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 Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension. Care should be exercised in operating machinery or driving a motor vehicle.
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.
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 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.
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 Suspension is administered to a nursing woman.
Safety and effectiveness in pediatric patients below the age of 2 years have not been established.
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
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.
To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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.
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, USP is supplied as a sterile ophthalmic suspension in a white, low density polyethylene extended LLDPE drop tip bottle with a white, polypropylene cap:
5 mL in 10 mL bottle – (NDC 68788-9702-5)
KEEP OUT OF REACH OF CHILDREN.
Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA
© Bausch & Lomb Incorporated
Relabeled By: Preferred Pharmaceuticals Inc.
FOR TOPICAL OPHTHALMIC
Do not touch dropper tip to any
surface, as this may contaminate
BAUSCH + LOMB
Relabeled By: Preferred Pharmaceuticals Inc.
| NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE |
neomycin sulfate, polymyxin b sulfate and dexamethasone suspension/ drops
|Labeler — Preferred Pharmaceuticals, Inc. (791119022)|
|Registrant — Preferred Pharmaceuticals, Inc. (791119022)|
|Preferred Pharmaceuticals, Inc.||791119022||RELABEL (68788-9702)|
Revised: 11/2019 Preferred Pharmaceuticals, Inc.
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