Product Description.:
PRED-G? sterile ophthalmic suspension is a topical anti-inflammatory/anti-infective combination product for ophthalmic use.
Gentamicin sulfate is the sulfate salt of gentamicin C1, gentamicin C2, and gentamicin C1A which are produced by the growth of Micromonospora purpurea.
Contains: Actives: Gentamicin sulfate equivalent to 0.3% gentamicin base prednisolone acetate (microfine suspension) 1.0%. 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 the 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.
INDICATIONS
PRED-G? suspension is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.
Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns or penetration of foreign bodies.
The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.
The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Haemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.
