Dexamethasone

VetTek
Bimeda, Inc. Division of Cross Vetpharm Group

FULL PRESCRIBING INFORMATION

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

DESCRIPTION:  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 Dexamethasone Solution offers enhanced anti-inflammatory effect compared to older corticosteroids.  The dosage of Dexamethasone Solution required is markedly lower than that of prednisone and predisolone.  Dexamethasone Solution is not species-specific; however, the veterinarian should read the sections INDICATIONS, DOSAGE, SIDE EFFECTS, CONTRAINDICATIONS, PRECAUTIONS, and WARNINGS before this drug is used.  Dexamethasone Solution 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 animals studies on dexamethasone have revealed it possesses greater anti-inflammatory activity than many steroids.  Veterinary clinical evidence indicates dexamethasone has approximately 20 times that 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 mineralcorticoid 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.

Uses

INDICATIONS:  Dexamethasone Solution is indicated for the treatment of primary bovine ketosis and as an anti-inflammatory agent in the bovine and equine.  As supportive therapy, Dexamethasone Solution may be used in the management of various rheumatic, allergic, dermatologic, and other diseases known to be responsive to anti-inflammatory corticosteroids.  Dexamethasone Solution may be used intravenously as supportive therapy when an immediate hormonal response is required.

Bovine Ketosis:  Dexamethasone Solution is offered for the treatment of primary ketosis.  The gluconeogenic effects of Dexamethasone Solution, when administered intramuscularly, are generally noted within the first 6 to 12 hours.  When Dexamethasone Solution is used intravenously, the effects may be noted sooner.  Blood suguar 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 Solution 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 Solution may be used as supportive therapy in mastitis, 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 Solution 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 Solution is indicated for the treatment of acute musculskeletal inflammations, such as bursitis, carpitis, osselets, tendonitis, myositis, and sprains.  If boney changes exist in any of these conditions, joints, or accessory structures, a response to Dexamethasone Solution cannot be expected.  In addition, Dexamethasone Solution may be used as supportive therapy in fatigue, heat exhaustion, influenza, laminitis, and retained placenta provided that the primary cause in determined and corrected.

ADMINISTRATION AND DOSAGE:  Therapy with Dexamethasone Solution, as with any other potent corticosteroid, should be individualized according to the severity of the condition being treated, anticipated duration of steroid therapy, and animals threshold or tolerance for steroid excess.

Treatment may be changed over to Dexamethasone Solution from any other glucocorticoid with proper reduction or adjustment of dosage.

Bovine:  Dexamethasone Solution:  5 - 20 mg intravenously or intramuscularly.

Equine:  Dexamethasone Solution:  2.5 - 5 mg intravenously or intramuscularly.

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

PRECAUTIONS:  Animals receiving Dexamethasone Solution should be under closed 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 Solution 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 transient drowsiness or lethargy in some horses.  The lethargy usually abates in 24 hours.

Use of corticosteroids, depending on the dose, duration, and specified 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 rapidly acting corticosteroid should be considered in unusually stressful situations.

HOW SUPPLIED:  Dexamethasone Solution, 2 mg per mL, 100 mL multiple dose vial.

STORAGE:  Store between 2 degrees and 30 degrees C (36 degrees and 86 degrees F).

NDC 60270-208-10

DEXAMETHASONE SOLUTION

Veterinary

100 mL Multiple Dose Vial Sterile

2 mg/mL

CAUTION:  Federal (U.S.A.) law restricts this drug to use by or on the order of a licensed veterinarian.

NET CONTENTS:  100mL

ANADA #200-312, Approved by FDA