Complete Up To Date Information about Otomax .
NADA Number: 140-896 | |
| Proprietary Name |
Otomax® |
|---|---|
| Sponsor |
Schering-Plough Animal Health Corp. |
| Sponsor Address |
P.O. Box 21 Sandown Village, NJ 3171 VIC Australia |
| Ingredients |
Gentamicin Sulfate Betamethasone Valerate Clotrimazole |
| Species |
Dog, no use class stated or implied |
| Routes of Administration |
Topical |
| Dose Form |
Ointment |
| Drug Form |
Ointment |
| Dispensing Status |
RX |
| Exclusivity |
Granted for the treatment of canine acute and chronic otitis externa associated with yeast (Malassezia pachydermatis, formerly Pityrosporum canis) and/or bacteria susceptible to gentamicin. |
|
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 milligrams betamethasone, and 10 milligrams clotrimazole. Conditions of use: Dogs Amount: From 7.5 or 15 gram tubes, 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. 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: Install ointment twice daily into the ear canal. Therapy should continue for 7 consecutive days. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Amount: From 215 gram 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. 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: Install ointment twice daily into the ear canal. Therapy should continue for 7 consecutive days. 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. |