Complete Up To Date Information about Hydeltrone Ointment.
NADA Number: 011-437 | |
| Proprietary Name |
Hydeltrone Ointment |
|---|---|
| Sponsor |
Merial Ltd. |
| Sponsor Address |
3239 Satellite Blvd. Bldg. 500 Duluth, GA 30096-4640 USA |
| Ingredients |
Prednisolone Sodium Phosphate Neomycin Sulfate |
| Species |
Cat, no use class stated or implied Dog, no use class stated or implied |
| Routes of Administration |
Topical Opthalmological |
| Dose Form |
Ointment |
| Drug Form |
Ointment |
| Dispensing Status |
RX |
|
Dosage Amount, Indications & Limitations |
524.1883 Prednisolone sodium phosphate-neomycin sulfate ophthalmic ointment. Specifications: Prednisolone sodium phosphate-neomycin sulfate ophthalmic ointment contains prednisolone sodium phosphate equivalent to 2.5 milligrams prednisolone 21-phosphate and 5 milligrams neomycin sulfate (equivalent to 3.5 milligrams neomycin base) in each gram of ointment. Conditions of use: Cats Amount: A small quantity of the ointment should be expressed into the conjunctival sac 4 times a day (at intervals of 1 to 8 hours) for a few days until there is a favorable response, then the frequency of application may be reduced to twice daily as long as the condition remains under control. Treatment may require from a few days to several weeks Indications: The drug is recommended for use in superficial ocular inflammations or infections limited to the conjunctiva or the anterior segment of the eye of cats, such as those associated with allergic reactions or gross irritants. 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 the infection is under control and corneal regeneration is well underway. For use only by or on the order of a licensed veterinarian. Dogs Amount: A small quantity of the ointment should be expressed into the conjunctival sac 4 times a day (at intervals of 1 to 8 hours) for a few days until there is a favorable response, then the frequency of application may be reduced to twice daily as long as the condition remains under control. Treatment may require from a few days to several weeks Indications: The drug is recommended for use in superficial ocular inflammations or infections limited to the conjunctiva or the anterior segment of the eye of dogs, such as those associated with allergic reactions or gross irritants. 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 the infection is under control and corneal regeneration is well underway. For use only by or on the order of a licensed veterinarian. NAS/NRC status: These conditions are NAS/NRC reviewed and deemed effective. Applications for these uses need not include effectiveness data as specified by 514.111 of this chapter, but may require bioequivalency and safety information. |
| 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. |