Dexamethasone

The drug is used in dogs for the treatment of inflammatory conditions, as supportive therapy in canine posterior paresis, as supportive therapy before or after surgery to enhance recovery of poor surgical risks, and as supportive therapy in nonspecific dermatosis.

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

Dex-A-Vet Injection

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

Otiserene®

The drug is recommended for use as an aid in the treatment of bacterial, mycotic, and inflammatory dermatoses and otitis externa in dogs.

For use only by or on order of a licensed veterinarian.

Tresaderm Dermatologic Solution

Supportive therapy in nonspecific dermatosis and inflammatory conditions.

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 they may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. Do not use in viral infections. Anti-inflammatory action of corticosteroids may mask signs of infection. Do not use in animals with tuberculosis, chronic nephritis, cushingoid syndrome, or peptic ulcers, except for emergency therapy. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Pet Derm® III Tablets

The drug is given for glucocorticoid and anti-inflammatory agent.

If permanent glucocorticoid effect is required, oral therapy may be substituted. When therapy is to be withdraw after prolonged use, the daily dose should be reduced gradually over several days. Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection 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. Do not use in viral infections. Anti-inflammatory action of glucocorticoids may mask signs of infection. Except when used for emergency therapy, the product is contraindicated in animals with tuberculosis, chronic nephritis, cushingoid syndrome, or peptic ulcers. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Dexamethasone Sodium Phosphate Inj.

Dexamethasone is indicated for use as an anti-inflammatory agent

Do not use in viral infections. Except for emergency therapy, do not use in animals with tuberculosis, chronic nephritis, cushingoid syndrome and peptic ulcers. Existence of congestive heart failure, diabetes and osteoporosis are relative contraindications. Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection 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. 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.

Dexium™ Tablets

The drug is indicated as an anti-inflammatory agent in dogs.

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

Dexium®

In treatment of dogs as an anti-inflammatory agent.

Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection to animals may induce the first stage of parturition when administered during the last trimester of pregnancy; and they may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. Do not use in viral infections. Anti-inflammatory action of corticosteroids may mask signs of infections. Do not use in animals with tuberculosis, chronic nephritis, cushingoid syndrome, or peptic ulcers, except for emergency therapy. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Azium® Tablets 0.25 mg

The drug is used as an anti-inflammatory agent.

Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection 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.

Zonometh Solution

Dexamethasone bolus is indicated in cases where horses require additional steroid therapy following its parenteral administration. The drug may be used as supportive therapy for management of inflammatory conditions such as acute arthritic lameness es; and for various stress conditions where corticosteroids are required while the animal is being treated for a specific condition.

Do not use in viral infections during the viremic stage. With bacterial infections, appropriate antibacterial therapy should be used. Do not use in animals with chronic nephritis and hypercorticalism (cushingoid syndrome) except for emergency therapy. Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection 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.

Azium® Boluses 10 mg

Dexamethasone powder is indicated in cases where horses require additional steroid therapy following its parenteral administration. The drug is used as supportive therapy for management or inflammatory conditions such as acute arthritic lameness; and for various stress conditions where corticosteroids are required while the animal is being treated for a specific condition.

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

Azium® Powder

The drug is used as a rapid adrenal glucocorticoid and/or anti-inflammatory agent in horses.

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. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Dexium-SP™

The drug is given for glucocorticoid and anti-inflammatory agent.

If permanent glucocorticoid effect is required, oral therapy may be substituted. When therapy is to be withdraw after prolonged use, the daily dose should be reduced gradually over several days. Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection 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. Do not use in viral infections. Anti-inflammatory action of glucocorticoids may mask signs of infection. Except when used for emergency therapy, the product is contraindicated in animals with tuberculosis, chronic nephritis, cushingoid syndrome, or peptic ulcers. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Dexamethasone Sodium Phosphate Inj.

The drug is indicated as an anti-inflammatory agent in horses.

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

Dexamethasone Injection

The drug is used as an anti-inflammatory agent.

Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection 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. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Zonometh Solution

For use as an anti-inflammatory agent.

Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Dexamethasone Solution

The drug is recommended for use as an aid in the treatment of bacterial, mycotic, and inflammatory dermatoses and otitis externa in cats.

For use only by or on order of a licensed veterinarian.

Tresaderm Dermatologic Solution

Dexamethasone is indicated for use as an anti-inflammatory agent

Do not use in viral infections. Except for emergency therapy, do not use in animals with tuberculosis, chronic nephritis, cushingoid syndrome and peptic ulcers. Existence of congestive heart failure, diabetes and osteoporosis are relative contraindications. Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection 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. 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.

Dexium™ Tablets

The drug is indicated as an anti-inflammatory agent in cats.

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

Dexium®

In treatment of cats as an anti-inflammatory agent.

Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection to animals may induce the first stage of parturition when administered during the last trimester of pregnancy; and they may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. Do not use in viral infections. Anti-inflammatory action of corticosteroids may mask signs of infections. Do not use in animals with tuberculosis, chronic nephritis, cushingoid syndrome, or peptic ulcers, except for emergency therapy. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Azium® Tablets 0.25 mg

The drug is used as an anti-inflammatory agent.

Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection 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.

Zonometh Solution

Dexamethasone bolus is indicated in cases where cattle require additional steroid therapy following its parenteral administration. The drug may be used as supportive therapy for management of inflammatory conditions such as acute arthritic lameness; and for various stress conditions where corticosteroids are required while the animal is being treated for a specific condition.

Do not use in viral infections during the viremic stage. With bacterial infections, appropriate antibacterial therapy should be used. Do not use in animals with chronic nephritis and hypercorticalism (cushingoid syndrome) except for emergency therapy. Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection 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. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

Azium® Boluses 10 mg

Dexamethasone powder is indicated in cases where cattle require additional steroid therapy following its parenteral administration. The drug is used as supportive therapy for management or inflammatory conditions such as acute arthritic lameness; and for various stress conditions where corticosteroids are required while the animal is being treated for a specific condition.

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. Federal law restricts this drug to use by or on the order of a licensed veterinarian. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

Azium® Powder

For the treatment of primary bovine ketosis and as an anti-inflammatory agent in cattle.

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

Dexamethasone Injection

The drug is indicated for the treatment of primary bovine ketosis.

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

Azium® Aqueous Suspension Veterinary

The drug is indicated as an anti-inflammatory agent in cattle.

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

Dexium®

DEXAMETHASONE INJECTION 2 mg/mL is indcated for the treatment of primary bovine ketosis an as an anti-inflammatory agent in the bovine and equine. As supportive therapy, DEXAMETHASONE INJECTION 2 mg/mL may be used in the management of vairious rheumatic, allergic dermatologic, and other diseases known to be responsive to anti-inflammatory corticosteroids. DEXAMETHASONE INJECTION 2 mg/mL may be used intravenously as supportive therapy when an immeidate hormonal response is required. Bovine Ketosis DEXAMETHASONE INJECTION 2 mg/mL is offered for the treatment of primary ktosis. The gluconeogenic effects of DEXAMETHASONE INJECTION 2 mg/mL, when administered intramuscularyly, are generally noted within the first 5 to 12 hours. When DEXAMETHASONE INJECTION 2 mg/mL is used intravenously, the effects may be noted sooner. Blood sugar levels rise to normal levels repidly and genreally rise to above normal levels within 12 to 24 hours. Acetone bodies are reduce to normal concentrations usually witnin 24 hours. The physical attitude of animals treated with DEXAMETHASONE INJCTION 2 mg/mL brighters and appetite improves, usually within 24 hours. The physical attitude of animals treated with DEXAMETHASONE INJECTION 2 mg/mL brightens and appetite improves, usually within 12 hours. Milk production, which is suppressed as a compensatory reaction in this condition, begins to increase. In some instances, it may even surpass previous peaks. The recovery procss usually takes from 3 to 7 days. Supportive Therapy DEXAMETHASONE INJECTION 2 mg/mL may be used as supportive therapy in mastitis, metritis, traumatic gastritis, and pyelonephritis, while appropriate primary therapy is administered. In these caases, the corticosteroid combats accompanying stress and enhances the feeling of genreal well-being. DEXAMETHASONE INJECTION 2 mg/mL may also bu used as supportive therapy in inflammatory conditions, such as arthritic conditions, shanke bite, acute mastitis, shipping fever, pneumonia, laminitis, and retaine dplacenta. Equine DEXAMETHASONE INJECTION 2 mg/mL is indicated for the treatment of acute bursitis, carpitis osselets, tendonitis, myositis, and sprains. If boney changes exist in any of the conditions, joints, or accessory structures, responses to DEXAMETHASONE INJECTION 2mg/mL may be used as supportive therapy in fatigue, heat exhaustion, influenza, laminitis, and retained placenta provided that the primary cause is determined and corrected.

