Shop Online : Clindamycin 150 mg Tablets

ANADA 200-316, Approved by FDA
Clintabs® Tablets
brand of clindamycin hydrochloride tablets, USP

DESCRIPTION
Clintabs Tablets contain clindamycin
hydrochloride which is the hydrated salt of
clindamycin. Clindamycin is a semisynthetic
antibiotic produced by a
7(S)-chlorosubstitution of the 7(R)-hydroxyl
group of a naturally produced antibiotic
produced by Streptomyces lincolnensis var.
lincolnensis.
Clintabs Tablets (For Use in Dogs Only):
25 mg Tablets, each white tablet is marked
"C 25" on one side and contains clindamycin
hydrochloride equivalent to 25 mg of
clindamycin.
75 mg Tablets, each white tablet is marked
"C 75" on one side and contains clindamycin
hydrochloride equivalent to 75 mg of
clindamycin.
150 mg Tablets, each white tablet is marked
"C 150" on one side and contains clindamycin
hydrochloride equivalent to 150 mg of
clindamycin.

ACTIONS
Site and Mode of Action: Clindamycin is
an inhibitor of protein synthesis in the
bacterial cell. The site of binding appears to
be in the 50S sub-unit of the ribosome.
Binding occurs to the soluble RNA fraction of
certain ribosomes, thereby inhibiting the
binding of amino acids to those ribosomes.
Clindamycin differs from cell wall inhibitors in
that it causes irreversible modification of the
protein-synthesizing subcellular elements at
the ribosomal level.

MICROBIOLOGY: Clindamycin is a
lincosaminide antimicrobial agent with activity
against a wide variety of aerobic and
anaerobic bacterial pathogens. Clindamycin is
a bacteriostatic compound that inhibits
bacterial protein synthesis by binding to the
50S ribosomal subunit. The minimum
inhibitory concentrations (MICs) of
Gram-positive and obligate anaerobic
pathogens isolated from dogs in the United
States are presented in Table 1. Bacteria
were isolated in 1998-1999. All MICs were
performed in accordance with the National
Committee for Clinical Laboratory Standards
(NCCLS).

Table 1. Clindamycin MIC Values (μg/mL) from
Diagnostic Laboratory Survey Data Evaluating
Canine Pathogens in the U.S. during 1998-991
Organism
Soft Tissue/Wound2
Staphylococcus
aureus
Staphylococcus
intermedius
Staphylococcus
spp.
Beta-hemolytic
streptococci
Streptococcus
spp.
17
28
18
46
11
0.5
0.25
0.5
0.5
0.5
0.5
0.5
0.5
0.5
≥4.0
≥4.0
≥4.0
≥4.0
≥4.0
≥4.0
0.25-≥4.0
0.125-≥4.0
.025-≥4.0
0.25-≥4.0
0.25-≥4.0
Osteomyelitis/Bone3
Staphylococcus
aureus
Staphylococcus
intermedius
Staphylococcus
spp.
Beta-hemolytic
streptococci
Streptococcus
spp.
20
15
18
21
21
0.5
0.5
0.5
0.5
≥4.0
0.5
≥4.0
≥4.0
2.0
≥4.0
0.5
≥4.0
≥4.0
2.0
≥4.0
0.54
0.25-≥4.0
0.25-≥4.0
0.25-≥4.0
0.25-≥4.0
Number
of
Isolates MIC50 MIC85 MIC90 Range
Dermal/Skin5
Staphylococcus
aureus
Staphylococcus
intermedius
Staphylococcus
spp.
Beta-hemolytic
streptococci
1
2
3
4
5
The correlation between the in vitro susceptibility data
and clinical response has not been determined.
Soft Tissue/Wound: includes samples labeled wound,
abscess, aspirate, exudates, draining tract, lesion, and
mass
Osteomyelitis/Bone: includes samples labeled bone,
fracture, joint, tendon
No range, all isolates yielded the same value
Dermal/Skin: includes samples labeled skin, skin
swab, biopsy, incision, lip
25
48
32
17
0.5
0.5
0.5
0.5
≥4.0
≥4.0
≥4.0
0.5
≥4.0
≥4.0
≥4.0
0.5
0.25-≥4.0
0.125-≥4.0
0.25-≥4.0
0.25-0.5
Dog Serum Levels: Serum levels at or
above 0.5 μg/mL can be maintained by oral
dosing at a rate of 2.5 mg/lb of clindamycin
hydrochloride every 12 hours. This same
study revealed that average peak serum
concentrations of clindamycin occur 1 hour
and 15 minutes after oral dosing. The
elimination half-life for clindamycin in dog
serum was approximately 5 hours. There was
no bioactivity accumulation after a regimen of
multiple oral doses in healthy dogs.

METABOLISM AND EXCRETION
Extensive studies of the metabolism and
excretion of clindamycin hydrochloride
administered orally in animals and humans
have shown that unchanged drug and
bioactive and bioinactive metabolites are
excreted in urine and feces. Almost all of the
bioactivity detected in serum after
clindamycin hydrochloride administration is due
to the parent molecule (clindamycin). Urine
bioactivity, however, reflects a mixture of
clindamycin and active metabolites,
especially N-dimethyl clindamycin and
clindamycin sulfoxide.

