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Meds A-Z

Enrofloxacin

Detailed information about Enrofloxacin

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 management of diseases associated with bacteria susceptible to enrofloxacin

What it does:

Fluoroquinolone antibiotic used for susceptible bacterial infections.

When it's needed:

Use caution in young/growing animals (joint/cartilage risk). Avoid in pets with known fluoroquinolone sensitivity.

Call your vet sooner if you notice:

  • Use caution in young/growing animals (joint/cartilage risk). Avoid in pets with known fluoroquinolone sensitivity.

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?
Talk to a Vet / Find a Vet Near You
Image for Enrofloxacin

Enrofloxacin

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

Species: Both

Manufacturer: Elanco US Inc.

Quick Facts

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

Species: Both
Manufacturer: Elanco US Inc.
Form: Chewable Tablets, Flavored Tablets, Injectable Solution, Liquid (Emulsion), Liquid (Solution), Otic emulsion
Identifiers:
ANADA: 200495 ANADA: 200513 ANADA: 200517 ANADA: 200527 ANADA: 200551 ANADA: 200598 ANADA: 200608 ANADA: 200628 ANADA: 200680 ANADA: 200688 ANADA: 200697 ANADA: 200708 ANADA: 200720 ANADA: 200737 ANADA: 200758 ANADA: 200764 ANADA: 200765 ANADA: 200782 ANADA: 200810 NADA: 140441
Source metadata:

Warnings / Contraindications

Use caution in young/growing animals (joint/cartilage risk). Avoid in pets with known fluoroquinolone sensitivity.

  • High: Use caution in young/growing animals (joint/cartilage risk). Avoid in pets with known fluoroquinolone sensitivity.
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
26
Species represented
2
Most Reported Reactions
Reaction Cases Species Serious cases
2 Cat, Dog 1
1 Dog 1
1 Cat 1
1 Dog 1
1 Cat 1
1 Cat 1
1 Dog 1
1 Cat 1

Species coverage: Cat (16) Dog (16)

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

Storage & Handling

Store at room temperature away from moisture.

Source metadata: No source yet.

Documents

Official label facts are separated from secondary summaries.

Official documents: 55 • Secondary summaries: 0

Official label facts
Secondary summaries

No source yet.

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, 7:40 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 16, 2026, 11:01 AM UTC
  • openFDA case summaries: Source FDA openFDA | Refreshed Feb 9, 2026, 3:19 AM UTC
Official (FDA)
Identity: Generic ingredient • FDA branded products available
Official FDA brands: Baytril® 100-CA1 Baytril® Antibacterial Injectable Solution Baytril® Antibacterial Tablets Baytril® Taste Tabs® Antibacterial Tablets Baytril® Otic Baytril® Soft Chewable Tablets ENROFLOXACIN 100 EnroMed™ 100 EnroPro™ 100 EnroPro™ 22.7 EnroPro™ Silver Otic Enrofloxacin Enrofloxacin Antibacterial Injectable Solution Enrofloxacin Flavored Tablets Enroflox® 100 Enroflox® Chewable Tablets Enroflox™ Injection for Dogs 2.27% Tenotryl™ Zobuxa™
Case-reported brands (openFDA): MSK
Catalog species: Both FDA-labeled species: Beef, Beef And Non-Lactating Dairy, Cat, Dog, No use class stated or implied, Replacement dairy heifers under 20 months of age
Rx/OTC: RX
Form/route: Chewable Tablets, Flavored Tablets, Injectable Solution, Liquid (Emulsion), Liquid (Solution), Otic emulsion, Tablet Injection, Intramuscular, Oral, Otic, Subcutaneous, Topical
Applications: ANADA 200-810 • ANADA 200-782 • ANADA 200-765 • ANADA 200-764 • ANADA 200-758 • NADA 141-527 • ANADA 200-737 • ANADA 200-720 • ANADA 200-688 • NADA 140-441 • NADA 141-176 • ANADA 200-628 • ANADA 200-708 • ANADA 200-697 • NADA 140-913 • ANADA 200-680 • ANADA 200-598 • ANADA 200-608 • ANADA 200-495 • ANADA 200-527 • ANADA 200-551 • ANADA 200-513 • ANADA 200-517
NDC: Packages 11695-6999-1 43457-649-25 58005-106-04 58005-106-05 58005-106-06 73309-107-01 Products 11695 43457 58005 58005 58005 73309
Documents: 31 (FOI: 31) • SPL: 24 Label highlights Official documents
Safety (openFDA)
Top reactions: Dog 56 Cat 56 View
Case summaries: 10 (showing 8) 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
ICD10_CM: H60.90
Otitis externa, unspecified ear

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
  • Use caution in young/growing animals (joint/cartilage risk). Avoid in pets with known fluoroquinolone sensitivity. (Contraindication, High)
Top reaction signals
Abnormal radiograph finding (1) Abnormal ultrasound finding (1) Abscess NOS (1) Acidosis (1) Anorexia (1) Ataxia (1) Autoimmune disorder NOS (1) Bacterial skin infection NOS (1) Blindness (1) CARBON DIOXIDE LOW, BLOOD (1) Cellulitis (1) Cholangiohepatitis (1) Circling - behavioural disorder (see also Neurological disorders) (1) Claw / hoof / nail disorder NOS (1) Crust (1) Death by euthanasia (1)