DEXAMETHASONE INJECTION 2 mg/mL

DEXAMETHASONE INJECTION 2 mg/mL is indicated for the treatment of primary bovine ketosis and as an anti-inflammatory agent in the bovine and equine. As supportive therapy, DEXAMETHASONE INJECTION 2 mg/mL may be used in the management of various rheumatic, allergic, dermatologic, and other diseases known to be responsive to anti-inflammatory corticosteroids. DEXAMETHASONE INJECTION 2 mg/mL may be used intravenously as supportive therapy when an immediate hormonal response is required. Bovine Ketosis DEXAMETHASONE INJECTION 2 mg/mL is offered for the treatment of primary ketosis. The gluconeogenic effects of DEXAMETHASONE INJECTION 2 mg/mL, when administered intramuscularly, are generally noted within the first 6 to 12 hours. When DEXAMETHASONE INJECTION 2 mg/mL is used intravenously, the effects may be noted sooner. Blood sugar levels rise to normal levels rapidly and generally rise to above normal levels within 12 to 24 hours. Acetone bodies are reduced to normal concentrations usually within 24 hours. The physical attitude of animals treated with DEXAMETHASONE INJECTION 2 mg/mL brightens and appetite improves, usually within 12 hours. Milk production, which is suppressed as a compensatory reaction in this condition, begins to increase. In some instances, it may even surpass previous peaks. The recovery process usually takes from 3 to 7 days. Supportive Therapy DEXAMETHASONE INJECTION 2 mg/mL may be used as supportive therapy in mastits, metritis, traumatic gastritis, and pyelonephritis, while appropriate primary therapy is administered. In these cases, the corticosteroid combats accompanying stress and enhances the feeling of general well-being. DEXAMETHASONE INJECTION 2 mg/mL may also be used as supportive therapy in inflammatory conditions, such as arthritic conditions, snake bite, acute mastitis, shipping fever, pneumonia, laminitis, and retained placenta. Equine DEXAMETHASONE INJECTION 2 mg/mL is indicated for the treatment of acute musculoskeletal inflammations, such as bursitis, carpitis, osselets, tendonitis, myositis, and sprains. If boney changes exist in any of the conditions, joints, or accessory structures, responses to DEXAMETHASONE INJECTION 2 mg/mL cannot be expected. In addition, DEXAMETHASONE INJECTION 2 mg/mL may be used as supportive therapy in fatigue, heat exhaustion, influenza, laminitis, and retained placenta provided that the primary cause is determined and corrected.

