NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC, AND HYDROCORTISONE- neomycin sulfate, polymyxin b sulfate, bacitracin zinc a

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 (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ)

Available from:

Henry Schein Inc.

INN (International Name):

Neomycin Sulfate

Composition:

Neomycin 3.5 mg in 1 g

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone 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-infective drugs in this produ

Product summary:

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone Ophthalmic Ointment, USP is supplied in a tube with ophthalmic applicator tip in the following size: NDC 0404-7195-1          1/8 oz (3.5 g) tube FOR OPHTHALMIC USE ONLY.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC, AND
HYDROCORTISONE- NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN ZINC
AND
HYDROCORTISONE OINTMENT
HENRY SCHEIN INC.
----------
NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC, AND HYDROCORTESONE
OPHTHALMIC OINTMENT, USP
RX ONLY
DESCRIPTION:
Neomycin and Polymyxin B Sulfates, Bacitracin Zinc, and Hydrocortisone
Ophthalmic
Ointment, USP is a sterile antimicrobial and anti-inflammatory
ointment for ophthalmic
use. The color of the product is colorless to light yellowish.
EACH GRAM CONTAINS:
ACTIVES: Neomycin Sulfate equivalent to 3.5 mg neomycin base,
Polymyxin B Sulfate
equal to 10,000 polymyxin B units, Bacitracin Zinc equivalent to 400
bacitracin units, and
Hydrocortisone 10 mg (1%);
INACTIVE: White Petrolatum q.s.
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 mcg 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:
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 then 40
bacitracin units per mg.
1
2
The structural formula is:
Hydrocortisone, 11β 17, 21-trihydroxypregn-4-ene-3, 20-dione, is an
anti-inflammatory
hormone. The structural formula is:
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