Azium Powder

Manufacturer: Schering-Plough

(dexamethasone)

Powder 10 Mg

Veterinary

For Cattle And Horses

Azium Powder Caution

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

Description

AZIUM (dexamethasone) 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 AZIUM powder offers an enhanced anti-inflammatory effect compared to older corticosteroids. The dosage of AZIUM Powder required is markedly lower than that of prednisone and prednisolone.

AZIUM is not species-specific; therefore, the veterinarian should read the sections on INDICATIONS, DOSAGE, SIDE EFFECTS, CONTRAINDICATIONS AND PRECAUTIONS, and WARNING before the drug is used.

AZIUM Powder is available in packets containing 10 mg crystalline dexamethasone.

Pharmacology

Experimental animal studies on dexamethasone have revealed that it possesses greater anti-inflammatory activity than many steroids. Veterinary clinical evidence indicates that 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 loss on exceedingly high dosages.

Azium Powder Indications

Cattle and Horses - The injectable form of AZIUM Solution is indicated for treatment of primary ketosis in cattle and as an anti-inflammatory agent in both cattle and horses. AZIUM Powder is indicated in cases where cattle and horses require additional steroid therapy following parenteral administration. This oral form may be used as supportive therapy for the management of inflammatory conditions such as acute arthritic lameness, and for various stress conditions when corticosteroids are required while the animal is being treated for a specific condition.

Contraindications

Except for emergency therapy, do not use in animals with chronic nephritis and hypercorticalism (Cushing's syndrome). The existence of congestive heart failure, diabetes and osteoporosis are relative contraindications. Do not use in viral infections during the viremic stage.

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.

Not for use in horses intended for food.

A Withdrawal Period Has Not Been Established For This Product In Preruminating Calves. Do Not Use In Calves To Be Processed For Veal.

Precautions

Animals receiving AZIUM (dexamethasone) 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.

AZIUM Powder may be administered to animals with acute or chronic bacterial infections providing that the infections are controlled with the appropriate antibiotic or chemotherapeutic agents.

Use of corticosteroids, depending upon dose, duration and specific steroid, may result in the 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.

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 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.

Administration And Dosage

Therapy with AZIUM Powder, 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 AZIUM Powder from any other glucocorticoid with proper reduction or adjustment of the dosage.

The Powder is intended for oral administration to cattle and horses. The powder is easily administered by drench or by sprinkling on a small amount of feed.

CATTLE AND HORSES - 5 to 10 mg the first day then 5 mg per day as required. If response is not achieved in a few days, the condition may not be amenable to AZIUM therapy.

In cases where animals have been treated with parenteral forms of dexamethasone, AZIUM Powder, the powder may be given, if required, at doses of 5 mg per day 24 to 48 hours after injections. Treatment may be repeated if necessary.

Store Between 2° And 30°c (36° And 86°f).

How Supplied

AZIUM Powder, packets containing 10 mg, boxes of 30 and 100.

NADA 30-434, Approved by FDA

March 2000

Schering-Plough Animal Health Corp., Union, NJ 07083

Made in Ireland

Copyright © 1978, 1993, 2000, Schering-Plough Animal Health Corp.

All rights reserved.

F-23975505

B-23975505

Nac No.

10470152