ClindaCure: Product Information

CLINDACURE- clindamycin hydrochloride liquid
VEDCO

Approved for use in dogs and cats.

Caution: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION

Clindamycin Hydrochloride Oral Drops (clindamycin hydrochloride liquid) contains 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.

Clindamycin Hydrochloride Oral Drops (For Use in Dogs and Cats) is a palatable formulation intended for oral administration. Each mL of Clindamycin Hydrochloride Oral Drops contains clindamycin hydrochloride equivalent to 25 mg clindamycin; and ethyl alcohol, 8.64%.

INDICATIONS

Clindamycin Hydrochloride Oral Drops (for use in dogs and cats) is 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 and 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.

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 Oral Drops 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:

Liquid

Clindamycin Hydrochloride Oral Drops , administer 1-6 mL/10 lbs body weight every 12 hours.

Dogs:

Osteomyelitis

Oral: 5.0-15.0 mg/lb body weight every 12 hours.

Duration: Treatment with Clindamycin Hydrochloride Oral Drops 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:

Liquid

Clindamycin Hydrochloride Oral Drops , administer 2-6 mL/10 lbs body weight every 12 hours.

Cats:

Infected Wounds, Abscesses and Dental Infections

5.0 — 15.0 mg/lb body weight once every 24 hours depending on the severity of the condition.

Duration: Treatment with Clindamycin Hydrochloride Oral Drops may be continued up to a maximum of 14 days if clinical judgment indicates. Treatment of acute infections should not be continued for more than three to four days if no clinical response to therapy is seen.

Dosage Schedule:

Clindamycin Hydrochloride Oral Drops , to provide 5.0 mg/lb, administer 1 mL/5 lbs body weight once every 24 hours; to provide 15.0 mg/lb, administer 3 mL/5 lbs body weight once every 24 hours.

CONTRAINDICATIONS

Clindamycin Hydrochloride Oral Drops is 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.

HUMAN WARNINGS

Keep out of reach of children. Not for human use.

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 Oral Drops occasionally results in overgrowth of non-susceptible organisms such as clostridia and yeasts. Therefore, the administration of Clindamycin Hydrochloride Oral Drops 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 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 Oral Drops should be used with caution in animals receiving such agents.

Safety in gestating bitches and queens or breeding male dogs and cats has not been established.

ADVERSE REACTIONS

Side effects occasionally observed in either clinical trials or during clinical use were vomiting and diarrhea.

To report a suspected adverse reaction or to request a material safety data sheet (MSDS), call 1-800-650-4899.

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 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 National Committee for Clinical Laboratory Standards (NCCLS).

Table 1. Clindamycin MIC Values (microgram/mL) from Diagnostic Laboratory Survey Data Evaluating Canine Pathogens in the U.S. During 1998-991
Organism

Number of

Isolates

MIC50 MIC85 MIC90 Range
Soft Tissue/Wound2
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/Bone3
Staphylococcus aureus 20 0.5 0.5 0.5 0.54
Staphylococcus intermedius 15 0.5 >4.0 >4.0 0.25->4.0
Staphylococcu s 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/Skin5
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
Staphlyococcus 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

1 The correlation between the in vitro susceptibility data and clinical response has not been determined.

2 Soft Tissue/Wound: includes samples labeled wound, abscess, aspirate, exudates, draining tract, lesion, and mass

3 Osteomyelitis/Bone: includes samples labeled bone, fracture, joint, tendon

4 No range, all isolates yielded the same value

5 Dermal/Skin: includes samples labeled skin, skin swab, biopsy, incision, lip

Table 2. Clindamycin MIC Values (microgram/mL) from Diagnostic Laboratory Survey Data Evaluating Feline Pathogens from Wound and Abscess Samples in the U.S. During 19981
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

1 The correlation between the in vitro susceptibility data and clinical response has not been determined.

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