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. 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.
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 neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment is administered to a nursing woman.
No overall clinical differences in safety or effectiveness have been observed between the elderly and other adult patients.
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 ingredients 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.
To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Apply a small amount into the conjunctival sac(s) up to three or four times daily.
How to Apply neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment:
- Tilt your head back.
- 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.
- Place a small amount (about 1/2 inch) of neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment in the “V” pocket. Do not let the tip of the tube touch your eye.
- 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.
Neomycin and polymyxin B sulfates and dexamethasone ophthalmic ointment, USP is supplied as a sterile ointment in a pre-printed aluminum tube with a natural high density polyethylene (HDPE) cannula and a white HDPE cap.
3.5 g in a aluminum tube NDC 24208-795-35
KEEP OUT OF REACH OF CHILDREN.
FOR OPHTHALMIC USE ONLY
Bausch & Lomb Americas Inc.
Bridgewater, NJ 08807 USA
Bausch & Lomb Incorporated
Tampa, FL 33637 USA
© 2023 Bausch & Lomb Incorporated or its affiliates
Revised: June 2023
FOR OPHTHALMIC USE ONLY
Net Wt. 3.5 g
BAUSCH + LOMB
| NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE |
neomycin sulfate, polymyxin b sulfate, and dexamethasone ointment
|Labeler — Bausch & Lomb Incorporated (196603781)|
|Bausch & Lomb Incorporated||079587625||MANUFACTURE (24208-795)|
Revised: 06/2023 Bausch & Lomb Incorporated
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