Spectramast DC: Product Information

SPECTRAMAST DC- ceftiofur hydrochloride suspension
Zoetis Inc.

SPECTRAMAST® DC

brand of ceftiofur hydrochloride sterile suspension

For Intramammary Infusion in Dry Dairy Cattle Only

FOR USE IN ANIMALS ONLY — NOT FOR HUMAN USE

CAUTION

Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian. Federal Law prohibits extra-label use of this drug in dry dairy cattle for disease prevention purposes; at unapproved doses, frequencies, durations, or routes of administration; and in unapproved major food producing species/production classes.

DESCRIPTION

Ceftiofur hydrochloride is a cephalosporin antibiotic.

Chemical Structure of Ceftiofur Hydrochloride
Chemical Structure
(click image for full-size original)
U-64279A

Chemical Name of Ceftiofur Hydrochloride

5-Thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, 7 — [[2-(2-amino-4-thiazolyl) — 2 -(methoxyimino)acetyl]amino]-3-[[(2-furanyl-carbonyl)thio]methyl]-8-oxo, hydrochloride.

Ceftiofur Hydrochloride Sterile Suspension is an oil based sterile suspension.

Each 10 mL PLASTET® Disposable Syringe Contains:

Ceftiofur Equivalents (as the hydrochloride salt) 500 mg
Microcrystalline Wax 700 mg
Oleoyl Polyoxylglyceride 500 mg
Cottonseed Oil q.s.

INDICATIONS FOR USE

SPECTRAMAST® DC Ceftiofur Hydrochloride Sterile Suspension is indicated for the treatment of subclinical mastitis in dairy cattle at the time of dry off associated with Staphylococcus aureus , Streptococcus dysgalactiae , and Streptococcus uberis.

SPECTRAMAST® DC Ceftiofur Hydrochloride Sterile Suspension has been proven effective against Staphylococcus aureus , Streptococcus dysgalactiae , and Streptococcus uberis.

DOSAGE

Infuse one (1) syringe into each affected quarter at the time of dry off.

DIRECTIONS FOR USING THE PLASTET® DISPOSABLE SYRINGE

The syringe is designed to provide the choice of either insertion of the full cannula as has traditionally been practiced, or insertion of no more than 1/8 inch of the cannula, as reported by Eberhart, R.J., et. al. 1987. Current Concepts of Bovine Mastitis, 3rd Edition, National Mastitis Council, Arlington, VA.

a. Full insertion: Remove the red end cap by pulling straight up as shown. Gently insert the full cannula into the teat canal; carefully infuse the product.

b. Partial insertion: Remove the red end cap by pulling straight up as shown. Gently insert the exposed white tip into the teat canal; carefully infuse the product.

Figure
(click image for full-size original)

ADMINISTRATION

Treatment:

Wash teats thoroughly with warm water containing a suitable dairy antiseptic. Dry teats thoroughly. Milk out udder completely. Using an alcohol pad provided, wipe off the end of the affected teat using a separate pad for each teat. Choose the desired insertion length (full or partial) and insert tip into teat canal; push plunger to dispense entire contents, massage the quarter to distribute the suspension into the milk cistern.

Reinfection:

After successful treatment, reinfection may occur unless good herd management, sanitation, and mechanical safety measures are practiced. Affected cows should be watched carefully to detect recurrence of infection and possible spread to other animals.

CONTRAINDICATIONS

As with all drugs, the use of SPECTRAMAST® DC Sterile Suspension is contraindicated in animals previously found to be hypersensitive to the drug.

Discard Empty Container: DO NOT REUSE
KEEP OUT OF REACH OF CHILDREN

WARNINGS

Penicillins and cephalosporins can cause allergic reactions in sensitized individuals. Topical exposures to such antimicrobials, including ceftiofur, may elicit mild to severe allergic reactions in some individuals. Repeated or prolonged exposure may lead to sensitization. Avoid direct contact of the product with the skin, eyes, mouth and clothing. Sensitization of the skin may be avoided by wearing protective gloves.

Persons with a known hypersensitivity to penicillin or cephalosporins should avoid exposure to this product.

In case of accidental eye exposure, flush with water for 15 minutes. In case of accidental skin exposure, wash with soap and water. Remove contaminated clothing. If allergic reaction occurs (e.g., skin rash, hives, difficult breathing), seek medical attention.

The Safety Data Sheet contains more detailed occupational safety information. For a copy of the Safety Data Sheet or to report adverse reactions, call Zoetis Inc. at 1-888-963-8471. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or at www.fda.gov/reportanimalae.

RESIDUE WARNINGS

  • Milk taken from cows completing a 30-day dry cow period may be used for food with no milk discard due to ceftiofur residues.
  • Following label use, no pre-slaughter withdrawal period is required for neonatal calves born from treated cows regardless of colostrum consumption.
  • Following intramammary infusion, a 16-day pre-slaughter withdrawal period is required for treated cows.
  • Use of this product in a manner other than indicated under DOSAGE might result in violative residues.

