Download Antirobe® Antirobe Aquadrops® rops

(clindamycin hydrochloride capsules, USP)
®
Antirobe Aquadrops
(clindamycin hydrochloride liquid)
Clindamycin Equivalent Activity (mcg/mL)
Antirobe®
C
concentrations
clindamycin
occur
1 hour
and 15 minutes after oral
hydrochlorideofequivalent
to 25
mg of
clindamycin.
dosing. The elimination half-life for clindamycin in dog serum was
75 mg Capsule, each green capsule contains clindamycin hydrochloride
approximately 5 hours. There was no bioactivity accumulation after a
equivalent to 75 mg of clindamycin.
regimen of multiple oral doses in healthy dogs.
150 mg Capsule, each light blue and green capsule contains clindamycin
Clindamycin
Serum 0.5
Concentrations
Cat Serum
Levels: Serum
levels
or mg
above
μg/mL can be maintained
hydrochloride
equivalent
toat150
of clindamycin.
2.5 mg/lb (5.5 mg/kg) After B.I.D. Oral
by oral dosing at a rate of 5 mg/lb
clindamycin
liquid
Doseof
of Antirobe
Capsules hydrochloride
to Dogs
mg Capsule,
each light
capsule
contains clindamycin
every300
24 hours.
The average
peakblue
serum
concentration
of clindamycin
10
hydrochloride
equivalent
to
300
mg
of
clindamycin.
occurs approximately 1 hour after oral dosing. The elimination half-life of
clindamycin
in feline
serum is approximately
In healthy
ANTIROBE
AQUADROPS
Liquid (For Use7.5
in hours.
Dogs and
Cats) iscats,
a palatable
minimal
accumulation
occurs
afteradministration.
multiple oral doses
formulation
intended
for oral
Eachof
mLclindamycin
of ANTIROBE
hydrochloride,
and Liquid
steady-state
should
be achieved
by the third
dose. to
AQUADROPS
contains
clindamycin
hydrochloride
equivalent
25 mg clindamycin; andClindamycin
ethyl alcohol,
8.64%.
Serum Concentrations
Microbiology: Clindamycin is a lincosaminide antimicrobial agent with
activity against a wide variety of aerobic and anaerobic bacterial
0.1
pathogens. Clindamycin is a bacteriostatic compound that inhibits
0
5
10
15
20
25
bacterial protein synthesis by binding to
the
5OS ribosomal sub-unit. The
Time
(hours)
minimum
inhibitory
concentrations
(MICs)
of
Gram-positive
and obligate
Metabolism and Excretion: Extensive studies of the metabolism
and
anaerobic
isolated
from dogs and
cats in the orally
UnitedinStates
excretionpathogens
of clindamycin
hydrochloride
administered
animals
areand
presented
in
Table
1
and
Table
2.
Bacteria
were
isolated
in
1998–1999.
humans have shown that unchanged drug and bioactive and
Allbioinactive
MICs weremetabolites
performed in
accordance
theand
Clinical
Laboratory
are
excreted inwith
urine
feces.and
Almost
all of the
Standards
Institute
(CLSI).
bioactivity
detected
in serum after ANTIROBE product administration is
due to the parent molecule (clindamycin). Urine bioactivity, however,
Table
1. Clindamycin
Values (μg/mL)
from metabolites,
Diagnostic Laboratory
reflects
a mixture ofMIC
clindamycin
and active
especially
Survey
Data Evaluating
Canine
Pathogens insulfoxide.
the U.S. during 1998–991
N-demethyl
clindamycin
and clindamycin
Organism
of
Site and Mode ofNumber
Action: Clindamycin
is an inhibitor of protein synthesis
MIC85 toMIC
Range
50
90 the 5OS sub-unit
in the bacterial cell.Isolates
The site ofMIC
binding
appears
be in
2
of Tissue/Wound
the ribosome. Binding occurs to the soluble RNA fraction of certain
Soft
ribosomes,
thereby inhibiting the binding of amino acids to those
Staphylococcus
DESCRIPTION: ANTIROBE Capsules and ANTIROBE AQUADROPS Liquid
Dog Serum Levels: Serum levels at or above 0.5 μg/mL can be maintained ribosomes.
from cell wall
it causes
aureus Clindamycin
17 differs 0.5
0.5 inhibitors
>4.0 in that
0.25–>4.0
contain clindamycin hydrochloride which is the hydrated salt of
by oral dosing at a rate of 2.5 mg/lb of clindamycin hydrochloride every
irreversible
modification of the protein-synthesizing subcellular elements
Staphylococcus
clindamycin. Clindamycin is a semisynthetic antibiotic produced by a
12 hours. This same study revealed that average peak serum
at the
ribosomal level.28
intermedius
0.25
0.5
>4.0 0.125–>4.0
7(S)-chlorosubstitution of the 7(R)-hydroxyl group of a naturally produced
0.1
concentrations of clindamycin occur 1 hour and 15 minutes after oral
StaphylococcusClindamycin is a lincosaminide antimicrobial agent with
antibiotic produced by Streptomyces lincolnensis var. lincolnensis.
