ENROPRO SILVER OTIC- enrofloxacin/silver sulfadiazine emulsion
EnroPro Silver Otic by
Drug Labeling and Warnings
EnroPro Silver Otic by is a Animal medication manufactured, distributed, or labeled by Cronus Pharma LLC. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
- SPL UNCLASSIFIED SECTION
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PRODUCT DESCRIPTION:
Each milliliter of EnroProTM Silver Otic contains: enrofloxacin 5 mg (0.5% w/v), silver sulfadiazine (SSD) 10 mg (1.0% w/v), benzyl alcohol (as a preservative) and cetostearyl alcohol (as a stabilizer) in a purified water emulsion, sorbitan monostearate, polysorbate 60, and medium chain triglycerides. The active ingredients are delivered via a physiological carrier (a nonirritating emulsion).
- CHEMICAL NOMENCLATURE AND STRUCTURE:
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ACTIONS:
Enrofloxacin, a 4-fluoroquinolone compound, is bactericidal with activity against a broad spectrum of both Gram negative and Gram positive bacteria. Fluoroquinolones elicit their bactericidal activities through interactions with two intracellular enzymes, DNA gyrase (DNA topoisomerase II) and DNA topoisomerase IV, which are essential for bacterial DNA transcription, synthesis and replication. It is believed that fluoroquinolones actively bind with bacterial DNA:ENZYME complexes and thereby inhibit the essential processes catalyzed by the enzymes (DNA supercoiling and chromosomal decatenation).1 The ultimate outcome of the fluoroquinolone intervention is DNA fragmentation and bacterial cell death.2,3
Silver sulfadiazine (SSD) is synthesized from silver nitrate and sodium sulfadiazine.4 This compound has a wide spectrum of antimicrobial activity against Gram negative and Gram positive bacteria and is also an effective antimycotic.5,6 SSD suppresses microbial growth through inhibition of DNA replication and modification of the cell membrane.
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MICROBIOLOGY:
In clinical field trials, enrofloxacin/silver sulfadiazine otic demonstrated elimination or reduction of clinical signs associated with otitis externa and in vitro activity against cultured organisms. enrofloxacin/silver sulfadiazine otic is effective when used as a treatment for canine otitis externa associated with one or more of the following organisms: Malassezia pachydermatis, coagulase-positive Staphylococcus spp., Pseudomonas aeruginosa, Enterobacter spp., Proteus mirabilis, Streptococci spp., Aeromonas hydrophila, Aspergillus spp., Klebsiella pneumoniae, and Candida albicans.
In vitro assays, such as disk-diffusion and agar/broth-dilution, are used to determine the susceptibilities of microbes to antimicrobial therapies. Results of agar/broth-dilution assays are reported as a Minimal Inhibitory Concentration (MIC) which represents the lowest antimicrobial concentration, expressed in μg/mL, capable of inhibiting the growth of a pathogenic microorganism. MICs are used in conjunction with pharmacokinetics to predict the in vivo efficacy of systemically administered antimicrobials. Topical administration of enrofloxacin/silver sulfadiazine otic to an exudate and debris-free canal, however, will generally result in local antimicrobial concentrations that greatly exceed serum and tissue levels resulting from systemic therapy. Therefore, when using enrofloxacin/silver sulfadiazine otic as a treatment for canine otitis externa, interpret susceptibility data cautiously.
- INDICATIONS:
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EFFECTIVENESS:
Due to its combination of active ingredients, enrofloxacin/silver sulfadiazine otic provides antimicrobial therapy against bacteria and fungi (which includes yeast) commonly encountered in cases of canine otitis externa.
The effectiveness of enrofloxacin/silver sulfadiazine otic was evaluated in a controlled, double-blind, multi-site clinical trial. One hundred and sixty-nine dogs (n=169), with naturally occurring active otitis externa participated in the study. The presence of active disease was verified by aural cytology, microbial culture and otoscopy/clinical scoring. Qualified cases were randomly assigned to either enrofloxacin/silver sulfadiazine otic treatment (n=113) or to a comparable placebo-based regimen (n=56). Treatments were administered twice daily for up to 14 days. Assessment of effectiveness was based on continued resolution of clinical signs 3 to 4 days following administration of the last dose.
At study conclusion, enrofloxacin/silver sulfadiazine otic was found to be a significantly more effective treatment for canine otitis externa than the placebo regimen. Based on the scoring system used to assess treatment response, therapeutic success occurred in 67% of enrofloxacin/silver sulfadiazine otic-treated infections compared to 14% with placebo (r-value2 0.001) after 14 days of treatment.
- CONTRAINDICATIONS:
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HUMAN WARNINGS:
Not for human use. Keep out of the reach of children. Avoid contact with eyes. In case of contact, immediately flush eyes with copious amounts of water for 15 minutes. In case of dermal contact, wash skin with soap and water. Consult a physician if irritation develops or persists following ocular or dermal exposures. Individuals with a history of hypersensitivity to quinolone compounds or antibacterials should avoid handling this product. In humans, there is a risk of user photosensitization within a few hours after excessive exposure to quinolones. If excessive accidental exposure occurs, avoid direct sunlight.
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PRECAUTIONS:
The use of EnroProTM Silver Otic in dogs with perforated tympanic membranes has not been evaluated. Therefore, the integrity of the tympanic membrane should be evaluated before administering this product. If hearing or vestibular dysfunction is noted during the course of treatment, discontinue use of EnroProTM Silver Otic.
