Neomycin and Polymyxin B Sulfates and Hydrocortisone neomycin sulfate, polymyxin b sulfate 3.5 mg/mL; 10000 [USP'U]/mL; 10 mg/mL Suspension, 7.5 mL — NDC 61314-641-75 (Billing 61314-0641-75)

WARNINGS NOT FOR INJECTION INTO THE EYE. Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension should never be directly introduced into the anterior chamber of the eye. Prolonged use of corticosteroids may result in ocular hypertension and/or 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 those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids. In acute purulent conditions of the eye, corticosteroids may mask infection or enhance existing infection.

If these products are used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in uncooperative patients. Corticosteroids should be used with caution in the presence of glaucoma. The use of corticosteroids after cataract surgery may delay healing and increase the incidence of filtering blebs.

Use of ocular corticosteroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of corticosteroid medication in the treatment of herpes simplex requires great caution. Topical antibiotics, particularly, neomycin sulfate, may cause cutaneous sensitization.

A precise incidence of hypersensitivity reactions (primarily skin rash) due to topical antibiotics is not known. The manifestations of sensitization to topical antibiotics are usually itching, reddening, and edema of the conjunctiva and eyelid. A sensitization reaction may manifest simply as a failure to heal.

During long-term use of topical antibiotic products, periodic examination for such signs is advisable, and the patient should be told to discontinue the product if they are observed. Symptoms usually subside quickly on withdrawing the medication. Application of products containing these ingredients should be avoided for the patient thereafter [see Precautions: General ] .

ADVERSE REACTIONS Adverse reactions have occurred with corticosteroid/anti-infective combination drugs which can be attributed to the corticosteroid component, the anti-infective component, or the combination. The exact incidence is not known. Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitization reactions including itching, swelling, and conjunctival erythema [see Warnings ].

More serious hypersensitivity reactions, including anaphylaxis, have been reported rarely. The reactions due to the corticosteroid component in decreasing order of frequency are: elevation of intraocular pressure (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 corticosteroids and antimicrobials.

Fungal and viral infections of the cornea are particularly prone to develop coincidentally with long-term applications of a corticosteroid. The possibility of fungal invasion must be considered in any persistent corneal ulceration where corticosteroid treatment has been used. Local irritation on instillation has also been reported.

To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

PRECAUTIONS General The initial prescription and renewal of the medication order beyond 20 mL should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated. The possibility of fungal infections of the cornea should be considered after prolonged corticosteroid dosing.

Fungal cultures should be taken when appropriate. If this product is used for 10 days or longer, intraocular pressure should be monitored [see Warnings ]. There have been reports of bacterial keratitis associated with the use of topical ophthalmic products in multiple-dose containers which have been inadvertently contaminated by patients, most of whom had a concurrent corneal disease or a disruption of the ocular epithelial surface [see Precautions: Information for Patients ].

Allergic cross-reactions may occur which could prevent the use of any or all of the following antibiotics for the treatment of future infections: kanamycin, paromomycin, streptomycin, and possibly gentamicin. Information for Patients Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, eyelid, fingers, or any other surface. The use of this product by more than one person may spread infection.

Patients should also be instructed that ocular products, if handled improperly, can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated products [see Precautions: General ]. If the condition persists or gets worse, or if a rash or allergic reaction develops, the patient should be advised to stop use and consult a physician.

Do not use this product if you are allergic to any of the listed ingredients. Keep tightly closed when not in use. Keep out of reach of children.

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 concentrations (80 ug/mL) tested; however, the effects of neomycin on carcinogenesis and mutagenesis in humans are unknown. Long-term studies in animals (rats, rabbits, mice) showed no evidence of carcinogenicity or mutagenicity attributable to oral administration of corticosteroids.

Long-term animal studies have not been performed to evaluate the carcinogenic potential of topical corticosteroids. Studies to determine mutagenicity with hydrocortisone have revealed negative results. Use of corticosteroid medication in the treatment of herpes simplex requires great caution.

Polymyxin B has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown. Long-term animal studies have not been performed to evaluate the effect on fertility of topical corticosteroids. Pregnancy Teratogenic Effects Pregnancy Category C.

Corticosteroids have been found to be teratogenic in rabbits when applied topically at concentrations of 0.5% on days 6 -18 of gestation and in mice when applied topically at a concentration of 15% on days 10 -13 of gestation. There are no adequate and well-controlled studies in pregnant women. Neomycin and Polymyxin B Sulfates and Hydrocortisone Ophthalmic Suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because o… [Excerpted — this section continues on DailyMed.]