Label: DEXASONE- dexamethasone injection, solution
- NDC Code(s): 46066-505-02
- Packager: Aspen Veterinary Resources, Ltd.
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
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Sterile - Veterinary
2 mg per mL
CAUTIONFederal Law restricts this drug to use by or on the order of a licensed veterinarian.
ANADA # 200-312, Approved by FDA
NET CONTENT: 100 mL
For intravenous or intramuscular injection.
Read accompanying directions carefully.
Keep Out of Reach of Children.
Dexamethasone Solution is a synthetic analogue of prednisolone, having similar but more potent anti-inflammatory therapeutic action and diversified hormonal and metabolic effects. Modification of the basic corticoid structure as achieved in Dexasone® offers enhanced anti-inflammatory effect compared to older corticosteroids. The dosage of Dexasone® required is markedly lower than that of prednisone and prednisolone.
Dexasone® is not species-specific; however, the veterinarian should read the sections on INDICATIONS, DOSAGE, SIDE EFFECTS, CONTRAINDICATIONS, PRECAUTIONS, and WARNINGS before this drug is used.
Dexasone® is intended for intravenous or intramuscular administration. Each mL contains 2 mg dexamethasone, 500 mg polyethylene glycol 400, 9 mg benzyl alcohol, 1.8 mg methylparaben and 0.2 mg propylparaben as preservatives, 4.75% alcohol, HCl to adjust pH to approximately 4.9, water for injection q.s.Close
- CLINICAL STUDIES
EXPERIMENTAL STUDIES:Experimental animal studies on dexamethasone have revealed it possesses greater anti-inflammatory activity than many steroids. Veterinary clinical evidence indicates dexamethasone has approximately 20 times the anti-inflammatory activity of prednisolone and 70 to 80 times that of hydrocortisone. Thymus involution studies show dexamethasone possesses 25 times the activity of prednisolone. In reference to mineralocorticoid activity, dexamethasone does not cause significant sodium or water retention. Metabolic balance studies show that animals on controlled and limited protein intake will exhibit nitrogen losses on exceedingly high dosages.Close
- INDICATIONS & USAGE
INDICATIONS: Dexasone® is indicated for the treatment of primary bovine ketosis and as an anti-inflammatory agent in the bovine and equine.
As supportive therapy, Dexasone® may be used in the management of various rheumatic, allergic, dermatologic, and other diseases known to be responsive to anti-inflammatory corticosteroids. Dexasone® may be used intravenously as supportive therapy when an immediate hormonal response is required.
Bovine KetosisDexasone® is offered for the treatment of primary ketosis. The gluconeogenic effects of Dexasone®, when administered intramuscularly, are generally noted within the first 6 to 12 hours. When Dexasone® 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 Dexasone® 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 TherapyDexasone® 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. Dexasone® 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.Close
EquineDexasone® 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 Dexasone® cannot be expected. In addition, Dexasone® may be used as supportive therapy in fatigue, heat exhaustion, influenza, laminitis, and retained placenta provided that the primary cause is determined and corrected.
- DOSAGE & ADMINISTRATION
ADMINISTRATION AND DOSAGE:
Therapy with Dexasone®, 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 Dexasone® from any other glucocorticoid with proper reduction or adjustment of dosage.
Bovine - Dexasone® - 5 to 20 mg intravenously or intramuscularly.
Equine - Dexasone® - 2.5 to 5 mg intravenously or intramuscularly.Close
CONTRAINDICATIONS: Except for emergency therapy, do not use in animals with chronic nephritis and hypercorticalism (Cushing's syndrome). Existence of congestive heart failure, diabetes, and osteoporosis are relative contraindications. Do not use in viral infections during the viremic stage.Close
PRECAUTIONS: Animals receiving Dexasone® should be under close observation. Because of the anti-inflammatory action of corticosteroids, signs of infection may be masked and it may be necessary to stop treatment until a further diagnosis is made. Overdosage of some glucocorticoids may result in sodium retention, fluid retention, potassium loss, and weight gain.
Dexasone® may be administered to animals with acute or chronic bacterial infections providing the infections are controlled with appropriate antibiotic or chemotherapeutic agents.
Doses greater than those recommended in horses may produce a transient drowsiness or lethargy in some horses. The lethargy usually abates in 24 hours.
Use of corticosteroids, depending on dose, duration, and specific steroid, may result in inhibition of endogenous steroid production following drug withdrawal. In patients presently receiving or recently withdrawn from systemic corticosteroid treatments, therapy with a rapid acting corticosteroid should be considered in unusually stressful situations.Close
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 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.Close
- ADVERSE REACTIONS
SIDE EFFECTS: 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.Close
- HOW SUPPLIED
HOW SUPPLIED: Dexasone®, 2 mg/mL, 100 mL multiple dose vial.
- STORAGE AND HANDLING
STORAGE: Store at 2oC and 36oC (36oF and 86oF).
- INGREDIENTS AND APPEARANCE
dexamethasone injection, solution
Product Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:46066-505 Route of Administration INTRAMUSCULAR, INTRAVENOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL) DEXAMETHASONE 2 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46066-505-02 100 mL in 1 VIAL, MULTI-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200312 04/08/2008 Labeler - Aspen Veterinary Resources, Ltd. (627265361) Registrant - Bimeda Inc., Division of Cross Vetpharm Group (060492923) Establishment Name Address ID/FEI Business Operations Bimeda- MTC Division of Cross Vetpharm Group 256232216 manufacture Establishment Name Address ID/FEI Business Operations Tianjin Tianyao Pharmaceuticals 654534197 api manufacture Establishment Name Address ID/FEI Business Operations Sanofi Chimie 291538267 api manufacture Establishment Name Address ID/FEI Business Operations Pharmacia and Upjohn Company 829076566 api manufacture