Amoxicillin and Clavulanate Potassium oral dry powder for
suspension (7:1) 200 mg/28.5 mg per 5 mL antibacterial drugs
Amoxicillin and Clavulanate Potassium
200 mg/28.5 mg per 5 mL
FOR ORAL SUSPENSION
When reconstituted, each 5 mL contains:
AMOXICILLIN, 200 MG,
as the trihydrate
CLAVULANIC ACID, 28.5 MG,
as clavulanate potassium
50 mL (when reconstituted)
Each teaspoonful (5 mL) will contain 200 mg amoxicillin and 28.5 mg
of clavulanic acid as the potassium salt.
Amoxicillin and clavulanate potassium for oral suspension 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. Chemically, amoxicillin is
carboxylic acid. trihydrate and has the following structural
INDICATIONS AND USAGE
To reduce the development of drug-resistant bacteria and maintain
the effectiveness of amoxicillin and clavulanate potassium for oral
suspension USP and other antibacterial drugs, amoxicillin and
clavulanate potassium for oral suspension USP should be used only
to treat or prevent infections that are proven or strongly
suspected to be caused by susceptible bacteria. When culture and
susceptibility information are available, they should be considered
in selecting or modifying antibacterial therapy. In the absence of
such data, local epidemiology and susceptibility patterns may
contribute to the empiric selection of therapy.
Amoxicillin and clavulanate potassium for oral suspension 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 Haemophilus influenzae and Moraxella (Branhamella)
Otitis Media– caused by β-lactamase-producing strains of
Haemophilus influenzae and Moraxella (Branhamella) catarrhalis.
Sinusitis– caused by β-lactamase-producing strains of Haemophilus
influenzae and Moraxella (Branhamella) catarrhalis.
Skin and Skin Structure Infections– caused by β-lactamase-producing
strains of Staphylococcus aureus, Escherichia coli and Klebsiella
Urinary Tract Infections– caused by β-lactamase-producing strains
of Escherichia coli, Klebsiella spp. and Enterobacter spp.
While amoxicillin and clavulanate potassium for oral suspension is
indicated only for the conditions listed above, infections caused
by ampicillin-susceptible organisms are also amenable to
amoxicillin and clavulanate potassium treatment due to its
amoxicillin content. Therefore, mixed infections caused by
ampicillin-susceptible organisms and β-lactamase-producing
organisms susceptible to amoxicillin and clavulanate potassium
should not require the addition of another antibiotic. Because
amoxicillin has greater in vitro activity against Streptococcus
pneumoniae than does ampicillin or penicillin, the majority of S.
pneumoniae strains with intermediate susceptibility to ampicillin
or penicillin are fully susceptible to amoxicillin and amoxicillin
and clavulanate potassium. (See Microbiology subsection.)
Bacteriological studies, to determine the causative organisms and
their susceptibility to amoxicillin and clavulanate potassium,
should be performed together with any indicated surgical
Therapy may be instituted prior to obtaining the results from
bacteriological and susceptibility studies to determine the
causative organisms and their susceptibility to amoxicillin and
clavulanate potassium when there is reason to believe the infection
may involve any of the β-lactamase-producing organisms listed
above. Once the results are known, therapy should be adjusted, if
Reconstituted amoxicillin and clavulanate potassium for oral
suspension may be taken without regard to meals; however,
absorption of clavulanate potassium is enhanced when amoxicillin
and clavulanate potassium for oral suspension is administered at
the start of a meal. To minimize the potential for gastrointestinal
intolerance, amoxicillin and clavulanate potassium for oral
suspension should be taken at the start of a meal.
Directions for mixing:
Tap bottle until all powder flows freely. Add approximately 2/3 of
total water for reconstitution (total = 50 mL) ; shake vigorously to wet powder. Add remaining water; again shake
|Amoxicillin and Clavulanate Potassium 200 mg/28.5 mg per 5 mL
|Bottle Size||Amount of Water Required for Suspension|
|100 mL||92 mL|
Dosage: Administer every 12 hours. See accompanying prescribing
Keep tightly closed. Shake well before using.
Must be refrigerated. Discard after 10 days.
Phenylketonurics: Contains phenylalanine 7 mg per 5 mL.
Net contents: Equivalent to 2 g amoxicillin and 0.285 g clavulanic acid.
Use only if inner seal is intact.
Store dry powder at or below 25°C .