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Ceftiofur

Detailed information about Ceftiofur

Official label facts Owner quick guide first Marketing clearly labeled
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Pet Owner Quick Guide

Start here: what this medicine is for, what it does, and when it's usually needed.

Usually used for:

For the 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 ca...

What it does:

For treatment of respiratory infections in horses associated with Streptococcus zooepidemicus . Treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica , P. multocida ,...

When it's needed:

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Treated swine must not be slaughtered for 4 days following the last treatment. Federal law restricts this drug to use by or on the ord...

Call your vet sooner if you notice:

  • Federal law restricts this drug to use by or on the order of a licensed veterinarian. Treated swine must not be slaughtered for 4 days following the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Treated cattle must not be slaughtered for 3 days following the last treatment. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Commonly reported reactions:

  • (2 reports)
  • (1 reports)
  • (1 reports)

What to ask your vet today:

  • Is this medicine the right fit for my pet’s current symptoms?
  • Which warning signs mean I should call back right away?
  • How should I handle missed doses or refusal to take the medicine?
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Ceftiofur

Ceftiofur

Drug type: Generic ingredient • Branded profile • FDA branded products available

Species: Both

Manufacturer: Zoetis Inc.

Quick Facts

Official label facts first, then secondary summaries. Marketing content is separated below.

Species: Both
Manufacturer: Zoetis Inc.
Form: Liquid (Solution), Liquid (Suspension), Powder-Sterile, Sterile suspension
Identifiers:
ANADA: 200421 ANADA: 200616 NADA: 140338 NADA: 140890 NADA: 141209 NADA: 141235 NADA: 141238 NADA: 141239 NADA: 141288 NDC Package: 49553-1261-1 NDC Package: 49553-1261-2 NDC Package: 54771-3362-1 NDC Package: 54771-3362-2 NDC Package: 54771-5223-1 NDC Package: 54771-5224-1 NDC Package: 54771-5224-2 NDC Package: 54771-5224-3 NDC Package: 54771-5224-4 NDC Package: 54771-5278-1 NDC Package: 54771-5278-2
Source metadata:

Warnings / Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Treated swine must not be slaughtered for 4 days following the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Treated cattle must not be slaughtered for 3 days following the last treatment. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

  • High: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Treated swine must not be slaughtered for 4 days following the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Treated cattle must not be slaughtered for 3 days following the last treatment. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Source metadata:

Adverse Reactions

Snapshot first, detailed rows second. This section summarizes signal data and is not a diagnosis.

Tap or hover a reaction to see what it means in plain language.

Tracked signals
32
Reported cases
32
Serious reports
32
Species represented
2
Most Reported Reactions
Reaction Cases Species Serious cases
2 Cat, Dog 2
1 Dog 1
1 Dog 1
1 Dog 1
1 Dog 1
1 Dog 1
1 Cat 1
1 Dog 1

Species coverage: Dog (24) Cat (8)

View detailed reaction table
Reaction Species Seriousness Frequency Reports
Dog Serious - 1
Dog Serious - 1
Dog Serious - 1
Cat Serious - 1
Dog Serious - 1
Dog Serious - 1
Dog Serious - 1
Dog Serious - 1
Cat Serious - 1
Cat Serious - 1
Cat Serious - 1
Dog Serious - 1
Cat Serious - 1
Cat Serious - 1
Dog Serious - 1
Dog Serious - 1
Dog Serious - 1
Dog Serious - 1
Dog Serious - 1
Dog Serious - 1
Dog Serious - 1
Dog Serious - 1
Dog Serious - 1
Cat Serious - 1
Dog Serious - 1
Dog Serious - 1
Cat Serious - 1
Dog Serious - 1
Dog Serious - 1
Dog Serious - 1
Dog Serious - 1
Dog Serious - 1
Source metadata:

Storage & Handling

No storage/handling guidance is linked yet.

Source metadata: No source yet.

Documents

Official label facts are separated from secondary summaries.

Official documents: 56 • Secondary summaries: 0

Official label facts
Secondary summaries

No source yet.

Source metadata:

Promotional Materials (Marketing)

This content is marketing material and not clinical guidance.

No marketing assets are linked yet.

No source yet.

Source metadata: No source yet.
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Technical appendix (vet reference)

Canonical medication sections are above. This legacy block remains available for deeper cross-reference without cluttering the primary workflow.

At a Glance

Quick facts and links to official labeling and safety signals.

Data freshness
  • Medication catalog: Source PetWisePlus | Refreshed Feb 12, 2026, 10:44 PM UTC
  • Animal Drugs @ FDA: Source FDA | Refreshed Feb 16, 2026, 11:00 AM UTC
    Applications/products are imported from FDA export data.
  • Animal Drugs @ FDA previews: Source FDA | Refreshed Feb 9, 2026, 3:05 AM UTC
    Label highlights/doc links are fetched from FDA preview endpoints.
  • Animal Drug Product Listing Directory (NDC): Source FDA | Refreshed Feb 16, 2026, 11:00 AM UTC
    Package/product NDCs from FDA’s electronic listing directory (XLS).
  • openFDA reaction terms: Source FDA openFDA | Refreshed Feb 9, 2026, 3:14 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:22 AM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: Cefenil® RTU Ceftiofur for Injection EXCEDE® EXCEDE® FOR SWINE EXCENEL® RTU EZ Excenel® Sterile Powder Excenel® RTU Excenel Sterile Suspension Naxcel® Sterile Powder Spectramast® LC Sterile Suspension Spectramast™ DC Sterile Suspension
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: 1 day-old broiler chicks, Beef, Beef And Non-Lactating Dairy, Cattle, Dairy, Day old poults, Day-Old Chicks, Dog, Goat, Horse, No Use Class Stated Or Implied, No use class stated or implied, Sheep, Swine, Turkey
Rx/OTC: RX
Form/route: Liquid (Solution), Liquid (Suspension), Powder-Sterile, Sterile suspension • Injection, Intramammary, Intramuscular, Subcutaneous
Applications: NADA 141-209 • NADA 141-235 • NADA 140-338 • NADA 141-288 • ANADA 200-616 • ANADA 200-421 • NADA 140-890 • NADA 141-239 • NADA 141-238
Documents: 45 (FOI: 37) • SPL: 11 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 8 • Cat 8 • View
Case summaries: 4 (showing 4) • View
openFDA reports are unverified and do not prove causation.
Explore
Linked using: Fda_Label (0.95), Fda_Label (0.95), Fda_Label (0.95)
Diagnosis Codes

