
clavulanate potassium tablets and other antibacterial drugs,
amoxicillin and clavulanate potassium tablets
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 tablets are 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. 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 has the following structural formula:
C
H N O S·3H O M.W. 419.46
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. 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 has the following
structural formula:
C
H KNO M.W. 237.25
16
19
3
5
2
8
8
5
Each tablet contains 500 mg or 875 mg amoxicillin as the trihydrate
and 125 mg clavulanic acid as the
potassium salt. Each amoxicillin and clavulanate potassium tablet
contains 0.63 mEq potassium.
INACTIVE