522.1410 Sterile methylprednisolone acetate suspension.

Specifications: Each milliliter of aqueous suspension contains 20 or 40 milligrams of methylprednisolone acetate.

Conditions of use:

Dogs

Amount: 2 to 40 milligrams (up to 120 milligrams in extremely large breeds or dogs with severe involvement) intramuscularly. Dosage may be repeated when necessary. Up to 20 milligrams intrasynovially. Dosage may be repeated when necessary.

Indications: Treatment of inflammation and related disorders in dogs; treatment of allergic and dermatologic disorders in dogs; and as supportive therapy to antibacterial treatment of severe infections in dogs.

Limitations: Not for human use. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 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. Systemic therapy with methylprednisolone acetate, as with other corticoids, is contraindicated in animals with arrested tuberculosis, peptic ulcer, and Cushing's syndrome. The presence of active tuberculosis, diabetes mellitus, osteoporosis, renal insufficiency, predisposition to thrombophlebitis hypertension, or congestive heart failure necessitates carefully controlled use of corticosteroids. Intrasynovial, intratendinous or other injections of corticosteroids for local effect are contraindicated in the presence of acute infectious conditions. Exacerbation of pain, further loss of joint motion, with fever and malaise following injection may indicate that the condition has become septic. Appropriate antibacterial therapy should be instituted immediately.

Cats

Amount: 10 to 20 milligrams intramuscularly. Dosage may be repeated when necessary.

Indications: Treatment of inflammation and related disorders in cats; treatment of allergic and dermatologic disorders in cats; and as supportive therapy to antibacterial treatment of severe infections in cats.

Limitations: Not for human use. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 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. Systemic therapy with methylprednisolone acetate, as with other corticoids, is contraindicated in animals with arrested tuberculosis, peptic ulcer, and Cushing's syndrome. The presence of active tuberculosis, diabetes mellitus, osteoporosis, renal insufficiency, predisposition to thrombophlebitis hypertension, or congestive heart failure necessitates carefully controlled use of corticosteroids. Intrasynovial, intratendinous or other injections of corticosteroids for local effect are contraindicated in the presence of acute infectious conditions. Exacerbation of pain, further loss of joint motion, with fever and malaise following injection may indicate that the condition has become septic. Appropriate antibacterial therapy should be instituted immediately.

Horses

Amount: 200 milligrams intramuscularly. Dosage may be repeated when necessary. 40 to 240 milligrams intrasynovially. Dosage may be repeated when necessary.

Indications: Treatment of inflammation and related disorders in horses.

Limitations: Not for use in horses intended for food. Not for human use. Federal law restricts this drug to use by or on the order of a licensed veterinarian. 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. Systemic therapy with methylprednisolone acetate, as with other corticoids, is contraindicated in animals with arrested tuberculosis, peptic ulcer, and Cushing's syndrome. The presence of active tuberculosis, diabetes mellitus, osteoporosis, renal insufficiency, predisposition to thrombophlebitis hypertension, or congestive heart failure necessitates carefully controlled use of corticosteroids. Intrasynovial, intratendinous or other injections of corticosteroids for local effect are contraindicated in the presence of acute infectious conditions. Exacerbation of pain, further loss of joint motion, with fever and malaise following injection may indicate that the condition has become septic. Appropriate antibacterial therapy should be instituted immediately.

NAS/NRC status: 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.

A tolerance is established for negligible residues of methylprednisolone in milk at 10 parts per billion.