DEXAMETHASONE INJECTION 2 mg/mL

Dermatologic Solution TRESADERM is indicated as an aid in the treatment of certain bacterial, mycotic, and inflammatory dermatoses and otitis externa in dogs and cats. Both acute and chronic forms of these skin disorders respond to treatment with TRESADERM. Many forms of dermatosis are caused by bacteria (chiefly Staphylococcus aureus, Proteus vulgaris and Pseudomonas aeruginosa). Moreover, these organisms often act as opportunistic or concurrent pathogens that may complicate already established mycotic skin disorders, or otoacariasis caused by Otodectes cynotis. The principal etiologic agents of dermatomycoses in dogs and cats are species of the genera Microsporum and Trichophyton. The efficacy of neomycin as an antibacterial agent, with activity against both gram-negative and gram-positive pathogens, is well documented. Detailed studies in various laboratories have verified the significant activity thiabendazole displays against the important dermatophytes. Dexamethasone, a synthetic adrenocorticoid steroid, inhibits the reaction of connective tissue to injury and suppresses the classic inflammatory manifestations of skin disease. The formulation for TRESADERM combines these several activities in a complementary form for control of the discomfort and direct treatment of dermatitis and otitis externa produced by the above-mentioned infectious agents.

Tresaderm® (thiabendazole, dexamethasone, neomycin sulfate solution)

INDICATIONS AND USAGE: Dexamethasone-SP (dexamethasone sodium phosphate injection) is indicated as a rapid adrenal glucocorticoid and/or anti-inflammatory agent in horses.

FDA application 200-317

As an aid in the treatment of bacterial, mycotic, and inflammatory dermatoses and otitis externa

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

Thiabendazole, Dexamethasone, Neomycin Sulfate Solution

CLINICAL PHARMACOLOGY: Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity. Dexamethasone sodium phosphate is a salt of dexamethasone that is particularly suitable for intravenous administration because it is highly water soluble, permitting administration of relatively large doses in a small volume of diluent. Dexamethasone, as a steroid, is equivalent in potency to some established steroids while being considerably more potent than others. In the case of the dog, dexamethasone is found to be about equivalent in dosage to prednisone but about 30 to 40 times more potent than prednisolone.

FDA application 200-317

CONTRAINDICATIONS: Do not use in viral infections. Except when used for emergency therapy, dexamethasone sodium phosphate is contraindicated in animals with tuberculosis and chronic nephritis. Existence of congestive heart failure, osteoporosis and diabetes are relative contraindications. In the presence of infection appropriate antibacterial agents should also be administered and should be continued for at least 3 days after discontinuance of the hormone and disappearance of all signs of infection.

FDA application 200-317

CONTRAINDICATIONS: Except for emergency therapy, do not use in animals with chronic nephritis and hyper-corticalism (Cushing's syndrome). Existence of congestive heart failure, diabetes, and osteoporosis are relative contraindications. Do not use in viral infections during with viremic stage.

FDA application 200-312

WARNINGS: 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. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. SIDE EFFECTS: Side effects, such as SAP and SGPT enzyme elevations, weight loss, anorexia, polydipsia, and polyuria, have occurred following the use of corticosteroids in dogs. Vomiting and diarrhea (occasionally bloody) have been observed in cats and dogs. Cushing's syndrome in dogs has been reported in association with prolonged or repeated steroid therapy. Corticosteroids reportedly cause laminitis in horses. To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Bimeda, Inc. at 1-888-524-6332. 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.

FDA application 200-312

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 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. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

DEXAMETHASONE INJECTION 2 mg/mL DEXAMETHASONE STERILE INJECTION

WARNINGS: Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection 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. 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.

FDA application 200-317

For topical use in dogs and cats. Avoid contact with eyes. Keep this and all drugs out of the reach of children. The Safety Data Sheet (SDS) contains more detailed occupational safety information. To report suspected adverse drug events, for technical assistance, or to obtain a copy of the Safety Data Sheet (SDS), contact Boehringer Ingelheim Animal Health USA Inc. at 1-888-637-4251. 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.

