Cefa-Tabs (100 mg) (Canada)

This page contains information on Cefa-Tabs (100 mg) for veterinary use.
The information provided typically includes the following:
  • Cefa-Tabs (100 mg) Indications
  • Warnings and cautions for Cefa-Tabs (100 mg)
  • Direction and dosage information for Cefa-Tabs (100 mg)

Cefa-tabs (100 Mg)

This treatment applies to the following species:
Manufacturer: Wyeth Animal Health

(cefadroxil Monohydrate)

For Veterinary Use Only

Veterinary Tablets

cefa-tabs (cefadroxil Monohydrate) Is A Semi-synthetic Cephalosporin Antibiotic Intended For Oral Administration.

chemistry

Cefadroxil is a member of a group of semi-synthetic derivatives of cephalosporin C, found among the metabolic products of the fungus of Cephalosporium acremonium. The cephalosporins are structurally related to the penicillins in that both contain a 4-member beta-lactam ring. Cefadroxil is a 7-amino cephalosporanic acid substituted at the 7 position to form a molecule designated chemically as (6R, 7R)-7-((R)-2-amino-2-(p-hydroxyphenyl)acetamido)-3-methyl-8-oxo-5-thia-1-azabicyclo (4.2.0) oct-2-ene-2-carboxylic acid monohydrate:

CEFADROXIL

Clinical Pharmacology

Action

Cefadroxil, like other beta-lactam antibiotics, is a bactericidal agent that causes the death of bacterial cells through a diversity of biological and biochemical effects on the cell wall. The spectrum of antibacterial activity includes many Gram-negative organisms since cefadroxil, like other cephalosporins, has the ability to penetrate the other envelope of Gram-negative bacilli, thereby gaining access to cell wall target sites. Cefadroxil is generally not broken down by penicillinases such as those produced by penicillin-resistant staphylococci, although cephalosporinases have been identified that can inactivate the molecule.

Microbiology

The effectiveness of CEFA-TABS (cefadroxil monohydrate) in skin and soft tissue infections caused by Staphylococcus aureus, (including penicillin-resistant strains) and in urinary tract infections caused by Staphylococcus aureus, Escherichia coli, and Proteus mirabilis, has been clinically demonstrated in the dog. In cats, the effectiveness of cefadroxil in skin and soft tissue infections caused by susceptible pathogens such as Pasteurella multocida, Staphylococcus aureus, Staphylococcus epidermidis and Streptococcus sp has also been demonstrated. In addition, cefadroxil has a broad spectrum of activity against both Gram-positive and Gram-negative human isolates. Although the clinical significance of in vitro data is unknown in the target species, the following human isolates are generally susceptible to cefadroxil at the indicated concentrations.(1)

Organism

Minimum Inhibitory Concentration (mcg/ml)

No. Of Isolates

Range

Mic90*

Streptococcus pyogenes

(24)

0.063-0.125

0.11

Streptococcus agalactiae

(27)

0.25-1

0.92

Streptococcus pneumoniae

(29)

0.5-2

1.2

Staphylococcus aureus, penicillin sensitive

(16)

2-16

3.2

Staphylococcus aureus, penicillin resistant

(63)

1-32

6.2

Staphylococcus epidermidis

(28)

0.125-4

2.13

Escherichia coli

(59)

4->125

16.0

Proteus mirabilis

(62)

4->125

15.6

Klebsiella pneumoniae

(61)

4-16

7.85

Salmonella sp

(22)

4-8

7.19

Shigella sp

(12)

2-8

6.98

Pasteurella multocida

(2)

 

1.4

*Concentration at which 90% of the isolates are susceptible.

The susceptibility of organisms to cefadroxil should be determined using the cephalosporin class disc, 30 mcg. Specimens for susceptibility testing should be collected prior to the initiation of antibiotic therapy.

Pharmacokinetics

Cefadroxil is stable in gastric acid and only moderately bound to serum proteins (approximately 20%). Cefadroxil is well absorbed from the gastro-intestinal tract even when administered with food. The drug is excreted largely unchanged by the kidney. In humans, high concentrations of cefadroxil activity are found in the urine within three hours after oral dosage.(2) The concurrent administration of probenecid retards the elimination rate.

In dogs, the oral administration of cefadroxil at a dosage of 22 mg/kg results in peak serum concentrations averaging 18.6 mcg/mL within 1 to 2 hours after treatment.(3) The serum half-life (T1/2) following oral administration is approximately 2 hours. Over 50% of an orally administered dose is excreted unchanged in the urine of dogs within 24 hours. Serum concentration time profiles in dogs following oral administration are illustrated graphically in Figure 1.

