NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE ointment

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

NuCare Pharmaceuticals,Inc.

Mode d'administration:

OPHTHALMIC

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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

Descriptif du produit:

Neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment is supplied as a STERILE ointment in an aluminum tube with a white polyethylene tip and white polyethylene cap as follows: Storage: Store at 2° to 25°C (36° to 77°F). Distributed by: Sandoz Inc. Princeton, NJ 08540 T2017-128 December 2017

Statut de autorisation:

New Drug Application Authorized Generic

Résumé des caractéristiques du produit

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE- NEOMYCIN
AND POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT
NUCARE PHARMACEUTICALS,INC.
----------
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OPHTHALMIC
OINTMENT
STERILE
DESCRIPTION
Neomycin and polymyxin B sulfates and dexamethasone ophthalmic
ointment 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:
Neomycin B (R
=H, R
=CH
NH
)
Neomycin C (R
=CH
NH
, R
=H)
The chemical structure for the active ingredient Polymyxin B Sulfate
is:
1
2
2
2
1
2
2
2
The chemical structure for the active ingredient Dexamethasone is:
C
H
FO
MW = 392.47
ESTABLISHED NAME: dexamethasone
CHEMICAL NAME: pregna-1, 4-diene-3, 20-dione, 9-fluoro-11,17,
21-trihydroxy-16-
methyl-, (11β, 16α)-.
EACH GRAM OF NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
OPHTHALMIC OINTMENT 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,
anhydrous
liquid lanolin.
22
29
5
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 molecu