Cefaseptin 300 mg (Canada)

Company: Vetoquinol

Cefalexin Chewable Tablets

VETERINARY USE ONLY

Cefaseptin 300 mg Indication

Antibiotic for the treatment of canine superficial pyoderma caused by susceptible strains of Staphylococcus pseudintermedius.

Note: It is recommended to obtain samples for in vitro culture and susceptibility testing prior to treatment. When this is not practical, culture and susceptibility results after initiation of Cefaseptin therapy should be reviewed to confirm susceptibility of the pathogens.

Cefaseptin 300 mg Dosage And Administration

Administer orally 25 mg/kg every 8 to 12 hours for 2 to 4 weeks, with or without food.

The determination of a dosage regimen for any particular patient should take into consideration factors such as the severity and the nature of the infection, susceptibility of the causative organisms, clinical experience and the integrity of the host-defence mechanisms. When treating dogs with superficial pyoderma, it is recommended to continue treatment for 7 days beyond a clinical cure.

If no clinical improvement is seen after 3-5 days of treatment, therapy should be discontinued and the case re-evaluated.

Contraindications

Do not use in animals with history of allergic reaction to cephalosporin antibiotics.

Cefaseptin 300 mg Cautions

Because there may be cross-reactivity, use cephalosporins cautiously in patients who are documented hypersensitive to other β-lactam antibiotics.

Cefalexin should be administered with caution in dogs with impaired renal function. Careful clinical observation and blood work analysis should be performed to determine a safe dosage regime.

The safety of Cefaseptin has not been investigated in pregnant, nursing or breeding dogs.

Warnings

Keep out of reach of children.

Adverse Reactions

Gastrointestinal disturbances, such as vomiting, soft stools and/or diarrhea, are the most frequently reported adverse reactions. Most cases are mild, transient and will resolve spontaneously. If not, discontinuation of Cefaseptin treatment should be recommended and symptomatic therapy may be instituted depending on the severity of the condition. Soft stools and/or diarrhea may be more common when dosing every 8 hours.

Occasionally, hypersensitivity reactions unrelated to dose can occur with cephalosporins and can manifest as rashes, fever, eosinophilia, lymphadenopathy, haemolytic anemia, arthralgia, or anaphylaxis.

Although rare, dose dependent adverse reactions are reported with cephalosporin use and may include neutropenia, thrombocytopenia, agranulocytosis, neurotoxicity, positive Coombs’ test, glomerular and interstitial nephritis, tubular necrosis, and hepatitis. These effects are associated with high doses and/or prolonged use of cephalosporins.

Clinical Pharmacology

Cefalexin is stable in the presence of gastric acid and may be given with food. It is rapidly and well absorbed from the duodenum and the jejunum after oral administration and diffuses readily into most body tissues and fluids, with the exception of brain and spinal fluid. It is mainly eliminated unchanged by renal excretion and to a small extent via the biliary tract. Cefalexin binds poorly to plasma proteins.

A comparative pharmacokinetic study was conducted in healthy dogs, using Cefaseptin 300 mg Chewable Tablet and cefalexin 250 mg/mL oral paste administered as a single target dose of 25 mg/kg once. In fasted dogs, for Cefaseptin Chewable Tablets, a mean maximum concentration (Cmax) of 26.06 µg/mL was reached at 1.91 hours with a total internal exposure of 107.3 µg.h/mL. In this study Cefaseptin Chewable Tablet was shown to be bioequivalent to cefalexin oral paste.

As a time-dependent bactericidal drug, clinical efficacy of cefalexin depends on the T>MIC. The minimum inhibitory concentration (MIC) for S. pseudintermedius isolates has been reported between 1 - 2 µg/mL. A 0.7-3.3 hour post-antibiotic in vitro effect of cefalexin against S. pseudintermedius isolates obtained from cases of canine pyoderma has previously been reported.

