Complete Up To Date Information about Topagen Ointment.
NADA Number: 113-231 | |
| Proprietary Name |
Topagen® Ointment |
|---|---|
| Sponsor |
Schering-Plough Animal Health Corp. |
| Sponsor Address |
P.O. Box 21 Sandown Village, NJ 3171 VIC Australia |
| Ingredients |
Gentamicin Sulfate Betamethasone Valerate |
| Species |
Dog, no use class stated or implied |
| Routes of Administration |
Topical |
| Dose Form |
Ointment |
| Drug Form |
Ointment |
| Dispensing Status |
RX |
|
Dosage Amount, Indications & Limitations |
524.1044d Gentamicin sulfate, betamethasone valerate ointment. Specifications: Each gram of ointment contains gentamicin sulfate equivalent to 3 milligrams of gentamicin base and betamethasone valerate equivalent to 1 milligram of betamethasone. Conditions of use: Dogs Amount: For the treatment of acute and chronic canine otitis externa the drug is administered by instillation of 3 to 8 drops into the ear canal twice daily for 7 days. The external ear and ear canal should properly cleaned and dried before treatment. Remove foreign material, debris, crusted exudates, etc., with suitable nonirritating solutions. Excessive hair should be clipped from the treatment area of the external ear. Indications: The drug is used or indicated for use in dogs in the treatment of acute and chronic canine otitis externa. Limitations: If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted. Concomitant use of drugs known to induce ototoxicity should be avoided. Observe patients for signs of adrenocorticoid overdosage. The antibiotic susceptibility of the pathogenic organism should be determined prior to use of this preparation. Administration of recommended doses beyond 7 days may result in delayed wound healing. Animals treated longer than 7 days should be monitored closely. For use by or on the order of a licensed veterinarian. Amount: For the treatment of canine infected superficial lesions, the lesion and adjacent area should be properly cleaned before treatment. Excessive hair should be removed. A sufficient amount of the drug should be applied to cover the treatment area. The drug should be administered twice daily for 7 to 14 days. Indications: The drug is used or indicated for canine infected superficial lesions caused by bacteria sensitive to gentamicin. Limitations: If hypersensitivity to any of the components occurs, treatment should be discontinued and appropriate therapy instituted. Concomitant use of drugs known to induce ototoxicity should be avoided. Observe patients for signs of adrenocorticoid overdosage. The antibiotic susceptibility of the pathogenic organism should be determined prior to use of this preparation. Administration of recommended doses beyond 7 days may result in delayed wound healing. Animals treated longer than 7 days should be monitored closely. For use by or on the order of a licensed veterinarian. |
| Tolerances |
A tolerance of 0.1 part per million is established for negligible residues of gentamicin sulfate in the uncooked edible tissues of chickens and turkeys. Tolerances are established for total residues of gentamicin in edible tissues of swine as follows: 0.1 part per million in muscle, 0.3 part per million in liver, and 0.4 part per million in fat and kidney. |