brand of clindamycin hydrochloride tablets
INDICATIONS
Dogs: Aerobic
bacteria: Clintabs (clindamycin hydrochloride) Tablets are indicated
for the treatment of soft tissue infections (wounds and abscesses), dental
infections and osteomyelitis caused by susceptible strains of
Staphylococcus aureus.
Anaerobic bacteria: Clintabs (clindamycin
hydrochloride) Tablets are indicated for the treatment of soft tissue
infections (deep wounds and abscesses), dental infections and osteomyelitis
caused by or associated with susceptible strains of
Bacteroides fragilis, Bacteroides melaninogenicus, Fusobacterium necrophorum
and Clostridium perfringens. (See Microbiology
section for additional information.)
DESCRIPTION
Clintabs (clindamycin hydrochloride) 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:
25 mg Tablet, each white tablet is
marked “C 25” on one side and contains clindamycin hydrochloride equivalent
to 25 mg of clindamycin.
75 mg Tablet, each white tablet is
marked “C 75” on one side and contains clindamycin hydrochloride equivalent
to 75 mg of clindamycin.
150 mg Tablet, each white tablet is
marked “C150” 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 5OS 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: The following clindamycin
in vitro data are available but their clinical
significance is unknown. Clindamycin has been shown to have
in vitro activity against canine isolates of the
following organisms:
Aerobic gram positive cocci,
including: Staphylococcus aureus (penicillinase and
non-penicillinase producing strains), Staphylococcus
epidermidis, Streptococci (except S. faecalis).
Anaerobic gram negative bacilli,
including: Bacteroides species, Fusobacterium species.
Anaerobic gram positive nonsporeforming
bacilli, including: Propionibacterium, Eubacterium,
Actinomyces species.
Anaerobic and microaerophilic gram
positive cocci, including: Peptococcus species,
Peptostreptococcus species, Microaerophilic streptococci.
Clostridia: Most
C. perfringens are susceptible, but other species
may be resistant to clindamycin.
OVERALL SUSCEPTIBILITY TO CLINDAMYCIN OF ANAEROBES
ISOLATED FROM CANINE LESIONS. DATA OBTAINED FROM THREE VETERINARY DIAGNOSTIC
LABORATORIES:
|
|
Susceptible
≤3.2 µg/mL |
Resistant
≥4.0 µg/mL |
|
All Isolates |
122/137 (89%) |
15/137 (11%) |
|
Clostridium spp. |
41/49 (84%) |
8/49 (16%) |
|
Bacteroides spp. |
42/46 (91%) |
4/46 (9%) |
|
Fusobacterium
spp. |
16/16 (100%) |
0/16 (0%) |
|
Peptostreptococcus spp. |
15/16 (94%) |
1/16 (6%) |
|
Actinomyces spp. |
5/6 (83%) |
1/6 (17%) |
|
Proprionibacterium spp. |
3/4 (75%) |
1/4 (25%) |
Mycoplasma species: Most mycoplasma
species are susceptible to clindamycin.
Clindamycin and erythromycin show parallel resistance.
Partial cross resistance has been demonstrated between clindamycin,
erythromycin and macrolide antibiotics.
PHARMACOLOGY
Absorption: Clindamycin hydrochloride is
rapidly absorbed from the canine gastrointestinal tract. Dogs orally dosed
with therapeutic amounts of clindamycin hydrochloride demonstrated
antibacterial serum levels of the drug within 15 minutes post-dosing.
Canine Serum Levels: Therapeutically
effective serum levels of clindamycin hydrochloride can be maintained by
oral dosing at the rate of 2.5 mg/lb every 12 hours. Dogs orally dosed with
clindamycin hydrochloride at 2.5 mg/lb every 12 hours during a 72 hours
dosing regimen continuously maintained antibacterial serum levels of the
drug. This same study revealed that average peak serum concentrations
occurred 1 hour and 15 minutes after dosing. The biological half-life for
clindamycin hydrochloride in dog serum was about 5 hours. There was no
bioactivity accumulation after a regimen of multiple oral doses.
