NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH HYDROCORTISONE ACETATE 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), BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I), HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

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:

Neomycin and polymyxin B sulfates and bacitracin zinc with hydrocortisone acetate ophthalmic ointment is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial 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 corticosteroid 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 (see CLINICAL PHARMACOLOGY: Microbiology ). The particular anti-infect

Product summary:

Neomycin and Polymyxin B Sulfates and Bacitracin Zinc with Hydrocortisone Acetate Ophthalmic Ointment is supplied in 3.5 g (1/8 Oz) sterile tamper proof tube with ophthalmic tip, NDC 54868-6122-0. Store at 15° to 25°C (59° to 77°F). E. FOUGERA & CO. a division of Altana Inc. MELVILLE, NEW YORK 11747 I22938E R8/04 #174 Relabeling of "Additional Barcode" by: Physicians Total Care, Inc. Tulsa, OK      74146

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC WITH
HYDROCORTISONE ACETATE - NEOMYCIN AND POLYMYXIN B SULFATES AND
BACITRACIN ZINC WITH
HYDROCORTISONE ACETATE OINTMENT
PHYSICIANS TOTAL CARE, INC.
----------
Sterile
RX ONLY
DESCDRIPTION
Neomycin and polymyxin B sulfates and bacitracin zinc with
hydrocortisone acetate ophthalmic ointment
is a sterile antimicrobial and anti-inflammatory ointment for
ophthalmic use. Each gram contains:
neomycin sulfate equivalent to 3.5 mg neomycin base, polymyxin B
sulfate equivalent to 10,000
polymyxin B units, bacitracin zinc equivalent to 400 bacitracin units,
hydrocortisone acetate 10 mg (1
%), in a white petrolatum and mineral oil base.
Bacitracin zinc is the zinc salt of bacitracin, a mixture of related
cyclic polypeptides (mainly bacitracin
A) produced by the growth of an organism of the _licheniformis_ group
of _Bacillus subtilis_ var Tracy. It has
a potency of not less than 40 bacitracin units per mg. The structural
formula is:
Hydrocortisone acetate,
Pregn-4-ene-3,20-dione,21-(acetyloxy)-11,17-dihydroxy-,(11β)–, is
an anti-
inflammatory hormone. Its structural formula is:
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 of not less than
600 ug of neomycin standard per mg, 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 mg, calculated on an anhydrous basis. The
structural formulae are:
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,
concomitant antimicrobial drugs may be used when this inhibition is
considered to be clinically
significa