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:

Alcon Laboratories, Inc.

INN (International Name):

NEOMYCIN SULFATE

Composition:

NEOMYCIN 3.5 mg in 1 g

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 species, Neisseria species, and Pseudomonas aeruginosa. This product does not provide adequate coverage against: Serratia   marcescens   and Streptococci, including

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 0065-0631-36 Storage : Store at 2°C to25°C (36°F- 77°F). © 2002, 2003, 2016, 2017 © Novartis Distributed by: ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA *a trademark of Novartis Alcon® a Novartis company T2017-122 December 2017

Authorization status:

New Drug Application

Summary of Product characteristics

MAXITROL- NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE
OINTMENT
ALCON LABORATORIES, INC.
----------
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
MW = 392.47
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: white petrolatum, anhydrous liquid lanolin.
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 relative potency of corticosteroids depends on