MAXITROL- neomycin sulfate, polymyxin b sulfate and dexamethasone ointment

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:

Novartis Pharmaceuticals Corporation

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 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 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/Enterobacter

Product summary:

MAXITROL® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment) is supplied as a STERILE ointment in an aluminum tube with a white polyethylene tip and white polyethylene cap as follows: 3.5 g in an aluminum tube NDC 0078-0771-01 Storage : Store at 2°C to 25°C (36°F to 77°F). After opening, MAXITROL (neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment) can be used until the expiration date on the tube. Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 © Novartis T2021-60 May 2021

Authorization status:

New Drug Application

Summary of Product characteristics

MAXITROL- NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND
DEXAMETHASONE OINTMENT
NOVARTIS PHARMACEUTICALS CORPORATION
----------
MAXITROL OINTMENT
MAXITROL (NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
OPHTHALMIC OINTMENT) STERILE
DESCRIPTION
MAXITROL
(neomycin and polymyxin B sulfates and dexamethasone ophthalmic
ointment) is a multiple dose anti-infective steroid combination in
sterile ointment form for
topical application. The chemical structure for the active ingredient
Neomycin Sulfate is:
Neomycin B (R =H, R =CH NH )
Neomycin C (R =CH NH , R =H)
The chemical structure for the active ingredient Polymyxin B Sulfate
is:
®
®
1
2
2
2
1
2
2
2
The chemical structure for the active ingredient dexamethasone is:
C
H FO
MOLECULAR WEIGHT = 392.47 G/MOL
ESTABLISHED NAME: dexamethasone
CHEMICAL NAME: pregna-1, 4-diene-3, 20-dione,9-fluoro-11,17,
21-trihydroxy-16-
methyl-, (11β, 16α)-.
EACH GRAM OF MAXITROL (NEOMYCIN AND POLYMYXIN B SULFATES AND
DEXAMETHASONE OPHTHALMIC OINTMENT) CONTAINS: ACTIVE: neomycin sulfate
equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units,
dexamethasone 0.1%.
PRESERVATIVES: methylparaben 0.05%, propylparaben 0.01%. INACTIVES:
anhydrous
liquid lanolin and white petrolatum.
CLINICAL PHARMACOLOGY
22
29
5
®
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, particularly, that the correct
volume of drug is
delivered and retained.
The relat