Tresaderm® (thiabendazole, dexamethasone, neomycin sulfate solution)

A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal. Store at 20°C to 25°C (68° to 77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Protect from freezing. READ ACCOMPANYING DIRECTIONS CAREFULLY. Approved by FDA under ANADA # 200-324

Dexasone® Dexamethasone Sterile Injection 2 mg/mL

A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

DEXAMETHASONE INJECTION 2 mg/mL Dexamethasone Sterile Injection

ADVERSE REACTIONS: The therapeutic use of dexamethasone sodium phosphate injection is unlikely to cause undesired accentuation of metabolic effects. However, if continued corticosteroid therapy is anticipated, a high protein intake should be provided to keep the animal in positive nitrogen balance. A retardant effect on wound healing should be considered when it is used in conjunction with surgery. Euphoria or an improvement of attitude, and increased appetite are the usual manifestations. Side effects such as glycosuria, hyperglycemia, diarrhea, polydipsia and polyuria have been observed in some species. Side effects such as SAP and SGPT enzyme elevations, eosinopenia, and vomiting have occurred following use of synthetic corticosteroids in dogs. Cushing's Syndrome in dogs has been reported in association with prolonged or repeated steroid therapy. Corticosteroids reportedly cause laminitis in horses. CONTACT INFORMATION: To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Bimeda, Inc. at 1-888-524-6332. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at https://www.fda.gov/reportanimalae.

FDA application 200-317

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

DEXAMETHASONE INJECTION 2 mg/mL DEXAMETHASONE STERILE INJECTION

0.25 to 1.25 milligrams per day. Administer by free-choice feeding or crumble over food. Administer 0.25 to 1.25 milligrams daily in single or two divided doses until response is noted or 7 days have elapsed. When response is attained, dosage should be gradually reduced by 0.125 milligram per day until maintenance level is achieved.

Oral

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 they may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. Do not use in viral infections. Anti-inflammatory action of corticosteroids may mask signs of infection. Do not use in animals with tuberculosis, chronic nephritis, cushingoid syndrome, or peptic ulcers, except for emergency therapy. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Pet Derm® III Tablets

In treating dermatoses affecting areas other than the ear, the surface of the lesions should be well moistened (two to four drops per square inch) twice daily. In treating otitis externa, five to 15 drops of the drug should be instilled in the ear twice daily. The is limited to 7 days maximum duration of administration.

Topical

For use only by or on order of a licensed veterinarian.

Tresaderm Dermatologic Solution

The drug is administered intravenously at 0.25 to 1 milligram initially. The dose may be repeated for 3 to 5 days or until a response is noted. If continued treatment is required, oral therapy may be substituted. When therapy is withdrawn after prolonged use, the daily dose should be reduced gradually over several days.

Intravenous

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

Dexamethasone Injection

0.25 to 1 milligrams depending on the severity of the condition. The drug is administered intravenously or intramuscularly and dosage may be repeated if necessary.

Intravenous, Intramuscular

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

Dexamethasone Solution

0.25 to 1 milligram initially, administered intravenously. May be repeated for 3 to 5 days or until response is noted.

Intravenous

If permanent glucocorticoid effect is required, oral therapy may be substituted. When therapy is to be withdraw after prolonged use, the daily dose should be reduced gradually over several days. Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection 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. Do not use in viral infections. Anti-inflammatory action of glucocorticoids may mask signs of infection. Except when used for emergency therapy, the product is contraindicated in animals with tuberculosis, chronic nephritis, cushingoid syndrome, or peptic ulcers. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Dexamethasone Sodium Phosphate Inj.

0.25 to 1 milligrams administered intravenously or intramuscularly; the dosage may be repeated if necessary.

Intramuscular, Intravenous

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

Azium® Aqueous Suspension Veterinary

Administer orally at 0.25 to 1.25 milligrams per day for up to 7 days.

Oral

Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection to animals may induce the first stage of parturition when administered during the last trimester of pregnancy; and they may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. Do not use in viral infections. Anti-inflammatory action of corticosteroids may mask signs of infections. Do not use in animals with tuberculosis, chronic nephritis, cushingoid syndrome, or peptic ulcers, except for emergency therapy. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Azium® Tablets 0.25 mg

0.25 to 1 milligrams administered intravenously or intramuscularly.

Intravenous, Intramuscular

Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection 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.

