NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE- neomycin sulfate, polymyxin b sulfate and dexamethasone suspension

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297), POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K), DEXAMETHASONE (UNII: 7S5I7G3JQL) (DEXAMETHASONE - UNII:7S5I7G3JQL)

Tilgængelig fra:

Preferred Pharmaceuticals, Inc.

INN (International Name):

NEOMYCIN SULFATE

Sammensætning:

NEOMYCIN 3.5 mg in 1 mL

Indgivelsesvej:

OPHTHALMIC

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the papebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids 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 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, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterob

Produkt oversigt:

Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension is supplied as a sterile ophthalmic suspension in a white, low density polyethylene DROP-TAINER* dispenser with a pink, polypropylene cap. 5 mL in 8 mL bottle - 68788-9120-1 STORAGE Store upright at 8° - 27°C (46° - 80° F). Rx Only *DROP-TAINER is a registered trademark of Alcon Manufacturing, Ltd.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE- NEOMYCIN SULFATE,
POLYMYXIN B SULFATE AND DEXAMETHASONE SUSPENSION
PREFERRED PHARMACEUTICALS, INC.
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NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OPHTHALMIC
SUSPENSION
STERILE
DESCRIPTION
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic
Suspension is a multiple dose anti-
infective steroid combination in sterile suspension form for topical
application. The chemical structure
for the active ingredient, dexamethasone, is:
MW = 392.45
Established name: dexamethasone
Chemical name: pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 17,
21-trihydroxy-16-methyl-, (11β, 16α)-.
The other active ingredients are neomycin sulfate and polymyxin B
sulfate. The structural formula for
neomycin sulfate is:
The structural formula for polymyxin B sulfate is:
EACH ML CONTAINS: ACTIVES: neomycin sulfate equivalent to neomycin 3.5
mg, polymyxin B sulfate
10,000 units, dexamethasone 0.1%. INACTIVES: hypromellose 2910 0.5%,
sodium chloride, polysorbate
20, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified
water, benzalkonium chloride
0.004% (preservative).
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.
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, 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