In the comparative pharmacokinetic study, in average dogs maintained a cefalexin plasma concentration above 1 µg/mL for almost 12 hours and a concentration above 2 µg/mL for 9 hours after administration of Cefaseptin Chewable Tablets.

Microbiology

Cephalexin is a first generation cephalosporin. It exhibits a bactericidal action against sensitive organisms during the active multiplication stage. It works by the inhibition of the biosynthesis of cell wall mucopeptides. Cefalexin has a relative resistance to common beta-lactamases (enzymes that inactivate antimicrobial agents by hydrolyzing their beta-lactam ring) like that carried by many staphylococci.

The Minimal Inhibitory Concentration of cefalexin for 90% (MIC90) of Staphylococcus pseudintermedius isolated from canine superficial pyoderma cases enrolled in the field clinical trial done to register cefalexin oral pastes is 1 µg/mL. Cefalexin is a time-dependent antibiotic.

MIC of cefalexin (µg/mL) for the staphylococcal isolates from the cases of canine superficial pyoderma enrolled in the field clinical trial done to register cefalexin oral pastes

Note: The correlation between in vitro susceptibility data (MIC) and clinical response has not been determined.

Clinical Efficacy Studies

A multi-center clinical field trial was conducted in 11 veterinary clinics in Canada to evaluate the efficacy of cefalexin oral pastes (100 and 250 mg/mL) for the treatment of canine superficial pyoderma. Dogs were administered either cefalexin oral paste at 25 mg/kg twice daily or amoxicillin/clavulanic acid tablets at 12.5 mg/kg twice daily, for 2 to 4 weeks. A total of 107 dogs were enrolled and efficacy analysis was performed on 92 dogs. Treatment was considered a success in 46/49 dogs given cefalexin oral paste (93.9%) and 36/43 dogs given amoxicillin/clavulanic acid tablet (83.7%). There was no statistically significant difference in the success rate between the two treatments. The mean duration of treatment was 20 days for both drug products.

Safety Studies

A 4-week target animal safety study was conducted using cefalexin oral paste (100 mg/ml). 24 Beagle dogs were treated orally, twice daily at 0x, 1x, 3x, and 5x the proposed label dose of 25 mg/kg. Treatment had no apparent effect on body weight, CBC, serum biochemistry, or urinalysis parameters. The most commonly seen adverse reactions were associated with the gastrointestinal system (vomiting and/or changes in fecal consistency/appearance). These observations were more prevalent in dogs receiving 5x volumes of excipient (0x group) and 5x dogs. This effect may have been related to the amount of triglyceride in the large volume of paste these two groups received.

The safety of cefalexin oral pastes was evaluated during a multi-center clinical field trial. There was no statistically significant difference in adverse reaction rates between cefalexin oral pastes and amoxicillin/clavulanic acid tablets. Gastrointestinal disturbances were the most frequently reported adverse reactions in dogs receiving cefalexin oral paste. They included vomiting, soft stools, or less frequently, diarrhea. These reactions were usually mild and transient.

Palatability

15 Beagle dogs were used to test the palatability of Cefaseptin Chewable Tablets when compared to unflavoured cefalexin tablets in a cross over design. Dogs were presented test or reference product in a bowl and were given the opportunity to freely eat the tablet. Cefaseptin Chewable Tablets were eaten in less than a minute by 13 of the 15 dogs (87%). Of the 3 dogs (20%) that consumed the unflavoured cefalexin tablets, only two dogs ate the tablet in less than a minute. Neither Cefaseptin Chewable Tablet nor the unflavoured cefalexin tablet was eaten by two of the dogs.

Presentation

Cefaseptin 300 mg is presented in blisters of 10 tablets; each carton contains 100 tablets.

Cefaseptin 750 mg is presented in blisters of 6 tablets; each carton contains 72 tablets.

Storage

Store between 15°C and 25°C.

Vetoquinol N.-A. Inc., 2000, ch. Georges, Lavaltrie, QC, Canada J5T 3S5

449325 0417 C

CPN: 1234445.1