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 product administration is due to the parent
molecule (clindamycin). Urine bioactivity, however, reflects a mixture of
clindamycin and active metabolites, especially N-demethyl clindamycin and
clindamycin sulfoxide.
TOXICOLOGY AND SAFETY
One year oral toxicity studies in rats and dogs at doses of
30, 100, and 300 mg/kg/day have shown clindamycin hydrochloride 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 for
six months tolerated the drug well; however, dogs orally dosed at 600
mg/kg/day vomited, had anorexia, and subsequently lost weight.
Safety in gestating bitches or breeding males has not been
established.
IN VITRO SUSCEPTIBILITY TESTING
Susceptibility tests should be done on samples collected
prior to initiation of therapy with Clintabs (clindamycin hydrochloride)
Tablets. Clindamycin susceptibility testing is performed by using CLEOCIN®
Susceptibility Disks (clindamycin 2 mcg) and CLEOCIN®
Susceptibility Powder 20 mg. A standardized disk testing procedure* is
recommended for determining susceptibility of aerobic bacteria to
clindamycin. A description is contained in the CLEOCIN®
Susceptibility Disk insert. Using this method, the laboratory can designate
isolates as resistant, intermediate, or susceptible. Tube or agar dilution
methods may be used for aerobic and anaerobic bacteria. When the directions
in the CLEOCIN® Susceptibility Powder insert
are followed, a MIC (minimal inhibitory concentration) of 1.6 mcg/mL may be
considered susceptible; MICs of 1.6 to 4.8 mcg/mL may be considered
intermediate and MICs greater than 4.8 mcg/mL may be considered resistant.
CONTRAINDICATIONS
Clintabs (clindamycin hydrochloride) 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
Not for human use.
PRECAUTIONS
Clintabs (clindamycin hydrochloride) Tablets should be
prescribed with caution in atopic animals.
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 clindamycin hydrochloride should be avoided
in those species sensitive to the gastrointestinal effects of clindamycin
(see CONTRAINDICATIONS). Should superinfections occur, appropriate measures
should be taken as indicated by the 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, clindamycin hydrochloride should
be used with caution in animals receiving such agents.
Safety in gestating bitches or breeding males has not been
established.
SIDE EFFECTS
Side effects occasionally observed in either clinical trials
or during clinical use were vomiting and diarrhea.
DOSAGE AND ADMINISTRATION
Canine Infected Wounds, Abscesses and
Dental Infections
Oral: 2.5 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 tablet
every 12 hours for each 10 pounds of body weight.
Clintabs 75 mg, administer 1 tablet
every 12 hours for each 30 pounds of body weight.
Clintabs 150 mg, administer 1 tablet
every 12 hours for each 60 pounds of body weight.
Canine Osteomyelitis
Oral: 5.0 mg/lb body weight every 12
hours. Duration: Treatment with Clintabs (clindamycin
hydrochloride) Tablets 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 1 tablet
every 12 hours for each 5 pounds of body weight.
Clintabs 75 mg, administer 1 tablet
every 12 hours for each 15 pounds of body weight.
Clintabs 150 mg, administer 1 tablet
every 12 hours for each 30 pounds of body weight.
HOW SUPPLIED
Clintabs Tablets are available as:
25 mg tablets supplied in bottles of 400
75 mg tablets supplied in bottles of 200
150 mg tablets supplied in bottles of 100
Store at controlled room temperature 20°-25°C (68°-77°F).
Keep container tightly closed.
Caution: Federal (USA) law restricts
this drug to use by or on the order of a licensed veterinarian.
For Use In Animals Only
|
VIRBAC Clintabs |
|
NDC |
|
25 mg |
400 Tablets |
051311-400-25 |
|
75 mg |
200 Tablets |
051311-402-75 |
|
150 mg |
100 Tablets |
051311-404-15 |