Cephalexin

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This page reprints a manufacturer label. Everything below in quotation marks is copied from RILEXINE® (cephalexin tablets) Chewable Tablets, published by FDA and retrieved on 2026-09-16. Nothing has been added, reworded or left out of the sections shown. It is the manufacturer’s label, reproduced as published.

This page reprints the FDA label for RILEXINE® (cephalexin tablets) Chewable Tablets by Virbac AH, Inc, a cephalexin product labelled for dogs and cats. The sections below are copied from that label without change, with the set id and the date it was retrieved from DailyMed.

The label

Product: RILEXINE® (cephalexin tablets) Chewable Tablets. Manufacturer: Virbac AH, Inc. FDA Structured Product Label set id 84506621-8429-4b65-a7b4-1c9375dcbd89. Label effective 2024-06-27. Retrieved 2026-09-16 from the DailyMed animal label release, and readable on DailyMed.

Indications

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

Dosage and Administration

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.

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. 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.

Precautions

Prescribing antibacterial drugs in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to treated animals and may increase the risk of the development of drug-resistant animal pathogens. RILEXINE chewable tablets are designed to taste good. Store RILEXINE chewable tablets out of reach of dogs, cats, and other pets in a secured location. Post approval experience has shown that dogs and cats may willingly consume more than the recommended dosage of RILEXINE chewable tablets, which can result in overdose. Adverse reactions may occur if large quantities of tablets are ingested (see Adverse Reactions, Animal Safety, and Information for Dog Owners sections). If the product is dispensed in a container other than the original, prescribers should consider adding a statement on the bottle label reminding the owner that RILEXINE chewable tablets are designed to taste good and should be stored out of reach of pets in a secured location. 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. Occasionally, cephalosporins have been associated with myelotoxicity, thereby creating a toxic neutropenia.1 Other hematological reactions observed with cephalosporin therapy include neutropenia, anemia, hypoprothrombinemia, thrombocytopenia, prolonged prothrombin time (PT) and partial thromboplastin time (PTT), platelet dysfunction, and transient increases in serum aminotransferases.2

Adverse Reactions

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. image description

Description

RILEXINE chewable tablets are a chewable, bisected tablet supplied in 3 sizes containing 150 mg, 300 mg, and 600 mg of cephalexin. Cephalexin is a cephalosporin, beta-lactam, broad spectrum antibiotic. The full chemical name for cephalexin is 7-(D-ɑ-amino-ɑ-phenylacetamido)-3-methyl-3-cephem-4-carboxylic acid monohydrate

FDA adverse event reports

The FDA Center for Veterinary Medicine publishes the adverse event reports it receives through openFDA. The counts below are the reports naming cephalexin as an active ingredient for each species this label names, as returned on 2026-09-16, coded by the VeDDRA reaction term the reporter chose. Reactions are counted per report, so one report can appear under several terms.

These are counts, not rates. Reporting is voluntary, the number of animals treated is not known, and a widely used product accumulates reports for that reason alone. A report records that an event followed a dose; it does not establish that the product caused it. The counts say nothing about how one product compares with another.

Dogs: 2,659 reports

Reactions most often coded in dogs, 2,659 reports
VeDDRA reaction termReports
Vomiting701
Emesis368
Lethargy (see also Central nervous system depression in 'Neurological')356
Diarrhoea214
Other abnormal test result NOS207
Overdose190
Lack of efficacy - NOS182
Anorexia173
Accidental exposure166
Death by euthanasia137
Seizure NOS133
Weight loss120
Elevated alanine aminotransferase (ALT)118
Death117
Decreased appetite107

Outcome as recorded by the reporter: Recovered/Normal 953; Ongoing 790; Outcome Unknown 564; Died 139; Euthanized 131; Recovered with Sequela 73.

Queries: reports, reactions, outcomes. Dataset: openFDA Animal and Veterinary Adverse Event Reports.

Cats: 89 reports

Reactions most often coded in cats, 89 reports
VeDDRA reaction termReports
Vomiting59
Accidental exposure37
Overdose29
Lethargy (see also Central nervous system depression in 'Neurological')13
Diarrhoea9
Behavioural disorder NOS7
Hiding7
Crystalluria6
Inappetence6
Death by euthanasia5
Decreased appetite5
Lethargy (see also Central nervous system depression in Neurological)5
Anorexia4
Elevated creatinine4
Vocalisation4

Outcome as recorded by the reporter: Outcome Unknown 42; Recovered/Normal 35; Ongoing 9; Euthanized 5; Died 3; Recovered with Sequela 1.

Queries: reports, reactions, outcomes. Dataset: openFDA Animal and Veterinary Adverse Event Reports.

Sources

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