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

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

NuCare Pharmaceuticals,Inc.

INN (Medzinárodný Name):

NEOMYCIN SULFATE

Zloženie:

NEOMYCIN 3.5 mg in 1 mL

Spôsob podávania:

OPHTHALMIC

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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 , Haemoph

Prehľad produktov:

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 68071-4375-5 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)

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

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:
22
29
5
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:
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
ant