Dexamethasone Sodium Phosphate Injection

Manufacturer: Vedco

FOR DOGS & HORSES

4 mg/mL for Intravenous Injection

NADA 123-815, APPROVED BY FDA

Description

Dexamethasone Sodium Phosphate (DSP) is a salt of dexamethasone, a synthetic corticosteroid which possesses glucocorticoid activity. DSP is a white or slightly yellow crystalline powder which is particularly suitable for intravenous administration because it is highly water soluble.

Each mL of sterile aqueous solution contains: dexamethasone sodium phosphate, 4 mg; sodium citrate, 10 mg; sodium bisulfite, 2 mg; benzyl alcohol, 1.5%; sodium hydroxide and/or hydrochloric acid to adjust pH; water for injection, q.s.

ACTIONS: Dexamethasone as a steroid is equivalent in potency to some established steroids and considerably more potent than others. In the case of the dog, dexamethasone is approximately equivalent in dosage to prednisone, but about 30 to 40 times more potent than prednisolone. DSP is especially well suited for intravenous use in situations requiring a rapid and intense glucocorticoid and/or anti-inflammatory effect.

Warning

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 premature parturition followed by dystocia, fetal death, retained placenta and metritis. Additionally, corticosteroids administered in dogs, rabbits, and rodents during pregnancy have resulted in cleft palate in offspring. Corticosteroids administered to dogs during pregnancy have also resulted in other congenital anomalies, including deformed forelegs.

Dexamethasone Sodium Phosphate Injection Indications

Dexamethasone sodium phosphate is indicated for use as an anti-inflammatory and/or glucocorticoid agent in conditions such as acute arthritis.

DSP may be used as supportive therapy in non-specific dermatoses such as summer eczema and atopy, provided proper therapy is also instituted to correct the cause of the underlying dermatosis. It may also be used prior to or after surgery to enhance recovery of poor surgical risks, provided that it is used in conjunction with full antibiotic coverage.

Contraindications

Do not use in viral infections. Except when used for emergency therapy, DSP is contraindicated in animals with tuberculosis, chronic nephritis, Cushings’ disease and peptic ulcers. Existence of congestive heart failure, osteoporosis and diabetes are relative contraindications.

When administered in the presence of infections, appropriate antibacterial agents should also be administered and continued for at least 3 days after discontinuance of the steroid.

Precautions

Because of the anti-inflammatory action of corticosteroids, signs of infection may be hidden. It may therefore be necessary to stop treatment until diagnosis is made. Overdosage of some glucocorticoids may result in sodium and fluid retention, potassium loss, and weight gains.

In infections characterized by overwhelming toxicity, DSP therapy in conjunction with indicated antibacterial therapy is effective in reducing mortality and morbidity. It is essential that the causative organism be known and an effective anti-bacterial agent be administered concurrently. The injudicious use of adrenal hormones in animals with infections can be hazardous.

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 steroid treatments, therapy with a rapid acting corticosteroid should be considered in unusually stressful situations.

Adverse Reactions

The therapeutic use of DSP is unlikely to cause undesired accentuation of metabolic effects. However, if continued corticosteroid therapy is anticipated, a high protein intake should be provided to keep the animal in positive nitrogen balance. A retardant effect on wound healing should be considered when it is used in conjunction with surgery. Euphoria, or an improvement of attitude, and increased appetite are the usual manifestations. The intra articular injection in leg injuries in the horse may lead to osseous metaplasia.

Side reactions such as glycosuria, hyperglycemia, diarrhea, polydipsia and polyuria have been observed in some species.

- Elevated levels of SGPT and SAP

- Vomiting and diarrhea (occasionally bloody).

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

- Corticosteroids reportedly cause laminitis in horses.

Dosage and Administration

For intravenous use only

DOGS - 0.25 to 1 mg intravenously as the initial dosage. (Based on 3 mg per mL of dexamethasone.) The dose may be repeated for three to five days or until a response is noted.

HORSES - 2.5 to 5 mg intravenously. (Based on 3 mg per mL of dexamethasone.) If permanent corticosteroid effect is required, oral therapy with dexamethasone may be substituted. When therapy is to be withdrawn after prolonged corticosteroid administration, the daily dose should be reduced gradually over a number of days in a stepwise fashion.

How Supplied

Dexamethasone Sodium Phosphate Injection is supplied in 100 and 30 mL vials containing 4 mg of dexamethasone sodium phosphate per mL. (Equivalent to 3 mg per mL of dexamethasone.)

Store between 15°C and 30°C (59°F and 86°F).

Dexamethasone Sodium Phosphate Injection Caution

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

KEEP OUT OF REACH OF CHILDREN

600109

Rev0107

Distributed By VEDCO, INC., St. Joseph, MO 64507

NAC No.: 10940443