Cephalexin

For the treatment of secondary superficial bacterial pyoderma in dogs caused by susceptible strains of Staphylococcus pseudintermedius.

Federal law restricts this drug to use by or on the order of a licensed veterinarian. For Oral Use in Dogs Only.

Rilexine®

For the treatment of secondary superficial bacterial pyoderma in dogs caused by susceptible strains of Staphylococcus pseudintermedius.

RILEXINE® (cephalexin tablets) Chewable Tablets

Cephalexin belongs to the cephalosporin family of bactericidal antibiotics. Cephalexin is readily and almost completely absorbed following oral administration (90% absolute bioavailability). Blood concentrations are proportional to dose within the range of at least 15 to 45 mg/kg. Binding to canine plasma proteins is low, ranging from 9 to 13% for cephalexin concentrations of 0.5 to 100 g/mL. Food reduces the peak cephalexin concentrations but has negligible effect on the extent of absorption. A summary of the pharmacokinetics (PK) observed in fed and fasted Beagle dogs administered a single 22 mg/kg dose is provided in Table 2. Table 2: Pharmacokinetics Parameter values (mean ± standard deviation), protein-corrected in fasted and fed dogs following a single administration of 22 mg/kg dose of RILEXINE chewable tablets (N = 12) Cephalosporins are associated with time dependent killing effects. Accordingly, the pharmacodynamic (PD) target is time above MIC (T>MIC). For staphylococcal infections, the goal for time above MIC is 40% of the dosing interval (which translates to 4.8 hrs for a BID dosing schedule). For streptococcal infections, the target for time above MIC is 60% of the dosing interval (i.e., 7.2 hrs). To assess whether or not the PK-PD target is met with a 22 mg/kg BID dosing regimen under fed and fasted conditions, it was assumed that the MIC90 for S.pseudintermedius is 2 μg/mL. Plasma drug concentrations were normalized to exactly 22 mg/kg dose and corrected for 10% protein binding (protein binding observed in canine plasma). Under fasted conditions, all targets were met in all dogs after the first daily dose. With food, the target for S. aureus was met by the second daily dose. Therefore, a 22 mg/kg BID dosing interval under fed or fasted conditions succeeded in attaining the PK-PD targets.

RILEXINE® (cephalexin tablets) Chewable Tablets

RILEXINE chewable tablets are contraindicated in dogs with a known allergy to cephalexin or to the β-lactam (any of the penicillins or cephalosporins) group of antibiotics.

RILEXINE® (cephalexin tablets) Chewable Tablets

For use in dogs only. Not for use in humans. Keep this drug out of the reach of children. Antimicrobials, including penicillins and cephalosporins, can cause allergic reactions in sensitized individuals. Sensitized individuals handling such antimicrobials, including cephalexin, should avoid contact of the product with the skin and mucous membranes in order to minimize the risk of allergic reactions. In case of ingestion by humans contact a physician immediately. Physicians may contact a poison control center for advice concerning cases of ingestion by humans.

RILEXINE® (cephalexin tablets) Chewable Tablets

The most common adverse reactions in dogs include diarrhea, vomiting, anorexia and lethargy. A total of 211 dogs were included in the field study safety analysis. Adverse reactions reported in dogs treated with RILEXINE chewable tablets and placebo are summarized in Table 1. Table 1: Number of Adverse Reactions* Reported During the Field Study with RILEXINE Chewable Tablets *Some dogs may have experienced more than one adverse reaction or more than one occurrence of the same adverse reaction during the study. No clinically significant differences were observed in the mean values for all laboratory tests including urinalysis between RILEXINE Chewable Tablets and placebo-treated dogs. At the end of treatment, group means for neutrophils, WBC, and globulin values were significantly higher in the placebo group than in the RILEXINE Chewable Tablets group; whereas, group mean values for eosinophils, A/G Ratio values, and total protein values were significantly higher in the RILEXINE Chewable Tablets group than in the placebo group. For all six of these parameters, the differences were not clinically significant and the mean values for each of the parameters remained within the normal range. To report suspected adverse drug events and/or obtain a copy of the Safety Data Sheet (SDS) or for technical assistance, contact Virbac at 1-800-338-3659. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDAVETS or online at http://www.fda.gov/AnimalVeterinary/SafetyHealth INFORMATION FOR DOG OWNERS: Owners should be advised that RILEXINE Chewable Tablets are designed to taste good. Owners should be instructed to keep the product in a secured storage area out of the reach of pets in order to prevent accidental ingestion or overdose. Post approval experience has shown that dogs and cats may willingly consume more than the recommended dosage of RILEXINE Chewable Tablets. Adverse reactions may occur if large quantities of tablets are ingested (see Precautions, Adverse Reactions, and Animal Safety sections). Owners should be advised to contact their veterinarian immediately and notify Virbac (1-800-338-3659) if the dog ingests more tablets than prescribed or if other pets ingest RILEXINE Chewable Tablets. In the case of accidental ingestion by humans, contact a physician immediately.

RILEXINE® (cephalexin tablets) Chewable Tablets

The recommended dose is 22 mg/kg (10 mg/lb) of body weight twice daily for 28 days.

Oral

Federal law restricts this drug to use by or on the order of a licensed veterinarian. For Oral Use in Dogs Only.

Rilexine®

The recommended dose is 22 mg/kg (10 mg/lb) of body weight twice daily for 28 days. Appropriate culture and susceptibility tests should be performed before treatment to determine the causative organism and its susceptibility to cephalexin. Therapy with RILEXINE chewable tablets may be initiated before results of these tests are known; once the results become available, antimicrobial therapy should be adjusted accordingly. If acceptable response to treatment is not observed, then the diagnosis should be re-evaluated and appropriate alternative therapy considered.

ORAL

RILEXINE® (cephalexin tablets) Chewable Tablets