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.
Safety and effectiveness in pediatric patients have not been established.
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.
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.
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.
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
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
Allergan USA, Inc.
Madison, NJ 07940
©2018 Allergan. All rights reserved.
All trademarks are the property of their respective owners.
| PRED-G |
gentamicin, prednisolone acetate suspension/ drops
|Labeler — Allergan, Inc. (144796497)|
Revised: 07/2020 Allergan, Inc.
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.