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

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:

MWI

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 product

Product summary:

Neomycin and Polymyxin B Sulfates, Bacitracin Zinc and Hydrocortisone Ophthalmic Ointment, USP is supplied in a tube with ophthalmic tip applicator in the following size: 3.5 g – NDC 13985-745-35 DO NOT USE IF CAP AND NECKRING ARE NOT INTACT. FOR OPHTHALMIC USE ONLY Store between 15° - 25°C (59°- 77°F). Keep tightly closed when not in use. KEEP OUT OF REACH OF CHILDREN. Revised: 10/2016 Manufactured by: Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA Distributed by: MWI Boise, ID 83705 9563300 (Flat) 9564100 (Folded)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND
HYDROCORTISONE- NEOMYCIN SULFATE AND POLYMYXIN B SULFATE, BACITRACIN
ZINC AND
HYDROCORTISONE OINTMENT
MWI
----------
NEOMYCIN AND POLYMYXIN B SULFATES,
BACITRACIN ZINC AND HYDROCORTISONE
OPHTHALMIC OINTMENT, USP
(STERILE)
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.
EACH GRAM CONTAINS
ACTIVES: 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 10 mg
(1%); INACTIVES: Mineral Oil, White Petrolatum.
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:
1
2
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, 11β, 17, 21-trihydroxypregn-4-ene-3, 20-dione, is an
anti-inflammatory hormone.
Its 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,
concomitant antimicrobial drugs may be used when this inhibition is
considered t