betamethasone

For the treatment of acute and chronic canine otitis externa associated with yeast (Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria susceptible to gentamicin.

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

GBC Ointment™

For the treatment of otitis externa in dogs associated with susceptible strains of bacteria (Staphylococcus pseudintermedius) and yeast (Malassezia pachydermatis).

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

Osurnia™

The drug is used in dogs in the treatment of infected superficial lesions caused by bacteria sensitive to gentamicin.

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

Gentamicin Sulfate Topical Spray

For the treatment of otitis externa in dogs, associated with susceptible strains of yeast (Malassezia pachydermatis).

DuOtic®

The drug is used or indicated for canine infected superficial lesions caused by bacteria sensitive to gentamicin.

If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted. Concomitant use of drugs known to induce ototoxicity should be avoided. Observe patients for signs of adrenocorticoid overdosage. The antibiotic susceptibility of the pathogenic organism should be determined prior to use of this preparation. Administration of recommended doses beyond 7 days may result in delayed wound healing. Animals treated longer than 7 days should be monitored closely. For use by or on the order of a licensed veterinarian.

Topagen® Ointment

The drug is used or indicated for use in dogs in the treatment of acute and chronic canine otitis externa.

If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted. Concomitant use of drugs known to induce ototoxicity should be avoided. Observe patients for signs of adrenocorticoid overdosage. The antibiotic susceptibility of the pathogenic organism should be determined prior to use of this preparation. Administration of recommended doses beyond 7 days may result in delayed wound healing. Animals treated longer than 7 days should be monitored closely. For use by or on the order of a licensed veterinarian.

Topagen® Ointment

For the treatment of acute and chronic otitis externa caused by bacteria sensitive to gentamicin in dogs.

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

Gentocin® Otic Solution

For the treatment of infected superficial lesions in dogs caused by bacteria susceptible to gentamicin.

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

GB Topical Spray

For the treatment of canine superficial infected lesions caused by bacteria sensitive to gentamicin.

If hypersensitivity to any of the components occurs treatment with this product should be discontinued and appropriate therapy instituted. Concomitant use with other drugs known to induce ototoxicity is not recommended. This preparation should not be used in conditions where corticosteroids are contraindicated. Do not administer parenteral corticosteroids during treatment with this drug. The antibiotic sensitivity of the pathogenic organism should be determined prior to use of this preparation. For use by or on the order of a licensed veterinarian.

VET BETA-GEN®

It is used as an aid in the control of pruritus associated with dermatoses.

It has been demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Betasone Aqueous Suspension

It is used or intended for use for the treatment of various inflammatory joint conditions; for example, acute and traumatic lameness involving the carpel and fetlock joints.

Not for use in horses intended or food. For use only by or on the order of a licensed veterinarian.

Betavet Soluspan Suspension

It is used as an aid in the control of inflammation associated with various arthropathies.

Not for use in horses intended for food. It has been demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Betasone Aqueous Suspension

For the control of pain and inflammation associated with osteoarthritis in horses.

Do not use in horses intended for human consumption.

BetaVet®

For the treatment of acute and chronic canine otitis externa caused by bacteria sensitive to gentamicin.

If hypersensitivity to any of the components occurs treatment with this product should be discontinued and appropriate therapy instituted. Concomitant use with other drugs known to induce ototoxicity is not recommended. This preparation should not be used in conditions where corticosteroids are contraindicated. Do not administer parenteral corticosteroids during treatment with this drug. The antibiotic sensitivity of the pathogenic organism should be determined prior to use of this preparation. For use by or on the order of a licensed veterinarian.

VET BETA-GEN®

For the treatment of feline superficial infected lesions caused by bacteria sensitive to gentamicin.

If hypersensitivity to any of the components occurs treatment with this product should be discontinued and appropriate therapy instituted. Concomitant use with other drugs known to induce ototoxicity is not recommended. This preparation should not be used in conditions where corticosteroids are contraindicated. Do not administer parenteral corticosteroids during treatment with this drug. The antibiotic sensitivity of the pathogenic organism should be determined prior to use of this preparation. For use by or on the order of a licensed veterinarian.

VET BETA-GEN®

INDICATIONS GENTOCIN DURAFILM Ophthalmic Solution is indicated for the treatment of external eye infections and inflammation in dogs. Clinical reports indicate it is useful for the management of some cases of pigmentary keratitis and pannus. Temporary remission of some of the pathological lesions of the aforementioned conditions have been noted following therapy with GENTOCIN DURAFILM Ophthalmic Solution.

