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

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

MWI

INN (Διεθνής Όνομα):

NEOMYCIN SULFATE

Σύνθεση:

NEOMYCIN 3.5 mg in 1 g

Οδός χορήγησης:

OPHTHALMIC

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment, USP is supplied in an ophthalmic tube in the following size: NDC 13985-744-35 – 3.5 g tube Store between 15°-25°C (59°-77°F). KEEP OUT OF REACH OF CHILDREN. DO NOT USE IF CAP AND NECKRING ARE NOT INTACT. FOR OPHTHALMIC USE ONLY Revised 10/2016 Manufactured by: Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA Distributed by: MWI Boise, ID 83705 956300 (Flat) 9564000 (Folded)

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE- NEOMYCIN SULFATE,
POLYMYXIN B SULFATE, AND DEXAMETHASONE OINTMENT
MWI
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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: 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
Corticoids suppress the inflammatory response to a variety of agents
and they probably delay or slow
healing. Since corticoids 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 corticoid 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
corticosteroid is indicated and
where bacterial infec