BLEPHAMIDE- sulfacetamide sodium and prednisolone acetate ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

sulfacetamide sodium (UNII: 4NRT660KJQ) (sulfacetamide - UNII:4965G3J0F5), prednisolone acetate (UNII: 8B2807733D) (prednisolone - UNII:9PHQ9Y1OLM)

Available from:

Physicians Total Care, Inc.

INN (International Name):

sulfacetamide sodium

Composition:

sulfacetamide sodium 100 mg in 1 g

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

BLEPHAMIDE® ophthalmic ointment 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 corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroid use in certain infective conjunctivitides is accepted to obtain 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 antibacterial drug in this product is active against the following common bacterial eye pathoge

Product summary:

BLEPHAMIDE® (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% is supplied sterile in ointment tubes of the following size: 3.5 g  -  NDC 54868-1157-0 Note: Store between 15°-25°C (59°-77°F). Rx only. Revised September 2004 © 2004 Allergan, Inc. Irvine, California 92612, U.S.A. ® Marks owned by Allergan, Inc. 6284X 71412US11P Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma     74146

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BLEPHAMIDE - SULFACETAMIDE SODIUM AND PREDNISOLONE ACETATE OINTMENT
PHYSICIANS TOTAL CARE, INC.
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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_.