NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE- neomycin sulfate, polymyxin b sulfate and dexamethasone suspension/ drops

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

NuCare Pharmaceuticals,Inc.

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 corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids 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, Klebsiel

Produkt oppsummering:

Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, USP is supplied in a controlled drop tip bottle with a white cap in the following size: NDC 66267-958-05 BOX OF 5mL DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. Store between 15°-25° C (59°-77° F). Store upright. KEEP OUT OF REACH OF CHILDREN. Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA ©Bausch & Lomb Incorporated Rev. 06/2016 9114203 (Folded) 9114303 (Flat)

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE- NEOMYCIN SULFATE,
POLYMYXIN B SULFATE AND DEXAMETHASONE SUSPENSION/ DROPS
NUCARE PHARMACEUTICALS,INC.
----------
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OPHTHALMIC
SUSPENSION, USP (STERILE)
RX ONLY
DESCRIPTION:
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic
Suspension, USP is a multiple
dose anti-infective steroid combination in a sterile suspension for
topical application. The active
ingredient, Dexamethasone, is represented by the following structural
formula:
C
H
FO
Mol. Wt. 392.47
Chemical Name: Pregna-1,4-diene-3,20-dione,
9-fluoro-11,17,21-trihydroxy-16-methyl-, (11β,16α)-.
Neomycin Sulfate is the sulfate salt of neomycin B and C which are
produced by the growth of
_Streptomyces fradiae _Waksman (Fam. Streptomycetaceae). It has a
potency equivalent to not less than 600
micrograms of neomycin base per milligram, calculated on an anhydrous
basis. The structural formula
is:
Polymyxin B Sulfate is the sulfate salt of polymyxin B
and B
which are produced by the growth of
_Bacillus polymyxa _(Prazmowski) Migula (Fam. Bacillaceae). It has a
potency of not less than 6,000
polymyxin B units per milligram, calculated on an anhydrous basis. The
structural formula is:
22
29
5
1
2
EACH ML CONTAINS: ACTIVES: Neomycin Sulfate (equivalent to 3.5 mg
neomycin), Polymyxin B
Sulfate equal to 10,000 polymyxin B units, Dexamethasone 1 mg (0.1%);
INACTIVES: Sodium
Chloride, Hypromellose, Polysorbate 20, Purified Water.
Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH
(3.5 – 6.0).
PRESERVATIVE ADDED: Benzalkonium Chloride 0.004%
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