DEXASONE- dexamethasone injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aspen Veterinary Resources, Ltd.

INN (International Name):

DEXAMETHASONE

Composition:

DEXAMETHASONE 2 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION

Therapeutic indications:

Dexasone® is indicated for the treatment of primary bovine ketosis and as an anti-inflammatory agent in the bovine and equine. As supportive therapy, Dexasone® may be used in the management of various rheumatic, allergic, dermatologic, and other diseases known to be responsive to anti-inflammatory corticosteroids. Dexasone® may be used intravenously as supportive therapy when an immediate hormonal response is required. Bovine Ketosis Dexasone® is offered for the treatment of primary ketosis. The gluconeogenic effects of Dexasone® , when administered intramuscularly, are generally noted within the first 6 to 12 hours. When Dexasone® 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 physical attitude of animals treated with Dexasone® brightens and appetite improves, usually within 12 hours. Milk production,

Product summary:

Dexasone® , 2 mg/mL, 100 mL multiple dose vial. Store at controlled room temperature of 20°C to 25°(68° to 77°), excursions permitted between 15°C and 30°C (between 59°F and 86°F). Protect from freezing.

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

DEXASONE - DEXAMETHASONE INJECTION, SOLUTION
ASPEN VETERINARY RESOURCES, LTD.
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DEXAS ONE DEXAMETHASONE STERILE INJECTION 2 MG/ML
Dexamethasone Sterile Injection 2 mg/mL
ANADA #: 200-324, Approved by FDA
FOR ANIMAL USE ONLY
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
Dexasone
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 Dexasone
offers enhanced anti-inflammatory effect compared to older
corticosteroids. The dosage of Dexasone
required is markedly lower than that of prednisone and
prednisolone.
Dexasone
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.
Dexasone
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
Dexasone
is indicated for the treatment o