Identifiers & Packages

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

Identifiers
ANADA: 200495 ANADA: 200513 ANADA: 200517 ANADA: 200527 ANADA: 200551 ANADA: 200598 ANADA: 200608 ANADA: 200628 ANADA: 200680 ANADA: 200688 ANADA: 200697 ANADA: 200708 ANADA: 200720 ANADA: 200737 ANADA: 200758 ANADA: 200764 ANADA: 200765 ANADA: 200782 ANADA: 200810 NADA: 140441 NADA: 140913 NADA: 141176 NADA: 141527 NDC Package: 11695-6954-1
Package NDC Product NDC Form / Route Status
11695-6954-1 11695 -
11695-6954-5 11695 -
11695-6955-2 11695 -
11695-6955-5 11695 -
11695-6956-2 11695 -
11695-6956-5 11695 -
11695-6999-1 11695 -
11695-7022-1 11695 -
11695-7022-2 11695 -
11695-7035-1 11695 -
11695-7035-2 11695 -
13985-709-20 13985 -
13985-709-50 13985 -
13985-978-05 13985 -
13985-978-10 13985 -
13985-979-25 13985 -
13985-979-50 13985 -
13985-980-20 13985 -
13985-980-50 13985 -
17033-303-10 17033 -

Enriched Documents

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

Data Sources & Revision History

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

Official 34 Clinical 2 Manufacturer 0 Marketing 0
Current Field Facts
  • overdose_info: Overdose may exacerbate GI and neurologic signs; in cats, high doses increase the risk of irreversible blindness. Supportive care is required. (Clinical, 2026-02-12)
  • storage_handling: Store at room temperature away from moisture. (Clinical, 2026-02-12)
  • contraindications: Use caution in young/growing animals (joint/cartilage risk). Avoid in pets with known fluoroquinolone sensitivity. (Official, 2026-02-12)
  • side_effects: GI upset. In cats, high doses can cause retinal toxicity and vision loss. (Official, 2026-02-12)
  • usage: Fluoroquinolone antibiotic used for susceptible bacterial infections. (Official, 2026-02-12)
Recent Revisions
  • side_effects updated 2026-02-12 19:40 by etl_backfill • Backfilled from existing medication fields
  • contraindications updated 2026-02-12 19:40 by etl_backfill • Backfilled from existing medication fields
  • usage updated 2026-02-12 19:40 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
Enrofloxacin Flavored Tablets
RX
Enrofloxacin
Flavored Tablets Oral
Hikma Pharmaceuticals USA, Inc. ANADA 200-810 Approved Mar 28, 2025
EnroPro™ Silver Otic
RX
Enrofloxacin Silver sulfadiazine
Otic emulsion Otic
Cronus Pharma Specialities India Private Ltd. ANADA 200-782 Approved Jun 3, 2024
EnroPro™ 100
RX
Enrofloxacin
Injectable Solution Intramuscular, Subcutaneous
Cronus Pharma Specialities India Private Ltd. ANADA 200-765 Approved Jan 2, 2024
EnroPro™ 22.7
RX
Enrofloxacin
Injectable Solution Intramuscular
Cronus Pharma Specialities India Private Ltd. ANADA 200-764 Approved Jan 2, 2024
Enrofloxacin
RX
Enrofloxacin
Injectable Solution Intramuscular, Subcutaneous
Felix Pharmaceuticals Pvt. Ltd. ANADA 200-758 Approved Nov 28, 2023
Baytril® 100-CA1
RX
Enrofloxacin
Injectable Solution Subcutaneous
Elanco US Inc. NADA 141-527 W May 3, 2023
Enrofloxacin
RX
Enrofloxacin
Flavored Tablets Oral
ZYVET AH, Inc. ANADA 200-737 Approved Mar 1, 2023
Enroflox® Chewable Tablets
RX
Enrofloxacin
Chewable Tablets Oral
Norbrook Laboratories, Ltd. ANADA 200-720 Approved Apr 1, 2022
Tenotryl™
RX
Enrofloxacin
Injectable Solution Intramuscular, Subcutaneous
Virbac AH, Inc. ANADA 200-688 Approved Apr 1, 2022
Baytril® Antibacterial Tablets Baytril® Taste Tabs® Antibacterial Tablets
RX
Enrofloxacin
Tablet Oral
Elanco US Inc. NADA 140-441 Approved Mar 30, 2022
Baytril® Otic
RX
Enrofloxacin Silver sulfadiazine
Liquid (Emulsion) Topical
Elanco US Inc. NADA 141-176 Approved Mar 8, 2022
ENROFLOXACIN 100
RX
Enrofloxacin
Injectable Solution Subcutaneous, Intramuscular
Sparhawk Laboratories, Inc. ANADA 200-628 Approved Nov 1, 2021
Enrofloxacin
RX
Enrofloxacin
Injectable Solution Intramuscular
Felix Pharmaceuticals Pvt. Ltd. ANADA 200-708 Approved Sep 1, 2021
Enrofloxacin
RX
Enrofloxacin
Injectable Solution Intramuscular
Accord Healthcare, Inc. ANADA 200-697 Approved May 3, 2021
Baytril® Antibacterial Injectable Solution
RX
Enrofloxacin
Liquid (Solution) Intramuscular
Elanco US Inc. NADA 140-913 Approved Jan 6, 2021
Enrofloxacin Flavored Tablets
RX
Enrofloxacin
Flavored Tablets Oral
Felix Pharmaceuticals Pvt. Ltd. ANADA 200-680 Approved Jun 17, 2020
EnroMed™ 100
RX
Enrofloxacin
Injectable Solution Intramuscular, Subcutaneous, Injection
Bimeda Animal Health Limited ANADA 200-598 Approved Jun 3, 2019
Baytril® Soft Chewable Tablets
RX
Enrofloxacin
Chewable Tablets Oral
Elanco US Inc. ANADA 200-608 Approved Aug 29, 2018
Enroflox® 100
RX
Enrofloxacin
Injectable Solution Intramuscular, Subcutaneous
Norbrook Laboratories, Ltd. ANADA 200-495 Approved Aug 2, 2018
Enrofloxacin Antibacterial Injectable Solution
RX
Enrofloxacin
Injectable Solution Intramuscular
Dechra Veterinary Products LLC ANADA 200-527 Approved Jun 1, 2016
Enrofloxacin Flavored Tablets
RX
Enrofloxacin
Tablet Oral
Dechra Veterinary Products LLC ANADA 200-551 Approved Jun 1, 2016
Enroflox™ Injection for Dogs 2.27%
RX
Enrofloxacin
Injectable Solution Intramuscular
Norbrook Laboratories, Ltd. ANADA 200-513 Approved Jun 1, 2016
Zobuxa™
RX
Enrofloxacin
Tablet Oral
Elanco US Inc. ANADA 200-517 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.

