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Neomycin and Polymyxin B Sulfates and Dexamethasone (Neomycin Sulfate / Polymyxin B Sulfate / Dexamethasone Ophthalmic) - Description and Clinical Pharmacology

 
 



DESCRIPTION:

Neoymcin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment USP is a multiple dose anti-infective steroid combination in a sterile ointment for topical application.  The active ingredient dexamethasone, is represented by the following structural formula:

Neomycin Sulfate is the sulfate salt of neomycin B and C which are produced by the growth of Streptomyces fradiae Waksman (Fam. Streptomycetaceae).  It has a potency equivalent to not less than 600 micrograms of neomycin base per milligram, calculated on an anhydrous basis.  The structural formula are:

Polymyxin B sulfate is the sulfate salt of polymyxin B1 and B2 which are produced by the growth of Bacillus polymyxa (Prazmowski) Migula (Fam. Bacillaceae).  It has a potency of not less than 6,000 polymyxin B units per milligram, calculated on an anhydrous basis.  The structural formula are:

Each gram of ointment contains: ACTIVES:  Dexamethasone 1 mg (0.1%), Neomycin Sulfate equivalent to Neomycin 3.5 mg base, Polymyxin B Sulfate 10,000 units in a base containing INACTIVES: White Petrolatum and Mineral Oil.

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 infections, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant in a particular case.

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 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.

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