Label: CLINTABS- clindamycin hydrochloride tablet

  • NDC Code(s): 51311-400-40, 51311-402-75, 51311-404-15
  • Packager: Virbac AH, Inc.
  • Category: PRESCRIPTION ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated 01/10

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  • DESCRIPTION

    Clintabs Tablets contain clindamycin hydrochloride which is the hydrated salt of clindamycin. Clindamycin is a semisyntheic 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 Tablet, each white bisected tablet is marked "C" above the bisect and "25" below the bisect and contains clindamycin hydrochloride equivalent to 25 mg of clindamycin.

    75 mg Tablet, each white bisected tablet is marked "C" above the bisect and "75" below the bisect and contains clindamycin hydrochloride equivalent to 75 mg of clindamycin.

    150 mg Tablet, each white tablet is marked "C 150" on one side and contains clindamycin hydrochloride equivalent to 150 mg of clindamycin.

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  • 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 1998-99*
    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 .025-≥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 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/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
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  • PHARMACOLOGY

    Absorption

    Clindamycin hydrochloride is rapidly absorbed from the canine 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.

    Figure
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  • 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 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 gallbladder.

    Safety in gestating bitches or breeding males has not been established.

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  • 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 Bateroides 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.

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  • 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.

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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 Clintabs Tablets 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, Clintabs Tablets should be used with caution in animals receiving such agents.

    Safety in gestating bitches or breeding male dogs 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 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 hour for each 30 pounds of body weight.

    Clintabs 150 mg, administer 2-6 tablets every 12 hours for each 60 pounds of body weight.

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  • 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].

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  • Caution

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

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  • SPL UNCLASSIFIED SECTION

    Mfd. for
    Virbac AH, Inc.
    Fort Worth, TX 76137-4611, USA

    Revised December 08
    301617-04

    Clintabs is a registered trademark of Virbac AH, Inc.

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  • PRINCIPAL DISPLAY PANEL - 25 mg/400 Tablet Bottle Label

    NDC-051311-400-40

    Virbac
    ANIMAL HEALTH

    Clintabs® Tablets
    clindamycin hydrochloride
    25 mg tablets, USP

    Equiv. to 25 mg clindamycin

    For Use in Dogs Only

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

    ANADA # 200-316, Approved by FDA

    400 Tablets

    PRINCIPAL DISPLAY PANEL - 25 mg/400 Tablet Bottle Label
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  • PRINCIPAL DISPLAY PANEL - 75 mg/200 Tablet Bottle Label

    NDC-051311-402-75

    Virbac
    ANIMAL HEALTH

    Clintabs® Tablets
    clindamycin hydrochloride
    75 mg tablets, USP

    Equiv. to 75 mg clindamycin

    For Use in Dogs Only

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

    ANADA # 200-316, Approved by FDA

    200 Tablets

    PRINCIPAL DISPLAY PANEL - 75 mg/200 Tablet Bottle Label
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  • PRINCIPAL DISPLAY PANEL - 150 mg/100 Tablet Bottle Label

    NDC-051311-404-15

    Virbac
    ANIMAL HEALTH

    Clintabs® Tablets
    clindamycin hydrochloride
    150 mg tablets, USP

    Equiv. to 150 mg clindamycin

    For Use in Dogs Only

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

    ANADA # 200-316, Approved by FDA

    100 Tablets

    PRINCIPAL DISPLAY PANEL - 150 mg/100 Tablet Bottle Label
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  • INGREDIENTS AND APPEARANCE
    CLINTABS 
    clindamycin hydrochloride tablet
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:51311-400
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    clindamycin hydrochloride (clindamycin) clindamycin hydrochloride 25 mg
    Product Characteristics
    Color WHITE Score 2 pieces
    Shape ROUND Size 6mm
    Flavor Imprint Code C25
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51311-400-40 400 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANADA ANADA200316 01/26/2010
    CLINTABS 
    clindamycin hydrochloride tablet
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:51311-402
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    clindamycin hydrochloride (clindamycin) clindamycin hydrochloride 75 mg
    Product Characteristics
    Color WHITE Score 2 pieces
    Shape ROUND Size 8mm
    Flavor Imprint Code C75
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51311-402-75 200 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANADA ANADA200316 01/26/2010
    CLINTABS 
    clindamycin hydrochloride tablet
    Product Information
    Product Type PRESCRIPTION ANIMAL DRUG LABEL Item Code (Source) NDC:51311-404
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    clindamycin hydrochloride (clindamycin) clindamycin hydrochloride 150 mg
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code C150
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51311-404-15 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANADA ANADA200316 01/26/2010
    Labeler - Virbac AH, Inc. (131568396)
    Establishment
    Name Address ID/FEI Business Operations
    Virbac Bridgeton 808558100 MANUFACTURE
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