Composition / specifications
22.7 mg, 68 mg, or 136 mg of enrofloxacin per tablet
Dogs
Indication

For the management of diseases associated with bacteria susceptible to enrofloxacin

Dosage

Administer orally at 5 to 20 milligrams per kilogram (2.27 to 9.07 milligrams per pound) of body weight. The dose may be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals.

Limitations
Cats
Indication

For the management of diseases associated with bacteria susceptible to enrofloxacin

Dosage

Administer orally at 5 milligrams per kilogram (2.27 milligrams per pound) of body weight. The dose may be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
Each milliliter contains enrofloxacin 5 mg (0.5% w/v), silver sulfadiazine (SSD)10 mg (1.0% w/v)
Dogs
Indication

As a treatment for canine otitis externa complicated by bacterial and fungal organisms susceptible to enrofloxacin and/or silver sulfadiazine.

Dosage

Administer 5 to 10 drops per treatment in dogs weighing 35 pounds or less and 10 to 15 drops per treatment in dogs weighing more than 35 pounds. Apply twice daily for a duration of up to 14 days.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied • Beef And Non-Lactating Dairy
Composition / specifications
100 mg/mL
Cattle (Beef and Non-Lactating Dairy)
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni in beef and non-lactating dairy cattle.

Dosage

Multiple-day therapy: 2.5 to 5.0 mg/kg of body weight (1.1 to 2.3 mL/100 lb) by subcutaneous injection. Treatment should be repeated at 24-hour intervals for three days. Additional treatments may be given on Days 4 and 5 to animals that have shown clinical improvement but not total recovery. Administered dose volume should not exceed 20 mL per injection site.

Limitations
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, and Histophilus somni, and Mycoplasma bovis in beef and non-lactating dairy cattle.

Dosage

Single-dose therapy: 7.5 to 12.5 mg/kg of body weight (3.4 to 5.7 mL/100 lb) by subcutaneous injection. Administered dose volume should not exceed 20 mL per injection site.

Limitations
Indication

For the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis.

Dosage

Single-dose therapy: 7.5 mg/kg of body weight (3.4 mL/100 lb) by subcutaneous injection. Administered dose volume should not exceed 20 mL per injection site.

Limitations
Swine
Indication

For the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae.

Dosage

Administer, either by intramuscular or subcutaneous (behind the ear) injection, a single dose of 7.5 mg/kg of body weight (3.4 mL/100 lb).

Limitations
Indication

For the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed

Dosage

Administer, either by intramuscular or subcutaneous (behind the ear) injection, a single dose of 7.5 mg/kg of body weight (3.4 mL/100 lb). For the control of colibacillosis, administration should be initiated within the first 60 days post-weaning when clinical signs are present in at least 2% of the animals in the group. If no improvement is noted within 48 hours, the diagnosis should be reevaluated.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
22.7 mg/mL (2.27%)
Dogs
Indication

For the management of diseases in dogs associated with bacteria susceptible to enrofloxacin.

Dosage

2.5 milligrams intramuscularly per kilogram (1.13 milligrams per pound) of body weight as a single initial dose only.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied • Beef And Non-Lactating Dairy
Composition / specifications
100 mg/mL
Cattle (Beef and Non-Lactating Dairy)
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non-lactating dairy cattle

Dosage

Single-Dose Therapy (BRD Treatment): Administer, by subcutaneous injection, a single dose of 7.5 – 12.5 mg/kg of body weight (3.4 – 5.7 mL/100 lb).

Limitations
Indication

For the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis.

Dosage

Single-Dose Therapy (BRD Control): Administer, by subcutaneous injection, a single dose of 7.5 mg/kg of body weight (3.4 mL/100 lb).

Limitations
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni in beef and non-lactating dairy cattle.

Dosage

Multiple-Day Therapy (BRD Treatment): Administer daily, a subcutaneous dose of 2.5 – 5 mg/kg of body weight (1.1 – 2.3 mL/100 lb). Treatment should be repeated at 24-hour intervals for three days. Additional treatments may be given on Days 4 and 5 to animals that have shown clinical improvement but not total recovery.

Limitations
Swine
Indication

For the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae; and for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed.

Dosage

Administer, either by intramuscular or subcutaneous (behind the ear) injection, a single dose of 7.5 mg/kg of body weight (3.4 mL/100 lb). Administered dose volume should not exceed 5 mL per injection site. For the control of colibacillosis, administration should be initiated within the first 60 days post-weaning when clinical signs are present in at least 2% of the animals in the group.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Replacement dairy heifers under 20 months of age • Beef, except beef calves less than 2 months of age and beef bulls intended for breeding (any age)
Composition / specifications
100 mg/mL
Cattle (replacement dairy heifers under 20 months of age and all classes of beef cattle except beef calves less than 2 months of age and beef bulls intended for breeding (any age))
Indication

Conditionally approved for the treatment of clinical anaplasmosis associated with Anaplasma marginale in replacement dairy heifers under 20 months of age and all classes of beef cattle except beef calves less than 2 months of age and beef bulls intended for breeding (any age). Not for use in any other class of dairy cattle or in veal calves.

