NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE 3.5 mg/g; 10000 [USP'U]/g; 1 mg/g Ointment, 1 tube — NDC 80425-0229-1 (Billing 80425-0229-01)

Warnings and Precautions NOT FOR INJECTION. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of steroid medication in the treatment of herpes simplex requires great caution; frequent slit lamp microscopy is recommended.

Prolonged use may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation. Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions or parasitic infections of the eye, steroids may mask infection or enhance existing infection.

In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. If this product is used for 10 days or longer, intraocular pressure (IOP) should be routinely monitored even though it may be difficult in children and uncooperative patients. Steroids should be used with caution in the presence of glaucoma.

IOP should be checked frequently. The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. Products containing neomycin sulfate may cause cutaneous sensitization.

Sensitivity to topically administered aminoglycosides, such as neomycin, may occur in some patients. Severity of hypersensitivity reactions may vary from local effects to generalized reactions such as erythema, itching, urticaria, skin rash, anaphylaxis, anaphylactoid reactions, or bullous reactions. If hypersensitivity develops during use of the product, treatment should be discontinued.

Cross-hypersensitivity to other aminoglycosides can occur, and the possibility that patients who become sensitized to topical neomycin may also be sensitive to other topical and/or systemic aminoglycosides should be considered. General The initial prescription and renewal of the medication order beyond 8 g of Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment should be made by a physician only after examination of the patient with the aid of magnification, such as a slit lamp biomicroscopy and, where appropriate, fluorescein staining.

The possibility of persistent fungal infections of the cornea should be considered after prolonged steroid dosing. Fungal infection should be suspected in patients with persistent corneal ulceration. Information for Patients If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician.

This product is sterile when packaged. To prevent contamination, care should be taken to avoid touching the tube tip to eyelids or to any other surface. The use of this tube by more than one person may spread infection.

Keep tube tightly closed when not in use. Keep out of reach of children. Patients should be advised that their vision may be temporarily blurred following dosing with Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment.

Care should be exercised in operating machinery or driving a motor vehicle. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals to evaluate carcinogenic or mutagenic potential have not been conducted with polymyxin B sulfate. Treatment of cultured human lymphocytes in vitro with neomycin increased the frequency of chromosome aberrations at the highest concentration (80 μg/mL) tested.

However, the effects of neomycin on carcinogenesis and mutagenesis in humans are unknown. Polymyxin B has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown. Pregnancy Dexamethasone has been shown to be teratogenic in mice and rabbits following topical ophthalmic application in multiples of the therapeutic dose.

In the mouse, corticosteroids produce fetal resorptions and a specific abnormality, cleft palate.… [Excerpted — this section continues on DailyMed.]

Adverse Reactions Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination. Exact incidence figures are not available since no denominator of treated patients is available. Reactions occurring most often from the presence of the anti-infective ingredients are allergic sensitizations.

The reactions due to the steroid component are: elevation of IOP with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing. Secondary Infection: The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroid.

The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used. Keratitis, conjunctivitis, corneal ulcers, and conjunctival hyperemia have occasionally been reported following use of steroids. Secondary bacterial ocular infection following suppression of host responses also occurs.

Additional adverse reactions identified from post marketing use include ulcerative keratitis, headache, and Stevens-Johnson syndrome. To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.