Gentocin® Durafilm® (gentamicin sulfate and betamethasone acetate ophthalmic solution)

INDICATIONS: OTOMAX ointment is indicated for the treatment of canine acute and chronic otitis externa associated with yeast (Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria susceptible to gentamicin.

Otomax® (GENTAMICIN SULFATE, BETAMETHASONE VALERATE, AND CLOTRIMAZOLE, OINTMENT)

OSURNIA is indicated for the treatment of otitis externa in dogs associated with susceptible strains of bacteria (Staphylococcus pseudintermedius) and yeast (Malassezia pachydermatis).

Osurnia® (florfenicol, terbinafine, betamethasone acetate)

For Otic Use in Dogs Only. CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Keep this and all drugs out of the reach of children.

Otomax® (GENTAMICIN SULFATE, BETAMETHASONE VALERATE, AND CLOTRIMAZOLE, OINTMENT)

For topical use in dogs only. For the treatment of infected superficial lesions in dogs caused by bacteria susceptible to gentamicin. Read accompanying directions carefully.

GENTACALM®​ Topical Spray

DuOtic™ is indicated for the treatment of otitis externa in dogs, associated with susceptible strains of yeast (Malassezia pachydermatis).

DuOtic™(terbinafine and betamethasone acetate otic gel)

For the treatment of infected superficial lesions in dogs caused by bacteria susceptible to gentamicin. Keep Out of Reach of Children.

GenOne™ Spray

BETAVET is indicated for the control of pain and inflammation associated with osteoarthritis in horses.

BETAVET® (Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension)

For the treatment of infected superficial lesions in dogs caused by bacteria susceptible to gentamicin.

GentaVed Topical Spray Gentamicin Sulfate With Betamethasone Valerate TOPICAL SPRAY

Gentamicin Sulfate, USP With Betamethasone Valerate, USP Veterinary For Topical Use in Dogs Only

GENTACALM®​ Topical Spray

For treatment of external eye infections and inflammation in dogs.

Gentocin® Durafilm®

CLINICAL PHARMACOLOGY GENTOCIN DURAFILM Ophthalmic Solution incorporates polyoxyl 40 stearate and polyethoxy 35 castor oil which provide a colloidal dispersion of active ingredients. This aqueous colloidal solution offers specific advantages in treating eye conditions. DURAFILM covers the conjunctiva with a thin, clear, quickly spreading film which carries therapeutic components to accessible structures and maintains prolonged contact. GENTOCIN DURAFILM Ophthalmic Solution provides the antibacterial properties of gentamicin sulfate plus the anti-inflammatory action of betamethasone acetate. Gentamicin sulfate, a wide-spectrum antibiotic, is a highly effective topical treatment in primary and secondary bacterial infections of the eye and surrounding tissues. Gentamicin is bactericidal in vitro against a wide variety of gram-positive and gram-negative bacteria. Concentrations of gentamicin sulfate required to inhibit growth of gram positive and gram-negative clinical and laboratory strains of bacteria tested were less than those of neomycin in most instances.1. Gentamicin is active against most gram-negative bacteria including Pseudomonas aeruginosa, indole positive and negative Proteus species, Escherichia coli, Kiebsiella pneumoniae, Aerobacter aerogenes, and Neisseria. Gentamicin is also active against strains of gram-positive bacteria including Staphylococcus species and Group A Beta-Hemolytic Streptococci. Betamethasone produces hormonal and metabolic effects common to all adrenocortical steroids, and in low dosage affords anti-inflammatory, anti-allergic, and anti-rheumatic effects. Studies in man show the glucocorticoid activity of betamethasone to be 10 to 15 times greater than prednisone. Betamethasone helps control excessive tissue reaction to infections, allergens, and trauma. The corticoids control the inflammatory and exudate phases of eye conditions, particularly those affecting the anterior chamber and external structure of the eye. However, they do not curtail the growth of the causative organisms. Betamethasone therapy may reduce the damaging sequelae in certain eye diseases and injuries as well as scarring and vascularization, and appears to alter the usual tissue response to injury. In initial acute phases of inflammation, local application of betamethasone provides prompt, symptomatic relief, accomplishing temporary control of the exudative phase, whether of bacterial, allergic, or traumatic origin. Betamethasone also inhibits fibroblast formation during tissue repair.