Diagnosis-code mappings are not available for this medication yet.

Counseling and Monitoring Highlights

Global Pet owner/Vet mode is controlled in the header. This section avoids duplicate in-page persona tabs.

Owner-facing counseling points
  • Federal law restricts this drug to use by or on the order of a licensed veterinarian. Treated swine must not be slaughtered for 4 days following the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Treated cattle must not be slaughtered for 3 days following the last treatment. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (Contraindication, High)
Top reaction signals
Abnormal cytology (1) Abnormal histology NOS (1) Corneal ulcer (1) Corneal ulcer (1) Death by euthanasia (1) Decreased appetite (1) Dermal plaque (1) Dermatitis (1) Diabetes (1) Elevated alanine aminotransferase (ALT) (1) Elevated serum alkaline phosphatase (ALP) (1) Erythematous rash (1) Hyperglycaemia (1) Hypophosphataemia (1) Injection site bleeding (1) Injection site bruising (1)

Identifiers & Packages

Normalized identifiers (NDC/NADA/ANADA) and package metadata from regulator listings.

Identifiers
ANADA: 200421 ANADA: 200616 NADA: 140338 NADA: 140890 NADA: 141209 NADA: 141235 NADA: 141238 NADA: 141239 NADA: 141288 NDC Package: 49553-1261-1 NDC Package: 49553-1261-2 NDC Package: 54771-3362-1 NDC Package: 54771-3362-2 NDC Package: 54771-5223-1 NDC Package: 54771-5224-1 NDC Package: 54771-5224-2 NDC Package: 54771-5224-3 NDC Package: 54771-5224-4 NDC Package: 54771-5278-1 NDC Package: 54771-5278-2 NDC Package: 54771-5279-1 NDC Package: 54771-5279-2 NDC Package: 54771-5402-1 NDC Package: 54771-5402-2
Package NDC Product NDC Form / Route Status
49553-1261-1 49553 -
49553-1261-2 49553 -
54771-3362-1 54771 -
54771-3362-2 54771 -
54771-5223-1 54771 -
54771-5224-1 54771 -
54771-5224-2 54771 -
54771-5224-3 54771 -
54771-5224-4 54771 -
54771-5278-1 54771 -
54771-5278-2 54771 -
54771-5279-1 54771 -
54771-5279-2 54771 -
54771-5402-1 54771 -
54771-5402-2 54771 -
55529-163-02 55529 -
55529-163-04 55529 -
58597-8170-9 58597 -
58597-8171-8 58597 -
58597-8171-9 58597 -

Enriched Documents

Documents are tiered by source trust: Official, Clinical, Manufacturer, Marketing.

