Sir Francis Bacon ClindaCure Generic Name: clindamycin hydrochloride liquid Dosage Form: FOR ANIMAL USE ONLY ClindaCure brand of clindamycin hydrochloride liquid ClindaCure 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%. 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 MIC 50 MIC 85 MIC 90 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 MIC 50 MIC 90 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 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 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 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. 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. 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. 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. 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 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. 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. ClindaCure 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. How is ClindaCure 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]. 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. 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 ClindaCure clindamycin hydrochloride liquid Product Information Product Type PRESCRIPTION ANIMAL DRUG 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 1 NDC:50989-495-09 1 BOTTLE, GLASS (BOTTLE) 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 Operations Virbac Bridgeton 808558100 MANUFACTURE, RELABEL, REPACK Revised: 01/2011 Vedco, Inc. 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