ANIMAL SAFETY SUMMARY
Rat and Dog Data: One year oral toxicity
studies in rats and dogs at doses of 30, 100
and 300 mg/kg/day (13.6, 45.5 and
136.4 mg/lb/day) have shown clindamycin
Clindamycin Serum Concentrations
2.5 mg/lb (5.5 mg/kg) After B.I.D. Oral Dose
of Clindamycin Hydrochloride to Dogs
Time (hours)
Clindamycin Equivalent Activity (mcg/mL)
0 6 12 18 24
0.1
1.0
10.0

PHARMACOLOGY
Absorption: Clindamycin hydrochloride is
rapidly absorbed from the canine
gastrointestinal tract.
1 2 3

PRECAUTIONS
During prolonged therapy of one month or
greater, periodic liver and kidney function
tests and blood counts should be performed.
The use of clindamycin hydrochloride
occasionally results in overgrowth of
non-susceptible organisms such as clostridia
and yeasts. Therefore, the administration of
Clintabs Tablets should be avoided in those
species sensitive to the gastrointestinal
effects of clindamycin (seeCONTRAINDICATIONS).
Should superinfections occur, appropriate
measures should be taken as indicated by the
clinical situation.
Patients with very severe renal disease
and/or very severe hepatic disease
accompanied by severe metabolic aberrations
should be dosed with caution, and serum
clindamycin levels monitored during high-dose
therapy.
Clindamycin hydrochloride has been shown to
have neuromuscular blocking properties that
may enhance the action of other neuromuscular
blocking agents. Therefore, Clintabs Tablets
should be used with caution in animals
receiving such agents.
Safety in gestating bitches or breeding male
dogs has not been established.

ADVERSE REACTIONS
Side effects occasionally observed in either
clinical trials or during clinical use were vomiting
and diarrhea.
To report adverse reactions or a suspected
adverse reaction, call 1-800-338-3659.

DOSAGE AND ADMINISTRATION
Dogs:
Infected Wounds, Abscesses, and Dental
Infections
Oral: 2.5-15.0 mg/lb body weight every 12
hours.
Duration: Treatment with clindamycin
hydrochloride products may be continued up
to a maximum of 28 days if clinical judgment
indicates. Treatment of acute infections
should not be continued for more than three
or four days if no response to therapy is seen.
Dosage Schedule:
Tablets
Clintabs 25 mg, administer 1-6 tablets every
12 hours for each 10 pounds of body weight.
Clintabs 75 mg, administer 1-6 tablets every
12 hours for each 30 pounds of body weight.
Clintabs 150 mg, administer 1-6 tablets
every 12 hours for each 60 pounds of body weight.
Dogs:
Osteomyelitis
Oral: 5.0-15.0 mg/lb body weight every 12 hours.
Duration: Treatment with clindamycin
hydrochloride is recommended for a minimum
of 28 days. Treatment should not be
continued for longer than 28 days if no
response to therapy is seen.
Dosage Schedule:
Tablets
Clintabs 25 mg, administer 2-6 tablets every
12 hours for each 10 pounds of body weight.
Clintabs 75 mg, administer 2-6 tablets every
12 hours for each 30 pounds of body weight.
Clintabs 150 mg, administer 2-6 tablets
every 12 hours for each 60 pounds of body weight.
HOW SUPPLIED
Clintabs Tablets are available as:
25 mg - bottles of 400
75 mg - bottles of 200
150 mg - bottles of 100
ANADA #200-316, Approved by FDA
To report a suspected adverse reaction or to
request a material safety data sheet (MSDS),
call 1-800-338-3659.
Store at controlled room temperature 20˚
to 25˚ C (68˚ to 77˚ F) [see USP].
Caution: Federal (USA) law restricts this
drug to use by or on the order of a licensed
veterinarian.
Mfd. for
Virbac AH, Inc.
Fort Worth, TX 76137-4611, USA
Revised April 2007 301617-03
Clintabs is a registered trademark of Virbac AH, Inc.
hydrochloride capsules to be well tolerated.
Differences did not occur in the parameters
evaluated to assess toxicity when comparing
groups of treated animals with contemporary
controls. Rats administered clindamycin
hydrochloride at 600 mg/kg/day (272.7 mg/lb/day)
for six months tolerated the drug well; however,
dogs orally dosed at 600 mg/kg/day
(272.7 mg/lb/day) vomited, had anorexia,
and subsequently lost weight. At necropsy
these dogs had erosive gastritis and focal
areas of necrosis of the mucosa of the gall
bladder.
Safety in gestating bitches or breeding males
has not been established.

INDICATIONS
Clintabs (brand of clindamycin
hydrochloride) Tablets (for use in dogs only)
are indicated for the treatment of infections
caused by susceptible strains of the
designated microorganisms in the specific
conditions listed below:
Dogs: Skin infections (wounds and
abscesses) due to: coagulase positive
staphylococci (Staphylococcus aureus or
Staphylococcus intermedius).
Deep wounds and abscesses due to
Bacteroides fragilis, Prevotella melaninogenicus,
Fusobacterium necrophorum and Clostridium
perfringens.
Dental infections due to Staphyloccus
aureus, Bacteroides fragilis, Prevotella
melaninogenicus, Fusobacterium
necrophorum and Clostridium perfringens.
Osteomyelitis due to Staphylococcus
aureus, Bacteroides fragilis, Prevotella
melaninogenicus, Fusobacterium
necrophorum and Clostridium perfringens.

CONTRAINDICATIONS
Clintabs Tablets are contraindicated in
animals with a history of hypersensitivity to
preparations containing clindamycin or
lincomycin.
Because of potential adverse
gastrointestinal effects, do not administer to
rabbits, hamsters, guinea pigs, horses,
chinchillas or ruminating animals.
WARNINGS
Keep out of reach of children. Not for
human use.
4 5 6