POLYDEX-N

Sterile Eye Ointment

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).

Composition:

Each g of ointment contains Dexamethasone 0.1%, Neomycin Sulphate 3,500 I.U./gm and Polymyxin B Sulphate 6,000 I.U./gm.

Clinical 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 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 diphteriae, 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 corticoid 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 doses 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:

It should be applied thinly and evenly to the conjunctival sac(s) at night (if eye drops used during the day) or 3-4 times daily (if eye ointment used alone).

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.

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.

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.

Pharmaceutical Precautions:

• Store below 30° C. Protected from light. It is desirable that the contents should not be used more than four weeks after first opening the tube.

• Keep all medicines out of the reach of children.

• To be dispensed only by or on the prescription of a registered physician.

Packing:

Ophthalmic tube containing 3 g.