DEXAMETHASONE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL)

Available from:

VetTek

INN (International Name):

DEXAMETHASONE

Composition:

DEXAMETHASONE 2 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION

Therapeutic indications:

DEXAMETHASONE INJECTION 2 mg/mL is indicated for the treatment of primary bovine ketosis and as an anti-inflammatory agent in the bovine and equine. As supportive therapy, DEXAMETHASONE INJECTION 2 mg/mL may be used in the management of various rheumatic, allergic, dermatologic, and other diseases known to be responsive to anti-inflammatory corticosteroids. DEXAMETHASONE INJECTION 2 mg/mL may be used intravenously as supportive therapy when an immediate hormonal response is required. Bovine Ketosis DEXAMETHASONE INJECTION 2 mg/mL is offered for the treatment of primary ketosis. The gluconeogenic effects of DEXAMETHASONE INJECTION 2 mg/mL, when administered intramuscularly, are generally noted within the first 6 to 12 hours. When DEXAMETHASONE INJECTION 2 mg/mL is used intravenously, the effects may be noted sooner. Blood sugar levels rise to normal levels rapidly and generally rise to above normal levels within 12 to 24 hours. Acetone bodies are reduced to normal concentrations usually within 24 hours. The

Product summary:

DEXAMETHASONE INJECTION 2 mg/mL, 100 mL multiple dose vial. Store at 20o C to 25o C (86o F to 77o F), excursions permitted between 15o C and 30o (between 59o F and 86o F). Protect from freezing

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

DEXAMETHASONE - DEXAMETHASONE INJECTION, SOLUTION
VETTEK
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DEXAMETHASONE INJECTION 2 MG/ML DEXAMETHASONE STERILE INJECTION
Solution for intravenous or intramuscular injection
Veterinary
CAUTION
Federal Law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION
DEXAMETHASONE INJECTION 2 mg/mL is a synthetic analogue of
prednisolone, having similar but
more potent anti-inflammatory therapeutic action and diversified
hormonal and metabolic effects.
Modification of the basic corticoid structure as achieved in
DEXAMETHASONE INJECTION 2
mg/mL offers enhanced anti-inflammatory effect compared to older
corticosteroids. The dosage of
DEXAMETHASONE INJECTION 2 mg/mL required is markedly lower than that
of prednisone and
prednisolone.
DEXAMETHASONE INJECTION 2 mg/mL is not species-specific; however, the
veterinarian should
read the sections on INDICATIONS, DOSAGE, SIDE EFFECTS,
CONTRAINDICATIONS,
PRECAUTIONS, and WARNINGS before this drug is used.
DEXAMETHASONE INJECTION 2 mg/mL is intended for _intravenous or
intramuscular_ administration.
Each mL contains 2 mg dexamethasone, 500 mg polyethylene glycol 400, 9
mg benzyl alcohol, 1.8 mg
methylparaben and 0.2 mg propylparaben as preservatives, 4.75%
alcohol, HCl to adjust pH to
approximately 4.9, water for injection q.s.
EXPERIMENTAL STUDIES
Experimental animal studies on dexamethasone have revealed it
possesses greater anti-inflammatory
activity than many steroids. Veterinary clinical evidence indicates
dexamethasone has approximately
twenty times the anti-inflammatory activity of prednisolone and
seventy to eighty times that of
hydrocortisone. Thymus involution studies show dexamethasone possesses
twenty-five times the
activity of prednisolone. In reference to mineralocorticoid activity,
dexamethasone does not cause
significant sodium or water retention. Metabolic balance studies show
that animals on controlled and
limited protein intake will exhibit nitrogen losses on exceedingly
high dosages.
INDICATIONS
DEXAMETHASONE INJECTION 2 mg