DEXAJECT SP - dexamethasone sodium phosphate 4mg injection injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

dexamethasone sodium phosphate (UNII: AI9376Y64P) (dexamethasone - UNII:7S5I7G3JQL)

Available from:

Butler Animal Health Supply, LLC, D/B/A/ Henry Schein Animal Health

INN (International Name):

dexamethasone sodium phosphate

Composition:

dexamethasone 3 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION

Therapeutic indications:

INDICATIONS AND USAGE: DexaJect SP 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.

Product summary:

HOW SUPPLIED: DexaJect SP, dexamethasone sodium phosphate injection 4 mg/mL (equivalent to 3 mg/mL dexamethasone) is available in 100 mL multiple dose vials.

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

DEXAJECT SP - DEXAMETHASONE SODIUM PHOSPHATE 4MG INJECTION INJECTION
BUTLER ANIMAL HEALTH SUPPLY, LLC, D/B/A/ HENRY SCHEIN ANIMAL HEALTH
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DEXAJECT SP
Dexamethasone Sodium Phosphate
Injection, USP 4 mg/mL
(equivalent to dexamethasone 3 mg/mL)
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 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 but about 30 to 40 times more
potent than prednisolone.
INDICATIONS AND USAGE:
DexaJect SP 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 lea