BLEPHAMIDE- sulfacetamide sodium and prednisolone acetate suspension/ drops

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 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

A steroid/anti-infective combination 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 pa

Product summary:

BLEPHAMIDE® (sulfacetamide sodium–prednisolone acetate ophthalmic suspension, USP) is supplied sterile in opaque white LDPE plastic bottles and white dropper tips with white high impact polystyrene (HIPS) caps as follows: 5 mL in 10 mL bottle — NDC 54868-0634-1   10 mL in 15 mL bottle Note: Protect from freezing. Shake well before using. Storage: Store at 8°-24°C (46°-75°F) in an upright position. PROTECT FROM LIGHT. Sulfonamide solutions darken on prolonged standing and exposure to heat and light. Do not use if solution has darkened. Yellowing does not affect activity. KEEP OUT OF REACH OF CHILDREN. Rx only Revised June 2004 © 2004 Allergan, Inc. Irvine, CA 92612, U.S.A. ® marks owned by Allergan, Inc. 6580X 71735US10P Distributed by: Physicians Total Care, Inc. Tulsa, OK        74146

Authorization status:

New Drug Application

Summary of Product characteristics

BLEPHAMIDE - SULFACETAMIDE SODIUM AND PREDNISOLONE ACETATE SUSPENSION/
DROPS
PHYSICIANS TOTAL CARE, INC.
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BLEPHAMIDE
(SULFACETAMIDE SODIUM – PREDNISOLONE ACETATE OPHTHALMIC SUSPENSION,
USP) 10%/0.2%
DESCRIPTION
BLEPHAMIDE ophthalmic suspension is a topical
anti-inflammatory/anti-infective combination
product for ophthalmic use.
STRUCTURAL FORMULAS:
CHEMICAL NAMES:
Sulfacetamide sodium: N-sulfanilylacetamide monosodium salt
monohydrate.
Prednisolone acetate: 11ß, 17, 21-trihydroxypregna-1, 4-diene-3,
20-dione 21-acetate.
CONTAINS :
ACTIVES: sulfacetamide sodium 10%, prednisolone acetate (microfine
suspension) 0.2%.
PRESERVATIVE: benzalkonium chloride (0.004%). INACTIVES: edetate
disodium; polysorbate 80; polyvinyl
alcohol 1.4%; potassium phosphate, monobasic; purified water; sodium
phosphate, dibasic; sodium
thiosulfate; hydrochloric acid and/or sodium hydroxide to adjust the
pH (6.6 to 7.2).
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 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. 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.
MICROBIOLOGY: Sulfacetamide sodium 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 the