Pred G (Gentamicin Sulfate / Prednisolone Acetate Ophthalmic) - Description and Clinical Pharmacology

DESCRIPTION

PRED-G ^® sterile ophthalmic suspension is a topical anti-inflammatory/anti-infective combination product for ophthalmic use.

Structural Formulae:

        prednisolone acetate                                                                           gentamicin sulfate

Chemical Names: Prednisolone acetate: 11ß,17,21-Trihydroxypregna-1,4-diene-3,20-dione 21-acetate.

Gentamicin sulfate is the sulfate salt of gentamicin C₁, gentamicin C₂, and gentamicin C_1A which are produced by the growth of Micromonospora purpurea.

Contains: Actives: Gentamicin sulfate equivalent to 0.3% gentamicin base; prednisolone acetate (microfine suspension) 1%. Preservative: Benzalkonium chloride 0.005%. Inactives: edetate disodium; hypromellose; polyvinyl alcohol 1.4%; polysorbate 80; purified water; sodium chloride; and sodium citrate, dihydrate. May contain sodium hydroxide and/or hydrochloric acid to adjust pH (5.4 to 6.6).

PRED-G ^® suspension is formulated with a pH from 5.4 to 6.6 and its osmolality ranges from 260 to 340 mOsm/kg.

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 PRED-G ^® is included to provide action against specific organisms susceptible to it. Gentamicin sulfate is active in vitro against susceptible strains of the following microorganisms: Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.

When a decision to administer both a corticosteroid 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. When both types of drugs are in the same formulation, compatibility of ingredients is assured and 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.