POLYDEX-N

Sterile Eye drops

Description:

The ophthalmic preparation of Polydex-N combines two antibiotics, Neomycin Sulphate and Polymyxin B Sulphate, offering broad-spectrum antibacterial activity with the anti-inflammatory activity of corticosteroid, dexamethasone, for combating certain microbial infections of the anterior segment of the eye(s). The eye drop is formulated in an isotonic menstrum containing hydroxypropyl methylcellulose for maximum effectiveness and comfort.

Composition:

Each ml of solution contains Dexamethasone 0.1%, Neomycin Sulphate 3,500 I.U./ml, Polymyxin B Sulphate 6,000 I.U./ml.

Clinical Pharmacology:

Corticosteroids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticosteroids may inhibit the body’s defense mechanism against infection, a concomitant antimicrobial drug may be used when this 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 Sulphate is considered active against the following microorganisms: Staphylococcus aureus, Corynebacterium diphtheriae, Streptococcus Viridans, Escherichia coli,Klebsiella pneumoniae,Proteus vulgaris, Aerobacter aerogenes, and Haemophilus influenzae.Polymyxin B Sulphate is considered active against the following microorganism: Pseudomonas aeruginosa, Aerobacter aerogenes, Escherichia coli, Klebsiella pneumoniae and Koch-Weeks bacillus.

When a decision to administer both a corticosteroids and an 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, concentration and release from the vehicle.

Indications:

Polydex-N is indicated in ocular inflammation when concurrent use of an antimicrobial is judged necessary.

Dosage & Administration:

One or two drops topically into the conjunctival sac(s). In severe disease, 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.

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 in decreasing order of frequency are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage, posterior sub-capsular cataract formation and delayed wound healing.

Contraindications:

Epithelial herpes simplex keratitis (dentritic 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).

The use of these combinations is always contraindicated after uncomplicated removal of a corneal foreign body.

Warnings/Precautions:

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 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 uncooperative patients.

Employment of steroid medication in the treatment of herpes simplex requires great caution. The possibility of persistent fungal infections of the cornea should be considered after prolonged steroid dosing.

Additional information:

Close the bottle immediately after use.

Do not use more than one month after first opening.

Packing:

Dropper bottle of 5 ml.