Prescription Drug Information: Neomycin Polymyxin B Sulfates and Dexamethasone (Page 2 of 2)

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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