Neomycin And Polymyxin B Sulfates And Dexamethasone

Description

DESCRIPTION Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment is a multiple dose anti-infective steroid combination in sterile ointment form for topical application. The chemical structure for the active ingredient Neomycin Sulfate is: Neomycin B (R 1 =H, R 2 =CH 2 NH 2 ) Neomycin C (R 1 =CH 2 NH 2 , R 2 =H) The chemical structure for the active ingredient Polymyxin B Sulfate is: The chemical structure for the active ingredient Dexamethasone is: C 22 H 29 FO 5 MW = 392.47 Established Name: Dexamethasone Chemical Name: Pregna-1, 4-diene-3, 20-dione, 9-fluoro-11,17, 21-trihydroxy-16-methyl-, (11β, 16α)-. Each gram contains: Actives: neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1%. Preservatives: methylparaben 0.05%, propylparaben 0.01%. Inactives: white petrolatum, anhydrous liquid lanolin. neomycin-chemical polymyxin-chemical polymyxin-text dexamethasone-chemical

What Is Neomycin And Polymyxin B Sulfates And Dexamethasone Used For?

INDICATIONS AND USAGE For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists. Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns ; or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. This product does not provide adequate coverage against: Serratia marcescens and Streptococci, including Streptococcus pneumoniae.

Dosage and Administration

DOSAGE AND ADMINISTRATION Apply a small amount into the conjunctival sac(s) up to three or four times daily. How to Apply Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment: 1. Tilt your head back. 2. Place a finger on your cheek just under your eye and gently pull down until a "V" pocket is formed between your eyeball and your lower lid. 3. Place a small amount (about 1/2 inch) of Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment in the "V" pocket. Do not let the tip of the tube touch your eye. 4. Look downward before closing your eye. Not more than 8 g should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

Side Effects (Adverse Reactions)

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 ingredient are allergic sensitizations. The reactions due to the steroid component 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 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. Secondary bacterial ocular infection following suppression of host responses also occurs.

Contraindications

CONTRAINDICATIONS Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Hypersensitivity to a component of the medication. (Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.)

Pregnancy and Breastfeeding

Pregnancy Pregnancy Category C. 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. In the rabbit, corticosteroids have produced fetal resorptions and multiple abnormalities involving the head, ears, limbs, palate, etc. There are no adequate or well-controlled studies in pregnant women. Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.

Nursing Mothers Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment is administered to a nursing woman.

How Supplied

HOW SUPPLIED 3.5 g STERILE Ointment supplied in an aluminum tube with a white polyethylene tip and white polyethylene cap. ( NDC 71205-330-35). STORAGE: Store at 2°- 25°C (36°- 77°F). Rx Only Revised: October 2003 Distributed by : FALCON Pharmaceuticals, Ltd. Fort Worth, Texas 76134 USA Manufactured by: S.A. ALCON-COUVREUR N.V. Puurs, Belgium Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 0501 45057-A