Excede Sterile: Product Information (Page 8 of 8)

MICROBIOLOGY

Ceftiofur is a cephalosporin antibiotic. Like other ß-lactam antimicrobials, ceftiofur exerts its inhibitory effect by interfering with bacterial cell wall synthesis. This interference is primarily due to its covalent binding to the penicillin-binding proteins (PBPs) (i.e., transpeptidase and carboxypeptidase), which are essential for synthesis of the bacterial wall. Ceftiofur is not active against Pseudomonas spp. and enterococci.

The minimum inhibitory concentration (MIC) values for ceftiofur against label-claim pathogens isolated from lower respiratory tract infections in horses enrolled in a 2007-2008 field effectiveness study are presented in Table 4. All MICs were determined in accordance with the Clinical and Laboratory Standards Institute (CLSI) standards.

Table 4. Activity of EXCEDE Against Pathogens Isolated from Horses Treated With EXCEDE in Field Studies in the U.S. During 2007-2008.
Disease Pathogen Treatment Outcome # of Isolates Time of Sample Collection MIC50 µg/mL MIC90 µg/mL MIC Range µg/mL
*
One horse cultured Staphylococcus aureus (successfully treated) and is not represented in the table.
Lower Respiratory Tract InfectionStreptococcus equi ssp. zooepidemicus Success 93* Pre-Treatment 0.06 0.12 0.03-0.5
Failure 42 Pre-Treatment 0.06 0.25 0.03-0.5

EFFECTIVENESS

A double masked, randomized, negative control, field study evaluated the effectiveness of two intramuscular doses of 6.6 mg/kg EXCEDE Sterile Suspension administered 4 days apart for the treatment of lower respiratory infections caused by Streptococcus equi ssp. zooepidemicus in the horse. In this study, a total of 278 horses were treated with EXCEDE, and 95 horses were treated with saline injections. One hundred ninety-three horses (136 EXCEDE and 57 saline placebo) were included in the statistical analysis. Therapeutic success was characterized by no worsening of clinical signs at Day 4, clinical improvement at Day 9, resolution of the clinical signs by Day 15, and no recurrence of clinical signs by Day 25 after initial dosing. EXCEDE was superior to the saline control. Table 5 summarizes the clinical success rates obtained 15 and 25 days after the first dose.

Table 5. Clinical success rates at Day 15 and 25.
Effectiveness parameter EXCEDE Saline Control P-value
Clinical success Day 15 73.53% 38.60% N/A
Clinical success Day 25 69.12% 31.58% 0.0215

ANIMAL SAFETY

Two studies, a target animal safety (TAS) study and a pharmacokinetic (PK) study (see CLINICAL PHARMACOLOGY section), were conducted to assess the safety of EXCEDE in the horse.

In the TAS study, healthy adult horses received 6 intramuscular (lateral neck) injections of EXCEDE Sterile Suspension at doses of either 3.0 (1×), 6.0 (2×) or 9.0 (3×) mg/lb with a 4 day interval between each injection. In the TAS study, there were no treatment related gastrointestinal findings for the three EXCEDE Sterile Suspension treatment groups. In the PK study, one horse treated with 6.0 mg/lb (2×) EXCEDE experienced a mild episode of colic the day after the second injection of EXCEDE. The horse recovered without treatment.

Injection sites were observed in both studies. In both studies, the largest injection volume administered was 20 mL per injection site. There were no observations of erythema, necrosis or drainage at the injection sites in these studies. Firmness, swelling, and/or sensitivity were observed in at least one injection site in all horses treated at the label dose. In the TAS study, injection site reaction measurements ranged from no measurable reaction to 16 × 33 × 1.5 cm. In the PK study, the largest area of edema associated with the injection site ranged from no detectable reaction to a 30 × 36 cm area of edema. Injection site reactions developed within 2 days of injection and resolved within 1-18 days. In the PK study, 2 horses had small areas of firmness that had not resolved at the end of the study (21 days after injection). In both studies, a greater incidence of injection site reactions occurred after the second injection, and in several horses, swelling at the injection site resolved then recurred 1-5 days later.

In the PK study, several horses developed clinical signs consistent with foot pain (stiff in the front limbs when turned in tight circles, and increased pulses and heat to the front feet). One horse in the NAXCEL group and one horse in the 6.0 mg/lb (2×) EXCEDE group were euthanized due to laminitis. Clinical signs of foot pain (stiff front limbs and increased heat and pulses in feet) affected more horses, for a longer period of time, in all EXCEDE-treated groups as compared to the NAXCEL-treated group. The study housing (multi-horse pens on concrete slabs) and diet (free choice alfalfa/grass mix and once a day pellets) may have contributed to the development of foot pain. The prevalence and severity of injection site reactions in EXCEDE-treated horses may also have contributed to the development of a stiff gait. A causal relationship between ceftiofur and foot pain could not be definitively determined.

STORAGE CONDITIONS

Store at controlled room temperature 20° to 25°C (68° to 77°F). Shake well before using. Contents should be used within 12 weeks after the first dose is removed.

HOW SUPPLIED

EXCEDE Sterile Suspension is available in the following package sizes:

100 mL vial
250 mL vial

Approved by FDA under NADA # 141-209
zoetis
Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007
www.EXCEDE.com or call 1-888-963-8471

Revised: January 2020

40029632

PRINCIPAL DISPLAY PANEL — 100 mL Vial label

100 mL Vial label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 250 mL Vial label

250 mL Vial label
(click image for full-size original)

EXCEDE STERILE ceftiofur injection, suspension
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-5224
Route of Administration INTRAMUSCULAR, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CEFTIOFUR (CEFTIOFUR) CEFTIOFUR 200 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54771-5224-1 1 BOTTLE in 1 CARTON contains a BOTTLE (54771-5224-3)
1 NDC:54771-5224-3 100 mL in 1 BOTTLE This package is contained within the CARTON (54771-5224-1)
2 NDC:54771-5224-2 1 BOTTLE in 1 CARTON contains a BOTTLE (54771-5224-4)
2 NDC:54771-5224-4 250 mL in 1 BOTTLE This package is contained within the CARTON (54771-5224-2)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141209 09/05/2003
Labeler — Zoetis Inc. (828851555)

Revised: 06/2020 Zoetis Inc.

VetLabel.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VetLabel.com. Every individual animal healthcare product label entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Our database mirrors the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. VetLabel.com provides the full animal health subset of the FDA's repository. Veterinary information provided here is not intended as a substitute for direct consultation with a qualified veterinary professional.

Terms of Use | Copyright © 2024. All Rights Reserved.