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.
Quinolone-class drugs have been associated with cartilage erosions in weightbearing joints and other forms of arthropathy in immature animals of various species.
The safe use of EnroProTM Silver Otic in dogs used for breeding purposes, during pregnancy, or in lactating bitches, has not been evaluated.
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ADVERSE REACTIONS:
During clinical trials, 2 of 113 (1.7%) dogs exhibited reactions that may have resulted from treatment with enrofloxacin/silver sulfadiazine otic. Both cases displayed local hypersensitivity responses of the aural epithelium to some component within the enrofloxacin/silver sulfadiazine otic formulation. The reactions were characterized by acute inflammation of the ear canal and pinna.
To report suspected adverse drug events, for technical assistance or to obtain a copy of the SDS, contact Cronus Pharma LLC at 1-844-227-6687 or 1-844-2-CRONUS. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.
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SAFETY:
General Safety Study:
In a target animal safety study, enrofloxacin/silver sulfadiazine otic was administered in both ears of 24 clinically normal beagle dogs at either recommended or exaggerated dosages: 10, 30 or 50 drops applied twice daily for 42 consecutive days. A control group of 8 beagle dogs was treated by administering 50 drops of vehicle in one ear twice daily for 42 consecutive days, with the contralateral ear untreated. Erythema was noted in all groups, including both treated and untreated ears in the controls, which resolved following termination of treatment.
Oral Safety Study:
In order to test safety in case of ingestion, enrofloxacin/silver sulfadiazine otic was administered, twice daily for 14 consecutive days, to the dorsum of the tongue and to the left buccal mucosa of 6 clinically normal dogs. No adverse local or systemic reactions were reported.
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DOSAGE AND ADMINISTRATION:
Shake well before each use.
Tilt head so that the affected ear is presented in an upward orientation. Administer a sufficient quantity of EnroProTM Silver Otic to coat the aural lesions and the external auditory canal.
As a general guide, administer 5-10 drops per treatment in dogs weighing 35 lbs. or less and 10-15 drops per treatment in dogs weighing more than 35 lbs. Following treatment, gently massage the ear so as to ensure complete and uniform distribution of the medication throughout the external ear canal. Apply twice daily for a duration of up to 14 days.
- STORAGE:
- HOW SUPPLIED:
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REFERENCES:
1. Hooper DC and Wolfson JS. Mechanisms of quinolone action and bacterial killing in quinolone antimicrobial agents. Washington DC, American Society for Microbiology, 2nd ed., 1993: 53-75.
2. Gootz TD and Brightly KE. Fluoroquinolone antibacterial: mechanism of action, resistance and clinical aspects. Medicinal Research Reviews 1996:16 (5): 433-486.
3. Drlica K and Zhoa X. DNA gyrase, topoisomerase IV and the 4-quinolones. Microbiology and Molecular Biology Reviews 1997: 61(3): 377-392.
4. Fox CL. Silver sulfadiazine: a new topical therapy for Pseudomonas in burns. Archives of Surgery 1968: 96:184-188.
5. Wlodkowski TJ and Rosenkranz HS. Antifungal activity of silver sulfadiazine. Lancet 1973: 2:739-740.
6. Schmidt A. In vitro activity of climbazole, clotrimazole and silver sulfadiazine against isolates of Malassezia pachy-dermatis. J of Vet Medicine Series B 1997: 44:193-197.
Approved by FDA under ANADA # 200-782
Manufactured for:
Cronus Pharma LLC,
East Brunswick, NJ 08816.
Contact No: 1-844-227-6687
(1-844-2-CRONUS)
Made in IndiaRevised: 04/2024
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 69043-056-12
EnroPro™ Silver Otic
(enrofloxacin/silver sulfadiazine)
Antibacterial-Antimycotic Emulsion
For Ototopical Use in Dogs
CAUTION: Federal law restricts this drug to use by or on the order of a veterinarian.
►Federal law prohibits the extralabel use of this drug in food-producing animals.◄
Approved by FDA under ANADA # 200-782
15 mL
12 bottles of 15 mL each
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 69043-056-94
EnroPro™ Silver Otic
(enrofloxacin/silver sulfadiazine)
Antibacterial-Antimycotic Emulsion
For Ototopical Use in Dogs
CAUTION: Federal law restricts this drug to use by or on the order of a veterinarian.
►Federal law prohibits the extralabel use of this drug in food-producing animals.◄
Approved by FDA under ANADA # 200-782
30 mL
6 bottles of 30 mL each
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INGREDIENTS AND APPEARANCE
ENROPRO SILVER OTIC
enrofloxacin/silver sulfadiazine emulsionProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC: 69043-056 Route of Administration AURICULAR (OTIC) Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ENROFLOXACIN (UNII: 3DX3XEK1BN) (ENROFLOXACIN - UNII:3DX3XEK1BN) ENROFLOXACIN 5 mg in 1 mL SILVER SULFADIAZINE (UNII: W46JY43EJR) (SILVER CATION - UNII:57N7B0K90A) SILVER SULFADIAZINE 10 mg in 1 mL Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC: 69043-056-12 12 in 1 CARTON 1 15 mL in 1 BOTTLE, DROPPER 2 NDC: 69043-056-94 6 in 1 CARTON 2 30 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200782 12/01/2024 Labeler - Cronus Pharma LLC (079421067)
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