DEXAMETHASONE - dexamethasone injection, solution 
Agri Laboratories, Ltd.

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DEXAMETHASONE INJECTION 2 mg/mL

Solution for intravenous or intramuscular injection

Veterinary

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

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 DEXAMETHSONE INJECTION 2 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 orintramuscularadministration. 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 or injection q.s.

EXPERIMENTAL STUDIES

Experimental animal studies on dexamethasone have revealed it possesses greater anti-flammatory activity than may steroids. Veterinary clinical evidence indicates dexamethasone has approximately twenty times the anti-flammatory activity of prednisolone and seventy to eighty times that of hydrocortisone. Thymus involution studies show dexamethasone possesses twenty-five times the activity of predinsolone. In reference to mineralocorticoid activity, dexamethsone does not cause significant sodium or water retention.  Metabolic balance studies show tha tanimals on controlled and limited protein intake will exhibit nitrogen losses on exceedingly high doses.

INDICATIONS

DEXAMETHASONE INJECTION 2 mg/mL is indicated for the treatment of primary bovine ketosis and as an anti-inflammaotory agent in the bovine and equine.

As supportive therapy, DEXAMTHASONE 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 gluconeogeniceffects of DEXAMETHSONE INJECTION 2 mg/mL, when administered intramuscularly, are generally noted within the first 5 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 12-24 hours. The physical attitude of animals treated with DEXAMTHASONE INJECTION 2 mg/mL brightens and appetite improves, usually within 12 hours. Milk production, which is suppressed as a compensatory reaction in this condition, begins to increase. In some instances, it may even surpass previous peaks. The recovery process usually takes from 3 to 7 days.


Supportive Therapy

DEXAMETHASONE INJECTION 2 mg/mL may be used as supportive therapy in mastitis, metritis, traumatic gastritis and pyelonephritis, while appropriate primary therapy is administered. In these case, the corticosteroid combats accompanying stress and enhances the feeling of general well-being.

DEXAMETHASONE INJECTION2 mg/mL may also be used as supportive therapy in inflammatory conditions, such as arthritic conditions, snake ite, acute mastitis, shipping fever, pneumonia, laminitis, and retained placenta.


Equine

DEXAMETHASONE INJECTION 2 mg/mL is indicated for the treatment of acute musculoskeletal inflammations, such as bursitis, carpitis, osselets, tendonitis, myositis, and sprains. If boney changes exist in any of the conditions, joints, or accessory structures, responses to DEXAMETHSONE INJECTION 2 mg/mL cannot be expected. In addition, DEXAMETHASONE INJECTION 1 mg/mL may be used as supportive therapy in fatigue, heat exhaustion, influenza, laminitis, and retained placenta provded that the primary cause is determined and conrrected.

ADMINISTRATION AND DOSAGE

Therapy with DEXAMETHASONE INJECTION 2 mg/mL, as with any other potent corticosteroid, should be individualized according to the severity of the condition being treated, anticipated duration of steroid therapy, and the animals threshold or tolerance for steroid excess.

Treatment may be changed over to DEXAMETHASONE INJECTION  2 mg/mL from any other glucocorticoid with proper reduction or adjustment of dosage.

Bovine - DEXAMETHASONE INJECTION 2 mg/mL - 5 o 20 mg intravenously or intramuscularly.

Dexamethasone Powder may be administered or the parenteral dose repeated as needed.

Equine - DEXAMETHASONE INJECTION 2 mg/mL - 2.5 to 5 mg intravenously or intramuscularly.

Dexamethasone Powder may be administered or the parenteral dose repeated as need.

CONTRAINDICATIONS

Except for emergency therapy, do not use in animals with chronic nephritis and hypercorticalism (Cushing's syndrome). Existence of congestive heart failure, diabetes, and osteoporosis are relative contraindications. Do not use in viarla infections during the viremic stage.

PRECAUTIONS

Animals receiving DEXAMETHASONE INJECTION 2 mg/mL should be under close observation. Because of the anti-flammatory action of corticosteroids, signs of infection may be masked and it may be necessary to stop treatment until a further diagnosis is made. Overdosage of some glucocorticoids may result in sodium retention, fluid retention, potassium loss and weight gain.

DEXAMETHASONE INJECTION 2 mg/mL may be administered to animals with acute or chronic bacterial infections providing the infections are controlled with appropriate antibiotic or chemotherapeutic agents.

Doses greater than those recommended in horses may produce a transient drowsiness or lethargy in some horses. The lethargy usually abates in 24 hours.

Use of corticosteroids, depending on dose, duration, and specific steroid, may result in inhibition of endogenous steroid production following drug withdrawal. In patients presently receiving or recently withdrawn from systemic corticosteroid treatment therapy with rapid acting corticosteroid should be considered in unusually stressful situations.

WARNINGS

Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition when administered during the last trimester of pregnancy and may precipitate parturition followed by dystocia, fetal death, retained placenta, and metritis.

Additionally, corticosteroids administered to dogs, rabbits, and rodents during pregnancy have produced cleft palate. Other congenital anomalies including deformed forelegs phocomelia, and anasarca have been reported in offspring of dogs which received corticosteroids during pregnancy.

A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

SIDE EFFECTS

Side effects, such as SAP and SGPT enzyme elevations, weight loss, anorexia, polydipsia, and polyuria have occurred following the use of synthetic corticosteroids in dogs. Vomiting and diarrhea (occasionally bloody) have been observed in dogs and cats.

Cushing's syndrome in dogs has been reported in association with prolonged or repeated steroid therapy.

Corticoseroids reportedly cause laminitis in horses.

HOW SUPPLIED

DEXAMETHASONE INJECTION 2mg/mL, 100 mL multiple dose vial.

Store at 20oC to 25oC (68oF to 77oF), excursions permitted between 15oC and 30oC (between 59oF to 86oF).

Protect from freezing.

TAKE TIME OBSERVE LABEL DIRECTIONS


AL Dexamethasone Injection

AL Dexamethasone Injection Onsert

DEXAMETHASONE 
dexamethasone injection, solution
Product Information
Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:57561-953
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL) DEXAMETHASONE2 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57561-953-04100 mL in 1 VIAL, MULTI-DOSE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANADAANADA20032407/21/200608/22/2016
Labeler - Agri Laboratories, Ltd. (155594450)

Revised: 8/2016
 
Agri Laboratories, Ltd.