Polymyxin B sulfate, neomycin sulfate, dexamethasone.
Polymyxin B Sulfate, Neomycin Sulfate, Dexamethasone 0.1% is a multiple dose anti-infective steroid combination in sterile suspension for topical application. The ophthalmic preparation of Polymyxin B Sulfate, Neomycin Sulfate, Dexamethasone 0.1% combines two antibiotics offering broad-spectrum antibacterial activity with the anti-inflammatory activity of a tested corticosteroid, dexamethasone for combating certain microbial infections of the anterior segment of the eye(s). The preparation is formulated in an isotonic vehicle containing hydroxypropyl methylcellulose for maximum effectiveness and comfort.
Each mL of suspension contains: Polymyxin B Sulfate 8,000 units, Neomycin Sulfate 3.5 mg, Dexamethasone 1 mg.
Excipients/Inactive Ingredients: Preservatives: Benzalkonium Chloride 0.004%.
Vehicle: Hydroxypropyl Methylcellulose 0.5% Inactives and Purified Water.
Pharmacology: Corticoids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticoids may inhibit the body's defense mechanism against infection, a concomitant anti-microbial drug may be used when the inhibition is considered to be clinically significant in a particular case. The anti-infective component in the combination is included to provide action against specific organisms susceptible to it. Neomycin sulfate is considered active against the following microorganisms: Staphylococcus aureus, Corynebacterium diphteriae, Streptococcus viridans, Escherichia coli, Haemophilus influenzae. Polymyxin B Sulfate is considered active against the following microorganisms: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Koch-Weeks bacillus. When a decision to administer both a corticoid and antimicrobial is made, the administration of such drugs in combination has the advantage of greater patient compliance and convenience, with the added assurance that the appropriate dosage of both drugs is administered, plus assured compatibility of ingredients when both types of drugs are in the same formulation and, particularly that the correct volume of drug is delivered and retained. The relative potency of corticosteroids depends on the molecular structure, the concentration and release from the vehicle.
For the treatment of ocular infections requiring anti-inflammatory therapy.
Neomycin Sulfate, Polymyxin B Sulfate, Dexamethasone 0.1% Drops: One or two drops topically in the conjunctival sac(s). In severe diseases, drops may be used hourly being tapered to discontinuation as the inflammation subsides. In mild disease, drops may be used up to four to six times daily or as prescribed by the physician.
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 the ocular structures. Hypersensitivity to a component of the medication. (Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.) The use of these combinations is always contraindicated after uncomplicated removal of a corneal foreign body.
Prolonged use may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior or 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 steroids. In acute purulent conditions of the eye, steroids 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 children and in uncooperative patients. Employment of steroid medication in the treatment of herpes simplex requires great caution.
The initial prescription and renewal of the medication order beyond 20 mL or 8 g 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. The possibility of persistent fungal infections of the cornea should be considered after prolonged steroid dosing.
Adverse reactions have occurred with steroid/anti-infective combination of drugs that 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 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.
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 infection 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.
Keep tightly closed after use. Store at temperatures not exceeding 30°C.
S01CA01 - dexamethasone and antiinfectives ; Belongs to the class of corticosteroids in combination with antiinfectives. Used in the treatment of eye diseases.
Eye drops (sterile) 5 mL.