Complete Up To Date Information about Mometamax™ Otic Suspension.
NADA Number: 141-177 | |
| Proprietary Name |
Mometamax™ Otic Suspension |
|---|---|
| Sponsor |
Schering-Plough Animal Health Corp. |
| Sponsor Address |
P.O. Box 21 Sandown Village, NJ 3171 VIC Australia |
| Ingredients |
Mometasone Furoate Monohydrate Gentamicin Sulfate Clotrimazole |
| Species |
Dog, no use class stated or implied |
| Routes of Administration |
Topical |
| Dose Form |
Liquid (suspension) |
| Drug Form |
Liquid (suspension) |
| Dispensing Status |
RX |
| Patent Number |
4472393 5502222 5616742 5750745 5886200 6127353 |
| Exclusivity |
Granted for the use as a once daily dose of 3 milligrams gentamicin, 1 milligram mometasone, and 10 milligrams clotrimazole. Granted for the treatment of otitis externa associated with yeast (Malassezia pachydermatis) and/or bacteria susceptible to gentamicin in dogs. |
|
Dosage Amount, Indications & Limitations |
524.1044h Gentamicin sulfate, mometasone furoate, clotrimazole otic suspension. Specifications: Each gram contains gentamicin sulfate, United States Pharmacopeia (USP) equivalent to 3 milligrams gentamicin base, mometasone furoate monohydrate equivalent to 1 milligram mometasone, and 10 milligrams clotrimazole, USP. Dogs Amount: For dogs weighing less than 30 pounds, instill 4 drops from the 7.5-, 15-, or 30-gram bottle into the ear canal (2 drops from the 215-gram bottle) or, for dogs weighing 30 pounds or more, instill 8 drops from the 7.5-, 15-, or 30-gram bottle into the ear canal (4 drops from the 215-gram bottle), once or twice daily for 7 days. Indications: For the treatment of otitis externa caused by susceptible strains of yeast (Malassezia pachydermatis) and bacteria (Pseudomonas species [including P. aeruginosa], coagulase-positive staphylococci, Enterococcus faecalis, Proteus mirabilis, and beta-hemolytic streptococci). Limitations: 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. |