Vetropolycin HC Ophthalmic Ointment

Company: Dechra

bacitracin-neomycin-polymyxin with hydrocortisone acetate 1% veterinary ophthalmic ointment

STERILE- ANTIBACTERIAL

NADA # 065-015. Approved by FDA.

Description

Each gram contains Bacitracin Zinc 400 units. Neomycin Sulfate 5 mg (equivalent to 3.5 mg of Neomycin base), Polymyxin B Sulfate 10,000 units, Hydrocortisone Acetate 10 mg (1%), 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 Vetropolycin^® HC (bacitracin-neomycin-polymyxin-hydrocortisone acetate 1%) veterinary ophthalmic ointment permits effective management of many disorders of the anterior segment of the eye in which combined activity is needed.

Vetropolycin HC Ophthalmic Ointment 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.

Contraindications

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.

Serious hypersensitivity (anaphylactic) reactions have been reported in cats within 4 hours of application of antibiotic ophthalmic preparations.

Some of these reactions have resulted in death.

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 a reaction occurs, discontinue use of the preparation. The prolonged use of antibiotic-containing preparations may result in overgrowth of nonsusceptible organisms including fungi. Appropriate measures should be taken if this occurs. If infection does not respond to treatment in two or three 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, polyuria 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 acting corticosteroid should be considered in unusually stressful situations. Care should be taken not to contaminate the applicator tip during the 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.

For a copy of the Material Safety Data Sheet (MSDS), or to report adverse reactions, call Dechra Veterinary Products at (866) 933-2472.

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.

Vetropolycin HC Ophthalmic Ointment Caution

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

How Supplied

3.5 g (1/8 Oz) sterile tamper proof tubes.

NDC 17033-030-38.

STORE AT 15°-25°C (59°-77°F).

Manufactured for: Dechra Veterinary Products, Overland Park, KS 66211

033496-00-I

Ini0912

R0514

CPN: 1459055.1