Neobacimyx-H

Manufacturer: Schering-Plough

(bacitracin-neomycin-polymyxin-hydrocortisone Acetate 1%)

Sterile, Veterinary Ophthalmic Ointment

NADA 65-015, Approved by FDA

Neobacimyx-H Caution

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Description

Each gram contains: 400 units bacitracin zinc, 0.5% neomycin sulfate (equivalent to 3.5 mg neomycin base), 10,000 units polymyxin B sulfate, 1% hydrocortisone acetate, in a base of white petrolatum and mineral oil.

Actions

The overlapping spectra of these three antibiotics provide effective bactericidal action against most commonly occurring gram-positive and gram-negative bacteria associated with infections of the eyes. The range of bactericidal activity encompasses many bacteria which are, or have become, resistant to other antibiotics, notably Pseudomonas and Staphylococcus. In susceptible organisms, resistance rarely develops, even on repeated or prolonged usage. Hydrocortisone acetate exerts a marked anti-inflammatory action at the tissue level and effectively suppresses inflammation in many disorders of the anterior segment of the eye. Local application to the eye often gives rapid relief of pain and photophobia, particularly in lesions of the cornea.

The combined anti-inflammatory and antimicrobial activity of NEOBACIMYX-H Ophthalmic Ointment permits effective management of many disorders of the anterior segment of the eye in which combined activity is needed.

Neobacimyx-H Indications

It may be used in acute or chronic conjunctivitis, when caused by organisms susceptible to the antibiotics contained in this ointment. Laboratory tests should be conducted including in vitro culturing and susceptibility tests on samples collected prior to treatment.

Contraindication

Ophthalmic preparations containing corticosteroids are contraindicated in the treatment of those deep, ulcerative lesions of the cornea where the inner layer (endothelium) is involved, in fungal infections and in the presence of viral infections.

Warnings

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 under way.

Clinical and experimental data have demonstrated that corticosteroids administered orally or by injection to animals may induce the first stage of parturition if used during the last trimester of pregnancy and may precipitate premature parturition followed by dystocia, fetal death, retained placenta, and metritis.

Additionally, corticosteroids administered to dogs, rabbits, and rodents during pregnancy have resulted in cleft palate in offspring. Corticosteroids administered to dogs during pregnancy have also resulted in other congenital anomalies including deformed forelegs, phocomelia, and anasarca.

Precautions

Sensitivity to this ophthalmic ointment is rare, however, if reactions occur, discontinue use of the preparation.

The prolonged use of antibiotic containing preparations may result in overgrowth of non-susceptible organisms including fungi. Appropriate measures should be taken if this occurs. If infection does not respond to treatment in 2 or 3 days, the diagnosis and therapy should be re-evaluated. Animals under treatment with this product should be observed for usual signs of corticosteroid overdose which include polydipsia and occasionally an increase in weight.

Use of corticosteroids, depending on dose, duration, and specific steroid, may result in inhibition of endogenous steroid production following drug withdrawal. In patients presently receiving or recently withdrawn from systemic corticosteroid treatments, therapy with a rapidly action corticosteroid should be considered in unusually stressful situations. Care should be taken not to contaminate the applicator tip during administration of the preparation.

Adverse Reactions

Itching, burning, or inflammation may occur in animals sensitive to the product. Discontinue use in such cases.

SAP and SGPT (ALT) enzyme elevations, polydipsia, and polyuria have occurred following parenteral or systemic use of synthetic corticosteroids in dogs. Vomiting and diarrhea (occasionally bloody) have been observed in dogs.

Cushing's syndrome in dogs has been reported in association with prolonged or repeated steroid therapy.

Neobacimyx-H Dosage And Administration

Apply a thin film over the cornea three or four times daily. The area to be treated should be properly cleansed prior to use. Foreign bodies, crusted exudates and debris should be carefully removed. Insert the tip of the tube beneath the lower lid and express a small quantity of the ointment into the conjunctival sac in dogs and cats.

How Supplied

NEOBACIMYX-H Ophthalmic Ointment is available in cartons of 12 - 1/8 oz (3.5 g) sterile, tamper-proof tubes.

Store At Room Temperature.

January 1999

Manufactured for Schering-Plough Animal Health Corporation, Union, NJ 07083

by Altana Inc., Melville, NY 11747

Copyright © 1985, 1990, 1998, Schering-Plough Animal Health Corp.

All rights reserved.

F-13342920

B-13342920

IF13038A Scher

#304

R6/99 / Rev. 1/99

Nac No.

10471351