0
6
12
18
24
Microbiology:
1.0
dosing. The elimination
half-life for
clindamycin
in
dog
serum
was
spp. against a wide18variety of0.5aerobic and
0.5 anaerobic
>4.0 bacterial
0.25–>4.0
Time (hours)
activity
approximately 5 hours. There was no bioactivity accumulation after a
Beta-hemolytic
ANTIROBE Capsules (For Use in Dogs Only):
pathogens.
Clindamycin is a bacteriostatic compound that inhibits
regimen
of
multiple
oral
doses
in
healthy
dogs.
streptococci
46 by binding
0.5
0.5 5OS ribosomal
>4.0 0.25–>4.0
Cat Serum Levels: Serum levels at or above 0.5 μg/mL can be maintained
bacterial
protein synthesis
to the
sub-unit. The
®
Streptococcus
by oral dosing at a rate of 5 mg/lb
of clindamycin hydrochloride liquid
25 mg Capsule, each yellow and white capsule contains clindamycin
minimum
inhibitory concentrations (MICs) of Gram-positive and obligate
Clindamycin Serum Concentrations
spp.
11
0.5
>4.0
>4.0
0.25–>4.0
2.5 mg/lb
(5.5 mg/kg)
After B.I.D. Oral of clindamycin
every 24 hours. The average peak
serum
concentration
hydrochloride equivalent to 25 mg of clindamycin.
anaerobic pathogens isolated from dogs and cats in the United States
Dose of Antirobe Capsules to Dogs
(clindamycin hydrochloride capsules, USP)
occurs approximately 1 hour after oral dosing. The elimination half-life of
are presented in Table 1 and Table 2. Bacteria were isolated in 1998–1999.
75 mg Capsule, each green capsule contains clindamycin hydrochloride
10
0.1 serum is approximately 7.5 hours. In healthy cats,
clindamycin in feline
All MICs were performed in accordance with the Clinical and Laboratory
equivalent to 75 mg of clindamycin.
®
5 after
10 multiple
15
20 doses
25 of clindamycin
minimal accumulation0 occurs
oral
Standards Institute (CLSI).
Time (hours)
150 mg Capsule, each light blue and green capsule contains clindamycin
hydrochloride, and steady-state should be achieved by the third dose.
Metabolism and Excretion: Extensive studies of the metabolism and
(clindamycin
hydrochloride
liquid)
hydrochloride
equivalent
to 150 mg of clindamycin.
Table 1. Clindamycin MIC Values (μg/mL) from Diagnostic Laboratory
Clindamycin Serum Concentrations
excretion of clindamycin hydrochloride
administered
orally in animals
5 mg/lb (11 mg/kg)
After Single Oral
Survey Data Evaluating Canine Pathogens in the U.S. during 1998–991
300 mg Capsule, each light blue capsule contains clindamycin
of Antirobe drug
Aquadrops
Cats
unchanged
andtobioactive
and
Caution: Federal (USA) law restricts this drug to use by or on the order of and humans have shown that Dose
hydrochloride equivalent to 300 mg of clindamycin.
Organism
Number of
bioinactive metabolites10.0
are1 excreted in urine and feces. Almost all of the
a licensed veterinarian.
MIC85
MIC90
Range
Isolates MIC50
ANTIROBE AQUADROPS Liquid (For Use in Dogs and Cats) is a palatable
bioactivity detected in serum after ANTIROBE product administration is
formulation
intended
for oral administration.
Each mL ofAQUADROPS
ANTIROBE Liquid due to the parent molecule (clindamycin). Urine bioactivity, however,
DESCRIPTION:
ANTIROBE
Capsules and ANTIROBE
Soft Tissue/Wound2
AQUADROPS
Liquid contains
clindamycin
hydrochloride
equivalent
reflects a mixture of clindamycin and active metabolites, especially
contain clindamycin
hydrochloride
which
is the hydrated
salt of to
Staphylococcus
25 clindamycin.
mg clindamycin;
and ethylisalcohol,
8.64%. antibiotic produced by a
N-demethyl clindamycin and clindamycin sulfoxide.