Dosage

Administer as a single dose for treatment of clinical anaplasmosis. Administer, by subcutaneous injection, a single dose of 12.5 mg/kg of body weight (5.7 mL/100 lb). Administered dose volume should not exceed 20 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
22.7 mg, 68 mg, or 136 mg of enrofloxacin per tablet
Dogs
Indication

For the management of diseases associated with bacteria susceptible to enrofloxacin

Dosage

Administer orally at a rate to provide 5-20 mg/kg (2.27 to 9.07 mg/lb) of body weight. The dose may be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals. Selection of a dose within the range should be based on clinical experience, the severity of disease, and susceptibility of the pathogen. Animals which receive doses in the upper-end of the dose range should be carefully monitored for clinical signs that may include inappetence, depression, and vomition.

Limitations
Cats
Indication

For the management of diseases associated with bacteria susceptible to enrofloxacin

Dosage

Administer orally at 5 mg/kg (2.27 mg/lb) of body weight. The dose may be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals. The dose should be continued for at least 2-3 days beyond cessation of clinical signs, to a maximum of 30 days.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
22.7 mg, 68 mg, or 136 mg of enrofloxacin per tablet
Dogs
Indication

For the management of diseases associated with bacteria susceptible to enrofloxacin.

Dosage

Administer orally at a rate to provide 5-20 mg/kg (2.27 to 9.07 mg/lb) of body weight as a single daily dose or divided into two (2) equal daily doses at twelve (12) hour intervals.

Limitations
Cats
Indication

For the management of diseases associated with bacteria susceptible to enrofloxacin.

Dosage

Administer orally at 5 mg/kg (2.27 mg/lb) of body weight as a single daily dose or divided into two (2) equal daily doses at twelve (12) hour intervals.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied • Beef And Non-Lactating Dairy
Composition / specifications
100 mg/mL
Beef cattle and non-lactating dairy cattle
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non-lactating dairy cattle.

Dosage

Administer, by subcutaneous injection, a single dose of 7.5 – 12.5 mg/kg of body weight (3.4 – 5.7 mL/100 lb).

Limitations
Indication

For the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis.

Dosage

Administer, by subcutaneous injection, a single dose of 7.5 mg/kg of body weight (3.4 mL/100 lb). Administered dose volume should not exceed 20 mL per injection site.

Limitations
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni in beef and non-lactating dairy cattle.

Dosage

Administer daily, a subcutaneous dose of 2.5 – 5 mg/kg of body weight (1.1 – 2.3 mL/100 lb). Treatment should be repeated at 24-hour intervals for three days. Additional treatments may be given on Days 4 and 5 to animals that have shown clinical improvement but not total recovery.

Limitations
Swine
Indication

For the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae. It is also indicated for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed.

Dosage

Administer, either by intramuscular or subcutaneous (behind the ear) injection, a single dose of 7.5 mg/kg of body weight (3.4 mL/100 lb). Administered dose volume should not exceed 5 mL per injection site. For the control of colibacillosis, administration should be initiated within the first 60 days post-weaning when clinical signs are present in at least 2% of the animals in the group.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
Each tablet contains either 22.7, 68.0, or 136 milligrams of enrofloxacin.
Cats
Indication
For management of diseases associated with bacteria susceptible to enrofloxacin.
Dosage
5 milligrams per kilogram (2.27 milligrams per pound) of body weight.
Limitations
Dogs
Indication
For management of diseases associated with bacteria susceptible to enrofloxacin.
Dosage
5 to 20 milligrams per kilogram (2.27 to 9.07 milligrams per pound) of body weight.
Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
Each milliliter contains 5 milligrams enrofloxacin and 10 milligrams silver sulfadiazine.
Dogs
Indication
For the treatment of otitis externa complicated by bacterial and fungal organisms susceptible to enrofloxacin and/or silver sulfadiazine.
Dosage
5 to 10 drops for dogs weighing 35 pounds or less and 10 to 15 drops for dogs weighing more than 35 pounds; applied twice daily for up to 14 days.
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extra- label use of this drug in food-producing animals.

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied • Beef And Non-Lactating Dairy
Composition / specifications
100 mg/mL
Beef cattle, non-lactating dairy cattle
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non-lactating dairy cattle; and for the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis.

Dosage

Administer, by subcutaneous injection, a single dose of 7.5-12.5 mg/kg of body weight (3.4-5.7 mL/100 lb).

Limitations
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni in beef and non-lactating dairy cattle.

Dosage

Administer daily, a subcutaneous dose of 2.5-5 mg/kg of body weight (1.1-2.3 mL/100 lb). Treatment should be repeated at 24-hour intervals for three days. Additional treatments may be given on Days 4 and 5 to animals that have shown clinical improvement but not total recovery.

Limitations
Swine
Indication

For the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae. It is also indicated for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed.

Dosage

Administer, either by intramuscular or subcutaneous (behind the ear) injection, a single dose of 7.5 mg/kg of body weight (3.4 mL/100 lb). Administered dose volume should not exceed 5 mL per injection site. For the control of colibacillosis, administration should be initiated within the first 60 days post-weaning when clinical signs are present in at least 2% of the animals in the group.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
22.7 mg/mL (2.27%)
Dogs
Indication

For the management of diseases in dogs associated with bacteria susceptible to enrofloxacin.

Dosage

Enrofloxacin Injectable Solution may be used as the initial dose at 2.5 mg/kg. It should be administered intramuscularly (IM) as a single dose, followed by initiation of enrofloxacin tablet therapy. The initial enrofloxacin injectable administration should be followed 12 hours later by initiation of enrofloxacin tablet therapy.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
22.7 mg/mL (2.27%)
Dogs
Indication

For the management of diseases in dogs associated with bacteria susceptible to enrofloxacin.

