NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE suspension/ drops

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Unit Dose Services

INN (Διεθνής Όνομα):

NEOMYCIN SULFATE

Σύνθεση:

NEOMYCIN 3.5 mg in 1 mL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE- NEOMYCIN SULFATE,
POLYMYXIN B SULFATE AND DEXAMETHASONE SUSPENSION/ DROPS
UNIT DOSE SERVICES
----------
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OPHTHALMIC
SUSPENSION, USP (STERILE)
RX ONLY
DESCRIPTION:
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic
Suspension, USP is a multiple
dose anti-infective steroid combination in a sterile suspension 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 formula
is:
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 is:
22
29
5
1
2
EACH ML 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: Sodium
Chloride, Hypromellose, Polysorbate 20, Purified Water.
Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH
(3.5 – 6.0).
PRESERVATIVE ADDED: Benzalkonium Chloride 0.004%
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 when this inhibition is
considered to be clinically
significant in a particular case.
When a decision to administer both a corticosteroid and an
antimicr