Animal NDC 50989-437-12 Dexamethasone
Animal Product Information
| Field Name | Field Value |
|---|---|
| Animal NDC Code | 50989-437-12 |
| Proprietary Name | Dexamethasone What is the Proprietary Name? The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes. |
| Non-Proprietary Name | Dexamethasone What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product. |
| Labeler Name | Vedco, Inc. |
| Product Type | Prescription Animal Drug |
| Usage Information |
|
| Active Ingredient(s) |
|
| Marketing Category | ANADA - ABBREVIATED NEW ANIMAL DRUG APPLICATION What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| FDA Application Number | ANADA200324 What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
Dexamethasone Images
Dexamethasone Animal Product Labeling Information
The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Table of Contents
Description
Solution for intravenous or intramuscular injection
Veterinary
CAUTIONFederal Law restricts this drug to use by or on the order of a licensed veterinarian.
DESCRIPTION
DEXAMETHASONE INJECTION 2 mg/mL 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 DEXAMETHASONE INJECTION 2 mg/mL offers enhanced anti-inflammatory effect compared to older corticosteroids. The dosage of DEXAMETHASONE INJECTION 2 mg/mL required is markedly lower than that of prednisone and prednisolone.
DEXAMETHASONE INJECTION 2 mg/mL 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.
DEXAMETHASONE INJECTION 2 mg/mL 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.
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 twenty times the anti-inflammatory activity of prednisolone and seventy to eighty times that of hydrocortisone. Thymus involution studies show dexamethasone possesses twenty-five 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.
Administration And Dosage
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 teh animal's threshold or tolerance for steroid excess.
Treatment may be changed over to DEXAMETHASONE INJECTION2 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.
Indications
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.
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.
Precautions
Animals receiving DEXAMETHASONE INJECTION 2 mg/mL 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.
DEXAMETHASONE INJECTION 2 mg/mL 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.
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.
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.
How Supplied
DEXAMETHASONE INJECTION 2 mg/mL, 100 mL multiple dose vials.
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 qs.
TAKE TIME OBSERVE LABEL DIRECTIONS
Storage And Handling
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (between 50°F and 86°F)
Protect from freezing
Package Label.Principal Display Panel
* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.