  • ucm118047.pdf • FOI summary • Official • Feb. 28, 2024
    FDA FOI summary for application 141235
  • UCM235349.pdf • FOI summary • Official • Feb. 28, 2024
    FDA FOI summary for application 141235
  • ucm117761.pdf • FOI summary • Official • Feb. 28, 2024
    FDA FOI summary for application 141209
  • ucm117768.pdf • FOI summary • Official • Feb. 28, 2024
    FDA FOI summary for application 141209
  • ucm117772.pdf • FOI summary • Official • Feb. 28, 2024
    FDA FOI summary for application 141209
  • UCM203951.pdf • FOI summary • Official • Feb. 28, 2024
    FDA FOI summary for application 141209
  • UCM307680.pdf • FOI summary • Official • Feb. 28, 2024
    FDA FOI summary for application 141209
  • UCM478009.pdf • FOI summary • Official • Sept. 6, 2022
    FDA FOI summary for application 140338
  • UCM490826.pdf • FOI summary • Official • Sept. 6, 2022
    FDA FOI summary for application 140338
  • N140338_Supp_03-15-1991.pdf • FOI summary • Official • Sept. 6, 2022
    FDA FOI summary for application 140338
  • N140338_Supp_08_04_1992.pdf • FOI summary • Official • Sept. 6, 2022
    FDA FOI summary for application 140338
  • UCM539438.pdf • FOI summary • Official • Sept. 6, 2022
    FDA FOI summary for application 140338
  • N140338_Supp_08-24-1995.pdf • FOI summary • Official • Sept. 6, 2022
    FDA FOI summary for application 140338
  • UCM470933.pdf • FOI summary • Official • Sept. 6, 2022
    FDA FOI summary for application 140338
  • N140338_Supp_10_25_96.pdf • FOI summary • Official • Sept. 6, 2022
    FDA FOI summary for application 140338
  • ucm049841.pdf • FOI summary • Official • Sept. 6, 2022
    FDA FOI summary for application 140338
  • ucm049842.pdf • FOI summary • Official • Sept. 6, 2022
    FDA FOI summary for application 140338
  • ucm049843.pdf • FOI summary • Official • Sept. 6, 2022
    FDA FOI summary for application 140338
  • ucm049844.pdf • FOI summary • Official • Sept. 6, 2022
    FDA FOI summary for application 140338
  • ucm049846.pdf • FOI summary • Official • Sept. 6, 2022
    FDA FOI summary for application 140338
  • ucm049847.pdf • FOI summary • Official • Sept. 6, 2022
    FDA FOI summary for application 140338
  • UCM208544.pdf • FOI summary • Official • June 3, 2019
    FDA FOI summary for application 141288
  • UCM377873.pdf • FOI summary • Official • June 3, 2019
    FDA FOI summary for application 141288
  • FOI Summary sN 141-288 Approved May 6, 2019.pdf • FOI summary • Official • June 3, 2019
    FDA FOI summary for application 141288
  • FOI Summary oA 200-616 Approved January 28, 2019.pdf • FOI summary • Official • Jan. 31, 2019
    FDA FOI summary for application 200616
  • UCM307677.pdf • FOI summary • Official • Jan. 16, 2018
    FDA FOI summary for application 200421
  • ucm059120.pdf • FOI summary • Official • Dec. 18, 2017
    FDA FOI summary for application 140890
  • ucm059122.pdf • FOI summary • Official • Dec. 18, 2017
    FDA FOI summary for application 140890
  • ucm059124.pdf • FOI summary • Official • Dec. 18, 2017
    FDA FOI summary for application 140890
  • ucm059127.pdf • FOI summary • Official • Dec. 18, 2017
    FDA FOI summary for application 140890
  • ucm059128.pdf • FOI summary • Official • Dec. 18, 2017
    FDA FOI summary for application 140890
  • ucm059129.pdf • FOI summary • Official • Dec. 18, 2017
    FDA FOI summary for application 140890
  • ucm118053.pdf • FOI summary • Official • June 1, 2016
    FDA FOI summary for application 141239
  • ucm118055.pdf • FOI summary • Official • June 1, 2016
    FDA FOI summary for application 141239
  • ucm118051.pdf • FOI summary • Official • June 1, 2016
    FDA FOI summary for application 141238
  • ucm118052.pdf • FOI summary • Official • June 1, 2016
    FDA FOI summary for application 141238
  • UCM446090.pdf • FOI summary • Official • June 1, 2016
    FDA FOI summary for application 141238

Data Sources & Revision History

Every non-trivial field is expected to include provenance and update timestamps.

Official 40 Clinical 0 Manufacturer 0 Marketing 0
Current Field Facts
  • contraindications: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Treated swine must not be slaughtered for 4 days following the last treat… (Official, 2026-02-12)
  • side_effects: Top reported reactions (openFDA): Abnormal cytology, Abnormal histology NOS, Corneal ulcer, Death by euthanasia, Decreased appetite, Dermal plaque. (Official, 2026-02-12)
  • usage: For treatment of respiratory infections in horses associated with Streptococcus zooepidemicus . Treatment of bovine respiratory disease (shipping fever, pneumo… (Official, 2026-02-12)
Recent Revisions
  • side_effects updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-02-12 22:44 by etl_backfill • Backfilled from existing medication fields

FDA Products & Applications (Animal Drugs @ FDA)

Official sponsor/proprietary-name/application-status records linked by active ingredient.

Product Sponsor Application Status Published
EXCEDE®
RX
Ceftiofur Crystalline Free Acid
Sterile suspension • Subcutaneous, Intramuscular
Label highlights
Official documents
Zoetis Inc. NADA 141-209 Approved Feb 28, 2024
EXCEDE® FOR SWINE
RX
Ceftiofur Crystalline Free Acid
Sterile suspension • Intramuscular
Label highlights
Official documents
Zoetis Inc. NADA 141-235 Approved Feb 28, 2024
Naxcel® Sterile Powder
RX
Ceftiofur Sodium
Liquid (Solution) • Intramuscular, Subcutaneous
Label highlights
Official documents
Zoetis Inc. NADA 140-338 Approved Sep 6, 2022
EXCENEL® RTU EZ
RX
Ceftiofur Hydrochloride
Liquid (Suspension) • Intramuscular, Subcutaneous
Label highlights
Official documents
Zoetis Inc. NADA 141-288 Approved Jun 3, 2019
Cefenil® RTU
RX
Ceftiofur Hydrochloride
Sterile suspension • Injection
Label highlights
Official documents
Norbrook Laboratories, Ltd. ANADA 200-616 Approved Jan 31, 2019
Ceftiofur for Injection
RX
Ceftiofur Sodium
Powder-Sterile • Subcutaneous, Intramuscular
Label highlights
Official documents
Hospira, Inc. ANADA 200-421 W Jan 16, 2018
Excenel® Sterile Powder Excenel® RTU Excenel Sterile Suspension
RX
Ceftiofur Hydrochloride
Liquid (Suspension) • Subcutaneous, Intramuscular
Label highlights
Official documents
Zoetis Inc. NADA 140-890 Approved Dec 18, 2017
Spectramast™ DC Sterile Suspension
RX
Ceftiofur Hydrochloride
Liquid (Suspension) • Intramammary
Label highlights
Official documents
Zoetis Inc. NADA 141-239 Approved Jun 1, 2016
Spectramast® LC Sterile Suspension
RX
Ceftiofur Hydrochloride
Liquid (Suspension) • Intramammary
Label highlights
Official documents
Zoetis Inc. NADA 141-238 Approved Jun 1, 2016

Data source: FDA Animal Drugs @ FDA (public search export).

