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Dexium Tablets

Generic Name: dexamethasone tablet
Dosage Form: FOR ANIMAL USE ONLY


Dexium Tablets

(Dexamethasone Tablets, U.S.P.)


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.  Dexamethsone, as with other corticosteroids, is not specific.  It differs from other corticosteroids only in its anti-inflammatory potency and ability to manifest mineralocorticoid properties.

INDICATIONS:  Dexamethsone 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.  Exsitence 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 gradual dosage reduction may help to accelerate the normal adrenocortical function.  Use of corticosteroids, depending on the dose, duration, and specific steroid, may result in inhibition of endogenous steriod 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  In patients presently receiving or recently withdrawn from systemic corticosteroid treatments, therapy with a rapid acting corticosteroid should be considered in unusually stressful situations.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 parental or systemic use ofsynthetic 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 demonstration 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.

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

HOW SUPPLIED:  Available in bottles of 100 and 1000 tablets, each tablet containing 0.25 mg. Dexamethasone.

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


Dexium
(Dexamethasone Tablets, USP) 0.25 mg

FOR ANIMAL USE ONLY
KEEP OUT OF REACH OF CHILDREN


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

NADA 095-218, Approved by FDA

Net Contents: 1000 Tablets


DEXIUM 
dexamethasone tablet
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:61133-5801
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Dexamethasone (Dexamethasone) Dexamethasone 0.25 mg  in 1 g
Product Characteristics
Color white (NA) Score no score
Shape ROUND (tablet) Size 10mm
Flavor Imprint Code NA
Contains         
Packaging
# Item Code Package Description
1 NDC:61133-5801-1 1 g in 1 JAR
2 NDC:61133-5801-2 1 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA095218 12/17/1976
Labeler - Bimeda, Inc. Division of Cross Vetpharm Group (043653216)
Registrant - Bimeda, Inc. Division of Cross Vetpharm Group (043653216)
Establishment
Name Address ID/FEI Operations
Bimeda, Inc. Division of Cross Vetpharm Group 043653216 manufacture
Revised: 11/2010
 
Bimeda, Inc. Division of Cross Vetpharm Group



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