Gentocin® Durafilm® (gentamicin sulfate and betamethasone acetate ophthalmic solution)

CHEMISTRY Gentamicin is a mixture of aminoglycoside antibiotics derived from the fermentation of Micromonospora purpurea. Gentamicin sulfate is a mixture of sulfate salts of the antibiotics produced in this fermentation. The salts are weakly acidic and freely soluble in water. Gentamicin sulfate contains not less than 500 micrograms of gentamicin base per milligram. Betamethasone valerate is a synthetic glucocorticoid. PHARMACOLOGY Gentamicin, a broad-spectrum antibiotic, is a highly effective topical treatment for bacterial infections of the skin. In vitro, gentamicin is bactericidal against a wide variety of gram-positive and gram-negative bacteria isolated from domestic animals.1,2 Specifically, gentamicin is active against the following organisms isolated from canine skin: Alcaligenes sp., Citrobacter sp., Klebsiella sp., Pseudomonas aeruginosa, indole-positive and negative Proteus sp., Escherichia coli, Enterobacter sp., Staphylococcus sp., and Streptococcus sp. Betamethasone valerate emerged from intensive research as the most promising of some 50 newly synthesized corticosteroids in the experimental model described by McKenzie3, et al. This human bioassay technique has been found reliable for evaluating the vasoconstrictor properties of new topical corticosteroids and is useful in predicting clinical efficacy. Betamethasone valerate in veterinary medicine has been shown to provide anti-inflammatory and antipruritic activity in the topical management of corticosteroid-responsive infected superficial lesions in dogs.

GentaVed Topical Spray Gentamicin Sulfate With Betamethasone Valerate TOPICAL SPRAY

OSURNIA is a fixed combination of three active substances: florfenicol (antibacterial), terbinafine (antifungal) and betamethasone acetate (steroidal anti-inflammatory). Florfenicol is a bacteriostatic antibiotic which acts by inhibiting protein synthesis. Its spectrum of activity includes Gram-positive and Gram-negative bacteria. Terbinafine is an antifungal which selectively inhibits the early synthesis of ergosterol. Betamethasone acetate is a glucocorticosteroid with anti-inflammatory activity. OSURNIA dissolves in ear wax and is slowly eliminated from the ear mechanically. Ear inflammation can increase the percutaneous absorption of active substances in OSURNIA. In a laboratory study conducted in healthy dogs (see Animal Safety ), low plasma concentrations of florfenicol, terbinafine, and betamethasone acetate were measurable during the first 2-4 days after administration of 1× dose, and during the first 2-7 days after administration of 5× dose. No quantifiable plasma concentrations of any of the three active ingredients were observed in the pre-dose samples of most dogs prior to second and third administrations. Although total and peak exposure in the blood tended to be highly variable between dogs, systemic drug concentrations tended to increase in a less than dose-proportional manner as the administered dose increased from 1× to 5×.

Osurnia® (florfenicol, terbinafine, betamethasone acetate)

DuOtic™ is a fixed combination of two active ingredients: terbinafine (antifungal) and betamethasone acetate (steroidal anti-inflammatory). Terbinafine is an antifungal which selectively inhibits the early synthesis of ergosterol. Betamethasone acetate is a glucocorticosteroid with anti-inflammatory activity. DuOtic™ dissolves in ear wax and is slowly eliminated from the ear mechanically. Ear inflammation can increase the percutaneous absorption of active substances in DuOtic™. In a laboratory study conducted in healthy dogs administered Osurnia® (see Target Animal Safety ), low plasma concentrations of florfenicol, terbinafine, and betamethasone acetate were measurable during the first 2-4 days after administration of 1X dose, and during the first 2-7 days after administration of 5X dose. No quantifiable plasma concentrations of any of the three active ingredients were observed in the pre-dose samples of most dogs prior to second and third administrations. Although total and peak exposure in the blood tended to be highly variable between dogs, systemic drug concentrations tended to increase in a less than dose-proportional manner as the administered dose increased from 1X to 5X. The systemic exposure of terbinafine and betamethasone are not expected to be affected by the removal of florfenicol from the formulation.

DuOtic™(terbinafine and betamethasone acetate otic gel)

Gentamicin, a broad-spectrum antibiotic, is a highly effective topical treatment for bacterial infections of the skin. In vitro, gentamicin is bactericidal against a wide variety of gram-positive and gram-negative bacteria isolated from domestic animals.1,2 Specifically, gentamicin is active against the following organisms isolated from canine skin: Alcaligenes sp., Citrobacter sp., Klebsiella sp., Pseudomonas aeruginosa, indole-positive and -negative Proteus sp., Escherichia coli, Enterobacter sp., Staphylococcus sp., and Streptococcus sp. Betamethasone valerate emerged from intensive research as the most promising of some 50 newly synthesized corticosteroids in the experimental model described by McKenzie,3 et al. This human bioassay technique has been found reliable for evaluating the vasoconstrictor properties of new topical corticosteroids and is useful in predicting clinical efficacy. Betamethasone valerate in veterinary medicine has been shown to provide anti-inflammatory and antipruritic activity in the topical management of corticosteroid-responsive infected superficial lesions in dogs.

