Pfizer Animal Health
(amoxicillin trihydrate/clavulanate potassium)
For veterinary oral suspension
For use in dogs and cats
CAUTION:
Federal law restricts this drug to use by or on the order of a licensed
veterinarian.
DESCRIPTION:
Clavamox (amoxicillin trihydrate/clavulanate potassium) is an orally
administered formulation comprised of the broad-spectrum antibiotic Amoxi®
(amoxicillin trihydrate) and the β-lactamase inhibitor, clavulanate
potassium (the potassium salt of clavulanic acid).
Amoxicillin trihydrate is a
semisynthetic antibiotic with a broad spectrum of bactericidal activity
against many gram-positive and gram-negative, aerobic and anaerobic
microorganisms. It does not resist destruction by β-lactamases; therefore,
it is not effective against β-lactamase-producing bacteria. Chemically, it
is D(-)-α-amino-p-hydroxybenzyl penicillin trihydrate.
Clavulanic acid, an inhibitor
of β-lactamase enzymes, is produced by the fermentation of
Streptomyces clavuligerus. Clavulanic acid by
itself has only weak antibacterial activity. Chemically, clavulanate
potassium is potassium z-(3R,5R)-2-β-hydroxyethylidene clavam-3-carboxylate.
ACTIONS:
Clavamox is stable in the presence of gastric acid and is not significantly
influenced by gastric or intestinal contents. The 2 components are rapidly
absorbed resulting in amoxicillin and clavulanic acid concentrations in
serum, urine, and tissues similar to those produced when each is
administered alone.
Amoxicillin and clavulanic
acid diffuse readily into most body tissues and fluids with the exception of
brain and spinal fluid, which amoxicillin penetrates adequately when
meninges are inflamed. Most of the amoxicillin is excreted unchanged in the
urine. Clavulanic acid's penetration into spinal fluid is unknown at this
time. Approximately 15% of the administered dose of clavulanic acid is
excreted in the urine within the first 6 hours.
Clavamox combines the
distinctive properties of a broad-spectrum antibiotic and a β-lactamase
inhibitor to effectively extend the antibacterial spectrum of amoxicillin to
include β-lactamase as well as non-β-lactamase-producing aerobic and
anaerobic organisms.
MICROBIOLOGY:
Amoxicillin is bactericidal in action and acts through the inhibition of
biosynthesis of cell wall mucopeptide of susceptible organisms. The action
of clavulanic acid extends the antimicrobial spectrum of amoxicillin to
include organisms resistant to amoxicillin and other β-lactam antibiotics.
Amoxicillin/clavulanate has been shown to have a wide range of activity
which includes β-lactamase-producing strains of both gram-positive and
gram-negative aerobes, facultative anaerobes, and obligate anaerobes. Many
strains of the following organisms, including β-lactamase-producing strains,
isolated from veterinary sources, were found to be susceptible to
amoxicillin/clavulanate in vitro but the clinical
significance of this activity has not been demonstrated for some of these
organisms in animals.
Aerobic bacteria, including
Staphylococcus aureus*, β-lactamase-producing
Staphylococcus aureus* (penicillin resistant),
Staphylococcus species*,
Staphylococcus epidermidis, Staphylococcus intermedius, Streptococcus
faecalis, Streptococcus species*, Corynebacterium
pyogenes, Corynebacterium species,
Erysipelothrix rhusiopathiae, Bordetella bronchiseptica,
Escherichia coli*, Proteus mirabilis, Proteus
species, Enterobacter species,
Klebsiella pneumoniae, Salmonella dublin, Salmonella typhimurium,
Pasteurella multocida*, Pasteurella hemolytica,
Pasteurella species*.
* The susceptibility of these
organisms has also been demonstrated in in vivo
studies.
Studies have demonstrated that
both aerobic and anaerobic flora are isolated from gingival cultures of dogs
with clinical evidence of periodontal disease. Both gram-positive and
gram-negative aerobic and anaerobic subgingival isolates indicate
sensitivity to amoxicillin/clavulanic acid during antimicrobial
susceptibility testing.
INDICATIONS: Clavamox Drops are indicated in the treatment of:
Dogs:
Skin and soft tissue infections such as wounds, abscesses, cellulitis,
superficial/juvenile and deep pyoderma due to susceptible strains of the
following organisms: β-lactamase-producing
Staphylococcus aureus, non-β-lactamase-producing
Staphylococcus aureus, Staphylococcus spp.,
Streptococcus spp., and E. coli.
Periodontal infections due to
susceptible strains of both aerobic and anaerobic bacteria. Clavamox has
been shown to be clinically effective for treating cases of canine
periodontal disease.
Cats:
Skin and soft tissue infections such as wounds, abscesses, and cellulitis/dermatitis
due to susceptible strains of the following organisms: β-lactamase-producing
Staphylococcus aureus, non-β-lactamase-producing
Staphylococcus aureus, Staphylococcus spp.,
Streptococcus spp., E. coli,
Pasteurella multocida, and Pasteurella spp.
Urinary tract infections
(cystitis) due to susceptible strains of E. coli.
Therapy may be initiated with
Clavamox prior to obtaining results from bacteriological and susceptibility
studies. A culture should be obtained prior to treatment to determine
susceptibility of the organisms to Clavamox. Following determination of
susceptibility results and clinical response to medication, therapy may be
reevaluated.
CONTRAINDICATIONS: The use of this drug is contraindicated in animals
with a history of an allergic reaction to any of the penicillins or
cephalosporins.
ADVERSE
REACTIONS: Clavamox contains a semisynthetic penicillin (amoxicillin)
and has the potential for producing allergic reactions. If an allergic
reaction occurs, administer epinephrine and/or steroids.
WARNINGS:
Safety of use in pregnant or breeding animals has not been determined. For
use in dogs and cats only.
DOSAGE AND
ADMINISTRATION:
Dogs:
The recommended dosage is 6.25 mg/lb (1 mL/10 lb) of body weight twice a
day. Skin and soft tissue infections such as abscesses, cellulitis, wounds,
superficial/juvenile pyoderma, and periodontal infections should be treated
for 5-7 days or for 48 hours after all symptoms have subsided. If no
response is seen after 5 days of treatment, therapy should be discontinued
and the case reevaluated. Deep pyoderma may require treatment for 21 days;
the maximum duration of treatment should not exceed 30 days.
Cats:
The recommended dosage is 62.5 mg (1 mL) twice a day. Skin and soft tissue
infections such as abscesses and cellulitis/dermatitis should be treated for
5-7 days or 48 hours after all symptoms have subsided, not to exceed 30
days. If no response is seen after 3 days of treatment, therapy should be
discontinued and the case reevaluated.
Urinary tract infections may
require treatment for 10-14 days or longer. The maximum duration of
treatment should not exceed 30 days.
RECONSTITUTION
INSTRUCTIONS--ORAL SUSPENSION: Add 14 mL of water to the 15-mL bottle
and shake vigorously. Each mL of suspension will contain 50 mg of
amoxicillin activity as the trihydrate and 12.5 mg of clavulanic acid
activity as the potassium salt.
Note: Any
unused portion of the reconstituted suspension must be discarded after 10
days. Refrigeration of the reconstituted suspension is required.
HOW SUPPLIED:
Clavamox Drops are supplied in 15-mL bottles containing 50 mg of
amoxicillin/12.5 mg of clavulanic acid per mL.