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

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Aidarex Pharmaceuticals LLC

INN (Διεθνής Όνομα):

DEXAMETHASONE

Σύνθεση:

DEXAMETHASONE 1 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 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, Haemophilus influenzae , Klebsiella / Enterob

Περίληψη προϊόντος:

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. 3.5 GRAM in a TUBE/1 TUBE in a CARTON (53217-289-01) Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Repackaged by Aidarex Pharmaceuticals, LLC Corona, CA 92880

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE- NEOMYCIN,
POLYMYXIN B SULFATES, DEXAMETHASONE OINTMENT
AIDAREX PHARMACEUTICALS LLC
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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 do