Dexium Tablets

Company: Bimeda

(Dexamethasone Tablets, U.S.P.)

FOR DOGS AND CATS ONLY

NADA 095-218, Approved by FDA

Description

Dexamethasone is a synthetic analogue of prednisolone. It acts similarly to prednisolone but has more potent anti-inflammatory, hormonal and metabolic effects. It is described chemically as 9-alpha-fluoro, 16-alpha-methyl prednisolone.

ACTION:

Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity. Dexamethasone, as with other corticosteroids, is not specific. It differs from other corticosteroids only in its anti-inflammatory potency and ability to manifest mineralocorticoid properties.

Dexium Tablets Indications

Dexamethasone is indicated for use as an anti-inflammatory agent.

Dosage and Administration

Dosage and administration for Dexium Tablets are as follows:

Dogs: Administer orally at 0.25 to 1.25 mg. per day up to 7 days

Cats: Administer orally at 0.125 to 0.5 mg. per day up to 7 days

Contraindications

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.

Precautions

Because of the anti-inflammatory action of corticosteroids, signs of infection may be hidden and it may be necessary to stop treatment until diagnosis is made. Overdosage of some glucocorticoids may result in sodium retention, fluid retention, potassium loss and weight gain. When therapy with Dexamethasone is to be discontinued after long use, the dosage should be reduced gradually. The administration of ACTH during the period of gradual dosage reduction may help to accelerate the normal adrenocortical function.

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 In patients presently receiving or recently withdrawn from systemic corticosteroid treatments, therapy with a rapid acting corticosteroid should be considered in unusually stressful situations.

Side Effects

Side reactions such as weight loss, anorexia, diarrhea, polydypsia, and polyuria have been frequently observed during corticosteroid therapy.

SAP AND SGPT (ALT) enzyme elevations, polydypsia and polyuria have occurred following parenteral or systemic use of synthetic corticosteroids in dogs. Vomiting and diarrhea (occasionally bloody) have been observed in dogs.

Cushing’s syndrome in dogs has been reported in association with prolonged or repeated steroid therapy.

Warning

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 Caution

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

How Supplied

Available in bottles of 100 tablets, each tablet containing 0.25 mg. Dexamethasone.

Storage

Store at controlled room temperature 20°-25°C (68°-77°F), with excursions permitted to 15°-30°C (59°-86°F).

FOR ANIMAL USE ONLY.

KEEP OUT OF REACH OF CHILDREN.

Dexium is a Registered Trademark of Bimeda, Inc.

Bimeda, Inc. is a Division of Cross Vetpharm Group Ltd.

Manufactured by: Bimeda, Inc., Le Sueur, MN 56058

8DEX002 Rev. 10/13

CPN: 1399072.4