GENTACALM®​ Topical Spray

Betamethasone is a potent glucocorticoid steroid with anti-inflammatory and immunosuppressive properties. Depending upon their physico-chemical properties, drugs administered intra-articularly may enter the general circulation because the synovial joint cavity is in direct equilibrium with the surrounding blood supply. After the intra-articular administration of 9 mg BETAVET in horses, there were quantifiable concentrations of betamethasone (above 1.0 ng/mL) in the plasma. Maximum plasma concentrations (Cmax) and time to Cmax (Tmax) values ranged from 2.70 to 3.88 ng/mL and 4.5 to 8 hours, respectively. The effective plasma terminal elimination half-life ranged from 4 to 8 hours. The non-compartmental area-underthe curve to the limit of quantification (AUCLOQ) ranged from 29.24 to 42.96 hr*ng/mL. In contrast, most of the betamethasone disodium phosphate concentrations and all of the betamethasone acetate concentrations were below the limit of quantification in plasma.

BETAVET® (Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension)

CONTRAINDICATIONS Corticosteroids are contraindicated in initial treatment of corneal ulcers. GENTOCIN DURAFILM Ophthalmic Solution is contraindicated in ocular conditions where there is deep ulceration without vascularization and in conditions of viral origin before healing has commenced.

Gentocin® Durafilm® (gentamicin sulfate and betamethasone acetate ophthalmic solution)

CONTRAINDICATIONS: If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted. Concomitant use of drugs known to induce ototoxicity should be avoided. Do not use in dogs with known perforation of eardrums.

Otomax® (GENTAMICIN SULFATE, BETAMETHASONE VALERATE, AND CLOTRIMAZOLE, OINTMENT)

BETAVET is contraindicated in horses with hypersensitivity to betamethasone. Intra-articular injection of corticosteroids for local effect is contraindicated in the presence of septic arthritis.

BETAVET® (Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension)

Do not use in dogs with known tympanic perforation (see Precautions ). Do not use in dogs with a hypersensitivity to florfenicol, terbinafine or corticosteroids.

Osurnia® (florfenicol, terbinafine, betamethasone acetate)

If hypersensitivity to any of the components occurs, discontinue treatment and institute appropriate therapy.

GenOne™ Spray

Do not use in horses intended for human consumption. Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. Additionally, corticosteroids administered to dogs, rabbits and rodents during pregnancy have resulted in cleft palate in offspring. Corticosteroids administered to dogs during pregnancy have also resulted in other congenital anomalies including deformed forelegs, phocomelia and anasarca. Therefore, before use of corticosteroids in pregnant animals, the possible benefits to the pregnant animal should be weighed against potential hazards to its developing embryo or fetus. Human Warnings: Not for use in humans. For use in animals only. Keep this and all medications out of the reach of children. Consult a physician in the case of accidental human exposure.

BETAVET® (Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension)

WARNINGS: The use of OTOMAX ointment has been associated with deafness or partial hearing loss in a small number of sensitive dogs (e.g., geriatric). The hearing deficit is usually temporary. If hearing or vestibular dysfunction is noted during the course of treatment, discontinue use of OTOMAX ointment immediately and flush the ear canal thoroughly with a nonototoxic solution. Corticosteroids administered to dogs, rabbits, and rodents during pregnancy have resulted in cleft palate in offspring. Other congenital anomalies including deformed forelegs, phocomelia, and anasarca have been reported in offspring of dogs which received corticosteroids during pregnancy. Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis.

Otomax® (GENTAMICIN SULFATE, BETAMETHASONE VALERATE, AND CLOTRIMAZOLE, OINTMENT)

WARNINGS Not for human use. Keep this and all drugs out of the reach of children. Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. Additionally, corticosteroids administered to dogs, rabbits, and rodents during pregnancy have produced cleft palate. Other congenital anomalies including deformed forelegs, phocomelia, and anasarca have been reported in offspring of dogs which received corticosteroids during pregnancy.

Gentocin® Durafilm® (gentamicin sulfate and betamethasone acetate ophthalmic solution)

Clinical and experimental data have demonstrated that corticosteriods administrated orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. Additionally, corticosteroids administered to dogs, rabbits and rodents during pregnancy have produced cleft palate. Other congenital abnormalities including deformed forelegs, phocomelia, and anasarca have been reported in offspring of dogs which received corticosteroids during pregnancy.