Clindamycin
a semisynthetic
aureus
17
0.5
0.5
>4.0 0.25–>4.0
7(S)-chlorosubstitution of the 7(R)-hydroxyl group of a naturally produced Site and Mode of Action: Clindamycin is an inhibitor of protein synthesis
Staphylococcus
CLINICAL
PHARMACOLOGY
antibiotic
produced by Streptomyces lincolnensis var. lincolnensis.
intermedius
28
0.25
0.5
>4.0 0.125–>4.0
in the bacterial cell. The1.0site
0.1 of binding appears to be in the 5OS sub-unit
Absorption: Clindamycin hydrochloride is rapidly absorbed from the
Staphylococcus
of the ribosome. Binding occurs
to the
of certain
0
6 soluble
12 RNA fraction
18
24
canine
and
feline
gastrointestinal
tract.
ANTIROBE Capsules (For Use in Dogs Only):
spp.
18
0.5
0.5
>4.0 0.25–>4.0
(hours) acids to those
ribosomes, thereby inhibiting the bindingTime
of amino
Beta-hemolytic
Dog Serum Levels: Serum levels at or above 0.5 μg/mL can be maintained ribosomes. Clindamycin differs from cell wall inhibitors in that it causes
mgdosing
Capsule,
yellow
and white
capsule contains
clindamycin
streptococci
46
0.5
0.5
>4.0 0.25–>4.0
by 25
oral
at aeach
rate of
2.5 mg/lb
of clindamycin
hydrochloride
every
irreversible modification of the protein-synthesizing subcellular elements
equivalent
to 25 mgthat
of clindamycin.
Streptococcus
12 hydrochloride
hours. This same
study revealed
average peak serum
at the ribosomal level.
spp.
11
0.5
>4.0
>4.0 0.25–>4.0
concentrations
of clindamycin
occur 1 contains
hour andclindamycin
15 minutes after
oral
75 mg Capsule,
each green capsule
hydrochloride
Microbiology: Clindamycin
is a lincosaminide antimicrobial agent with
0.1
dosing.
The elimination
for clindamycin in dog serum was
equivalent
to 75 mg ofhalf-life
clindamycin.
activity against a wide variety
of 5aerobic
anaerobic
bacterial
0
10 and15
20
25
approximately 5 hours. There was no bioactivity accumulation after a
Time (hours)
compound that inhibits
150 mg Capsule, each light blue and green capsule contains clindamycin pathogens. Clindamycin is a bacteriostatic
regimen of multiple oral doses in healthy dogs.
Metabolism
and
Excretion:
Extensive
studies
the metabolism
and
bacterial
protein
synthesis
by binding
to the
5OSof
ribosomal
sub-unit.
The
hydrochloride equivalent to 150 mg of clindamycin.
excretion
of clindamycin
hydrochloride
orally
in obligate
animals
minimum
inhibitory
concentrations
(MICs) administered
of Gram-positive
and
Clindamycin Serum Concentrations
300 mg Capsule, each light
blue capsule contains clindamycin
2.5 mg/lb (5.5 mg/kg) After B.I.D. Oral
and humans
have shown
that
unchanged
bioactive
and
anaerobic
pathogens
isolated
from
dogs anddrug
catsand
in the
United States
of Antirobe
to Dogs
hydrochloride equivalentDose
to 300
mg ofCapsules
clindamycin.
areTable
excreted
in urinewere
and isolated
feces. Almost
all of the
arebioinactive
presentedmetabolites
in Table 1 and
2. Bacteria
in 1998–1999.
10
ANTIROBE AQUADROPS
Liquid (For Use in Dogs and Cats) is a palatable Allbioactivity
in serum
after ANTIROBE
MICs weredetected
performed
in accordance
with theproduct
Clinical administration
and Laboratoryis
formulation intended for oral administration. Each mL of ANTIROBE
due
to
the
parent
molecule
(clindamycin).
Urine
bioactivity,
however,
Standards Institute (CLSI).
AQUADROPS Liquid contains clindamycin hydrochloride equivalent to
reflects a mixture of clindamycin and active metabolites, especially
Clindamycin Equivalent Activity (mcg/mL)
Antirobe
Clindamycin Equivalent Activity (mcg/mL)
Antirobe Aquadrops
L)
1
5 mg/lb (11 mg/kg) After Single Oral
Dose of Antirobe Aquadrops to Cats
CLINICAL PHARMACOLOGY
Absorption: Clindamycin
hydrochloride is rapidly absorbed from the
10.0
canine and feline gastrointestinal tract.
Clindamycin Equivalent Activity (mcg/mL)
Caution: Federal (USA) law restricts this drug to use by or on the order of
a licensed veterinarian.