What It's For (FDA Label Highlights)

Extracted from FDA Animal Drugs @ FDA product labeling. Always confirm details with your veterinarian.

Species: Beef • Dairy, lactating • Dairy, non-lactating • No Use Class Stated Or Implied
Composition / specifications
Each milliliter of suspension contains 200 milligrams ceftiofur equivalents.
Beef, non-lactating dairy, and lactating dairy cattle
Indication

For the 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.

Dosage

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). 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.

Limitations

Indication

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.

Dosage

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 CE/lb (6.6 mg CE/kg) BW. In beef and non-lactating dairy cattle, 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.

Limitations
Beef and non-lactating dairy cattle
Indication

For the control of respiratory disease in beef and non-lactating dairy catte which are at high risk of developing BRD associated with M. haemolytica, P. multocida, and H. somni.

Dosage

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.

Limitations
Horses
Indication
For the treatment of lower respiratory tract infections in horses caused by susceptible strains of Streptococcus equi ssp. zooepidemicus.
Dosage
Administer two intramuscular injections to horses, 4 days apart, at a dose of 6.6 mg/kg. A maximum of 20 mL per injection site may be administered.
Limitations
Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Cattle (lactating dairy)
Indication

For treatment of acute metritis (0-10 days post-partum) associated with bacterial organisms susceptible to ceftiofur in lactating dairy cattle.

Dosage

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. Repeat this dose in the contra-lateral (opposite) ear approximately 72 hours following the initial dose.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied
Composition / specifications
100 mg ceftiofur equivalents (CE) per mL suspension.
Swine
Indication

For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, and Streptococcus suis; and for the control of SRD associated with A. pleuropneumoniae, P. multocida, H. parasuis, and S. suis in groups of pigs where SRD has been diagnosed.

Dosage

Administer by intramuscular (IM) injection in the post-auricular region of the neck as a single dosage of 5.0 mg ceftiofur equivalents (CE)/kg body weight (BW). No more than 2 mL should be injected in a single injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied • Horse, Not For Meat Production • Goat, No Use Class Stated Or Implied • No use class stated or implied • Beef • Dairy • Day old poults • 1 day-old broiler chicks • Sheep, No Use Class Stated Or Implied
Composition / specifications
Each milliliter of aqueous solution constituted from ceftiofur sodium powder contains 50 milligrams (mg) ceftiofur equivalents.
Horses
Indication
For treatment of respiratory infections in horses associated with Streptococcus zooepidemicus.
Dosage
2.2 to 4.4 mg/kg (1.0 to 2.0 mg/lb) body weight by intramuscular injection. Treatment should be repeated every 24 hours, continued for 48 hours after clinical signs have disappeared, and should not exceed 10 days. A maximum of 10 mL should be administered per injection site.
Limitations
Cattle
Indication
Treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, P. multocida, and Histophilus somni in beef and dairy cattle
Dosage
0.5 to 1.0 mg/lb body weight by intramuscular or subcutaneous injection for 3 days. Additional treatments may be given on days 4 and 5 for animals which do not show satisfactory response.
Limitations
Indication

For treatment of acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.

Dosage
0.5 to 1.0 mg/lb body weight by intramuscular or subcutaneous injection for 3 days. Additional treatments may be given on days 4 and 5 for animals which do not show satisfactory response.
Limitations
Swine
Indication
For treatment and control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis.
Dosage
3 to 5 mg per kilogram (/kg) body weight by intramuscular injection for 3 consecutive days.
Limitations
Sheep
Indication
For treatment of sheep respiratory disease (pneumonia) associated with M. haemolytica and P. multocida.
Dosage
0.5 to 1.0 mg/lb body weight by intramuscular injection for 3 days. Additional treatments may be given on days 4 and 5 for animals which do not show satisfactory response.
Limitations
Chickens (Day Old Chicks)
Indication
For control of early mortality associated with Escherichia coli organisms susceptible to ceftiofur in day-old chicks.
Dosage
0.08 to 0.20 mg as a single subcutaneous injection in the neck.
Limitations
Turkeys (Day Old Poults)
Indication
For control of early mortality associated with E. coli organisms susceptible to ceftiofur in day-old poults.
Dosage
0.17 to 0.5 mg as a single subcutaneous injection in the neck.
Limitations
Dogs
Indication
Treatment of canine urinary tract infections associated with E. coli and Proteus mirabilis.
Dosage
1.0 mg/lb (2.2 mg/kg) body weight by subcutaneous injection. Treatment should be repeated at 24-hour intervals, continued for 48 hours after clinical signs have disappeared, for 5 to 14 days.
Limitations
Goats
Indication
For treatment of caprine respiratory disease (goat pneumonia) associated with M. haemolytica and P. multocida.
Dosage
0.5 to 1.0 mg/lb body weight by intramuscular injection for 3 days. Additional treatments may be given on days 4 and 5 for animals which do not show satisfactory response.
Limitations

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied • Beef And Non-Lactating Dairy • Dairy, lactating
Composition / specifications
Each mL contains 50 mg of ceftiofur equivalents (CE).
Cattle (Beef, Non-Lactating Dairy, Lactating Dairy)
Indication
For treatment of Acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.
Dosage
Administer by intramuscular or subcutaneous administration 0.5 to 1 mg CE/lb (1.1 to 2.2 mg CE/kg) BW (1 to 2 mL sterile suspension per 100 lb BW). Administer daily at 24-hour intervals for a total of three consecutive days. Additional treatments may be administered on Days 4 and 5 for animals which do not show a satisfactory response (not recovered) after the initial three treatments.
Limitations
Indication
For treatment of Acute metritis (0 to 14 days post-partum) associated with bacterial organisms susceptible to ceftiofur.
Dosage

Administer by intramuscular or subcutaneous administration at the dosage of 1 mg CE/lb (2.2 mg CE/kg) BW (2 mL sterile suspension per 100 lb BW). Administer at 24 hour intervals for five consecutive days. Do not inject more than 15 mL per injection site.

