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Blephamide (Sulfacetamide Sodium / Prednisolone Acetate Ophthalmic) - Description and Clinical Pharmacology

 
 



BLEPHAMIDE®
(sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10% / 0.2%

sterile

DESCRIPTION

BLEPHAMIDE® (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) is a sterile topical ophthalmic ointment combining an antibacterial and a corticosteroid which have the following chemical structures:

Chemical Names:

Sulfacetamide sodium: N-sulfanilylacetamide monosodium salt monohydrate. Prednisolone acetate: 11β, 17, 21-trihydroxpregna-1, 4-diene-3, 20-dione, 21-acetate.

Contains: Actives: sulfacetamide sodium 10%, prednisolone acetate 0.2%; Preservative: phenylmercuric acetate 0.0008%; Inactives: mineral oil, petrolatum (and) lanolin alcohol, and white petrolatum.

CLINICAL PHARMACOLOGY

Corticosteriods 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 antibacterial drug may be used when this inhibition is considered to be clinically significant in a particular case.

When a decision to administer both a corticosteroid and an antibacterial 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.

Microbiology: Sulfacetamide exerts a bacteriostatic effect against susceptible bacteria by restricting the synthesis of folic acid required for growth through competition with p-aminobenzoic acid.

Some strains of these bacteria may be resistant to sulfacetamide or resistant strains may emerge in vivo.

The anti-infective component in BLEPHAMIDE® ointment is included to provide action against specific organisms susceptible to it. Sulfacetamide sodium is active in vitro against susceptible strains of the following microorganisms: Escherichia coli, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus (viridans group). Haemophilus influenzae, Klebsiella species, and Enterobacter species. This product does not provide adequate coverage against: Neisseria species, Pseudomonas species, and Serratia marcescens (see INDICATIONS AND USAGE).

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