NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE ointment

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)

Tillgänglig från:

Major Pharmaceuticals

INN (International namn):

NEOMYCIN SULFATE

Sammansättning:

NEOMYCIN SULFATE 3.5 mg in 1 g

Receptbelagda typ:

PRESCRIPTION DRUG

Bemyndigande status:

Abbreviated New Drug Application

Produktens egenskaper

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE- NEOMYCIN SULFATE,
POLYMYXIN B SULFATE, AND DEXAMETHASONE OINTMENT
MAJOR PHARMACEUTICALS
----------
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-, (11β,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 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 milligram, calculated on an anhydrous basis.
The structural formulae are:
22
29
5
1
2
EACH GRAM CONTAINS: ACTIVES: Neomycin Sulfate (equivalent to 3.5 mg
Neomycin), Polymyxin B
Sulfate, equal to 10,000 polymyxin B units; Dexamethasone 1 mg (0.1%).
INACTIVES: White
Petrolatum, Lanolin, Mineral Oil.
PRESERVATIVES ADDED: Methylparaben 0.05%, Propylparaben 0.01%.
CLINICAL PHARMACOLOGY:
Corticoids suppress the inflammatory response to a variety of agents
and they probably delay or slow
the 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 complia