Limitations
Indication
For treatment of Bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
Dosage

Administer by intramuscular or subcutaneous administration at the dosage of 0.5 to 1 mg CE/lb (1.1 to 2.2 mg CE/kg) BW (1 to 2 mL sterile suspension per 100 lb BW). Administer daily at 24 hour intervals for a total of three consecutive days. Additional treatments may be administered on Days 4 and 5 for animals which do not show a satisfactory response (not recovered) after the initial three treatments. Alternatively, for BRD only, administer intramuscularly or subcutaneously 1 mg CE/ lb (2.2 mg CE/kg) BW every other day on Days 1 and 3 (48 hour interval). Selection of dosage level (0.5 to 1 mg CE/lb) and regimen/duration (daily or every other day for BRD only) should be based on an assessment of the severity of disease, pathogen susceptibility and clinical response. Do not inject more than 15 mL per injection site.

Limitations
Swine
Indication
For treatment/control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella Choleraesuis and Streptococcus suis.
Dosage

Administer intramuscularly at a dosage of 1.36 to 2.27 mg ceftiofur equivalents (CE)/lb (3 to 5 mg CE/kg) body weight (BW) (1 mL of sterile suspension per 22 to 37 lb BW). Treatment should be repeated at 24 hour intervals for a total of three consecutive days. Do not inject more than 15 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied • No Use Class Stated Or Implied
Composition / specifications
50 mg/mL
Swine
Indication

For treatment/control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis and Streptococcus suis.

Dosage

Administer intramuscularly at a dosage of 1.36 to 2.27 mg ceftiofur equivalents/lb (3.0 to 5.0 mg/kg) BW (1 mL of sterile suspension per 22 to 37 lb BW). Treatment should be repeated at 24 h intervals for a total of three consecutive days.

Limitations
Cattle
Indication

For treatment of the following bacterial diseases:

  • Bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
  • Acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.
  • Acute metritis (0 to 14 days post-partum) associated with bacterial organisms susceptible to ceftiofur.
Dosage

For bovine respiratory disease and acute bovine interdigital necrobacillosis: administer by intramuscular or subcutaneous administration at the dosage of 0.5 to 1.0 mg ceftiofur equivalents/lb (1.1 to 2.2 mg/kg) BW (1 to 2 mL sterile suspension per 100 lb BW). Administer daily at 24 h intervals for a total of three consecutive days. Additional treatments may be administered on Days 4 and 5 for animals which do not show a satisfactory response (not recovered) after the initial three treatments. In addition, for BRD only, administer intramuscularly or subcutaneously 1.0 mg ceftiofur equivalents/lb (2.2 mg/kg) BW every other day on Days 1 and 3 (48 h interval). Do not inject more than 15 mL per injection site. Selection of dosage level (0.5 to 1.0 mg/lb) and regimen/duration (daily or every other day for BRD only) should be based on an assessment of the severity of disease, pathogen susceptibility and clinical response. For acute post-partum metritis: administer by intramuscular or subcutaneous administration at the dosage of 1.0 mg ceftiofur equivalents/lb (2.2 mg/kg) BW (2 mL sterile suspension per 100 lb BW). Administer at 24 h intervals for five consecutive days. Do not inject more than 15 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied • Goat, No Use Class Stated Or Implied • Swine, No Use Class Stated Or Implied • Cattle, No Use Class Stated Or Implied • No Use Class Stated Or Implied • Turkey, Poults, Day Old • Day-Old Chicks • Sheep, No Use Class Stated Or Implied
<strong>Cattle</strong>
Indication
For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.  Also, for treatment of acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.
Dosage
0.5 to 1.0 mg per pound (1.1 to 2.2 mg/kg) of body weight (1-2 mL reconstituted sterile solution per 100 lbs body weight). Treatment should be repeated at 24-hour intervals for a total of 3 consecutive days. Additional treatments may be given on days four and five for animals which do not show a satisfactory response (not recovered) after the initial three treatments
Limitations
<strong>Swine</strong>
Indication
For treatment/control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis.
Dosage
1.36 to 2.27 mg per pound (3.0 to 5.0 mg/kg) of body weight (1 mL of reconstituted sterile solution per 22 to 37 lbs body weight). Treatment should be repeated at 24-hour intervals for a total of 3 consecutive days.
Limitations
<strong>Sheep</strong>
Indication
For treatment of sheep respiratory disease (sheep pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida.
Dosage
0.5 to 1.0 mg per pound (1.1 to 2.2 mL reconstituted sterile solution per 100 lbs body weight).  Treatment should be repeated at 24-hour intervals for a total of 3 consecutive days. Additional treatments may be given on days four and five for animals which do not show a satisfactory response (not recovered) after the initial three treatments.
Limitations
<strong>Goats</strong>
Indication
For treatment of caprine respiratory disease (goat pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida.
Dosage
0.5 to 1.0 mg per pound (1.1 to 2.2 mg/kg) of body weight (1-2 mL reconstituted sterile solution per 100 lbs body weight). Treatment should be repeated at 24-hour intervals for a total of 3 consecutive days. Additional treatments may be given on days four and five for animals which do not show a satisfactory response (not recovered) after the initial three treatments.
Limitations
<strong>Horses</strong>
Indication
For treatment of respiratory infections in horses associated with Streptococcus zooepidemicus.
Dosage
1.0 to 2.0 mg per pound (2.2 to 4.4 mg/kg) of body weight (2-4 mL reconstituted sterile solution per 100 lb body weight). A maximum of 10 mL may be administered per injection site.  Treatment should be repeated at 24-hour intervals, continued for 48 hours after clinical signs have disappeared and should not exceed 10 days.
Limitations
<strong>Dogs</strong>
Indication
For the treatment of canine urinary tract infections associated with Escherichia coli and Proteus mirabilis.
Dosage
1.0 mg per pound 2.2 mg/kg) of body weight (0.1 mL reconstituted sterile solution per 5 lbs body weight). Treatment should be repeated at 24 hour intervals for 5-14 days.
Limitations
<strong>Day-Old Chicks</strong>
Indication
For the control of early mortality, associated with E. coli organisms susceptible to ceftiofur, in day-old chicks.
Dosage
0.08 to 0.20 mg/chick. One mL of the 50 mg/mL reconstituted solution will treat approximately 250 to 625 day-old chicks.
Limitations
<strong>Day-Old Turkey Poults</strong>
Indication
For the control of early mortality, associated with E. coli organisms susceptible to ceftiofur, in day-old turkey poults.
Dosage
0.17 to 0.5 mg/poult. 1 ml of the 50 mg/mL reconstituted solution will treat approximately 100 to 294 day-old turkey poults.
Limitations

