Neomycin Polymyxin B Sulfates and Dexamethasone (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 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. 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 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

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.

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

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)

Storage: Store between 15°-25° C (59°-77° F). Store upright.

KEEP OUT OF REACH OF CHILDREN.

Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807 USA
© Bausch & Lomb Incorporated

Rev. 09/2018

update p/n
update p/n

Relabeled By: Preferred Pharmaceuticals Inc.

Principal Display Panel

Neomycin and Polymyxin B Sulf. and Dex. Ophth. Suspension
(click image for full-size original)

NDC 68788-9702-5

Neomycin and
Polymyxin B
Sulfates and
Dexamethasone
Ophthalmic
Suspension, USP
(Sterile)

FOR TOPICAL OPHTHALMIC
USE ONLY.

PRECAUTION:
Do not touch dropper tip to any
surface, as this may contaminate
the suspension.

Rx only

5 mL

BAUSCH + LOMB

Relabeled By: Preferred Pharmaceuticals Inc.

NEOMYCIN POLYMYXIN B SULFATES AND DEXAMETHASONE
neomycin sulfate, polymyxin b sulfate and dexamethasone suspension/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68788-9702(NDC:24208-830)
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
HYDROCHLORIC ACID
HYPROMELLOSE, UNSPECIFIED
POLYSORBATE 20
WATER
SODIUM CHLORIDE
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-9702-5 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 5 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (68788-9702-5)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA064135 03/14/2013
Labeler — Preferred Pharmaceuticals, Inc. (791119022)
Registrant — Preferred Pharmaceuticals, Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals, Inc. 791119022 RELABEL (68788-9702)

Revised: 11/2019 Preferred Pharmaceuticals, Inc.

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