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

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Bausch & Lomb Incorporated

INN (International ime):

NEOMYCIN SULFATE

Sastav:

NEOMYCIN 3.5 mg in 1 g

Administracija rute:

OPHTHALMIC

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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

Proizvod sažetak:

Neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment, USP is supplied as a sterile ointment in a pre-printed aluminum tube with a natural high density polyethylene (HDPE) cannula and a white HDPE cap. 3.5 g in a aluminum tube NDC 24208-795-35 KEEP OUT OF REACH OF CHILDREN. FOR OPHTHALMIC USE ONLY Distributed by: Bausch & Lomb Americas Inc. Bridgewater, NJ 08807 USA Manufactured by: Bausch & Lomb Incorporated Tampa, FL 33637 USA © 2023 Bausch & Lomb Incorporated or its affiliates Revised: June 2023 9797300 (Folded) 9797400 (Flat)

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE- NEOMYCIN
SULFATE, POLYMYXIN B SULFATE, AND DEXAMETHASONE OINTMENT
BAUSCH & LOMB INCORPORATED
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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
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
cortico