Zonometh Solution

Administer one dose (1 tube) per affected ear once.

Otic

Otiserene®

0.25 to 1 milligrams administered intravenously.

Intravenous

Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection 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.

Dexachel

The drug is administered intravenously at a dosage of 2.5 to 5.0 milligrams. If permanent corticosteroid effect is required, oral therapy may be substituted. When therapy is withdrawn after prolonged use, the daily dose should be reduced gradually over several days.

Intravenous

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. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Dexium-SP™

The drug is administered at a dosage level of 5 to 10 milligrams per animal the first day then 5 milligrams per day as required by drench or by sprinkling on a small amount of feed.

Oral

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

Azium® Powder

2.5 to 5 milligrams depending on the severity of the condition. The drug is administered intravenously or intramuscularly and dosage may be repeated if necessary.

Intravenous, Intramuscular

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

Dexamethasone Solution

2.5 to 5 milligrams administered intravenously or intramuscularly; the dosage may be repeated if necessary.

Intramuscular, Intravenous

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. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not for use in horses intended for food.

Azium® Aqueous Suspension Veterinary

Administered orally, 5 to 10 milligrams for the first day, then 5 milligrams per day as required.

Oral

Do not use in viral infections during the viremic stage. With bacterial infections, appropriate antibacterial therapy should be used. Do not use in animals with chronic nephritis and hypercorticalism (cushingoid syndrome) except for emergency therapy. Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection 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.

Azium® Boluses 10 mg

2.5 to 5 milligrams administered intravenously or intramuscularly.

Intravenous, Intramuscular

Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection 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. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Zonometh Solution

2.5 to 5 milligrams administered intravenously.

Intravenous

If permanent glucocorticoid effect is required, oral therapy may be substituted. When therapy is to be withdraw after prolonged use, the daily dose should be reduced gradually over several days. Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection 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. Do not use in viral infections. Anti-inflammatory action of glucocorticoids may mask signs of infection. Except when used for emergency therapy, the product is contraindicated in animals with tuberculosis, chronic nephritis, cushingoid syndrome, or peptic ulcers. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Dexamethasone Sodium Phosphate Inj.

In treating dermatoses affecting areas other than the ear, the surface of the lesions should be well moistened (two to four drops per square inch) twice daily. In treating otitis externa, five to 15 drops of the drug should be instilled in the ear twice daily. The is limited to 7 days maximum duration of administration.

Topical

For use only by or on order of a licensed veterinarian.

Tresaderm Dermatologic Solution

0.125 to 0.5 milligrams depending on the severity of the condition. The drug is administered intravenously or intramuscularly and dosage may be repeated if necessary.

Intravenous, Intramuscular

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

Dexamethasone Solution

0.125 to 0.5 milligrams administered intravenously or intramuscularly; the dosage may be repeated if necessary.

Intramuscular, Intravenous

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

Azium® Aqueous Suspension Veterinary

0.125 to 0.5 milligrams administered intravenously or intramuscularly.

Intravenous, Intramuscular

Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection 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.

Zonometh Solution

Administer orally at 0.125 to 0.5 milligram per day for up to 7 days.

Oral

Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection to animals may induce the first stage of parturition when administered during the last trimester of pregnancy; and they may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. Do not use in viral infections. Anti-inflammatory action of corticosteroids may mask signs of infections. Do not use in animals with tuberculosis, chronic nephritis, cushingoid syndrome, or peptic ulcers, except for emergency therapy. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Azium® Tablets 0.25 mg

0.125 to 0.5 milligrams administered intravenously.

Intravenous

Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection 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.

Dexachel

The drug is administered at a dosage level of 5 to 10 milligrams per animal the first day then 5 milligrams per day as required by drench or by sprinkling on a small amount of feed.

Oral

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. Federal law restricts this drug to use by or on the order of a licensed veterinarian. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

Azium® Powder

5 to 20 milligrams depending on the severity of the condition. The drug is administered intravenously or intramuscularly and dosage may be repeated if necessary.

