Maxitrol (Page 2 of 2)

Information for Patients

If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician.

This product is sterile when packaged. To prevent contamination, care should be taken to avoid touching the bottle tip to eyelids or to any other surface. The use of this bottle by more than one person may spread infection. Keep bottle tightly closed when not in use. Keep out of reach of children.

Patients should be advised that their vision may be temporarily blurred following dosing with MAXITROL® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension). Care should be exercised in operating machinery or driving a motor vehicle.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to evaluate carcinogenic or mutagenic potential have not been conducted with polymyxin B sulfate. Treatment of cultured human lymphocytes in vitro with neomycin increased the frequency of chromosome aberrations at the highest concentration (80 mcg/mL) tested. However, the effects of neomycin on carcinogenesis and mutagenesis in humans are unknown. Polymyxin B has been reported to impair the motility of equine sperm, but its effects on male or female fertility are unknown.

Pregnancy

Dexamethasone has been shown to be teratogenic in mice and rabbits following topical ophthalmic application in multiples of the therapeutic dose.

In the mouse, corticosteroids produce fetal resorptions and a specific abnormality, cleft palate. In the rabbit, corticosteroids have produced fetal resorptions and multiple abnormalities involving the head, ears, limbs, palate, etc.

There are no adequate or well-controlled studies in pregnant women. However, prolonged or repeated corticoid use during pregnancy has been associated with an increased risk of intra-uterine growth retardation. MAXITROL® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the embryo or fetus. Infants born of mothers who have received substantial doses of corticosteroids during pregnancy should be observed carefully for signs of hypoadrenalism.

Nursing Mothers

Systemically administered corticosteroids appear in human milk, could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when MAXITROL® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 2 years have not been established.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Adverse Reactions to Maxitrol

Adverse reactions have occurred with corticosteroid/anti-infective combination drugs which can be attributed to the corticosteroid component, the anti-infective component, or the combination. Exact incidence figures are not available since no denominator of treated patients is available.

Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitizations. The reactions due to the corticosteroid component are: elevation of IOP with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing. Corticosteroid-containing preparations have also been reported to cause perforation of the globe. Keratitis, conjunctivitis, corneal ulcers, and conjunctival hyperemia have occasionally been reported following use of steroids.

Additional adverse reactions identified from post marketing use include ulcerative keratitis, headache, and Stevens-Johnson syndrome.

The following additional adverse reactions have been reported with dexamethasone use:

Cushing’s syndrome and adrenal suppression may occur after use of dexamethasone in excess of the listed dosing instructions in predisposed patients, including children and patients treated with CYP3A4 inhibitors.

DOSAGE AND ADMINISTRATION

One to two drops in the conjunctival sac(s). In severe disease, drops may be used hourly, being tapered to discontinuation as the inflammation subsides. In mild disease, drops may be used up to four to six times daily. Not more than 20 mL should be prescribed initially, and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

HOW SUPPLIED

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 0998-0630-06

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

T2021-61

May 2021

PRINCIPAL DISPLAY PANEL

NDC 0998-0630-06

Alcon®

Maxitrol®

(neomycin and

polymyxin B sulfates

and dexamethasone

ophthalmic

suspension)

5 mL Sterile

NDC 0998-0630-06
Alcon® 
Maxitrol®
(neomycin and
polymyxin B sulfates
and dexamethasone
ophthalmic
suspension)
5 mL   Sterile
(click image for full-size original)
MAXITROL
neomycin sulfate, polymyxin b sulfate and dexamethasone suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0998-0630
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN 3.5 mg in 1 mL
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B 10000 [USP’U] in 1 mL
DEXAMETHASONE (DEXAMETHASONE) DEXAMETHASONE 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE
HYPROMELLOSE 2910 (4000 MPA.S)
SODIUM CHLORIDE
POLYSORBATE 20
HYDROCHLORIC ACID
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0998-0630-06 5 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050023 11/15/1964
Labeler — Alcon Laboratories, Inc. (008018525)

Revised: 05/2021 Alcon Laboratories, Inc.

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