Dosage

Enrofloxacin Injectable Solution may be used as the initial dose at 2.5 mg/kg. It should be administered intramuscularly (IM) as a single dose, followed by initiation of enrofloxacin tablet therapy. The initial Enrofloxacin Injectable administration should be followed 12 hours later by initiation of enrofloxacin tablet therapy.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
Each milliliter of sterile aqueous solution contains 22.7 milligrams of enrofloxacin.
Dogs
Indication
Dogs for management of diseases associated with bacteria susceptible to enrofloxacin.
Dosage
2.5 milligrams intramuscularly per kilogram (1.13 milligrams per pound) of body weight as a single initial dose only.
Limitations

As a single, intramuscular, initial dose followed by use of tablets twice daily for 2 to 3 days beyond cessation of clinical signs to a maximum of 30 days.

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
22.7 mg, 68 mg, and 136 mg enrofloxacin per tablet
Dogs
Indication

For the management of diseases associated with bacteria susceptible to enrofloxacin.

Dosage

Administer orally at a rate to provide 5-20 mg/kg (2.27 to 9.07 mg/lb) of body weight. May be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals. The dose should be continued for at least 2-3 days beyond cessation of clinical signs to a maximum of 30 days.

Limitations
Cats
Indication

For the management of diseases associated with bacteria susceptible to enrofloxacin.

Dosage

Administer orally at 5 mg/kg (2.27 mg/lb) of body weight. May be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals. The dose should be continued for at least 2-3 days beyond cessation of clinical signs to a maximum of 30 days.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied • Beef And Non-Lactating Dairy
Composition / specifications
100 mg/mL
Cattle (beef and non-lactating dairy)
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non-lactating dairy cattle; and for the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis.

Dosage

Single-Dose Therapy (BRD Treatment): Administer, by subcutaneous injection, a single dose of 7.5-12.5 mg/kg of body weight (3.4-5.7 mL/100 lb).

Limitations
Indication

For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni in beef and non-lactating dairy cattle.

Dosage

Multiple-Day Therapy (BRD Treatment): Administer daily, a subcutaneous dose of 2.5-5 mg/kg of body weight (1.1-2.3 mL/100 lb). Treatment should be repeated at 24-hour intervals for three days. Additional treatments may
be given on Days 4 and 5 to animals that have shown clinical improvement but not total recovery.

Limitations
Swine
Indication

For the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae. and for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed.

Dosage

Administer, either by intramuscular or subcutaneous (behind the ear) injection, a single dose of 7.5 mg/kg of body weight (3.4 mL/100 lb). Administered dose volume should not exceed 5 mL per injection site.

Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
22.7, 68.0, or 136.0 milligrams (mg) enrofloxacin
Cats
Indication

For the management of diseases associated with bacteria susceptible to enrofloxacin.

Dosage

Administer orally at 5 mg/kg (2.27 mg/lb) of body weight. The dose for dogs and cats may be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals. The dose should be continued for at least 2-3 days beyond cessation of clinical signs, to a maximum of 30 days. All tablet sizes are double scored for accurate dosing.

Limitations

For use in animals only. In rare instances, use of this product in cats has been associated with Retinal Toxicity. Do not exceed 5 mg/kg of body weight per day in cats. Safety in breeding or pregnant cats has not been established. Keep out of reach of children.

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Federal law prohibits the extra label use of this drug in food-producing animals.

Quinolone-class drugs should be used with caution in animals with known or suspected Central Nervous System (CNS) disorders. In such animals, quinolones have, in rare instances, been associated with CNS stimulation which may lead to convulsive seizures.

Dogs
Indication

For the management of diseases associated with bacteria susceptible to enrofloxacin.

Dosage

Administer orally at a rate to provide 5-20 mg/kg (2.27 to 9.07 mg/lb) of body weight. Selection of a dose within the range should be based on clinical experience, the severity of disease, and susceptibility of the pathogen. Animals which receive doses in the upper-end of the dose range should be carefully monitored for clinical signs that may include inappetence, depression, and vomition. All tablet sizes are double scored for accurate dosing.

Limitations

The use of enrofloxacin is contraindicated in small and medium breeds of dogs during the rapid growth phase (between 2 and 8 months of age). The safe use of enrofloxacin has not been established in large and giant breeds of dogs during the rapid growth phase.

For use in animals only. Keep out of reach of children.

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Federal law prohibits the extra label use of this drug in food-producing animals.

Quinolone-class drugs should be used with caution in animals with known or suspected Central Nervous System (CNS) disorders. In such animals, quinolones have, in rare instances, been associated with CNS stimulation which may lead to convulsive seizures.

FDA page: Open in Animal Drugs @ FDA

Species: No use class stated or implied • Beef And Non-Lactating Dairy
Composition / specifications
100 mg/mL
Swine
Indication

Enroflox 100 is indicated for the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis and Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae.

Enroflox 100 is indicated for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed.

Dosage

Administer, either by intramuscular or subcutaneous (behind the ear) injection, a single dose of 7.5 mg/kg of body weight (3.4 mL/100 lb). Administered dose volume should not exceed 5 mL per injection site. For the control of colibacillosis, administrations should be initiated within the first 60 days post-weaning when clinical signs are present in at least 2% of the animals in the group.

Limitations

Animals intended for human consumption must not be slaughtered within five days of receiving a single-injection dose.

Cattle (Single- Dose Therapy)
Indication

Enroflox 100 is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non-lactating dairy cattle.

Dosage
Administer, by subcutaneous injection, a single dose of 7.5-12.5 mg/kg of body weight (3.4-5.7 mL/100 lb).
Limitations

Animals intended for human consumption must not be slaughtered within 28 days from the last treatment. This product is not approved for female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

Indication

Enroflox 100 is indicated for the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis.

