MAXITROL- 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:

Harrow Eye, LLC

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 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 S treptococci , including Streptococcus pneumoniae . MAXITROL ® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) is contraindicated in most viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. MAXITROL is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

Product summary:

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 82667-100-05 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.

Authorization status:

New Drug Application

Summary of Product characteristics

MAXITROL- NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND
DEXAMETHASONE SUSPENSION
HARROW EYE, LLC
----------
MAXITROL- NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE
SUSPENSION
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)-.
®
®
22
29
5
The other active ingredients are neomycin sulfate and polymyxin B
sulfate. The
structural formula for neomycin sulfate is:
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 bot