GentaVed Topical Spray Gentamicin Sulfate With Betamethasone Valerate TOPICAL SPRAY

Adverse reactions reported during a field study of 239 horses of various breeds which had been administered either BETAVET (n=119) or a saline control (n=120) are summarized in Table 1. One BETAVET treated horse was removed from the study for onset of acute non-weight bearing lameness on Day 4. Treatment for presumed joint sepsis was instituted immediately, but the horse was eventually euthanized several weeks later due to a thromboembolic event associated with prolonged intravenous catheter placement. One BETAVET treated horse developed bilateral forelimb lameness on Day 8, with snow packed in the shoes and poor hoof conformation noted by the investigator. The horse was diagnosed with laminitis. Radiographs showed no abnormalities, and the horse was sound shortly after shoeing changes were implemented. Table 1. Adverse Reactions Adverse Reaction Number (%) of BETAVET treated horses Number (%) of saline treated horses Acute joint effusion and/or local injection site swelling (within 2 days of injection) 18 (15%) 16 (13%) Increased lameness (within the first 5 days) 8 (6.7%) 10 (8.3%) Loose stool 7 (5.9%) 10 (8.3%) Increased heat in joint 3 (2.5%) 6 (5%) Depression 7 (5.9%) 2 (1.6%) Agitation/anxiety 5 (4.2%) 3 (2.5%) Delayed swelling of treated joint (5 or more days after injection) 3 (2.5%) 4 (3.3%) Inappetance 4 (3.4%) 3 (2.5%) Dry stool 2 (1.7%) 0 (0%) Excessive sweating 1 (0.8%) 0 (0%) Acute non-weight bearing lameness 1 (0.8%) 0 (0%) Laminitis 1 (0.8%) 0 (0%)

BETAVET® (Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension)

ADVERSE REACTIONS SAP and SGPT (ALT) enzyme elevations, polydipsia, and polyuria have occurred following parenteral or systemic use of synthetic corticosteroids in dogs. Vomiting and diarrhea (occasionally bloody) have been observed in dogs. Cushing's syndrome in dogs has been reported in association with prolonged or repeated steroid therapy. A transient stinging sensation, usually expressed as some form of resentment by the animal, following topical application of the drug, has been noted in a small number of cases. Usually this does not require discontinuance of therapy. To report an adverse reaction, product-related problem, or human exposure, please call Merck Animal Health Technical Services at 1-800-224-5318. To obtain a copy of the Material Safety Data Sheet (MSDS), call 1-800-770-8878. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

Gentocin® Durafilm® (gentamicin sulfate and betamethasone acetate ophthalmic solution)

The following adverse reactions were reported during the course of a US field study for treatment of otitis externa in dogs treated with OSURNIA with 1 tube per affected ear(s) and repeated after 7 days: Frequency of Adverse Reaction by Treatment Adverse Reaction OSURNIA (n=190) Placebo (n=94) Elevated Alkaline Phosphatase 15 (7.9%) 3 (3.2%) Vomiting 7 (3.7%) 1 (1.1%) Elevated AST, ALT, ALPAspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP). Two dogs with pre-existing elevations in ALP were reported to have an increase in liver enzymes (ALP, ALT and/or AST) at study exit. Subsequent clinical chemistries returned to pre-treatment levels in one dog, while no follow-up was performed for the second dog. 2 (1.1%) 0 (0.0%) Weight loss (>10% body weight) 1 (0.53%) 0 (0.0%) Hearing Decrease/Loss 1 (0.53%) 1 (1.1%)

Osurnia® (florfenicol, terbinafine, betamethasone acetate)

The following adverse reactions were reported during the course of a US field study for treatment of otitis externa in dogs treated with DuOtic™ with 1 tube per affected ear(s) and repeated after 7 days: Number (%) of dogs with Adverse Reactions by Treatment Adverse Reaction DuOtic™ (n=120) Control (n=119) Elevated alanine aminotransferaseFour dogs were reported to have an increase in alanine aminotransferase at Study Exit. The levels reported in subsequent clinical chemistries returned to normal in three dogs, while no follow up was performed for the fourth dog. 4 (3.3%) 0 (0.0%) Conjunctivitis 1 (0.8%) 0 (0.0%) Ocular discharge 1 (0.8%) 2 (1.7%) Ear discharge 0 (0.0%) 1 (0.8%) Ear pruritus 3 (2.5%) 4 (3.4%)

DuOtic™(terbinafine and betamethasone acetate otic gel)

Side effects such as SAP and SGPT enzyme elevations, weight loss, anorexia, polydipsia, and polyuria have occurred following parenteral or systemic use of synthetic corticosteroids in dogs. Vomiting and diarrhea (occasionally bloody) have been observed in dogs. Cushing’s syndrome in dogs has been reported in association with prolonged or repeated steroid therapy.

