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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

STAT RX LLC USA

INN (International Name):

NEOMYCIN SULFATE

Composition:

NEOMYCIN SULFATE 3.5 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial 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 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,

Product summary:

Sterile ophthalmic suspension in 5 mL plastic DROP-TAINER* dispenser (NDC 61314-630-06). STORAGE: Store at 8°-27°C (46°-80°F). Rx Only *DROP-TAINER is a registered trademark of Alcon Manufacturing, Ltd. FALCON LOGO IMAGE FALCON Pharmaceuticals, Ltd. Fort Worth, Texas 76134 USA Mfd by: ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Printed in USA 340905-0803      

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE - NEOMYCIN,
POLYMYXIN B AND DEXAMETHASONE SUSPENSION
STAT RX LLC USA
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DESCRIPTION
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:
DEX STRUCTURE IMAGE
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.
EACH ML CONTAINS: ACTIVES: neomycin sulfate equivalent to neomycin 3.5
mg, polymyxin B sulfate
10,000 units, dexamethasone 0.1%. PRESERVATIVE: benzalkonium chloride
0.004%. VEHICLE:
hypromellose 2910 0.5%. INACTIVES: sodium chloride, polysorbate 20,
hydrochloric acid and/or sodium
hydroxide (to adjust pH), purified water.
CLINICAL PHARMACOLOGY
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
from the vehicle.
INDICATIONS AND USAGE
INDICATIONS AND USAGE
For steroid-responsive inflammatory ocular conditions for which a
corticosteroid is indicated