PRED-G (Page 2 of 2)

Pediatric Use:

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use:

No overall differences in safety or effectiveness have been observed between elderly and young patients.

Adverse Reactions to PRED-G

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.

The most frequent reactions observed include ocular discomfort, irritation upon instillation of the medication and punctate keratitis. These reactions have resolved upon discontinuation of the medication. Other reactions reported with PRED-G ® include eye burning, eye stinging, ocular hyperemia, eye pain, eye discharge, lacrimation increased, eye edema, visual impairment, blurry vision, foreign body sensation in eyes, and dysgeusia. Hypersensitivity including signs and symptoms related to ocular allergy (e.g. conjunctivitis), angioedema (e.g. tongue edema) and allergic skin reactions (e.g. rash and contact allergy) has also been reported.

Reactions occurring most often from the presence of the anti-infective ingredient are allergic sensitizations. The reactions due to the steroid component in decreasing order of frequency are: elevation of intraocular pressure (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 ocular infection has occurred after use of combinations containing steroids and antimicrobials. Fungal and viral 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. (See WARNINGS) Secondary bacterial ocular infection following suppression of host responses also occurs.

DOSAGE AND ADMINISTRATION

A small amount (1/2 inch ribbon) of ointment should be applied in the conjunctival sac one to three times daily. Care should be taken not to discontinue therapy prematurely.

Not more than 8 grams should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

If signs and symptoms fail to improve after two days, the patient should be re-evaluated (see PRECAUTIONS).

HOW SUPPLIED

PRED-G ® (gentamicin and prednisolone acetate ophthalmic ointment, USP) 0.3%/0.6% is supplied sterile in collapsible aluminum tubes with epoxy-phenolic liners with tips with black LDPE caps of the following size:

3.5g NDC 0023-0066-04

Storage : Store at 15° — 25°C (59° — 77°F)

Revised : 0 6 /201 8

Distributed by:

Allergan USA, Inc.

Madison, NJ 07940

©2018 Allergan. All rights reserved.

All trademarks are the property of their respective owners.

v1.1USPI0066

PRINCIPAL DISPLAY PANEL

NDC 0023-0066-04
Rx Only
PRED-G
(gentamicin and
prednisolone
acetate
ophthalmic
ointment, USP)
0.3 % 0.6 %
Sterile
3.5 g

NDC 0023-0066-04
Rx Only
PRED-G
(gentamicin and 
prednisolone 
acetate 
ophthalmic 
ointment, USP)
0.3 % 0.6 %
Sterile
3.5 g
(click image for full-size original)
PRED-G
gentamicin sulfate and prednisolone acetate ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0023-0066
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GENTAMICIN SULFATE (GENTAMICIN) GENTAMICIN 3 mg in 1 g
PREDNISOLONE ACETATE (PREDNISOLONE) PREDNISOLONE ACETATE 6 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CHLOROBUTANOL
MINERAL OIL
LANOLIN ALCOHOLS
WATER
PETROLATUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0023-0066-04 1 TUBE in 1 CARTON contains a TUBE
1 3.5 g in 1 TUBE This package is contained within the CARTON (0023-0066-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050612 01/01/1990
Labeler — Allergan, Inc. (144796497)

Revised: 11/2019 Allergan, Inc.

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