NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE- neomycin, polymyxin b sulfates, dexamethasone ointment

Country: Stati Uniti

Lingwa: Ingliż

Sors: NLM (National Library of Medicine)

Ingredjent attiv:

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

Disponibbli minn:

Proficient Rx LP

INN (Isem Internazzjonali):

DEXAMETHASONE

Kompożizzjoni:

DEXAMETHASONE 1 mg in 1 g

Rotta amministrattiva:

OPHTHALMIC

Tip ta 'preskrizzjoni:

PRESCRIPTION DRUG

Indikazzjonijiet terapewtiċi:

For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or 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 infective conjunctivitises 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, Haemophilusinfluenzae, Klebsiella/Enterobacter sp

Sommarju tal-prodott:

Neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment USP is supplied in 3.5 g (1/8 oz) sterile tamper evident tubes with ophthalmic tip. NDC 63187-395-35 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Manufactured For Perrigo® Minneapolis, MN 55427 1R200 RC J1 Rev 12-13 A Ini 1113 R1113

L-istatus ta 'awtorizzazzjoni:

Abbreviated New Drug Application

Karatteristiċi tal-prodott

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE- NEOMYCIN,
POLYMYXIN B SULFATES, DEXAMETHASONE OINTMENT
PROFICIENT RX LP
----------
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-, (11ß, 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 formula
are:
22
29
5
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 formula are:
Each gram of ointment contains: ACTIVES: Dexamethasone 1 mg (0.1%),
Neomycin Sulfate equivalent
to Neomycin 3.5 mg base, Polymyxin B Sulfate 10,000 units in a base
containing INACTIVES: White
Petrolatum and Mineral Oil.
CLINICAL PHARMACOLOGY:
Corticoids suppress the inflammatory response to a variety of agents
and they probably delay or slow
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 compliance and
1
2
convenience, with the added assurance that the appropriate dosage of
bot