MAXITROL (Page 2 of 2)

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 ointment) 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 ointment) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

No overall clinical differences in safety or effectiveness have been observed between the elderly and other adult patients.

Adverse Reactions to MAXITROL

Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid 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 steroid component are: elevation of IOP with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.

Secondary Infection: The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroid. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used. Keratitis, conjunctivitis, corneal ulcers, and conjunctival hyperemia have occasionally been reported following use of steroids. Secondary bacterial ocular infection following suppression of host responses also occurs.

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

Apply a small amount into the conjunctival sac(s) up to three or four times daily.

How to Apply MAXITROL® (neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment):

1. Tilt your head back.

2. Place a finger on your cheek just under your eye and gently pull down until a “V” pocket is formed between your eyeball and your lower lid.

3. Place a small amount (about ½ inch) of MAXITROL (neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment) in the “V” pocket. Do not let the tip of the tube touch your eye.

4. Look downward before closing your eye.

Not more than 8 g 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 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

PRINCIPAL DISPLAY PANEL

NDC 0078-0771-01

Maxitrol®

(neomycin and polymyxin B

sulfates and dexamethasone

ophthalmic ointment)

Sterile 3.5 g Net Wt.

Rx Only

NOVARTIS

NDC 0078-0771-01
							Maxitrol®
							(neomycin and polymyxin B
							sulfates and dexamethasone
							ophthalmic ointment)
							Sterile 3.5 g Net Wt.
							Rx Only
							NOVARTIS
(click image for full-size original)
MAXITROL
neomycin sulfate, polymyxin b sulfate and dexamethasone ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0078-0771
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 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B 10000 [USP’U] in 1 g
DEXAMETHASONE (DEXAMETHASONE) DEXAMETHASONE 1 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
METHYLPARABEN
PROPYLPARABEN
PETROLATUM
LANOLIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0078-0771-01 3.5 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050065 01/17/1972
Labeler — Novartis Pharmaceuticals Corporation (002147023)

Revised: 07/2022 Novartis Pharmaceuticals Corporation

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