Complete Up To Date Information about Neo-Delta Cortef Sterile Solution.
NADA Number: 091-534 | |
| Proprietary Name |
Neo-Delta Cortef® Sterile Solution |
|---|---|
| Sponsor |
Pharmacia & Upjohn Co. |
| Sponsor Address |
a Division of Pfizer, Inc. 235 East 42nd St. New York, NY 10017 USA |
| Ingredients |
Prednisolone Acetate Neomycin Sulfate |
| Species |
Cat, no use class stated or implied Dog, no use class stated or implied |
| Routes of Administration |
Opthalmological |
| Dose Form |
Liquid (suspension) |
| Drug Form |
Liquid (suspension) |
| Dispensing Status |
RX |
|
Dosage Amount, Indications & Limitations |
524.1881b Prednisolone acetate-neomycin sulfate sterile suspension. Specifications: Prednisolone acetate-neomycin sulfate sterile suspension contains 2.5 milligrams of prednisolone acetate and 5 milligrams of neomycin sulfate (equivalent to 3.5 milligrams of neomycin base) in each milliliter of sterile suspension. Conditions of use: Dogs Amount: For beginning treatment of acute ocular inflammations 1 or 2 drops may be placed in the conjunctival sac 3 to 6 times during a 24 hour period. When improvement occurs, the dosage may be reduced to 1 drop 2 to 4 times daily. In otitis externa, 2 to 6 drops may be placed in the external ear canal 2 or 3 times daily. Indications: The drug is indicated for treating infectious allergic and traumatic keratitis and conjunctivitis, otitis externa, and chronic otitis externa in dogs. Limitations: All topical ophthalmic preparations containing corticosteroids with or without an anti-microbial 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. Federal law restricts this drug to use by or on the order of a licensed veterinarian. Cats Amount: For beginning treatment of acute ocular inflammations 1 or 2 drops may be placed in the conjunctival sac 3 to 6 times during a 24 hour period. When improvement occurs, the dosage may be reduced to 1 drop 2 to 4 times daily. In otitis externa, 2 to 6 drops may be placed in the external ear canal 2 or 3 times daily. Indications: The drug is indicated for treating infectious allergic and traumatic keratitis and conjunctivitis, otitis externa, and chronic otitis externa in cats. Limitations: All topical ophthalmic preparations containing corticosteroids with or without an anti-microbial 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. Federal law restricts this drug to use by or on the order of a licensed veterinarian. |
| Tolerances |
A tolerance of zero is established for residues of prednisolone in milk from dairy animals. 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. |