MAXITROL- neomycin sulfate, polymyxin b sulfate and dexamethasone suspension

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Novartis Pharmaceuticals Corporation

Stjórnsýsluleið:

OPHTHALMIC

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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 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 drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae , Klebsiella

Vörulýsing:

MAXITROL ® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) is supplied as a sterile ophthalmic suspension in a white, low density polyethylene dispenser with a pink, polypropylene cap as follows: 5 mL in 8 mL bottle………………………………………………………. NDC 0078-0792-05 Storage : Store upright at 8°C to 27°C (46°F to 80°F). After opening, MAXITROL (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) can be used until the expiration date on the bottle. © Novartis Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 Revised: June 2021 T2021-79

Leyfisstaða:

New Drug Application

Vara einkenni

MAXITROL- NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND
DEXAMETHASONE SUSPENSION
NOVARTIS PHARMACEUTICALS CORPORATION
----------
MAXITROL (NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
OPHTHALMIC SUSPENSION)
STERILE
DESCRIPTION
MAXITROL
(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:
MOLECULAR WEIGHT = 392.45 G/MOL
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 MAXITROL (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: benzalkonium chloride 0.004% (preservative), hydrochloric
acid and/or
sodium hydroxide (to adjust pH), hypromellose 2910 0.5%, polysorbate
20, purified
water, sodium chloride.
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
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