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

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:

NuCare Pharmaceuticals,Inc.

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 steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid 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/E

Product summary:

Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment is supplied as a STERILE ointment in a pre-printed aluminum tube with a natural HDPE cannula and a white HDPE cap. (3.5 g in an aluminum tube NDC 68071-2428-3) Store between 15°-25°C (59°-77°F). KEEP OUT OF REACH OF CHILDREN. FOR OPHTHALMIC USE ONLY Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA © 2018 Bausch & Lomb Incorporated Revised September 2018 9114006 ( Folded ) 9114106 ( Flat )

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE- NEOMYCIN
SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE OINTMENT
NUCARE PHARMACEUTICALS,INC.
----------
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
OPHTHALMIC OINTMENT, USP
Sterile
RX ONLY
DESCRIPTION
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic
Ointment, USP is a
multiple dose anti-infective steroid combination in sterile ointment
form for topical
application.
The chemical structure for the active ingredient Neomycin Sulfate is:
The chemical structure for the active ingredient Polymyxin B Sulfate
is:
The chemical structure for the active ingredient Dexamethasone is:
Established Name: Dexamethasone
Chemical Name: pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 17,
21-trihydroxy-16-
methyl-, (11β, 16α) -
EACH GRAM CONTAINS: ACTIVES: neomycin sulfate equivalent to neomycin
3.5 mg,
polymyxin B sulfate 10,000 units, dexamethasone 0.1%. PRESERVATIVES:
methylparaben 0.05%, propylparaben 0.01%. INACTIVES: white petrolatum,
lanolin,
mineral oil.
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
For steroid-responsive inflammatory ocular conditions for which a
corticos