PRED-G (Page 2 of 2)

Nursing Mothers

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause untoward effects. Because of the potential for serious adverse reactions in nursing infants from PRED-G ® suspension, a decision should be made whether to discontinue nursing while the drug is being administered or to discontinue the medication.

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 younger 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.

Reactions reported with PRED-G ® include eye burning, eye stinging, eye irritation, 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. Superficial punctate keratitis has been reported occasionally with onset occurring typically after several days of use.

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 steroids. The possibility of fungal invasion should 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

Instill one drop into the conjunctival sac two to four times daily. During the initial 24 to 48 hours, the dosing frequency may be increased, if necessary, up to 1 drop every hour. Care should be taken not to discontinue therapy prematurely.

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

Not more than 20 milliliters should be prescribed initially, and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

HOW SUPPLIED

PRED-G ® (gentamicin and prednisolone acetate ophthalmic suspension, USP) 0.3%/1% is supplied sterile in white LDPE plastic bottles with droppers with white high impact polystyrene (HIPS) caps as follows:

5 mL in 10 mL bottle – NDC 0023-0106-05

Storage :

Store at 15°-25°C (59°-77°F). Avoid excessive heat, 40°C (104°F) and above. Protect from freezing. Shake well before using.

Revised : 0 7 / 201 8

Distributed by:
Allergan USA, Inc.
Madison, NJ 07940

©2018 Allergan. All rights reserved.
All trademarks are the property of their respective owners.

Allergan

v1.2USPI0106

PRINCIPAL DISPLAY PANEL

NDC 0023-0106-05
Rx Only
PRED-G ®
(gentamicin and
prednisolone
acetate ophthalmic
suspension, USP)
0.3%/1%
Sterile
5 mL

NDC 0023-0106-05
Rx Only
PRED-G®
(gentamicin and 
prednisolone 
acetate ophthalmic 
suspension, USP)
0.3%/1%
Sterile
5 mL
(click image for full-size original)

PRED-G
gentamicin, prednisolone acetate suspension/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0023-0106
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
GENTAMICIN (GENTAMICIN) GENTAMICIN 3 mg in 1 mL
PREDNISOLONE ACETATE (PREDNISOLONE) PREDNISOLONE ACETATE 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM
HYPROMELLOSES
POLYVINYL ALCOHOL, UNSPECIFIED
POLYSORBATE 80
WATER
SODIUM CHLORIDE
SODIUM CITRATE
SODIUM HYDROXIDE
HYDROCHLORIC ACID
BENZALKONIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0023-0106-05 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 5 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (0023-0106-05)
2 NDC:0023-0106-10 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
2 10 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (0023-0106-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA050586 02/19/1990
Labeler — Allergan, Inc. (144796497)

Revised: 07/2020 Allergan, Inc.

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