Intravenous, Intramuscular

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

Dexamethasone Solution

Administered orally, 5 to 10 milligrams for the first day, then 5 milligrams per day as required.

Oral

Do not use in viral infections during the viremic stage. With bacterial infections, appropriate antibacterial therapy should be used. Do not use in animals with chronic nephritis and hypercorticalism (cushingoid syndrome) except for emergency therapy. Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection 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. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

Azium® Boluses 10 mg

Prior to the administration of Dermatologic Solution TRESADERM, remove the ceruminous, purulent or foreign materials from the ear canal, as well as the crust which may be associated with dermatoses affecting other parts of the body. The design of the container nozzle safely allows partial insertion into the ear canal for ease of administration. The amount to apply and the frequency of treatment are dependent upon the severity and extent of the lesions. Five to 15 drops should be instilled in the ear twice daily. In treating dermatoses affecting other than the ear the surface of the lesions should be well moistened (2 to 4 drops per square inch) with Dermatologic Solution TRESADERM twice daily. The volume required will be dependent upon the size of the lesion. Application of TRESADERM should be limited to a period of not longer than one week.

TOPICAL

Tresaderm® (thiabendazole, dexamethasone, neomycin sulfate solution)

Therapy with DEXAMETHASONE INJECTION 2 mg/mL, as with any other potent corticosteroid, should be individualized according to the severity of the condition being treated, anticipated duration of steroid therapy, and the animal's threshold or tolerance for steroid excess. Treatment may be changed over to DEXAMETHASONE INJECTION 2 mg/mL from any other glucocorticoid with proper reduction or adjustment of dosage. Bovine - DEXAMETHASONE INJECTION 2 mg/mL - 5 to 20 mg intravenously or intramuscularly. Dexamethasone Powder may be administered or the parenteral dose repeated as needed. Equine - DEXAMETHASONE INJECTION 2 mg/mL - 2.5 to 5 mg intravenously or intramuscularly. Dexamethasone Powder may be administered or the parenteral dose repeated as needed.

INTRAMUSCULAR, INTRAVENOUS

DEXAMETHASONE INJECTION 2 mg/mL

ADMINISTRATION AND DOSAGE: Therapy with Dexium, as with any other potent corticosteroid, should be individualized according to the severity of the condition being treated, anticipated duration of steroid therapy, and animal's threshold or tolerance for steroid excess. Treatment may be changed over to Dexium from any other glucocorticoid with proper reduction or adjustment of dosage. Bovine: Dexium: 5 - 20 mg intravenously or intramuscularly. Equine: Dexium: 2.5 - 5 mg intravenously or intramuscularly.

INTRAMUSCULAR, INTRAVENOUS

FDA application 200-312

DOSAGE AND ADMINISTRATION: For Intravenous Use Only. Horses: The usual intravenous dosage is 2.5 to 5 mg (based on 3 mg per mL of dexamethasone content). If permanent corticosteroid effect is required, oral therapy with dexamethasone may be substituted. When therapy is to be withdrawn after prolonged corticosteroid administration, the daily dose should be reduced gradually over a number of days, in stepwise fashion.

INTRAVENOUS

FDA application 200-317

In treating dermatoses affecting areas other than the ear, the surface of the lesions should be well moistened (2 to 4 drops per square inch) twice daily. In treating otitis externa, instill 5 to 15 drops in the ear twice daily. Treat for up to 7 days

Topical

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

Thiabendazole, Dexamethasone, Neomycin Sulfate Solution

For intravenous or intramuscular injection Bovine-5 to 20 mg Equine-2.5 to 5 mg

INTRAMUSCULAR, INTRAVENOUS

Dexasone® Dexamethasone Sterile Injection 2 mg/mL

Bovine-5 to 20 mg Equine-2.5 to 5 mg

INTRAMUSCULAR, INTRAVENOUS

DEXAMETHASONE INJECTION 2 mg/mL DEXAMETHASONE STERILE INJECTION