RILEXINE® (cephalexin) Chewable Tablets for Dogs Antimicrobial for Oral Use in Dogs only


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


BRIEF SUMMARY: Please consult package insert for complete product information.


INDICATION: For the treatment of secondary superfi cial bacterial pyoderma in dogs caused by susceptible strains of Staphylococcus pseudintermedius.


CONTRAINDICATIONS: 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.


WARNINGS: 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.


PRECAUTIONS: Prescribing antibacterial drugs in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefi t to treated animals and may increase the risk of the development of drug-resistant animal pathogens.


The safe use of RILEXINE Chewable Tablets in dogs intended for breeding and in pregnant or lactating bitches has not been evaluated.


Positive direct Coombs’ test results and false positive reactions for glucose in the urine have been reported during treatment with some cephalosporin antimicrobials. Cephalosporin antimicrobials may also cause falsely elevated urine protein determinations. Some antimicrobials, including cephalosporins, can cause lowered albumin values due to interference with certain testing methods.


cephalosporin therapy include neutropenia, anemia, hypoprothrombinemia, thrombocytopenia, prolonged prothrombin time (PT) and partial thromboplastin time (PTT), platelet dysfunction, and transient increases in serum aminotransferases2


.


ADVERSE REACTIONS: The most common adverse reactions in dogs include diarrhea, vomiting, anorexia and lethargy. To report suspected adverse reactions call Virbac at 1-800-338-3659.


ANIMAL SAFETY: RILEXINE Chewable Tablets were administered orally three times a day to 12-week-old healthy Beagles at 0 mg/kg (placebo), 22 mg/kg (1X), 66 mg/kg (3X), and 110 mg/kg (5X) for 12 weeks, and at 22 mg/kg twice a day for 12 weeks. The most common clinical fi ndings included epiphora, salivation, vomiting and diarrhea among all the dose groups. Three dogs had decreased activity (1 in each from the 22 mg/kg twice a day, 22 mg/kg three times a day, and the 66 mg/kg three times a day groups). These observations were mild and sporadic.


There were increases in alanine aminotransferase (ALT) in the 110 mg/kg three times a day group and in the 22 mg/kg twice a day group that increased in a dose-dependent pattern. There was an increase in sorbitol dehydrogenase (SDH) in the 110 mg/kg three times a day group compared to the controls. These changes were minimal and the values remained within expected historical control ranges. There were several decreases in total protein (in the 110 mg/kg three times a day group) and/or globulin (in the 22, 66, and 110 mg/kg three times a day groups) compared to the controls. These changes resulted in occasional increases in albumin/globulin ratios. Although a drug effect cannot be ruled-out, these changes were not clinically relevant.


A mild prolongation in prothrombin time (PT) was observed in the 22 mg/kg three times a day group. This was not considered clinically relevant due to the small change that remained within the reference ranges.


One dog in the 110 mg/kg three times a day group had moderate amounts of bilirubinuria at the Week 8 and Week 12 samplings. No clinical signifi cance was noted.


Cephalexin was not present in any Day 1 samples prior to dosing or in any control animals. After dosing, cephalexin was well absorbed into systemic circulation of the treated dogs. Within gender and dosage level, Week 8 mean trough concentrations were generally higher than the Week 4 and 12 mean trough concentrations (between a 0.9 and 3.6-fold difference). The geometric mean plasma cephalexin trough concentration following three times daily administration of the 110 mg/kg dose was 11.2 µg/mL compared to 2.6 µg/mL and 8.7 µg/mL following 22 mg/kg and 66 mg/ kg, respectively at Week 12. Geometric mean plasma cephalexin trough concentrations following administration of 22 mg/kg twice daily were 0.7, 1.3, and 1.0 µg/mL at Weeks 4, 8, and 12, respectively.


STORAGE INFORMATION: Store at 20°C-25°C (68°F-77°F), with excursions permitted between 15°C-30°C (59°F-86°F).


HOW SUPPLIED: RILEXINE (cephalexin) Chewable Tablets are supplied in 75 mg, 150 mg, 300 mg, and 600 mg tablets packaged in bottles of 100 and 500 tablets or boxes of 28 blister-packs, 7 tablets per blister pack.


NADA 141-326, Approved by FDA.


Distributed by: Virbac Animal Health, Inc. Fort Worth, TX 76137 USA Revision date: 08/2011 ©2013 Virbac AH, Inc. All Rights Reserved.


RILEXINE is a registered trademark of Virbac S.A. in the United States and Canada.


Occasionally, cephalosporins have been associated with myelotoxicity, thereby creating a toxic neutropenia1 Other hematological


reactions observed with .


PYODERMA IS NO LONGER SUCH A


TREATING DOGS WITH


HUMAN PILL


BITTER TO SWALLOW.


Introducing RILEXINE (cephalexin) Chewable Tablets for Dogs


®


The fi rst veterinary approved cephalexin makes treating superfi cial pyoderma feel more like giving a treat.


Human generic cephalexin may be your fi rst-line choice for secondary superfi cial bacterial pyoderma, but it’s a bitter pill to swallow for your canine patients. RILEXINE


® (cephalexin)


Chewable Tablets, the fi rst FDA-approved cephalexin specifi cally designed for the veterinary market, fi nally combines proven palatability with the effi cacy you’ve come to expect. Plus, it comes in three convenient sizes for more precise dosing. You and your canine patients are about to get a taste for better compliance. Ask your Virbac representative for details.


RILEXINE Chewable Tablets are not for use in dogs with a history of allergic reactions to penicillins or cephalosporins. Sensitized individuals should avoid contact of the product with the skin and mucous membranes. The safety of RILEXINE Chewable Tablets in breeding, pregnant and lactating bitches has not been evaluated. For additional product information, refer to the brief summary.


For more information call 800-338-3659. virbacvet.com ©2013 Virbac AH, Inc. All Rights Reserved. RILEXINE is a registered trademark of Virbac S.A. in the United States and Canada.


Passionate About Animal Health


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