AMOXICILLIN AND CLAVULANATE POTASSIUM tablet, film coated

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

STAT Rx USA LLC

INN (Kansainvälinen yleisnimi):

AMOXICILLIN

Koostumus:

AMOXICILLIN ANHYDROUS 500 mg

Antoreitti:

ORAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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

Tuoteyhteenveto:

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 clavulanic acid as the potassium salt. They are available in bottles of 20 - NDC # 42549-531-20 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 - NDC # 42549-570-20 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.

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

AMOXICILLIN AND CLAVULANATE POTASSIUM - AMOXICILLIN AND CLAVULANATE
POTASSIUM TABLET, FILM COATED
STAT RX USA LLC
----------
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 USP 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 USP
contains 0.63 mEq potassium.
INACTIVE IN