Zoetis
clindamycin hydrochloride capsules, USP
clindamycin hydrochloride liquid
Caution: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.
DESCRIPTION
ANTIROBE Capsules and ANTIROBE AQUADROPS Liquid 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.
ANTIROBE Capsules (For Use in Dogs Only):
25 mg Capsule, each yellow and white capsule contains clindamycin hydrochloride equivalent to 25 mg of clindamycin.
75 mg Capsule, each green capsule contains clindamycin hydrochloride equivalent to 75 mg of clindamycin.
150 mg Capsule, each light blue and green capsule contains clindamycin hydrochloride equivalent to 150 mg of clindamycin.
300 mg Capsule, each light blue capsule contains clindamycin hydrochloride equivalent to 300 mg of clindamycin.
ANTIROBE AQUADROPS Liquid (For Use in Dogs and Cats) is a palatable formulation intended for oral administration. Each mL of ANTIROBE AQUADROPS Liquid contains clindamycin hydrochloride equivalent to 25 mg clindamycin; and ethyl alcohol, 8.64%.
CLINICAL PHARMACOLOGY
Absorption
Clindamycin hydrochloride is rapidly absorbed from the canine and feline gastrointestinal tract.
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.
Clindamycin Serum Concentrations 2.5 mg/lb (5.5 mg/kg) After B.I.D. Oral Dose of Antirobe Capsules to Dogs
Cat Serum Levels
Serum levels at or above 0.5 µg/mL can be maintained by oral dosing at a rate of 5 mg/lb of clindamycin hydrochloride liquid every 24 hours. The average peak serum concentration of clindamycin occurs approximately 1 hour after oral dosing. The elimination half-life of clindamycin in feline serum is approximately 7.5 hours. In healthy cats, minimal accumulation occurs after multiple oral doses of clindamycin hydrochloride, and steady-state should be achieved by the third dose.
Clindamycin Serum Concentrations 5 mg/lb (11 mg/kg) After Single Oral Dose of Antirobe Aquadrops to Cats
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 5OS ribosomal sub-unit. The minimum inhibitory concentrations (MICs) of Gram-positive and obligate anaerobic pathogens isolated from dogs and cats in the United States are presented in Table 1 and Table 2. Bacteria were isolated in 1998-1999. All MICs were performed in accordance with the Clinical and Laboratory Standards Institute (CLSI).
Table 1. Clindamycin MIC Values (µg/mL) from Diagnostic Laboratory Survey Data Evaluating Canine Pathogens in the U.S. during 1998-99*
|
Organism
|
Number of Isolates
|
MIC50
|
MIC85
|
MIC90
|
Range
|
|
Soft Tissue/Wound1
|
|
Staphylococcus aureus
|
17
|
0.5
|
0.5
|
≥4.0
|
0.25-≥4.0
|
|
Staphylococcus intermedius
|
28
|
0.25
|
0.5
|
≥4.0
|
0.125-≥4.0
|
|
Staphylococcus spp.
|
18
|
0.5
|
0.5
|
≥4.0
|
0.25-≥4.0
|
|
Beta-hemolytic streptococci
|
46
|
0.5
|
0.5
|
≥4.0
|
0.25-≥4.0
|
|
Streptococcus spp.
|
11
|
0.5
|
≥4.0
|
≥4.0
|
0.25-≥4.0
|
|
Osteomyelitis/Bone2
|
|
Staphylococcus aureus
|
20
|
0.5
|
0.5
|
0.5
|
0.53
|
|
Staphylococcus intermedius
|
15
|
0.5
|
≥4.0
|
≥4.0
|
0.25-≥4.0
|
|
Staphylococcus spp.
|
18
|
0.5
|
≥4.0
|
≥4.0
|
0.25-≥4.0
|
|
Beta-hemolytic streptococci
|
21
|
0.5
|
2.0
|
2.0
|
0.25-≥4.0
|
|
Streptococcus spp.
|
21
|
≥4.0
|
≥4.0
|
≥4.0
|
0.25-≥4.0
|
|
Dermal/Skin4
|
|
Staphylococcus aureus
|
25
|
0.5
|
≥4.0
|
≥4.0
|
0.25-≥4.0
|
|
Staphylococcus intermedius
|
48
|
0.5
|
≥4.0
|
≥4.0
|
0.125-≥4.0
|
|
Staphylococcus spp.
|
32
|
0.5
|
≥4.0
|
≥4.0
|
0.25-≥4.0
|
|
Beta-hemolytic streptococci
|
17
|
0.5
|
0.5
|
0.5
|
0.25-0.5
|
*The correlation between the in vitro susceptibility data and clinical response has not been determined.
1Soft Tissue/Wound: includes samples labeled wound, abscess, aspirate, exudates, draining tract, lesion, and mass
2Osteomyelitis/Bone: includes samples labeled bone, fracture, joint, tendon
3No range, all isolates yielded the same value
4Dermal/Skin: includes samples labeled skin, skin swab, biopsy, incision, lip
Table 2. Clindamycin MIC Values (µg/mL) from Diagnostic Laboratory Survey Data Evaluating Feline Pathogens from Wound and Abscess Samples in the U.S. during 1998*
|
Organism
|
Number of Isolates
|
MIC50
|
MIC90
|
Range
|
|
Bacteroides/Prevotella
|
30
|
0.06
|
4.0
|
≤0.015-4.0
|
|
Fusobacterium spp.
|
17
|
0.25
|
0.25
|
≤0.015-0.5
|
|
Peptostreptococcus spp.
|
18
|
0.13
|
0.5
|
≤0.015-8.0
|
|
Porphyromonas spp.
|
13
|
0.06
|
0.25
|
≤0.015-8.0
|
*The correlation between the in vitro susceptibility data and clinical response has not been determined.
INDICATIONS
ANTIROBE (brand of clindamycin hydrochloride) Capsules (for use in dogs only) and AQUADROPS Liquid (for use in dogs and cats) 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 Staphylococcus aureus, Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum and Clostridium perfringens. Osteomyelitis due to Staphylococcus aureus, Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum and Clostridium perfringens.
Cats: Skin infections (wounds and abscesses) due to Staphylococcus aureus, Staphylococcus intermedius, Streptococcus spp. Deep wounds and infections due to Clostridium perfringens and Bacteroides fragilis.
Dental infections due to Staphylococcus aureus, Staphylococcus intermedius, Streptococcus spp., Clostridium perfringens and Bacteroides fragilis.
CONTRAINDICATIONS
ANTIROBE Capsules and ANTIROBE AQUADROPS Liquid 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.