Dosage
Administer, by subcutaneous injection, a single dose of 7.5 mg/kg of body weight (3.4 ml/100 lb).
Limitations

Animals intended for human consumption must not be slaughtered within 28 days from the last treatment. This product is not approved for female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

Cattle (Multiple Day Therapy)
Indication
Enroflox 100 is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni in beef an non-lactating dairy cattle.
Dosage

Administer daily, a subcutaneous dose of 2.5-5 mg/kg of body weight (1.1-2.3 mL/100 lb). Treatment should be repeated at 24-hour intervals for three days. Additional treatments may be given on Days 4 and 5 to animals that have shown clinical improvement but not total recovery.

Limitations

Animals intended for human consumption must not be slaughtered within 28 days from the last treatment. This product is not approved for female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
22.7 mg/mL enrofloxacin
Label highlights
Indication
For the management of diseases in dogs associated with bacteria susceptible to enrofloxacin
Dosage
Administer 2.5 mg/kg as a single dose, followed by initiation of enrofloxacin tablet therapy
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: Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
Each tablet contains 22.7, 68, or 136 mg of enrofloxacin.
<strong>Dogs</strong>
Indication
For the management of diseases associated with bacteria susceptible to enrofloxacin
Dosage
Administer orally at a rate to provide 5-20 mg/kg (2.27-9.07 mg/lb) of body weight as a single, daily dose, or divided into two equal doses at 12-hour intervals.

Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals
<strong>Cats</strong>
Indication
For the management of diseases associated with bacteria susceptible to enrofloxacin
Dosage
Administer orally at a rate to provide 5 mg/kg (2.27 mg/lb) of body weight as a single, daily dose, or divided into two equal doses at 12-hour intervals
Limitations
Federal law restricts this drug to use by or on the order of a licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied
Composition / specifications
22.7 mg/mL
Dogs
Indication
For the management of diseases in dogs associated with bacteria susceptible to enrofloxacin.
Dosage
Administer intramuscularly (IM) as a single injection at the rate of 1 mL/9.1 kg (20 lb) to provide 2.5 mg/kg (1.13 mg/lb). The injectable dose should be followed by oral tablet treatment in 12 hours.
Limitations

FDA page: Open in Animal Drugs @ FDA

Species: Dog, No Use Class Stated Or Implied • Cat, No Use Class Stated Or Implied
Composition / specifications
22.7 mg, 68 mg, 136 mg, and 272 mg
<strong>Dogs</strong>
Indication
For the management of diseases associated with bacteria susceptible to enrofloxacin
Dosage
Administer orally at a rate to provide 5-20 mg/kg (2.27 to 9.07 mg/lb) of body weight. Selection of a dose within the range should be based on clinical experience, the severity of disease, and susceptibility of the pathogen. Animals which receive doses in the upper-end of the dose range should be carefully monitored for clinical signs that may include inappetence, depression, and vomition
Limitations
Federal law restricts this drug to use by or on the order of licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals
<strong>Cats</strong>
Indication
For the management of diseases associated with bacteria susceptible to enrofloxacin
Dosage
Administer orally at 5 mg/kg (2.27 mg/lb) of body weight. The dose for dogs and cats may be administered either as a single daily dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals. The doses should be continued for at least 2-3 days beyond cessation of clinical signs, to a maximum of 30 days
Limitations
Federal law restricts this drug to use by or on the order of licensed veterinarian. Federal law prohibits the extralabel use of this drug in food-producing animals

FDA page: Open in Animal Drugs @ FDA

Official Documents (FDA)

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

Documents
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    Cattle- Single-Dose Therapy: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non-lactating dairy cattle; and for the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis.

    Cattle- Multiple-Day Therapy: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni in beef and non-lactating dairy cattle.

    Swine: For the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae. For the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    Cattle- Single-Dose Therapy: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non-lactating dairy cattle; and for the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis.

    Cattle- Multiple-Day Therapy: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni in beef and non-lactating dairy cattle.

    Swine: For the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae; and for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed.


SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    For the treatment of clinical anaplasmosis associated with Anaplasma marginale in replacement dairy heifers under 20 months of age and all classes of beef cattle except beef calves less than 2 months of age and beef bulls intended for breeding (any age). Not for use in any other class of dairy cattle or in veal calves.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    Cattle-Single-Dose Therapy: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non-lactating dairy cattle; and for the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis.

    Cattle-Multiple-Day Therapy: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni in beef and non-lactating dairy cattle.

    Swine: For the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae. It is also indicated for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    This supplement lowers the dose in cats to 5 mg/kg (2.27 mg/lb) of body weight either as a single dose or divided into two (2) equal daily doses administered at twelve (12) hour intervals, and provides for the addition of post-approval adverse drug experience information and fluoroquinolone class safety statements in labeling regarding retinal toxicity in cats.
  • Summary
    For the management of diseases in dogs and cats associated with bacteria susceptible to enrofloxacin.
  • Summary
    Revises dosage frequency, indications, and limitations.
  • Summary

    This supplemental application amends the NADA to remove the contradiction against use in breeding female dogs.

  • Summary
    This supplemental application amends the NADA to provide for the use of Baytril® Tablets in cats.
  • Summary

    For the treatment of dermal infections, respiratory infections, and urinary cystitis caused by susceptible strains of bacteria in dogs.

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    Baytril® Otic is indicated for the treatment of canine otitis externa complicated by acterial and fungal organisms susceptible to enrofloxacin and/or silver sulfadiazine.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    Cattle - Single-Dose Therapy: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non-lactating dairy cattle; and for the control of BRD in beef and nonlactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis.

    Cattle - Multiple-Day Therapy: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni in beef and nonlactating dairy cattle.