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied • Cattle, Excluding Veal Calves
Composition / specifications
Each milliliter of ceftiofur hydrochloride suspension contains 50 milligrams (mg) of ceftiofur equivalents.
Swine
Indication
For treatment and control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis.
Dosage
3 to 5 milligrams per kilogram of body weight by intramuscular injection. Treatment should be repeated at 24-hour intervals for a total of 3 consecutive days.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Treated swine must not be slaughtered for 4 days following the last treatment.
Cattle (excluding veal calves)
Indication
For treatment of bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, P. multocida, and Histophilus somni; acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus; and acute metritis (0 to 14 days post-partum) associated with bacteria susceptible to ceftiofur.
Dosage
1.1 to 2.2 mg/kg of body weight by intramuscular or subcutaneous injection, at 24-hour intervals for 3 to 5 consecutive days. For bovine respiratory disease, 2.2 mg/kg of body weight may be administered twice at a 48-hour interval. For acute metritis, administer 2.2 mg/kg of body weight daily for 5 consecutive days.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Treated cattle must not be slaughtered for 3 days following the last treatment. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Dairy, dry cows
Composition / specifications
Each single-use, 10-milliliter syringe of ceftiofur hydrochloride suspension contains or 500 milligrams (mg)ceftiofur equivalents.
Dairy cattle (At Dry Off)
Indication
For the treatment of subclinical mastitis in dairy cattle at the time of dry off associated with Staphylococcus aureus, Streptococcus dysgalactiae, and Streptococcus uberis.
Dosage
Infuse 500 mg per affected quarter at the time of dry off.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian.

FDA page: Open in Animal Drugs @ FDA

Species: Dairy, lactating
Composition / specifications
Each single-use, 10-milliliter syringe of ceftiofur hydrochloride suspension contains 125 milligrams (mg) ceftiofur equivalents.
Lactating Dairy Cattle
Indication
For use in lactating dairy cattle for (1) the treatment of clinical mastitis associated with coagulase-negative staphylococci, Streptococcus dysgalactiae, and Escherichia coli and (2) the treatment of diagnosed subclinical mastitis associated with coagulase-negative staphylococci and Streptococcus dysgalactiae.
Dosage
Infuse 125 mg per affected quarter. Repeat treatment in 24 hours. Once daily treatment may be repeated for up to 8 consecutive days.
Limitations
Milk taken from cows during treatment (a maximum of eight daily infusions) and for 72 hours after the last treatment must not be used for human consumption. Following label use for up to eight consecutive days, a 2-day pre-slaughter withdrawal period is required. Federal 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 lactating dairy cattle for disease prevention purposes; at unapproved doses; frequencies, durations, or routes of administration; and in unapproved major food producing species/production classes.

FDA page: Open in Animal Drugs @ FDA

Official Documents (FDA)

Direct links to FDA-hosted PDFs and SPL packages (when available).

Documents
  • Summary
    This supplemental application provides for the addition of a new indication for the treatment of acute metritis (0 to 10 days postpartum) associated with bacterial organisms susceptible to ceftiofur in lactating dairy cattle; and to provide modified injection techniques for the base of the ear route of administration.
  • Summary
    This supplement provides for a new indication, for the treatment of lower respiratory tract infections in horses caused by susceptible strains of Streptococcus equi ssp. zooepidemicus.
  • Summary
    This supplement provides for a new indication, treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii in beef, non-lactating dairy, and lactating dairy cattle.
  • Summary

    1. To add a new route of administration for injection in the posterior aspect of the ear where it attaches to the head (base of ear).
    2. To add a new indication, “For the treatment of bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in lactating dairy cattle.”
    3. To establish a 13-day pre-slaughter withdrawal period for cattle.

