Complete Up To Date Information about Tri-Otic Ointment.
ANADA Number: 200-229 | |
| Proprietary Name |
Tri-Otic Ointment |
|---|---|
| Sponsor |
Med-Pharmex, Inc. |
| Sponsor Address |
2727 Thompson Creek Rd. Pomona, CA 91767-1861 USA |
| Ingredients |
Gentamicin Sulfate Betamethasone Valerate Clotrimazole |
| Species |
Dog, restricted during pregnancy |
| Routes of Administration |
Topical |
| Dose Form |
Ointment |
| Drug Form |
Ointment |
| Dispensing Status |
RX |
|
Dosage Amount, Indications & Limitations |
524.1044g Gentamicin sulfate, betamethasone valerate, clotrimazole ointment. Specifications: Each gram of ointment contains gentamicin sulfate equivalent to 3 milligrams gentamicin base, betamethasone valerate equivalent to 1 milligram betamethasone, and 10 milligrams clotrimazole. Conditions of use: Dogs Amount: From 7.5- or 15-g tube; 10-, 15-, or 25-g bottles install 4 drops of ointment twice daily into the ear canal of dogs weighing less than 30 pounds, instill 8 drops twice daily for dogs weighing 30 pounds or more. From 215-g bottle, instill 2 drops of ointment twice daily into the ear canal of dogs weighing less than 30 pounds, instill 4 drops twice daily for dogs weighing 30 pounds or more. Therapy should continue for 7 consecutive days. The external ear should be cleaned and dried before treatment. Remove foreign material, debris, crusted exudates, etc. with suitable solutions. Excessive hair should be clipped from the treatment area. If hypersensitivity occurs, treatment should be discontinued and alternate therapy instituted. Indications: The drug is used for the treatment of canine otitis externa associated with yeast (Malassezia pachydermatis, formerly Pityrosporum canis), and/or bacteria susceptible to gentamicin. Limitations: Corticosteroids administered to dogs, rabbits, and rodents during pregnancy have resulted in cleft palate in offspring. Other congenital anomalies including deformed forelegs, phocomelia, and anasarca have been reported in offspring of dogs which received corticosteroids during pregnancy. Clinical and experimental data have demonstrated that corticosteroids administered orally or parenterally to animals may induce the first stage of parturition if used 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. |
| 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. |