    Swine: For the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae. It is also indicated for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    Revises dosage frequency, indications, and limitations.
  • Summary

    Baytril (brand of enrofloxacin) Antibacterial Tablets and Injectable Solution are indicated for the treatment of the following bacterial infections in dogs: Dermal infections (wounds and abscesses) caused by susceptible strains of Escherichia coli, Klebsiella pneumoniae , Proteus mirabilis, and Staphylococcus aureus. Respiratory infections (pneumonia, tonsillitis, rhinitis) caused by susceptible strains of Escherichia coli and Staphylococcus aureus. Urinary cystitis caused by susceptible strains of Escherichia coli, Proteus mirabilis and Staphylococcus aureus.

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    For the management of diseases associated with bacteria susceptible to enrofloxacin in dogs and cats.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    Cattle-Single-Dose Therapy: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non-lactating dairy cattle; and for the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis.
    Cattle-Multiple-Day Therapy: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni in beef and non-lactating dairy cattle.
    Swine: For the treatment and control of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Haemophilus parasuis, Streptococcus suis, Bordetella bronchiseptica and Mycoplasma hyopneumoniae and for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed.

SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary

    The effect of the supplement provides for the addition of the use of the drug via intramuscular injection in swine, the addition of two pathogens, Bordetella bronchiseptica and Mycoplasma hyopneumoniae, to the swine respiratory disease (SRD) treatment and control indications and the addition of indications for the control of colibacillosis in groups or pens of weaned pigs where colibacillosis associated with Escherichia coli has been diagnosed.

  • Summary
    This supplement provides for the addition of new indications, “Single-Dose Therapy: Enroflox® 100 is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni and Mycoplasma bovis in beef and non-lactating dairy cattle; and for the control of BRD in beef and non-lactating dairy cattle at high risk of developing BRD associated with M. haemolytica, P. multocida, H. somni and M. bovis”.
  • Summary

    Cattle: For the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolitica, Pasturella multocida, and Histophilus somni in beef and non-lactating dairy cattle (multiple-day therapy).
    Swine: For the treatment and control 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
    For the management of diseases in dogs associated with bacteria susceptible to enrofloxacin.

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    For the management of diseases associated with bacteria susceptible to enrofloxacin.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    For the management of diseases in dogs associated with bacteria susceptible to enrofloxacin.

FDA page: Open in Animal Drugs @ FDA

Documents
  • Summary
    For the management of diseases associated with bacteria susceptible to enrofloxacin.
SPL Packages

FDA page: Open in Animal Drugs @ FDA

Usage

Fluoroquinolone antibiotic used for susceptible bacterial infections.

Source: FDA Animal Drugs @ FDA • Reference

Contraindications

Use caution in young/growing animals (joint/cartilage risk). Avoid in pets with known fluoroquinolone sensitivity.

Side Effects

GI upset. In cats, high doses can cause retinal toxicity and vision loss.

Source: FDA openFDA • Reference

Top Reported Reactions (openFDA)

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

Dog
Digestive
Vomiting (373) Loss of appetite (198) Diarrhea (184) Diarrhea (3) Diarrhea (3) Diarrhea (3) Diarrhea (3) Diarrhea (3) Diarrhea (3)
Neurologic
Tiredness (lethargy) (273) Tiredness (lethargy) (4) Tiredness (lethargy) (4) Tiredness (lethargy) (4) Tiredness (lethargy) (4) Tiredness (lethargy) (4) Tiredness (lethargy) (4)
Effectiveness
Lack of efficacy - NOS (162)
Other
Death by euthanasia (229) Other abnormal test result NOS (196) Death (182) Fever (6) Fever (6) Fever (6) Fever (6) Fever (6) Fever (6) Not eating (4) Not eating (4) Not eating (4) Not eating (4) Not eating (4) Not eating (4) Elevated serum alkaline phosphatase (3) Elevated serum alkaline phosphatase (3) Elevated serum alkaline phosphatase (3) Elevated serum alkaline phosphatase (3) Elevated serum alkaline phosphatase (3) Elevated serum alkaline phosphatase (3) Medication error NOS (3) Medication error NOS (3) Medication error NOS (3) Medication error NOS (3) Medication error NOS (3) Medication error NOS (3) Pneumonia (3) Pneumonia (3) Pneumonia (3) Pneumonia (3) Pneumonia (3) Pneumonia (3) Urinary tract infection (3) Urinary tract infection (3) Urinary tract infection (3) Urinary tract infection (3) Urinary tract infection (3) Urinary tract infection (3)
Cat
Digestive
Loss of appetite (41) Loss of appetite (2) Loss of appetite (2) Loss of appetite (2) Loss of appetite (2) Loss of appetite (2) Loss of appetite (2)
Neurologic
Tiredness (lethargy) (35) Unsteady walking (ataxia) (29) Tiredness (lethargy) (4) Tiredness (lethargy) (4) Tiredness (lethargy) (4) Tiredness (lethargy) (4) Tiredness (lethargy) (4) Tiredness (lethargy) (4)
Behavior
Behavioral disorder (unspecified) (35)
Other
Death by euthanasia (56) Blindness (37) Death (35) Weight loss (33) Elevated alanine aminotransferase (3) Elevated alanine aminotransferase (3) Elevated alanine aminotransferase (3) Elevated alanine aminotransferase (3) Elevated alanine aminotransferase (3) Elevated alanine aminotransferase (3) Ketosis (3) Ketosis (3) Ketosis (3) Ketosis (3) Ketosis (3) Ketosis (3) Abnormal radiograph finding (2) Abnormal radiograph finding (2) Abnormal radiograph finding (2) Abnormal radiograph finding (2) Abnormal radiograph finding (2) Abnormal radiograph finding (2) Elevated creatinine (2) Elevated creatinine (2) Elevated creatinine (2) Elevated creatinine (2) Elevated creatinine (2) Elevated creatinine (2) Elevated total bilirubin (2) Elevated total bilirubin (2) Elevated total bilirubin (2) Elevated total bilirubin (2) Elevated total bilirubin (2) Elevated total bilirubin (2) Hiding (2) Hiding (2) Hiding (2) Hiding (2) Hiding (2) Hiding (2)

