Complete Up To Date Information about Methylprednisolene Tablets.
NADA Number: 135-771 | |
| Proprietary Name |
Methylprednisolene Tablets |
|---|---|
| Sponsor |
Boehringer Ingelheim Vetmedica, Inc. |
| Sponsor Address |
2621 North Belt Highway St.Joseph, MO 64502 USA |
| Ingredients |
Methylprednisolone |
| Species |
Cat, restricted during pregnancy Dog, restricted during pregnancy |
| Routes of Administration |
Per Os |
| Dose Form |
Tablet |
| Drug Form |
Tablet |
| Dispensing Status |
RX |
|
Dosage Amount, Indications & Limitations |
520.1408 Methylprednisolone tablets. Specifications: Each table contains 1 or 2 milligrams of methylprednisolone. Conditions of use: Dogs Amount: Administer total daily dose orally in equally divided doses 6 to 10 hours apart until response is noted or 7 days have elapsed. When response is attained, dosage should be gradually reduced until maintenance level is achieved. 5 to 15 pounds: 2 milligrams; 15 to 40 pounds: 2 to 4 milligrams; 40 to 80 pounds: 4 to 8 milligrams. Indications: For use as an anti-inflammatory agent. Limitations: Hazardous 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 is contraindicated in animals with arrested tuberculosis, peptic ulcer, acute psychoses, cushingoid syndrome. The presence of active tuberculosis diabetes, osteoporosis, chronic psychotic reactions, predisposition to thrombophlebitis, hypertension, congestive heart failure or renal insufficiency necessitates carefully controlled use of corticosteroids. Some of these conditions occur only rarely but should be kept in mind. Anti-inflammatory action of corticosteroids may mask signs of infection. Cats Amount: Administer total daily dose orally in equally divided doses 6 to 10 hours apart until response is noted or 7 days have elapsed. When response is attained, dosage should be gradually reduced until maintenance level is achieved. 5 to 15 pounds: 2 milligrams; 15 to 40 pounds: 2 to 4 milligrams; 40 to 80 pounds: 4 to 8 milligrams. Indications: For use as an anti-inflammatory agent. Limitations: Hazardous 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 is contraindicated in animals with arrested tuberculosis, peptic ulcer, acute psychoses, cushingoid syndrome. The presence of active tuberculosis diabetes, osteoporosis, chronic psychotic reactions, predisposition to thrombophlebitis, hypertension, congestive heart failure or renal insufficiency necessitates carefully controlled use of corticosteroids. Some of these conditions occur only rarely but should be kept in mind. Anti-inflammatory action of corticosteroids may mask signs of infection. NAS/NRC status: The conditions of use have been NAS/NRC reviewed and found effective. NADA's for approval of drugs for these conditions of use need not include effectiveness data specified by 514.111 of this chapter, but may require bioequivalency and safety information. |
| Tolerances |
A tolerance is established for negligible residues of methylprednisolone in milk at 10 parts per billion. |