Complete Up To Date Information about Neo-Cortef Sterile Ointment.
NADA Number: 093-514 | |
| Proprietary Name |
Neo-Cortef® Sterile Ointment |
|---|---|
| Sponsor |
Pharmacia & Upjohn Co. |
| Sponsor Address |
a Division of Pfizer, Inc. 235 East 42nd St. New York, NY 10017 USA |
| Ingredients |
Hydrocortisone Acetate Neomycin Sulfate |
| Species |
Cat, no use class stated or implied Dog, no use class stated or implied |
| Routes of Administration |
Opthalmological |
| Dose Form |
Ointment |
| Drug Form |
Ointment |
| Dispensing Status |
RX |
|
Dosage Amount, Indications & Limitations |
524.1484i Neomycin sulfate, hydrocortisone acetate, sterile ointment. Specifications: The drug contains 5 milligrams of sulfate, equivalent to 3.5 milligrams of neomycin base, and 5 milligrams of hydrocortisone acetate in each gram of ointment. Conditions of use: Dogs Amount: Apply three or four times daily into the conjunctival sac. With improvement, frequency may be reduced to two or three times daily. For treatment of ear canker and other inflammatory conditions of the external ear canal, fill external ear canal one to three times daily. Indications: For treating infections, allergic, and traumatic keratitis, conjunctivitis, acute otitis externa and, to a lesser degree, chronic otitis externa in dogs. Limitations: All topical ophthalmic preparations containing corticosteroids, with or without an antimicrobial agent, are contraindicated in the initial treatment of corneal ulcers. They should not be used until infection is under control and corneal regeneration is well underway. Incomplete response or exacerbation of corticosteroid responsive lesions may be due to the presence of non-susceptible organisms or to prolonged use on antibiotic-containing preparations resulting in overgrowth of non-susceptible organisms, particularly Monilia. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Cats Amount: Apply three or four times daily into the conjunctival sac. With improvement, frequency may be reduced to two or three times daily. For treatment of ear canker and other inflammatory conditions of the external ear canal, fill external ear canal one to three times daily. Indications: For treating infections, allergic, and traumatic keratitis, conjunctivitis, acute otitis externa and, to a lesser degree, chronic otitis externa in cats. Limitations: All topical ophthalmic preparations containing corticosteroids, with or without an antimicrobial agent, are contraindicated in the initial treatment of corneal ulcers. They should not be used until infection is under control and corneal regeneration is well underway. Incomplete response or exacerbation of corticosteroid responsive lesions may be due to the presence of non-susceptible organisms or to prolonged use on antibiotic-containing preparations resulting in overgrowth of non-susceptible organisms, particularly Monilia. Federal law restricts this drug to use by or on the order of a licensed veterinarian. |
| Tolerances |
Tolerances are established for residues of parent neomycin in uncooked edible tissues as follows: a. In cattle, swine, sheep, and goats: 7.2 parts per million in kidney (target tissue) and fat, 3.6 ppm in liver, and 1.2 ppm in muscle. b. In turkeys: 7.2 ppm in skin with adhering fat, 3.6 parts per million in liver, and 1.2 ppm in muscle. c. In milk: 0.15 part per million. A tolerance is established for negligible residues of hydrocortisone (as hydrocortisone sodium succinate or hydrocortisone acetate) in milk at 10 parts per billion. |