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, Cat (unknown), Female, 14 year, 4.17 kilogram • Drug: MSK, Emulsion, Auricular (Otic), Frequency: 1 per day • Reactions: Ear canal disorder, Tiredness (lethargy), Head shake - ear disorder • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-055973
  • Serious AE: No
  • Treated For AE: No
  • Sex: Female
  • Age: 14.00 Year
  • Weight: 4.170 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Auricular (Otic)
  • Form: Emulsion
  • Frequency: 1 per day
Reactions Reported:
Ear canal disorder Tiredness (lethargy) Head shake - ear disorder
Outcomes: Ongoing

Dog, ['Terrier - Jack Russell', 'Dog (unknown)'], Male, 12 year, 13.61 kilogram • Drug: MSK, Unassigned, Unknown • Reactions: Localised hair loss, Claw / hoof / nail disorder NOS, Crust, Itching, Bacterial skin infection NOS… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-056052
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 12.00 Year
  • Weight: 13.610 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Unassigned
Reactions Reported:
Localised hair loss Claw / hoof / nail disorder NOS Crust Itching Bacterial skin infection NOS Dermatophytosis Pododermatitis
Outcomes: Ongoing

Cat, Domestic Mediumhair, Female, 13 year, 2.858 kilogram • Drug: MSK, Solution, Unknown • Reactions: Tiredness (lethargy), Unresponsive to stimuli, Not eating, Not drinking, Hiding… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-055801
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Female
  • Age: 13.00 Year
  • Weight: 2.858 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Solution
Reactions Reported:
Tiredness (lethargy) Unresponsive to stimuli Not eating Not drinking Hiding Unsteady walking (ataxia) Abnormal radiograph finding Hypothermia Tympanic opacity Weight loss Malaise Muscle weakness NOS Intentional misuse Lack of efficacy - NOS
Outcomes: Ongoing

Dog, Shepherd Dog - Australian, Male, 6 year, 17.872 kilogram • Drug: MSK, Solution, Unknown • Reactions: Abscess NOS, Dehiscence, Dermatitis, Pain NOS, Fever… • Outcome: Euthanized

  • Report ID: USA-USFDACVM-2025-US-055651
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Male
  • Age: 6.00 Year
  • Weight: 17.872 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Solution
Reactions Reported:
Abscess NOS Dehiscence Dermatitis Pain NOS Fever Cellulitis Skin necrosis Steatitis Panniculitis Skin abscess Immune-mediated polyarthropathy Decreased haematocrit Immune mediated haemolytic anaemia Autoimmune disorder NOS Elevated protein:creatinine ratio Glomerulonephritis Elevated total bilirubin Elevated liver enzymes NOS Diarrhea Increased percentage reticulocytes Death by euthanasia
Outcomes: Euthanized

Dog, Terrier - West Highland White, Male, 13 year, 8.346 kilogram • Drug: MSK, Tablet, Oral • Reactions: Lack of efficacy - NOS • Outcome: Outcome Unknown

  • Report ID: USA-USFDACVM-2025-US-054340
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 13.00 Year
  • Weight: 8.346 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet
Reactions Reported:
Lack of efficacy - NOS
Outcomes: Outcome Unknown

Dog, Schnauzer - Miniature, Male, 2 year, 11.567 kilogram • Drug: MSK, Tablet, chewable, Oral • Reactions: Urinary tract infection, Fever, Prostatitis, Knuckling, Proprioception deficit… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-055520
  • Serious AE: No
  • Treated For AE: Yes
  • Sex: Male
  • Age: 2.00 Year
  • Weight: 11.567 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
Reactions Reported:
Urinary tract infection Fever Prostatitis Knuckling Proprioception deficit Medication error NOS Not himself/herself
Outcomes: Ongoing

Dog, Siberian Husky, Female, 7.7 year, 20.68 kilogram • Drug: MSK, Tablet, chewable, Oral, Dose: 1 tablet per animal • Reactions: Circling - behavioural disorder, Seizure NOS • Outcome: Recovered/Normal

  • Report ID: USA-USFDACVM-2025-US-053779
  • Serious AE: Yes
  • Treated For AE: Yes
  • Sex: Female
  • Age: 7.70 Year
  • Weight: 20.680 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Oral
  • Form: Tablet, chewable
  • Dose: 1 tablet per animal
Reactions Reported:
Circling - behavioural disorder Seizure NOS
Outcomes: Recovered/Normal

Cat, Domestic Longhair, Male, 11.5 year, 9.66 kilogram • Drug: MSK, Tablet, Unknown • Reactions: Decreased appetite, Hiding, Weight loss, Fever, Elevated liver enzymes NOS… • Outcome: Ongoing

  • Report ID: USA-USFDACVM-2025-US-054368
  • Serious AE: No
  • Treated For AE: No
  • Sex: Male
  • Age: 11.50 Year
  • Weight: 9.660 Kilogram
  • Case-reported brand: MSK
  • Case-reported manufacturer: MSK
  • Route: Unknown
  • Form: Tablet
Reactions Reported:
Decreased appetite Hiding Weight loss Fever Elevated liver enzymes NOS Ketosis Tiredness (lethargy) Elevated creatinine Monocytopenia High pancreatic-specific lipase Eosinopenia
Outcomes: Ongoing

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

Overdose Information

Overdose may exacerbate GI and neurologic signs; in cats, high doses increase the risk of irreversible blindness. Supportive care is required.

Storage & Handling

Store at room temperature away from moisture.

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