Vetolexin 250 (Canada)

This page contains information on Vetolexin 250 for veterinary use.
The information provided typically includes the following:
  • Vetolexin 250 Indications
  • Warnings and cautions for Vetolexin 250
  • Direction and dosage information for Vetolexin 250

Vetolexin 250

This treatment applies to the following species:
Manufacturer: Vétoquinol

Cephalexin Oral Paste

VETERINARY USE ONLY

Meat flavour

Pr Vetolexin 100

DIN 02353911

Active Ingredient

Each mL of paste contains 100 mg Cephalexin (as monohydrate) in a triglyceride base.

Pr Vetolexin 250

DIN 02353938

Active Ingredient

Each mL of paste contains 250 mg Cephalexin (as monohydrate) in a triglyceride base.

Vetolexin 250 Indication

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

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 Vetolexin therapy should be reviewed to confirm susceptibility of the pathogens.

Vetolexin 250 Dosage And Administration

Administer orally 25 mg/kg every 8 to 12 hours for 2 to 4 weeks. Vetolexin can be given with or without food. Administer directly into the dogs mouth or onto its 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.

HOW TO USE THE DIAL-A-DOSE SYRINGE

1. Hold the syringe with the tip pointing upward (make sure the cap is still secured) and the marks on the graduated plunger clearly visible.

2. Turn the ring to the left, so that it moves down the plunger.

3. Set the recommended dose as follows: Turn the ring 1 full turn for each mL of paste required (i.e., 2 full turns for a 2 mL dose), until the topside of the ring (the side facing the tube) reaches the next black mark on the plunger (2 marks for a 2 mL dose).

4. When you are ready to administer the dose, remove the cap and insert the tip of the syringe into the side of the dog’s mouth or on its food. Press the plunger to dispense the paste.

5. Replace the cap securely on the tip of the syringe.

Contraindications

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

Vetolexin 250 Cautions

Because there may be cross-reactivity, use cephalosporins cautiously in patients who are documented hypersensitive to other β-lactam antibiotics. Cephalexin 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. Due to high lipid content of Vetolexin, caution should be used when treating dogs with a history of pancreatitis or hyperlipidemia. The safety of Vetolexin has not been investigated in pregnant, nursing or breeding dogs.

Warning

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 Vetolexin 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 dependant 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

Cephalexin 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. Cephalexin binds poorly to plasma proteins.

Two pharmacokinetic studies were conducted in healthy dogs, using Vetolexin 100 administered as a single dose of 25 mg/kg once, or repeated daily for 5 days. A wide variability in PK parameter values were observed between subjects. In fasted dogs, a mean maximum concentration (Cmax) of 20.76 µg mL was reached at 2.67 hours with a total internal exposure of 98.8 µg.h/mL and an elimination half-life of approximately 3 hours. No statistically significant difference was detected in PK parameters between fasted and fed dogs. The absolute bioavailability was estimated at 65-79%.

As a time-dependent bactericidal drug, clinical efficacy of cephalexin depends on the T>MIC. The minimum inhibitory concentration (MIC) for S. intermedius isolates has been reported between 1 - 2 µg mL. A 0.7-3.3 hour post-antibiotic in vitro effect of cephalexin against S. intermedius isolates obtained from cases of canine pyoderma has previously been reported. In the pharmacokinetic study in which dogs received Vetolexin once daily for 5 days, 4 out of 6 dogs maintained a cephalexin plasma concentration above 1 µg/mL, 12 hours after treatment administration (C12). Overall, 24 out of 30 (80%) C12 blood samples had a concentration of cephalexin above 1 µg/mL.

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. Cephalexin 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 cephalexin for 90% (MIC90) of Staphylococcus intermedius isolated from canine superficial pyoderma cases enrolled in the field clinical trial done to register Vetolexin is 1 µg/mL. Cephalexin is a time-dependent antibiotic.

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

MIC

0.0625

0.125

0.25

0.5

1

2

4

16

32

64

>64

No. of Staph. intermedius (n=70)

0

1

1

28

39

1

0

0

0

0

0

No. of Staph. spp (n=18)

0

0

1

2

13

1

1

0

0

0

0

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 Vetolexin 100 and Vetolexin 250 for the treatment of canine superficial pyoderma. Dogs were administered either Vetolexin at 25 mg/kg twice daily or amoxicillin/clavulanic acid 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 Vetolexin (93.9%) and 36/43 dogs given amoxicillin/clavulanic acid (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 Vetolexin 100. 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 Vetolexin was evaluated during a multi-center clinical field trial. There was no statistically significant difference in adverse reaction rates between Vetolexin and amoxicillin/clavulanic acid tablets. Gastrointestinal disturbances were the most frequently reported adverse reactions in dogs receiving Vetolexin. They included vomiting, soft stools, or less frequently, diarrhea. These reactions were usually mild and transient.

Palatability

14 Beagle dogs were used to test the palatability of meat flavored Vetolexin 250 when 1 mL was administered directly into their mouth or onto their food. When administered directly into their mouth, the dogs swallowed the paste. At no time was a dog observed to spit out the paste, salivate or regurgitate after dosing. The Average Percent On-Feed Acceptance was 87%. No dog refused to eat its food because of the presence of the paste on it.

Presentation

Vetolexin 100 and Vetolexin 250 oral pastes are presented in 15 mL dial-a-dose syringes.

Storage

Store between 15°C and 25°C. Protect from direct sunlight. Replace the cap securely on the tip of the syringe after use.

992564A

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

 

Net

Code

 

Vetolexin 100

6 x 15 mL

992864

992562, 992560

Vetolexin 250

6 x 15 mL

992863

992563, 992561

NAC No.: 12343532

VÉTOQUINOL N.-A. INC.
Commercial Division

2000, CHEMIN GEORGES, LAVALTRIE, QC, J5T 3S5
Telephone:   450-586-2252
Order Desk:   800-363-1700
Fax:   450-586-4649
Website:   www.vetoquinol.ca
Email:   info@vetoquinol.ca
Every effort has been made to ensure the accuracy of the Vetolexin 250 information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the Canadian product label or package insert.

Copyright © 2014 North American Compendiums. Updated: 2014-09-05

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