Dexium SP Injection

Generic name: dexamethasone sodium phosphate injection
Dosage form: FOR ANIMAL USE ONLY

Dexium-SP™

(dexamethasone sodium phosphate)

INJECTION USP FOR HORSES

4 mg/mL

Equivalent to dexamethasone 3 mg/mL

Multiple Dose Vial Sterile

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

ANADA #200-317, Approved by FDA

Net Contents: 100mL

FOR INTRAVENOUS USE IN HORSES ONLY

NOT FOR USE IN HUMANS

KEEP OUT OF REACH OF CHILDREN

WARNING: DO NOT USE IN HORSES INTENDED FOR FOOD

DESCRIPTION:

Dexamethasone sodium phosphate (a synthetic adrenocortical steroid), is a white or slightly yellow crystalline powder. It is freely soluble in water and is exceedingly hygroscopic. Each mL of sterile aqueous solution contains Dexamethasone Sodium Phosphate 4 mg (equivalent to dexamethasone 3 mg), Sodium Citrate 10 mg, Sodium Bisulfite 2 mg, Benzyl Alcohol 1.5% as preservative, in Water for Injection q.s. Sodium Hydroxide and/or Hydrochloric Acid to adjust pH to between 7.0 and 8.5.

CLINICAL PHARMACOLOGY:

Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity. Dexamethasone sodium phosphate is a salt of dexamethasone that is particularly suitable for intravenous administration because it is highly water soluble, permitting administration of relatively large doses in a small volume of diluent. Dexamethasone, as a steroid, is equivalent in potency to some established steroids while being considerably more potent that others. In the case of the dog, dexamethasone is found to be about equivalent in dosage to prednisone but about 30 to 40 times more potent than prednisolone.

INDICATIONS AND USAGE:

Dexamethasone sodium phosphate injection is indicated as a rapid adrenal glucocorticoid and/or anti-inflammatory agent in horses.

CONTRAINDICATIONS:

Do not use in viral infections. Except when used for emergency therapy, dexamethasone sodium phosphate is contraindicated in animals with tuberculosis and chronic nephritis. Existence of congestive heart failure, osteoporosis and diabetes are relative contraindications. In the presence of infection appropriate antibacterial age...