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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

RPK Pharmaceuticals, Inc.

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids use in certain infective conjunctivides 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 drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enteroba

Product summary:

Product: 53002-9511 NDC: 53002-9511-1 5 mL in a BOTTLE, DROPPER

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE- NEOMYCIN
SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE SUSPENSION
RPK PHARMACEUTICALS, INC.
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NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE OPHTHALMIC
SUSPENSION
STERILE
RX ONLY
DESCRIPTION
Neomycin and polymyxin B sulfates and dexamethasone ophthalmic
suspension is a
multiple dose anti-infective steroid combination in sterile suspension
form for topical
application. The chemical structure for the active ingredient,
dexamethasone, is:
MW = 392.45
C
H FO
ESTABLISHED NAME: dexamethasone
CHEMICAL NAME: pregna-1, 4-diene-3, 20-dione, 9-fluoro-11, 17,
21-trihydroxy-16-
methyl-, (11β, 16α)-.
The other active ingredients are neomycin sulfate and polymyxin B
sulfate. The
structural formula for neomycin sulfate is:
22
29
5
Neomycin B (R =H, R =CH NH )
Neomycin C (R =CH NH , R =H)
The structural formula for polymyxin B sulfate is:
EACH ML OF NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
OPHTHALMIC SUSPENSION CONTAINS: ACTIVES: neomycin sulfate equivalent
to
neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1%.
INACTIVES:
hypromellose 2910 0.5%, sodium chloride, polysorbate 20, hydrochloric
acid and/or
sodium hydroxide (to adjust pH), purified water, benzalkonium chloride
0.004%
(preservative).
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
1
2
2
2
1
2
2
2
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
antimicrobial is made, the
administration of such drugs in combination has the advantage of
greater patient
compliance and convenience, with the added assurance that the
appropriate dosage of
both drugs is administered, plus assured compatibility of ingredients
when both types of
drugs are in the same formulation and, partic