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

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Proficient Rx LP

INN (Διεθνής Όνομα):

NEOMYCIN SULFATE

Σύνθεση:

NEOMYCIN 3.5 mg in 1 g

Οδός χορήγησης:

OPHTHALMIC

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a 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 cases of 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. The particular anti-infective drugs in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enter

Περίληψη προϊόντος:

Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Ointment USP is supplied in an ophthalmic tube in the following size: 3.5 gram tube – NDC 63187-669-35 Store between 15°-25° C (59°-77° F). KEEP OUT OF REACH OF CHILDREN. DO NOT USE IF CAP AND NECKRING ARE NOT INTACT. FOR OPHTHALMIC USE ONLY. Revised November 2007 Bausch & Lomb Incorporated Tampa, FL 33637 ©Bausch & Lomb Incorporated Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 9114002 (Folded) 9114102 (Flat)

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE- NEOMYCIN
SULFATE, POLYMYXIN B SULFATE, AND 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-,
(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:
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 formulae are:
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
compliance and c