GenOne™ Spray

To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact First Priority, Inc. at (800) 650-4899 or www.prioritycare.com. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae

GenOne™ Spray

To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Dechra at (866) 933-2472. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at http://www.fda.gov/reportanimalae

GENTACALM®​ Topical Spray

From 7.5- or 15-g tube; 10-, 15-, or 25-g bottles install 4 drops of ointment twice daily into the ear canal of dogs weighing less than 30 pounds, instill 8 drops twice daily for dogs weighing 30 pounds or more. From 215-g bottle, instill 2 drops of ointment twice daily into the ear canal of dogs weighing less than 30 pounds, instill 4 drops twice daily for dogs weighing 30 pounds or more. Therapy should continue for 7 consecutive days. The external ear should be cleaned and dried before treatment. Remove foreign material, debris, crusted exudates, etc. with suitable solutions. Excessive hair should be clipped from the treatment area. If hypersensitivity occurs, treatment should be discontinued and alternate therapy instituted.

Topical

Corticosteroids administered to dogs, rabbits, and rodents during pregnancy have resulted in cleft palate in offspring. Other congenital anomalies including deformed forelegs, phocomelia, and anasarca have been reported in offspring of dogs which received corticosteroids during pregnancy. Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition, followed by dystocia, fetal death, retained placenta and metritis. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Tri-Otic® Ointment

The drug is administered by instillation of 3 to 8 drops of solution into the ear canal twice daily for 7 to 14 days. Duration of treatment will depend upon the severity of the condition and the response obtained. The duration of treatment and/or frequency of the dosage may be reduced but care should be taken not to discontinue therapy prematurely. The external ear and ear canal should be properly cleaned and dried before treatment. Remove foreign material, debris, crusted exudates, etc., with suitable nonirritating solutions. Excessive hair should be clipped from the treatment area of the external ear.

Topical

If hypersensitivity to any of the components occurs treatment with this product should be discontinued and appropriate therapy instituted. Concomitant use with other drugs known to induce ototoxicity is not recommended. This preparation should not be used in conditions where corticosteroids are contraindicated. Do not administer parenteral corticosteroids during treatment with this drug. The antibiotic sensitivity of the pathogenic organism should be determined prior to use of this preparation. For use by or on the order of a licensed veterinarian.

VET BETA-GEN®

For the treatment of acute and chronic canine otitis externa the drug is administered by instillation of 3 to 8 drops into the ear canal twice daily for 7 days. The external ear and ear canal should properly cleaned and dried before treatment. Remove foreign material, debris, crusted exudates, etc., with suitable nonirritating solutions. Excessive hair should be clipped from the treatment area of the external ear.

Topical

If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted. Concomitant use of drugs known to induce ototoxicity should be avoided. Observe patients for signs of adrenocorticoid overdosage. The antibiotic susceptibility of the pathogenic organism should be determined prior to use of this preparation. Administration of recommended doses beyond 7 days may result in delayed wound healing. Animals treated longer than 7 days should be monitored closely. For use by or on the order of a licensed veterinarian.

Topagen® Ointment

For the treatment of infected superficial lesions, the lesion and adjacent area should be properly cleaned before treatment. Excessive hair should be removed. Hold bottle upright 3 to 6 inches from the lesion and depress the sprayer head twice. One actuation of the sprayer delivers 0.7 milliliter of the spray. The drug should be administered with two spray actuations 2 to 4 times daily for 7 days.

Topical

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

Gentocin® Topical Spray

Install ointment twice daily into the ear canal. Therapy should continue for 7 consecutive days. From 10-g bottles: 4 drops for dogs weighing less than 30 pounds (lb) or 8 drops for dogs weighing 30 lb or more. From 20-, 40-, or 215-g bottles: 2 drops for dogs weighing less than 30 lb or 4 drops for dogs weighing 30 lb or more.

Topical

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

GBC Ointment™

It is administered by intramuscular injection at a dosage of 0.25 to 0.5 milliliter per 20 pounds of body weight, depending on the severity of the condition. Frequency of dosage depends on recurrence of pruritic symptoms. Dosage may be repeated every 3 weeks or when symptoms recur, not to exceed a total of 4 injections.

Intra-Articular, Intramuscular

It has been demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Betasone Aqueous Suspension

For the treatment of canine infected superficial lesions, the lesion and adjacent area should be properly cleaned before treatment. Excessive hair should be removed. A sufficient amount of the drug should be applied to cover the treatment area. The drug should be administered twice daily for 7 to 14 days.