  • Summary
    NAXCEL XT STERILE SUSPENSION is indicated for treatment of BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, P. multocida and H. omnus. NAXCEL XT STERILE SUSPENSION is also indicated for the control of respiratory disease in cattle which are at high risk of developing BRD associated with Mannheimia. haemolytica, P. multocida and H. somnus.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    This supplement provides for a new indication for the control of SRD associated with A. pleuropneumoniae, P. multocida, H. parasuis, and S. suis in groups of pigs where SRD has been diagnosed.
  • Summary
    For the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, and Streptococcus suis.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    To establish a 4-day pre-slaughter withdrawal period for cattle
  • Summary
    For the treatment and control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis type 2.
  • Summary
    This supplement updates survey microbiological data and adds the National Committee for Clinical Laboratory Standards’ (NCCLS) interpretive criteria for equine isolates to the NAXCEL Sterile Powder package insert.
  • Summary
    This supplement provides four specific changes to the product insert, 1) revision of the “clinical microbiology” section to update the MIC table using the new MIC data for ceftiofur, 2) the addition of a table listing acceptable quality control ranges for ceftiofur, 3) the addition of the latest National Committee for Clinical Laboratory Standards (NCCLS) reference at the end of the insert, and 4) clarification of the statement under “Storage Conditions” dealing with the storage of reconstituted Naxcel via freezing.
  • Summary
    Provides for the use of a subcutaneous (SC) route of administration for NAXCEL® Sterile Powder in cattle.
  • Summary
    The approval of this supplement will allow for the use of ceftiofur sodium (NAXCEL? Sterile Powder) for the treatment of bacterial pneumonia in goats to be added to the previously approved NAXCEL label.
  • Summary

    The approval of this supplement will allow for the use of ceftiofur sodium (NAXCEL Sterile Powder) for the treatment of bacterial pneumonia in sheep.

  • Summary
    Provides for an additional species, day-old turkey poults, to be added to the previously approved product, NAXCEL® Sterile Powder; also provides for revision of the chick indication.
  • Summary

    Provides for the use of ceftiofur sodium (NAXCEL® Sterile Powder) in cattle for a new indication.

  • Summary
    The supplement provides data in support of a request for approval of Naxcel ® Sterile Powder for an additional species (equine). The issue of the Freedom of Information (FOI) Summary should be considered an extension of previously approved version describing data in support of Naxcelreg., NADA 140-338, approved as a treatment for respiratory disease in cattle January 25, 1988.
  • Summary

    This supplement provides for an additional species, swine, to be added to the previously approved product, NAXCEL®.

  • Summary

    Provides for the use of ceftiofur sodium (NAXCEL Sterile Powder) in lactating dairy cattle, a new class of animal, for the same indications approved in the parent NADA.

  • Summary
    This supplemental application provides for a change in the approved dosage of 0.5 mg/lb body weight to a range of 0.5 mg to 1.0 mg ceftiofur sodium/lb of body weight.
  • Summary
    Naxcel Sterile Powder is indicated for treatment of bovine respiratory disease (shipping fever, pneumonia).
  • EA 140-338
  • FONSI 140-338
  • EA 140-338
  • FONSI 140-338
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    This supplement provides for an increase in the maximum injection site volume in swine from 5 mL to 15 mL. The larger maximum injection site volume will reduce the number of injections needed in larger pigs.

  • Summary
    This supplement provides for a reformulated product for use in swine and cattle, addition of a new route of administration (intramuscular injection) in cattle, change of withdrawal period in cattle, and a 250 mL vial size.
  • Summary

    For treatment/control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella Choleraesuis, and Streptococcus suis. For treatment of the following bacterial diseases in cattle:  1) bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni; 2) acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus; and 3) acute metritis (0 to 14 days post-partum) associated with bacterial organisms susceptible to ceftiofur.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    Swine: For treatment/control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis and Streptococcus suis.

    Cattle: For treatment of the following bacterial diseases:

    • Bovine respiratory disease (BRD, shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.
    • Acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus.
    • Acute metritis (0 to 14 days post-partum) associated with bacterial organisms susceptible to ceftiofur.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    Cattle: For treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni. Also, for treatment of acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus. 
    Swine:     For treatment/control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis.
    Sheep:     For treatment of sheep respiratory disease (sheep pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida.
    Goats:     For treatment of caprine respiratory disease (goat pneumonia) associated with Mannheimia haemolytica and Pasteurella multocida.
    Horses:     For treatment of respiratory infections in horses associated with Streptococcus zooepidemicus.
    Dogs:     For the treatment of canine urinary tract infections associated with Escherichia coli and Proteus mirabilis.
    Day-Old Chicks:     For the control of early mortality, associated with E. coli organisms susceptible to ceftiofur, in day-old chicks.
    Day-Old Turkey Poults: For the control of early mortality, associated with E. coli organisms susceptible to ceftiofur, in day-old turkey poults.orum and Bacteroides melaninogenicus.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    To establish a 3-day pre-slaughter withdrawal period for cattle
  • Summary
    For the treatment and control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus (Haemophilus) pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis, and Streptococcus suis type 2.
  • Summary

    To make the following four changes to the product insert:
    1. revise the current "Microbiology" section to a "Clinical Microbiology" section
    2. revise the minimum inhibitory concentration (MIC) table to include new MIC data for ceftiofur
    3. add a table listing acceptable quality control ranges for ceftiofur
    4. revise the National Committee for Clinical Laboratory Standards reference at the end to the insert.