Figure 1: Cefadroxil Serum Concentration Curves in Dogs.(3)

In cats, the oral administration of cefadroxil at a dosage of 22 mg/kg results in peak serum concentrations of 17.4 mcg/mL within 1 to 2 hours after treatment.(3) The serum half-life (T1/2) following oral administration to cats is 2 1/2 to 3 hours. Serum concentration time profiles in cats following oral administration are illustrated graphically in Figure 2.

Figure 2: Cefadroxil Serum Concentration Curves in Cats.(3)

Cefa-Tabs (100 mg) Indications

CEFA-TABS (cefadroxil monohydrate) is indicated for the treatment of the following conditions:

Dogs

Genito-urinary infections caused by susceptible strains of Escherichia coli, Proteus mirabilis and Staphylococcus aureus.

Skin and soft tissue infections including cellulitis, pyoderma, dermatitis, wound infections and abscesses caused by susceptible strains of Staphylococcus aureus.

Cats

Skin and soft tissue infections including abscesses, wound infections, cellulitis and dermatitis caused by cefadroxil susceptible organisms.

Contraindications

CEFA-TABS (cefadroxil monohydrate) should not be administered to dogs or cats with a known allergy to cephalosporins. In penicillin-allergic animals, CEFA-TABS (cefadroxil monohydrate) should be used with caution.

Warning

For use in dogs and cats only. Not to be used in animals which are raised for food production.

Cefa-Tabs (100 mg) Caution

Safety for use in pregnant female dogs and cats or in breeding males has not been determined (see Animal Toxicology).

Animal Toxicology

The LD50 in the dog has been shown to be greater than 500 mg/kg following oral administration. In subacute studies, dogs administered 100, 200 or 400 mg/kg per day for 13 weeks showed no consistent or distinct treatment-related histopathologic changes. In chronic toxicity studies, dogs receiving doses as high as 600 mg/kg/day for six months showed no discernible treatment related effects, with the exception of emesis in dogs receiving a 400 mg/kg/day dose at one time. No distinct or consistent meaningful drug-related changes in the hematologic, coagulation, or urinalysis test results or in histologic examination of tissues were observed when compared to controls. In cats, no laboratory or pathologic evidence of toxicity was encountered following an oral dosage of 240 mg cefadroxil per kg per day. No teratogenic or antifertility effects were seen in reproductive studies done in mice and rats receiving dosages as high as nine times the maximum recommended canine dosage.

Adverse Reactions

Occasional nausea and vomiting have been reported following CEFA-TABS (cefadroxil monohydrate) therapy. Administration with food appears to decrease nausea. Diarrhea and lethargy have been occasionally reported.

Dosage

Dogs

CEFA-TABS (cefadroxil monohydrate) should be administered orally at a dosage of 22 mg per kg of body weight twice daily. Dogs with skin or soft tissue infections should be treated for a minimum of three days. Genito-urinary tract infections should be treated for a minimum of seven days with cefadroxil. Maximum duration of therapy should not exceed 30 days.

Cats

CEFA-TABS (cefadroxil monohydrate) should be administered orally at a dosage of 22 mg per kg of body weight once daily. Maximum duration of therapy should not exceed 30 days. In all cases, drug treatment should continue for at least 48 hours after the animal is afebrile or asymptomatic. If no response is observed after three days of treatment, the therapy should be discontinued and the case should be reevaluated.

Supply

CEFA-TABS

50 mg

DIN 00844284

bottles of 500

CEFA-TABS

100 mg

DIN 00844241

bottles of 500

CEFA-TABS

200 mg

DIN 00844233

bottles of 250

References

1. Leitner, F., et al: Comparative antibacterial spectrum of cefadroxil. J. Antimicrob. Chemother. 10, Suppl. B, 1 (1982).

2. Harstein, A. L., et al: Comparison of pharmacological and antimicrobial properties of cefadroxil and cephalexin. Antimicrob. Agents Chemother. 12, 93 (1977).

3. Gingerich, D. A.: Clinical pharmacology of the cephalosporins and their present use in veterinary medicine. College of Veterinary Medicine Review, Mississippi State University, 2, 93 (1982).

Wyeth Animal Health, Division of Wyeth Canada, Guelph, Ontario, Canada

Trademarks used under license

93528

C6180B

Nac No.

11570273
WYETH ANIMAL HEALTH
Division of Wyeth Canada

400 MICHENER ROAD, GUELPH, ON, N1K 1E4
Telephone:   519-837-2040
Order Desk:   800-265-7200
Fax:   519-837-9342
Website:   www.wyethah.ca
Every effort has been made to ensure the accuracy of the Cefa-Tabs (100 mg) information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the Cefa-Tabs (100 mg) product label or package insert.

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

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