CLINICAL MICROBIOLOGY

Ceftiofur is a broad-spectrum cephalosporin antibiotic that exerts its effect by inhibiting bacterial cell wall synthesis. Like other ß-lactam antimicrobial agents, the cephalosporins inhibit cell wall synthesis by interfering with the enzymes essential for peptidoglycan synthesis. This effect results in lysis of the bacterial cell and accounts for the bactericidal nature of these agents. Ceftiofur has demonstrated in vitro activity against clinical isolates and isolates from diagnostic laboratories. The results of susceptibility testing of these isolates against ceftiofur are presented in Tables 1 and 2. Appropriate reference strains were also susceptibility tested and their minimum inhibitory concentration (MIC) values and zone of inhibition with a 30 μg disk are presented in Table 4.

Table 1. Ceftiofur MIC values for isolates from a multi-site clinical field study evaluating subclinical mastitis in dry dairy cows in the U.S. during 2000
Organism No. MIC90 *(μg/mL) MIC range(μg/mL)
*
The MIC for 90% of the isolates.
Staphylococcus aureus 300 1.0 ≤0.06 to 2.0
Streptococcus dysgalactiae 55 ≤0.06 ≤0.06 to >64.0
Streptococcus uberis 58 1.0 ≤0.06 to 4.0
* The MIC for 90% of the isolates.Table 2. Ceftiofur MIC values * for mastitis pathogens from diagnostic laboratories in the U.S. and Canada
Organism No. Date isolated MIC90 (μg/mL) MIC range(μg/mL)
*
The above in vitro data are available, but their clinical significance is unknown.
The MIC for 90% of the isolates.
No range, all isolates yielded the same value.
Staphylococcus aureus 135 1991–1992 1.0 0.13 to 2.0
10 1993 1.0 0.25 to 1.0
107 1995 1.0 0.25 to 2.0
61 2000 1.0 ≤0.06 to 2.0
Coagulase (-) staphylococci 139 2000–2001 1.0 ≤0.06 to 2.0
Streptococcus dysgalactiae 15 1991–1992 1.0 ≤0.06 to 2.0
15 1993 ≤0.0039 No range
152 1997–1999 0.25 0.25 to 4.0
64 2000 ≤0.06 ≤0.06 to 0.5
Streptococcus uberis 22 1991–1992 0.5 ≤0.06 to 4.0
15 1993 0.03 ≤0.0039 to 0.06
133 1997–1999 0.5 0.5 to 8.0
20 2000 1.0 <0.06 to 2.0
Escherichia coli 39 1991–1992 1.0 0.25 to 1.0
40 1993 0.5 0.13 to 1.0
52 2000 0.5 ≤0.06 to 1.0

* The above in vitro data are available, but their clinical significance is unknown.
** The MIC for 90% of the isolates.† No range, all isolates yielded the same value.

Based on pharmacokinetic, milk residue and clinical effectiveness studies in dairy cattle following intramammary infusion of ceftiofur and the MIC and disk (30 μg) diffusion data from mastitis pathogens, the following breakpoints are recommended by the National Committee for Clinical Laboratory Standards [now the Clinical and Laboratories Standards Institute (CLSI)] (Table 3).

Table 3. Current recommended interpretive criteria established by CLSI for ceftiofur for Bovine Mastitis
Bovine Mastitis Organisms Disk Content Zone Diameter (mm) MIC breakpoint (μg/mL)
S I R S I R
S – Susceptible
I – Intermediate
R – Resistant
Staphylococcus aureus
Streptococcus dysgalactiae
Streptococcus uberis 30 μg ≥21 18–20 ≤17 ≤2.0 4.0 ≥8.0
Streptococcus agalactiae
Escherichia coli

Standardized procedures require the use of laboratory control organisms for both standardized diffusion techniques and standardized dilution techniques. The 30 μg ceftiofur sodium disk should give the following zone diameters and the ceftiofur sodium standard reference powder (or disk) should provide the following MIC values for the reference strain. The ceftiofur sodium disks or standard reference powder is appropriate for ceftiofur hydrochloride (Table 4).

S – Susceptible
I – IntermediateR – Resistant

Table 4. Acceptable quality control ranges for ceftiofur against CLSI recommended American Type Culture Collection (ATCC) reference strains
Organism (ATCC No.) Zone Diameter *(mm) MIC range (μg/mL)
*
All testing performed using a 30 μg disk.
Escherichia coli (25922) 26 to 31 0.25 to 1.0
Staphylococcus aureus (29213) 0.25 to 1.0
Staphylococcus aureus (25923) 27 to 31
Pseudomonas aeruginosa (27853) 14 to 18 16.0 to 64.0

*All testing performed using a 30 μg disk.

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