FDA records indicate that there are no current recalls for this drug.
Are you a medical professional?
Trending Topics
Excede Sterile Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
FOR USE IN ANIMALS ONLY. NOT FOR HUMAN USE.
KEEP OUT OF REACH OF CHILDREN.
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 material safety data sheet contains more detailed occupational safety information. To obtain a material safety data sheet or to report any adverse event please call 1-888-963-8471.
Intra-arterial injection may occur during administration of EXCEDE Sterile Suspension via middle third of the ear injection or base of the ear injection directed towards the opposite eye. Intra-arterial injection of EXCEDE Sterile Suspension is likely to result in sudden death of the animal.
Not for use in humans. For use in animals only. Keep this and all drugs out of reach of children. Consult a physician in case of accidental human exposure.
Do not use in horses intended for human consumption.
Penicillins and cephalosporins can cause allergic reactions in sensitized individuals. Topical exposure 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 sensitivity to penicillin or cephalosporins should avoid exposure to this product. In the 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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
EXCEDE Sterile Suspension is indicated for treatment of bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in beef, non-lactating dairy, and lactating dairy cattle.
EXCEDE Sterile Suspension is also indicated for the control of respiratory disease in beef and non-lactating dairy cattle which are at high risk of developing BRD associated with M. haemolytica, P. multocida, and H. somni.
EXCEDE Sterile Suspension is also indicated for the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii in beef, non-lactating dairy, and lactating dairy cattle.
EXCEDE Sterile Suspension is also indicated for treatment of acute metritis (0-10 days post-partum) associated with bacterial organisms susceptible to ceftiofur in lactating dairy cattle.
EXCEDE Sterile Suspension is indicated for the treatment of lower respiratory tract infections in horses caused by susceptible strains of Streptococcus equi ssp. zooepidemicus.
History
There is currently no drug history available for this drug.
Other Information
EXCEDE Sterile Suspension is a ready-to-use formulation that contains the crystalline free acid of ceftiofur, which is a broad spectrum cephalosporin antibiotic active against Gram-positive and Gram-negative bacteria including ß-lactamase-producing strains. Like other cephalosporins, ceftiofur is bactericidal, in vitro, resulting from inhibition of cell wall synthesis.
Each mL of this ready-to-use sterile suspension contains ceftiofur crystalline free acid equivalent to 200 mg ceftiofur, in a caprylic/capric triglyceride (Miglyol®) and cottonseed oil based suspension.
Figure 1. Structure of ceftiofur crystalline free acid:
Chemical name of ceftiofur crystalline free acid:
7-[[2-(2-Amino-4-thiazolyl)-2-(methoxyimino)acetyl]amino]- 3-[[(2-furanylcarbonyl) thio] methyl]-8-oxo-5-thia-1- azabicyclo[4.2.0]oct-2-ene 2-carboxylic acid
EXCEDE Sterile Suspension is a ready-to-use formulation that contains the crystalline free acid of ceftiofur, which is a broad spectrum cephalosporin antibiotic active against Gram-positive and Gram-negative bacteria including ß-lactamase-producing strains. Like other cephalosporins, ceftiofur is bactericidal, in vitro, resulting from inhibition of cell wall synthesis.
Each mL of this ready-to-use sterile suspension contains ceftiofur crystalline free acid equivalent to 200 mg ceftiofur, in a caprylic/capric triglyceride (Miglyol®) and cottonseed oil based suspension.
Figure 1. Structure of ceftiofur crystalline free acid:
Chemical name of ceftiofur crystalline free acid:
7-[[2-(2-Amino-4-thiazolyl)-2-(methoxyimino)acetyl]amino]- 3-[[(2-furanylcarbonyl)thio] methyl]-8-oxo-5-thia-1- azabicyclo[4.2.0]oct-2-ene 2-carboxylic acid
Sources
Excede Sterile Manufacturers
-
Zoetis Inc.
Excede Sterile | Zoetis Inc.
Treatment of BRD and bovine foot rot
Administer as a single subcutaneous injection in the posterior aspect of the ear where it attaches to the head (base of the ear) to cattle at a dosage of 3.0 mg ceftiofur equivalents (CE)/lb (6.6 mg CE/kg) body weight (BW) (1.5 mL sterile suspension per 100 lb BW).
In beef and non-lactating dairy cattle, EXCEDE Sterile Suspension may also be administered as a single subcutaneous injection in the middle third of the posterior aspect of the ear at a dosage of 3.0 mg CE/lb (6.6 mg CE/kg) BW (1.5 mL sterile suspension per 100 lb BW).
Most animals will respond to treatment within three to five days. If no improvement is observed, the diagnosis should be reevaluated.
Control of BRD
Administer as a subcutaneous injection either in the middle third of the posterior aspect of the ear or in the posterior aspect of the ear where it attaches to the head (base of the ear) to beef and non-lactating dairy cattle at a dosage of 3.0 mg CE/lb (6.6 mg CE/kg) BW (1.5 mL sterile suspension per 100 lb BW).
Clinical studies indicate that administration of EXCEDE Sterile Suspension is effective for the control of respiratory disease in beef and non-lactating dairy cattle at "high risk" of developing BRD. One or more of the following factors typically characterizes calves on arrival at high risk of developing BRD.