Topical

If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted. Concomitant use of drugs known to induce ototoxicity should be avoided. Observe patients for signs of adrenocorticoid overdosage. The antibiotic susceptibility of the pathogenic organism should be determined prior to use of this preparation. Administration of recommended doses beyond 7 days may result in delayed wound healing. Animals treated longer than 7 days should be monitored closely. For use by or on the order of a licensed veterinarian.

Topagen® Ointment

The lesion and adjacent area should be properly cleaned before treatment. Excessive hair should be removed. A sufficient amount of the drug should be applied to cover the treatment area. The drug should be administered twice daily for 7 to 14 days.

Topical

If hypersensitivity to any of the components occurs treatment with this product should be discontinued and appropriate therapy instituted. Concomitant use with other drugs known to induce ototoxicity is not recommended. This preparation should not be used in conditions where corticosteroids are contraindicated. Do not administer parenteral corticosteroids during treatment with this drug. The antibiotic sensitivity of the pathogenic organism should be determined prior to use of this preparation. For use by or on the order of a licensed veterinarian.

VET BETA-GEN®

From 7.5 or 15 gram tubes, install 4 drops of ointment twice daily into the ear canal of dogs weighing less than 30 pounds, instill 8 drops twice daily for dogs weighing 30 pounds or more.

Topical

Install ointment twice daily into the ear canal. Therapy should continue for 7 consecutive days. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Vetro-Max®

Hold bottle upright 3 to 6 inches from the lesion and depress the sprayer head twice. The drug should be administered with two spray actuations 2 to 4 times daily for 7 days.

Topical

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

Gentamicin Sulfate Topical Spray

Hold bottle upright 3 to 6 inches from the lesion and depress the sprayer head twice. Administer 2 to 4 times daily for 7 days.

Topical

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

GB Topical Spray

Apply a sufficient amount of the drug to cover the treatment area twice daily for 7 to 14 days.

Topical

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

Gentocin® Otic Solution

Instill three to eight drops of solution into the ear canal twice daily for 7 to 14 days.

Topical

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

Gentocin® Otic Solution

Administer one dose (1 tube) per affected ear(s) and repeat administration in 7 days.

Otic

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

Osurnia™

Administer two depressions of the sprayer head 2 to 4 times daily for 7 days.

Topical

Gentamicin Topical Spray

The drug is administered by instillation of 3 to 8 drops of solution into the ear canal twice daily for 7 to 14 days. Duration of treatment will depend upon the severity of the condition and the response obtained. The duration of treatment and/or frequency of the dosage may be reduced but care should be taken not to discontinue therapy prematurely. The external ear and ear canal should be properly cleaned and dried before treatment. Remove foreign material, debris, crusted exudates, etc., with suitable nonirritating solutions. Excessive hair should be clipped from the treatment area of the external ear.

Topical

If hypersensitivity to any of the components occurs treatment with this product should be discontinued and appropriate therapy instituted. Concomitant use with other drugs known to induce ototoxicity is not recommended. This preparation should not be used in conditions where corticosteroids are contraindicated. Do not administer parenteral corticosteroids during treatment with this drug. The antibiotic sensitivity of the pathogenic organism should be determined prior to use of this preparation. For use by or on the order of a licensed veterinarian.

VET BETA-GEN®

The lesion and adjacent area should be properly cleaned before treatment. Excessive hair should be removed. A sufficient amount of the drug should be applied to cover the treatment area. The drug should be administered twice daily for 7 to 14 days.

Topical

If hypersensitivity to any of the components occurs treatment with this product should be discontinued and appropriate therapy instituted. Concomitant use with other drugs known to induce ototoxicity is not recommended. This preparation should not be used in conditions where corticosteroids are contraindicated. Do not administer parenteral corticosteroids during treatment with this drug. The antibiotic sensitivity of the pathogenic organism should be determined prior to use of this preparation. For use by or on the order of a licensed veterinarian.

VET BETA-GEN®

Apply a sufficient amount of the drug to cover the treatment area twice daily for 7 to 14 days.

Topical

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

Gentocin® Otic Solution

It is administered aseptically by intraarticular injection at a dosage of 2.5 to 5 milliliters per joint, depending on the severity of the condition and the joint size. Dosage may be repeated upon recurrence of clinical signs. Injection into the joint cavity should be preceded by withdrawal of synovial fluid.

Intra-Articular, Intramuscular

Not for use in horses intended for food. It has been demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Betasone Aqueous Suspension

Using strict aseptic technique, administer 1.5 mL BetaVet ® (9 mg total betamethasone) per joint by intra-articular injection. BetaVet ® may be administered concurrently in up to 2 joints per horse.

