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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

DIRECT RX

INN (International Name):

DEXAMETHASONE

Composition:

DEXAMETHASONE 1 mg in 1 g

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or 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 conjunctivitises 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 drugs in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilusinfluenzae, Klebsiella/Enterobacterspec

Product summary:

Neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment USP is supplied in 3.5 g (1/8 oz) sterile tamper evident tubes with ophthalmic tip. NDC 0574-4160-35 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Manufactured For Perrigo® Minneapolis, MN 55427 1R200 RC J1 Rev 12-13 A Ini 1113 R1113

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE- NEOMYCIN,
POLYMYXIN B SULFATES, DEXAMETHASONE OINTMENT
DIRECT RX
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NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic
Ointment USP is a multiple dose
anti-infective steroid combination in a sterile ointment for topical
application. The active ingredient
dexamethasone, is represented by the following structural formula:
[Structural Formula Image 1]
C22H29FO5 Mol. Wt. 392.47
Chemical Name: Pregna-1,4-diene-3,20-dione, 9-fluoro-11,
17,21-trihydroxy-16-methyl-, (11ß, 16α)-.
Neomycin Sulfate is the sulfate salt of neomycin B and C which are
produced by the growth of
Streptomyces fradiaeWaksman (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
are:
[Structural Formula Image 2]
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 are:
[Structural Formula Image 3]
Each gram of ointment contains: ACTIVES: Dexamethasone 1 mg (0.1%),
Neomycin Sulfate equivalent
to Neomycin 3.5 mg base, Polymyxin B Sulfate 10,000 units in a base
containing INACTIVES: White
Petrolatum and Mineral Oil.
Corticoids suppress the inflammatory response to a variety of agents
and they probably delay or slow
healing. Since corticoids 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 corticoid 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