Complete Up To Date Information about Gentavet Otic Solution.
ANADA Number: 200-183 | |
| Proprietary Name |
Gentavet® Otic Solution |
|---|---|
| Sponsor |
Med-Pharmex, Inc. |
| Sponsor Address |
2727 Thompson Creek Rd. Pomona, CA 91767-1861 USA |
| Ingredients |
Gentamicin Sulfate Betamethasone Valerate |
| Species |
Cat, no use class stated or implied Dog, no use class stated or implied |
| Routes of Administration |
Topical |
| Dose Form |
Liquid (solution) |
| Drug Form |
Liquid (solution) |
| Dispensing Status |
RX |
|
Dosage Amount, Indications & Limitations |
524.1044b Gentamicin sulfate betamethasone valerate otic solution. Specifications: Each cubic centimeter of solution contains gentamicin sulfate equivalent to 3 milligrams of gentamicin base and betamethasone valerate equivalent to 1 milligram of betamethasone alcohol. Conditions of use: Dogs Amount: The drug is administered by instillation of 3 to 8 drops of solution into the ear canal twice daily for 7 to 14 days. Duration of treatment will depend upon the severity of the condition and the response obtained. The duration of treatment and/or frequency of the dosage may be reduced but care should be taken not to discontinue therapy prematurely. The external ear and ear canal should be 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: For the treatment of acute and chronic canine otitis externa caused by bacteria sensitive to gentamicin, Limitations: If hypersensitivity to any of the components occurs treatment with this product should be discontinued and appropriate therapy instituted. Concomitant use with other drugs known to induce ototoxicity is not recommended. This preparation should not be used in conditions where corticosteroids are contraindicated. Do not administer parenteral corticosteroids during treatment with this drug. The antibiotic sensitivity of the pathogenic organism should be determined prior to use of this preparation. For use by or on the order of a licensed veterinarian. Amount: 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: For the treatment of canine superficial infected lesions caused by bacteria sensitive to gentamicin. Limitations: If hypersensitivity to any of the components occurs treatment with this product should be discontinued and appropriate therapy instituted. Concomitant use with other drugs known to induce ototoxicity is not recommended. This preparation should not be used in conditions where corticosteroids are contraindicated. Do not administer parenteral corticosteroids during treatment with this drug. The antibiotic sensitivity of the pathogenic organism should be determined prior to use of this preparation. For use by or on the order of a licensed veterinarian. Cats Amount: The drug is administered by instillation of 3 to 8 drops of solution into the ear canal twice daily for 7 to 14 days. Duration of treatment will depend upon the severity of the condition and the response obtained. The duration of treatment and/or frequency of the dosage may be reduced but care should be taken not to discontinue therapy prematurely. The external ear and ear canal should be 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: For the treatment of acute and chronic canine otitis externa caused by bacteria sensitive to gentamicin. Limitations: If hypersensitivity to any of the components occurs treatment with this product should be discontinued and appropriate therapy instituted. Concomitant use with other drugs known to induce ototoxicity is not recommended. This preparation should not be used in conditions where corticosteroids are contraindicated. Do not administer parenteral corticosteroids during treatment with this drug. The antibiotic sensitivity of the pathogenic organism should be determined prior to use of this preparation. For use by or on the order of a licensed veterinarian. Amount: 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: For the treatment of feline superficial infected lesions caused by bacteria sensitive to gentamicin. Limitations: If hypersensitivity to any of the components occurs treatment with this product should be discontinued and appropriate therapy instituted. Concomitant use with other drugs known to induce ototoxicity is not recommended. This preparation should not be used in conditions where corticosteroids are contraindicated. Do not administer parenteral corticosteroids during treatment with this drug. The antibiotic sensitivity of the pathogenic organism should be determined prior to use of this preparation. 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. |