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Ceftiofur Hydrochloride

Detailed information about Ceftiofur Hydrochloride

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

What it does:

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

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. 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.

Commonly reported reactions:

  • (1 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 Hydrochloride

Ceftiofur Hydrochloride

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 (Suspension), Sterile suspension
Identifiers:
ANADA: 200616 NADA: 140890 NADA: 141238 NADA: 141239 NADA: 141288 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 NDC Package: 55529-163-02 NDC Package: 55529-163-04 NDC Product: 54771 NDC Product: 55529
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. 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.

  • 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. 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.
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
22
Reported cases
14
Serious reports
11
Species represented
1
Most Reported Reactions
Reaction Cases Species Serious cases
1 Dog 1
1 Dog 1
1 Dog 1
1 Dog 1
1 Dog 1
1 Dog 1
1 Dog 1
1 Dog 1

Species coverage: Dog (22)

View detailed reaction table
Reaction Species Seriousness Frequency Reports
Dog Serious - 1
Dog Serious - 1
Dog Serious - 1
Dog Serious - 1
Dog Non-serious - 1
Dog Serious - 1
Dog Serious - 1
Dog Serious - 1
Dog Serious - 1
Dog Serious - 1
Dog Non-serious - 1
Dog Serious - 1
Dog Non-serious - 1
Dog Serious - 1
Dog Unknown - -
Dog Unknown - -
Dog Unknown - -
Dog Unknown - -
Dog Unknown - -
Dog Unknown - -
Dog Unknown - -
Dog Unknown - -
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: 26 • 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, 3:21 AM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: Cefenil® RTU EXCENEL® RTU EZ Excenel® Sterile Powder Excenel® RTU Excenel Sterile Suspension Spectramast® LC Sterile Suspension Spectramast™ DC Sterile Suspension
Case-reported brands (openFDA): MSK
Catalog species: Both • FDA-labeled species: Beef And Non-Lactating Dairy, Cattle, Dairy, No Use Class Stated Or Implied, No use class stated or implied
Rx/OTC: RX
Form/route: Liquid (Suspension), Sterile suspension • Injection, Intramammary, Intramuscular, Subcutaneous
Applications: NADA 141-288 • ANADA 200-616 • NADA 140-890 • NADA 141-239 • NADA 141-238
Documents: 19 (FOI: 15) • SPL: 7 • Label highlights • Official documents
Safety (openFDA)
Top reactions: Dog 8 • Cat 0 • View
Case summaries: 2 (showing 2) • 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. 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. (Contraindication, High)
Top reaction signals
Bloody diarrhoea (1) Death (1) Dehydration (1) Elevated alanine aminotransferase (ALT) (1) Hives (see also 'Skin') (1) Hypothermia (1) Lethargy (see also Central nervous system depression in 'Neurological') (1) Panting (1) Polydipsia (1) Proprioception deficit (1) Rubbing (1) Shaking (1) Swollen eye (1) Vomiting (1) Bloody diarrhoea (reports: 1, since 2016-02-12) (0) Death (reports: 1, since 2016-02-12) (0)

Identifiers & Packages

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

Identifiers
ANADA: 200616 NADA: 140890 NADA: 141238 NADA: 141239 NADA: 141288 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 NDC Package: 55529-163-02 NDC Package: 55529-163-04 NDC Product: 54771 NDC Product: 55529
Package NDC Product NDC Form / Route Status
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 -

Enriched Documents

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

  • 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
  • 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 18 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): Bloody diarrhoea, Death, Dehydration, Elevated alanine aminotransferase (ALT), Hives (see also 'Skin'), Hypothermia. (Official, 2026-02-12)
  • usage: For treatment and control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus pleuropneumoniae, Pasteurella multo… (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
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
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: 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: 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 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
    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 and control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Salmonella choleraesuis , and Streptococcus suis . 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. 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 .

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. 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.

Side Effects

No approved side-effect narrative is linked yet.

openFDA reaction signals are available for Dog 8 and Cat 0 (view top reported reactions).

Top Reported Reactions (openFDA)

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

Dog
Digestive
Bloody diarrhoea (1)
Skin & allergy
Hives (1)
Neurologic
Tiredness (lethargy) (1)
Other
Death (1) Dehydration (1) Elevated alanine aminotransferase (1) Hypothermia (1) Panting (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.

Dog, Maltese, Male, 3 year, 3.175 kilogram • Drug: MSK, Suspension, Unknown • Reactions: Rubbing, Swollen eye, Hives • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2019-US-038760
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 3.00 Year
  • Weight: 3.175 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Suspension
Reactions Reported:
Rubbing Swollen eye Hives
Outcomes: Ongoing

Dog, Ridgeback - Rhodesian, Male, 6 year, 32.749 kilogram • Drug: MSK, Suspension, Unknown • Reactions: Shaking, Panting, Tiredness (lethargy), Proprioception deficit, Dehydration… • Outcome: Died

  • Report ID: USA-USFDACVM-2019-US-026054
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 6.00 Year
  • Weight: 32.749 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Suspension
Reactions Reported:
Shaking Panting Tiredness (lethargy) Proprioception deficit Dehydration Elevated alanine aminotransferase Vomiting Polydipsia Bloody diarrhoea Vomiting Hypothermia Tiredness (lethargy) Death
Outcomes: Died

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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This medication has not been reviewed by a veterinarian yet.