Cattle are from multiple farm origins, cattle have had extended transport times (that may have included few if any rest stops), ambient temperature change from origin to arrival of 30° F or more, cattle have had continued exposure to extremely wet or cold weather conditions, cattle have experienced excessive shrink or excessive arrival processing procedures (such as castration, dehorning).Treatment of Acute Metritis
Administer as a subcutaneous injection in the posterior aspect of the ear where it attaches to the head (base of the ear) to lactating dairy cattle at a dosage of 3.0 mg CE/lb (6.6 mg CE/kg) BW (1.5 mL sterile suspension per 100 lb BW). Repeat this dose in the contra-lateral (opposite) ear approximately 72 hours following the initial dose.
Table 1. Dosing Schedule for EXCEDE Sterile Suspension. Weight
(lb) Dose Volume
(mL) Weight
(lb) Dose Volume
(mL) 100 1.5 1100 16.5 200 3.0 1200 18.0 300 4.5 1300 19.5 400 6.0 1400 21.0 500 7.5 1500 22.5 600 9.0 1600 24.0 700 10.5 1700 25.5 800 12.0 1800 27.0 900 13.5 1900 28.5 1000 15.0 2000 30.0 ADMINISTRATION FOR THE MIDDLE THIRD OF THE EAR Shake well before using. Please read the complete package insert before administering EXCEDE Sterile Suspension subcutaneously in the posterior ear of cattle. Deposit as a single subcutaneous injection in the middle third of the posterior aspect of the ear, avoiding all blood vessels. See Figures 2 and 3. Adjust the needle insertion point to avoid any blood vessels, previous implants, ear tags or ear tag holes. Do not administer intra-arterially. Deliver the entire contents of the syringe. When administered correctly, a subcutaneous bleb of EXCEDE Sterile Suspension will appear. When withdrawing the needle, apply pressure to the needle insertion point, and massage toward the base of the ear.Figure 2. Subcutaneous administration of EXCEDE Sterile Suspension in the middle third of the posterior aspect of the ear.
Figure 3. Diagram of the approximate locations of the major arteries of the posterior ear and the recommended needle insertion locations. Administration of EXCEDE Sterile Suspension into ear arteries is likely to be fatal.
In lactating dairy cattle the injection techniques for subcutaneous (SC) injection in the posterior aspect of the ear where it attaches to the head (base of the ear) can be made by the rostral or ventral injection techniques.
In beef and non-lactating dairy cattle the SC injection in the base of the ear can be made by the rostral, ventral or toward the opposite eye injection techniques.
Shake well before using. Please read the complete package insert before administering EXCEDE Sterile Suspension subcutaneously in the posterior aspect of the ear where it attaches to the head (base of the ear). The subcutaneous (SC) injection may be made using the toward the opposite eye, rostral, or ventral techniques. Hold the syringe and needle and insert the needle as described below. Deliver the entire contents of the syringe. Do not administer EXCEDE Sterile Suspension in the neck. Administration for the Base of the Ear: Toward the Opposite Eye Technique Hold the syringe and needle behind the ear to be dosed so the needle and syringe point in the direction of an imaginary line that would pass through the head toward the animal's opposite eye. See Figures 4 and 5. Insert the needle through the loose skin in the posterior aspect of the ear where it attaches to the head (base of the ear) while maintaining this angle. See Figure 4.Figure 4. Subcutaneous administration of EXCEDE Sterile Suspension in the posterior aspect of the ear where it attaches to the head (base of the ear).
Figure 5. Injection location for the subcutaneous administration of EXCEDE Sterile Suspension in the posterior aspect of the ear where it attaches to the head (base of the ear).
Administration for the Base of Ear: Toward the Same Eye Technique or Rostral Direction Hold the syringe and needle behind the ear to be dosed so the needle and syringe point in the direction of an imaginary line that would pass through the head toward the eye on the same side of the head. See Figures 5 and 6. Insert the needle through the loose skin in the posterior aspect of the ear where it attaches to the head (base of the ear) while maintaining the needle position. See Figure 6.Figure 6. Diagram of head showing the direction for the base of ear injections administered rostrally toward the eye on the same side of the head into the loose skin in the caudal aspect of the base of the ear.
Administration for Base of the Ear: Ventral Technique Hold the syringe and needle above the ear to be dosed so that the needle and syringe are pointing ventrally toward the base of the ear. The needle will be inserted into the loose skin in the posterior aspect of the ear where it attaches to the head (base of the ear) while pointing ventrally. Care should be taken to not insert the needle through the cartilage of the ear. See Figure 7. Insert the needle through the loose skin in the posterior aspect of the ear where it attaches to the head (base of the ear) while maintaining needle position. See Figure 7.Figure 7. Diagram of head showing the direction of base of ear injections when administered ventrally into the loose skin in the caudal aspect of the base of the ear.
Shake well before using.
Administer two intramuscular injections to horses, 4 days apart, at a dose of 3.0 mg/lb (6.6 mg/kg). A maximum of 20 mL per injection site may be administered. Therapeutic drug concentrations are maintained for 6 days after the second injection (or a total of 10 days from the beginning of treatment) against Streptococcus equi ssp. zooepidemicus.
Table 1. Dosing Schedule for EXCEDE Sterile Suspension. Weight
(lb) Dose Volume
(mL) Weight
(lb) Dose Volume
(mL) 100 1.5 1100 16.5 200 3.0 1200 18.0 300 4.5 1300 19.5 400 6.0 1400 21.0 500 7.5 1500 22.5 600 9.0 1600 24.0 700 10.5 1700 25.5 800 12.0 1800 27.0 900 13.5 1900 28.5 1000 15.0 2000 30.0
Login To Your Free Account