NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

NEOMYCIN SULFATE

Composition:

NEOMYCIN SULFATE 3.5 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 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 cases of 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 drugs in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Ente

Product summary:

Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment USP is supplied in an ophthalmic tube in the following size: 3.5 gram tube – NDC 54868-1192-1 Store between 15°-30° C (59°-86° F). KEEP OUT OF REACH OF CHILDREN. DO NOT USE IF CAP AND NECKRING ARE NOT INTACT. FOR OPHTHALMIC USE ONLY. Revised November 2007 Bausch & Lomb Incorporated Tampa, FL 33637 ©Bausch & Lomb Incorporated Relabeling of "Additional" barcode label by: Physicians Total Care, Inc. Tulsa, OK     74146

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE - NEOMYCIN AND
POLYMYXIN B SULFATES AND DEXAMETHASONE OINTMENT
PHYSICIANS TOTAL CARE, 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 a sterile ointment 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 formulae
are:
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 formulae are:
22
29
5
1
2
EACH GRAM 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: White
Petrolatum, Lanolin, Mineral Oil.
PRESERVATIVES ADDED: Methylparaben 0.05%, Propylparaben 0.01%.
CLINICAL PHARMACOLOGY:
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 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 compl