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:

Preferred Pharmaceuticals Inc.

INN (International Name):

NEOMYCIN SULFATE

Composition:

NEOMYCIN 3.5 mg in 1 g

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/Enterobacter s

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 68788-6841-3) 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 © Bausch & Lomb Incorporated Revised September 2018 Update p/n Update p/n Relabeled By: Preferred Pharmaceuticals Inc.

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
PREFERRED PHARMACEUTICALS INC.
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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
C
H N O 1203.48
56
98
16
13
Chemical Name: pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 17,
21-trihydroxy-16-methyl-, (11β, 16α) -
EACH GRAM CONTAINS: ACTIVE: 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 con