NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE suspension/ drops

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

DIRECT RX

INN (International ime):

NEOMYCIN SULFATE

Sastav:

NEOMYCIN 3.5 mg in 1 mL

Administracija rute:

OPHTHALMIC

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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 conjunctivitis 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 spec

Proizvod sažetak:

Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension USP is supplied in a controlled drop tip bottle in the following size: 5 mL - Prod. No. 04107 DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. FOR OPHTHALMIC USE ONLY Storage Store between 15°-25° C (59°-77° F). Store upright. KEEP OUT OF REACH OF CHILDREN. Revised September 2008 Bausch & Lomb Incorporated Tampa, FL 33637 ©Bausch & Lomb Incorporated 9114202 (Folded) 9114302 (Flat)

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE- NEOMYCIN POLYMYXIN B
SULFATES AND DEXAMETHASONE SUSPENSION/ DROPS
DIRECT RX
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NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE
DESCRIPTION SECTION
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:
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 B1 and B2 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 SECTION
Corticoids suppress the inflammatory response to a variety of agents
and they probably delay or slow
the 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 c