NADA Number: 108-687

Proprietary Name Pet Derm® III Tablets
Sponsor Pfizer, Inc.
Sponsor Address 235 East 42d St.
New York, NY    10017
USA
Ingredients Dexamethasone
Species Dog, restricted during pregnancy
Routes of Administration Per Os
Dose Form Tablet (chewable)
Drug Form Tablet (chewable)
Dispensing Status RX
Dosage Amount,
Indications
& Limitations

520.540c Dexamethasone chewable tablets.

Specifications: Each half-scored tablet contains 0.25 milligrams of dexamethasone.

Conditions of use:

Dogs

Amount: 0.25 to 1.25 milligrams per day. Administer by free-choice feeding or crumble over food. Administer 0.25 to 1.25 milligrams daily in single or two divided doses until response is noted or 7 days have elapsed. When response is attained, dosage should be gradually reduced by 0.125 milligram per day until maintenance level is achieved.

Indications: Supportive therapy in nonspecific dermatosis and inflammatory conditions.

Limitations: 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 they may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis. Do not use in viral infections. Anti-inflammatory action of corticosteroids may mask signs of infection. Do not use in animals with tuberculosis, chronic nephritis, cushingoid syndrome, or peptic ulcers, except for emergency therapy. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

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.

[44 FR 7130, Feb. 6, 1979; 56 FR 50653, Oct. 8, 1991]