Neomycin and Polymyxin B Sulfates and Dexamethasone (Page 2 of 2)

Pregnancy

Teratogenic Effects

Pregnancy Category C

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. 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 and 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 intraocular pressure (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.

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.

FOR TOPICAL OPHTHALMIC USE ONLY.

HOW SUPPLIED

Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension is supplied as a sterile ophthalmic suspension in a white, low density polyethylene DROP-TAINER* dispenser with a pink, polypropylene cap.

5 mL in 8 mL bottle (NDC 54868-1070-1)

STORAGE

Store upright at 8° — 27°C (46° — 80° F).

Rx Only

*DROP-TAINER is a registered trademark of Alcon Manufacturing, Ltd.

Revised: April 2008

Printed in USA

Dist. By:

FALCON Pharmaceuticals, Ltd.

Fort Worth, Texas 76134 USA

Mfd. By:

ALCON LABORATORIES, INC

Fort Worth, Texas 76134 USA

9003573-0408

Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma 74146

PRINCIPAL DISPLAY PANEL

NDC 54868-1070-1

image of package label
(click image for full-size original)

Rx Only

Neomycin and Polymyxin B Sulfates and Dexamethasone

Ophthalmic Suspension

5 mL STERILE

NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
neomycin sulfate, polymyxin b sulfate and dexamethasone suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-1070(NDC:61314-630)
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
HYPROMELLOSE 2910 (4000 MPA.S)
SODIUM CHLORIDE
POLYSORBATE 20
HYDROCHLORIC ACID
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-1070-1 5 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA062721 12/04/2007
Labeler — Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 06/2012 Physicians Total Care, Inc.

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