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

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Preferred Pharmaceuticals, Inc.

INN (International Name):

DEXAMETHASONE

Sammensetning:

DEXAMETHASONE 1 mg in 1 g

Administreringsrute:

OPHTHALMIC

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

Neomycin and polymixin B sulfates and dexamethasone ophthalmic ointment USP is supplied in 3.5 g (1/8 oz) sterile tamper evident tubes with ophthalmic tip. (NDC 68788-9373-3). STORAGE: Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Manufactured For Perrigo Minneapolis, MN 55427 1R200 RC J4 Rev 02-18 CD Ini 1113 R0218 Relabeled By: Preferred Pharmaceuticals Inc.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE- NEOMYCIN,
POLYMYXIN B SULFATES, 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:
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:
Polymyxin B (R=CH )
Polymyxin B (R=H)
1
2
2
2
1
2
2
2
1
3
2
DAB= α, γ-diaminobutyric acid
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 CONTAINS: ACTIVE: neomycin sulfate equivalent to neomycin
3.5 mg,
polymyxin B sulfate 10,000 units, dexamethasone 0.1%. INACTIVES: white
petrolatum,
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 infections, 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.
IND