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

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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)

可用日期:

Akorn

INN（国际名称）:

Neomycin Sulfate

组成:

neomycin 3.5 mg in 1 g

给药途径:

OPHTHALMIC

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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

產品總結:

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: FOR OPHTHALMIC USE ONLY. Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. KEEP OUT OF REACH OF CHILDREN Akorn Manufactured by: Akorn Inc. Lake Forest, IL 60045 NP00N Rev. 06/16

授权状态:

Abbreviated New Drug Application

产品特点

NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC, AND
HYDROCORTISONE- NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BACITRACIN
ZINC,
HYDROCORTISONE OINTMENT
AKORN
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NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC, AND HYDROCORTISONE
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.
The structural formula is:
1
2
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 may be
used whe