  • Summary
    This supplement provides a new indication, within the currently approved dose and duration, for use of ceftiofur hydrochloride sterile suspension (EXCENEL® RTU Sterile Suspension) in cattle, for the treatment of acute metritis (0-14 days post-partum) associated with bacterial organisms susceptible to ceftiofur.
  • Summary
    The supplemental application dated 7/26/98 provides for the use of an intramuscular or subcutaneous route of administration for Excenel® Sterile Suspension in new species cattle. The application dated 08/18/98 provides a revised label warning statement against use in veal calves.
  • Summary
    EXCENEL® Sterile Suspension is indicated for the treatment/control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis and Streptococcus suis Type 2.
  • EA 140-890
  • FONSI 140-890
  • EA 140-890
  • FONSI 140-890
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    To establish a 16-day pre-slaughter withdrawal period for cattle
  • Summary
    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.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    This supplement provides for the use of SPECTRAMAST LC (ceftiofur intramammary suspension) Sterile Suspension for the treatment of diagnosed subclinical mastitis in lactating dairy cattle associated with coagulase-negative staphylococci (CNS) and Streptococcus dysgalactiae when administered at a dose of 125 mg ceftiofur equivalents into the affected quarter every 24 hours for a minimum of two days and up to eight days.
  • Summary
    To establish a 2-day pre-slaughter withdrawal period for cattle
  • Summary
    SPECTRAMAST LC Sterile Suspension (ceftiofur hydrochloride) is indicated for the treatment of clinical mastitis in lactating dairy cattle associated with coagulase-negative staphylococci, Streptococcus dysgalactiae, and Escherichia coli. Cows with systemic clinical signs caused by mastitis should receive other appropriate therapy under the direction of a licensed veterinarian.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Usage

For treatment of respiratory infections in horses associated with Streptococcus zooepidemicus . Treatment of bovine respiratory disease (shipping fever, pneumonia) associated with Mannheimia haemolytica , P. multocida , and Histophilus somni in beef and dairy cattle For treatment of acute bovine interdigital necrobacillosis (foot rot, pododermatitis) associated with Fusobacterium necrophorum and Bacteroides melaninogenicus .

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Federal law restricts this drug to use by or on the order of a licensed veterinarian. Treated swine must not be slaughtered for 4 days following the last treatment. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Treated cattle must not be slaughtered for 3 days following the last treatment. A withdrawal period has not been established in preruminating calves. Do not use in calves to be processed for veal. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Side Effects

No approved side-effect narrative is linked yet.

openFDA reaction signals are available for Dog 8 and Cat 8 (view top reported reactions).

Top Reported Reactions (openFDA)

Aggregated reaction terms from FDA openFDA reports (not verified; does not prove causation).

Dog
Digestive
Decreased appetite (1)
Skin & allergy
Erythematous rash (1)
Other
Abnormal cytology (1) Abnormal histology NOS (1) Corneal ulcer (1) Death by euthanasia (1) Dermal plaque (1) Dermatitis (1)
Cat
Effectiveness
Lack of efficacy - NOS (1)
Other
Corneal ulcer (1) Diabetes (1) Elevated alanine aminotransferase (1) Elevated serum alkaline phosphatase (1) Hyperglycaemia (1) Hypophosphataemia (1) Neutrophilia (1)

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Adverse Event Case Summaries (openFDA)

These are individual FDA adverse event reports. They are unverified and do not prove the medication caused the reaction.

Cat, ['Domestic Mediumhair', 'Crossbred Feline/cat'], Male, 12 year, 4.536 kilogram • Drug: MSK, Ophthalmic • Reactions: Elevated alanine aminotransferase, Diabetes, Lack of efficacy - NOS, Corneal ulcer, Hyperglycaemia… • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-017231
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 12.00 Year
  • Weight: 4.536 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Ophthalmic
Reactions Reported:
Elevated alanine aminotransferase Diabetes Lack of efficacy - NOS Corneal ulcer Hyperglycaemia Elevated serum alkaline phosphatase Hypophosphataemia Neutrophilia
Outcomes: Outcome Unknown

Dog, Retriever - Labrador, Female, 8 year, 26 kilogram • Drug: MSK, Parenteral • Reactions: Localised oedema, Dermal plaque, Erythematous rash, Abnormal cytology, Abnormal histology NOS… • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2022-US-041779
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 8.00 Year
  • Weight: 26.000 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Parenteral
Reactions Reported:
Localised oedema Dermal plaque Erythematous rash Abnormal cytology Abnormal histology NOS Lymphadenopathy Dermatitis Panniculitis
Outcomes: Recovered/Normal

Dog, Rottweiler, Female, 19 month, 42.638 kilogram • Drug: MSK, Dose: 125 Milligram per animal • Reactions: Injection site bruising, Swelling NOS, Regurgitation, Injection site oedema, Injection site swelling… • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2019-US-044576
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 19.00 Month
  • Weight: 42.638 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Dose: 125 Milligram per animal
Reactions Reported:
Injection site bruising Swelling NOS Regurgitation Injection site oedema Injection site swelling Decreased appetite Injection site skin discolouration Injection site bleeding Injection site serosanguinous discharge Injection site self trauma Injection site infection Surgical site disorder Injection site necrosis Tendon injury
Outcomes: Outcome Unknown

Dog, Dog (unknown), Unknown • Drug: MSK, Injection, Intravenous, Frequency: 1 per day • Reactions: Death by euthanasia, Corneal ulcer • Outcome: Euthanized

  • Report ID: USA-USFDACVM-2016-US-044665
  • Serious AE: Yes
  • Treated For AE: No
  • Sex: Unknown
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Intravenous
  • Form: Injection
  • Frequency: 1 per day
Reactions Reported:
Death by euthanasia Corneal ulcer
Outcomes: Euthanized

Data source: FDA openFDA Animal & Veterinary adverse event reports.

Overdose Information

No approved overdose-management text is linked yet. If overdose is suspected, contact a veterinarian or emergency clinic immediately.

Storage & Handling

No approved storage guidance is linked yet for this ingredient. Use manufacturer packaging and veterinary guidance for handling/storage.

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