Posted by Heart on October 27, 2001, 8:05 am -------------------------------------------------------------------------------- -------------------------------------------------------------------------------- Specifications: Conditions of use: Dogs Amount: Indications: Limitations: Horses Amount: Indications: Limitations: NAS/NRC status:
104-606 (Rx)
Tradename(s) Dexamethasone Injection
Sponsor Steris Laboratories, Inc.
Ingredient(s) Dexamethasone Sodium Phosphate
Species Dog, no use class stated or implied; Horse, not for meat production
Route(s) Intravenous
DoseForm(s) Liquid (solution)
CFR Indications
522.540 Dexamethasone injection.
The drug is a sterile aqueous solution. Each milliliter contains 4.0 milligrams of dexamethasone sodium phosphate (equivalent to 3.0 milligrams dexamethasone).
The drug is administered intravenously at 0.25 to 1 milligram initially. The dose may be repeated for 3 to 5 days or until a response is noted. If continued treatment is required, oral therapy may be substituted. When therapy is withdrawn after prolonged use, the daily dose should be reduced gradually over several days.
The drug is used in dogs for the treatment of inflammatory conditions, as supportive therapy in canine posterior paresis as supportive therapy before or after surgery to enhance recovery of poor surgical risks, and as supportive therapy in nonspecific dermatosis.
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. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
The drug is administered intravenously at a dosage of 2.5 to 5.0 milligrams. If permanent corticosteroid effect is required, oral therapy may be substituted. When therapy is withdrawn after prolonged use, the daily dose should be reduced gradually over several days.
The drug is used as a rapid adrenal glucocorticoid and/or anti-inflammatory agent in horses.
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. Not for use in horses intended for food. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
These conditions are NAS/NRC-reviewed and deemed effective. Applications for these uses need not include effectiveness data as specified by 514.111 of this chapter, but may require bioequivalency and safety information.
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