Intra-Articular

Do not use in horses intended for human consumption.

BetaVet®

Administer from 2.5 to 5 cubic centimeters per dose by intra-articular injection. Dose may be repeated when necessary depending upon the duration of relief obtained.

Intra-Articular

Not for use in horses intended or food. For use only by or on the order of a licensed veterinarian.

Betavet Soluspan Suspension

DuOtic™ should be administered by a veterinary professional. Wear eye protection when administering DuOtic™ (see Human Safety Warnings, Precautions, Post-approval Experience, and Target Animal Safety ). Splatter may occur if the dog shakes its head following administration. Persons near the dog during administration should also take steps to avoid ocular exposure. Clean and dry the external ear canal before administering the initial dose of the product. Verify the tympanic membrane is intact prior to each administration (see Precautions, Contraindications, Target Animal Safety and Post-approval Experience ). Administer one dose (1 tube) per affected ear. Repeat administration in 7 days. Open tube by twisting the soft tip. Insert the flexible tip in the affected external ear canal and squeeze entire tube contents into the external ear canal. After application, gently massage the base of the ear to allow the gel to penetrate the lower part of the ear canal. Restrain dog to minimize post-application head shaking to reduce potential for splatter of product, and accidental eye exposure in people and dogs (see Post-Approval Experience and Target Animal Safety ). Do not clean the ear canal for 45 days after the initial administration to allow contact of the gel with the ear canal. Cleaning the ear may affect product effectiveness (see Effectiveness ). If alternative otic therapies are required, it is recommended to clean the ear(s) before application of those therapies.

AURICULAR (OTIC)

DuOtic™(terbinafine and betamethasone acetate otic gel)

DOSAGE AND ADMINISTRATION: The external ear should be thoroughly cleaned and dried before treatment. Remove foreign material, debris, crusted exudates, etc., with suitable nonirritating solutions. Excessive hair should be clipped from the treatment area. After verifying that the eardrum is intact, instill 4 drops from the 7.5 g and 15 g tube, and 15 g and 30 g bottle (2 drops from the 215 g bottle) of OTOMAX ointment twice daily into the ear canal of dogs weighing less than 30 lbs. Instill 8 drops from the 7.5 g and 15 g tube, and 15 g and 30 g bottle (4 drops from the 215 g bottle) twice daily into the ear canal of dogs weighing 30 lbs or more. Massage external ear canal carefully after instillation to ensure appropriate distribution of medication. Therapy should continue for 7 consecutive days.

AURICULAR (OTIC)

Otomax® (GENTAMICIN SULFATE, BETAMETHASONE VALERATE, AND CLOTRIMAZOLE, OINTMENT)

DOSAGE AND ADMINISTRATION The topical application of GENTOCIN DURAFILM Ophthalmic Solution should, in each instance, be administered to meet the specific needs of the individual case. One or two drops of the solution may be instilled into the conjunctival sac three or four times a day. Thereafter, the frequency of the dosage may be reduced but care should be taken not to discontinue therapy prematurely. In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of application.

OPHTHALMIC

Gentocin® Durafilm® (gentamicin sulfate and betamethasone acetate ophthalmic solution)

FOR TOPICAL USE IN DOGS ONLY Prior to treatment, remove excessive hair and clean the lesion and adjacent area. Hold bottle upright 3 to 6 inches from the lesion and depress the sprayer head twice. Administer 2 to 4 times daily for 7 days. Each depression of the sprayer head delivers 0.7 mL of Gentamicin sulfate, USP with betamethasone valerate, USP.

TOPICAL

Gentamicin Sulfate With Betamethasone Valerate TOPICAL SPRAY

Shake well immediately before use. Using strict aseptic technique, administer 1.5 mL BETAVET (9 mg total betamethasone) per joint by intra-articular injection. BETAVET may be administered concurrently in up to 2 joints per horse. Use immediately after opening, then discard any remaining contents.

INTRA-ARTICULAR

BETAVET® (Betamethasone Sodium Phosphate and Betamethasone Acetate Injectable Suspension)

Prior to treatment, remove excessive hair and clean the lesion and adjacent area. Hold bottle upright 3 to 6 inches from the lesion and depress the sprayer head twice. Administer 2 to 4 times daily for 7 days. Each depression of the sprayer head delivers 0.7 mL of GENTACALM® Topical Spray.

TOPICAL

GENTACALM®​ Topical Spray

Usual Dosage: Two depressions of the sprayer head 2 to 4 times daily for 7 days.

TOPICAL

GENTACALM®​ Topical Spray