Dexaject SP

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

Product Title(s) and General Warning/Precautions

Dexaject SP

Dexamethasone Sodium Phosphate Injection, USP 4mg/mL

(equivalent to Dexamethasone 3mg/mL)

FOR INTRAVENOUS USE IN HORSES ONLY

WARNING: DO NOT USE IN HORSES INTENDED FOR FOOD

FOR VETERINARY USE ONLY

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 4mg (equivalent to dexamethasone 3mg), Sodium Citrate 10mg, Sodium Bisulfite 2mg, 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 than others. In the case of the dog, dexamethasone is found to be about equivalent in dosage to prednisone by 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 agents should also be administered and should be continued for at least 3 days after discontinuance of the hormone and disappearance of all signs of infection.

Warnings

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 pro...