Label: CLINDACURE- clindamycin hydrochloride liquid

  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated 01/11

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  • DESCRIPTION

    ClindaCure 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.

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

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  • CLINICAL PHARMACOLOGY

    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 (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
    *
    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
    Soft Tissue/Wound
      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/Bone
      Staphylococcus
        aureus
    20 0.5 0.5 0.5 0.5§
      Staphylococcus
        intermedius
    15 0.5 ≥4.0 ≥4.0 0.25-≥4.0
      Staphylococcus
        spp.
    18 0.5 ≥4.0 ≥4.0 .025-≥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/Skin
      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
    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
    *
    The correlation between the in vitro susceptibility data and clinical response has not been determined.
    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
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  • 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 Clindamycin Hydrochloride to Dogs
    Serum Concentrations Image

    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 ClindaCure to Cats
    Serum Concentrations Image 2

    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.

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  • 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 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 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.

    Cat Data

    The recommended daily therapeutic dose range for clindamycin hydrochloride (ClindaCure) is 11 to 33 mg/kg/day (5 to 15 mg/lb/day) depending on the severity of the condition. Clindamycin hydrochloride (ClindaCure) was tolerated with little evidence of toxicity in domestic shorthair cats when administered orally at 10× the minimum recommended therapeutic daily dose (11 mg/kg; 5 mg/lb) for 15 days, and at doses up to 5× the minimum recommended therapeutic dose for 42 days. Gastrointestinal tract upset (soft feces to diarrhea) occurred in control and treated cats with emesis occurring at doses 3× or greater than the minimum recommended therapeutic dose (11mg/kg/day; 5 mg/lb/day). Lymphocytic inflammation of the gallbladder was noted in a greater number of treated cats at the 110 mg/kg/day dose level than for control cats. No other effects were noted. Safety in gestating queens or breeding male cats has not been established.

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  • INDICATIONS

    ClindaCure (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 ecrophorum 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 pefringens.

    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.

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  • CONTRAINDICATIONS

    ClindaCure 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.

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  • WARNINGS

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

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  • 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 ClindaCure 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, ClindaCure 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.

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  • 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.

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  • DOSAGE AND ADMINISTRATION

    Dogs

    Infected Wounds, Abscesses, and Dental Infections

    Oral

    2.5-15.0 mg/lb (1-6 mL/10 lbs) body weight every 12 hours.

    Duration

    Treatment with clindamycin hydrochloride 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

    ClindaCure, administer 1-6 mL/10 pounds body weight every 12 hours.

    Dogs

    Osteomyelitis

    Oral

    5.0-15.0 mg/lb (2-6 mL/10 lbs) 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:

    ClindaCure, administer 2-6 mL/10 pounds body weight every 12 hours.

    Cats

    Infected Wounds, Abscesses, and Dental Infections

    5.0-15.0 mg/lb (1-3 mL/5 lbs) body weight once every 24 hours depending on the severity of the condition.

    Duration

    Treatment with clindamycin hydrochloride 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

    ClindaCure, 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.

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  • HOW SUPPLIED

    ClindaCure is available as 20 mL filled in 30 mL bottles (25 mg/ml) supplied in packers containing 12 cartoned bottles with direction labels and calibrated dosing droppers, NDC-50989-495-09.

    ANADA #200-291, 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].

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  • SPL UNCLASSIFIED SECTION

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

    Mfd. for: VEDCO, INC.
    St. Joseph, MO 64507

    09/10

    302045-01

    ClindaCure is a trademark of VEDCO, Inc.

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  • PRINCIPAL DISPLAY PANEL - 20 mL Carton

    NDC 50989-495-09

    ClindaCure™
    clindamycin hydrochloride liquid

    Equivalent to 25 mg/mL clindamycin

    For Use in Animals Only

    VEDCO

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

    ANADA # 200-291, Approved by FDA

    20 mL

    PRINCIPAL DISPLAY PANEL - 20 mL Carton
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  • INGREDIENTS AND APPEARANCE
    CLINDACURE 
    clindamycin hydrochloride liquid
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:50989-495
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    clindamycin hydrochloride (clindamycin) clindamycin hydrochloride 25 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    alcohol  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50989-495-09 1 in 1 CARTON
    1 20 mL in 1 BOTTLE, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANADA ANADA200291 01/10/2011
    Labeler - Vedco, Inc. (021634266)
    Establishment
    Name Address ID/FEI Business Operations
    Virbac Bridgeton 808558100 MANUFACTURE, RELABEL, REPACK
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