PRED-G® sterile ophthalmic ointment is a topical anti-inflammatory/anti-infective combination product for ophthalmic use.
Chemical Names: Prednisolone acetate: 11(beta),17,21-Trihydroxypregna-1,4-diene-3, 20-dione 21-acetate.
Gentamicin sulfate is the sulfate salt of gentamicin C 1 , gentamicin C 2 , and gentamicin C 1A which are produced by the growth of Micromonospora purpurea.
Contains: Actives: gentamicin sulfate equivalent to 0.3% gentamicin base, prednisolone acetate 0.6%. Preservative: (chloral derivative) 0.5%. Inactives: white petrolatum; mineral oil; petrolatum (and) lanolin alcohol; and purified water.
Clinical Pharmacology: Corticosteroids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticosteroids may inhibit the body' defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant in a particular case.
The anti-infective component in PRED-G® is included to provide action against specific organisms susceptible to it. Gentamicin sulfate is active in vitro against susceptible strains of the following microorganisms: Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Hemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.
When a decision to administer both a corticosteroid and an antimicrobial is made, the administration of such drugs in combination has the advantage of greater patient compliance and convenience, with the added assurance that the appropriate dosage of both drugs is administered. When both types of drugs are in the same formulation, compatibility of ingredients is assured and the correct volume of drug is delivered and retained.
The relative potency of corticosteroids depends on the molecular structure, concentration, and release from the vehicle.
and Usage: PRED-G® is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.
Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation, or thermal burns or penetration of foreign bodies.
The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.
The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumoniae, Enterobacter aerogenes, Escherichia coli, Hemophilus influenzae, Klebsiella pneumoniae, Neisseria gonorrhoeae, Pseudomonas aeruginosa, and Serratia marcescens.
Contraindications: Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of the ocular structures. Hypersensitivity to a component of the medication. (Hypersensitivity to the antibiotic component occurs at a higher rate than for other components.)
PRED-G® is always contraindicated after uncomplicated removal of a corneal foreign body.
: Prolonged use may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision, and in posterior subcapsular cataract formation. Prolonged use may suppress the host immune response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, steroids may mask infection or enhance existing infection. If these products are used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients.
Employment of a steroid medication in the treatment of patients with a history of herpes simplex requires great caution. PRED-G® is contraindicated in patients with active herpes simplex keratitis.
General: Ocular irritation and punctate keratitis have been associated with the use of PRED-G®. The initial prescription and renewal of the medication order beyond 8 grams should be made by a physician only after examination of the patient' intraocular pressure, examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. The possibility of fungal infections of the cornea should be considered after prolonged steroid dosing.
Carcinogenesis, mutagenesis, impairment of fertility: There are no published carcinogenicity or impairment of fertility studies on gentamicin. Aminoglycoside antibiotics have been found to be non-mutagenic.
There are no published mutagenicity or impairment of fertility studies on prednisolone. Prednisolone has been reported to be non-carcinogenic.
Pregnancy: Pregnancy Category C: Gentamicin has been shown to depress newborn body weights, kidney weights, nephron counts and shows evidence of glomeruli and proximal tubule nephrotoxicity in rats when administered systemically in daily doses of approximately 500 times the maximum recommended ophthalmic dose in humans.
Prednisolone has been shown to be teratogenic in mice when given in doses 1-10 times the human dose. Dexamethasone, hydrocortisone and prednisolone were ocularly applied to both eyes of pregnant mice five times per day on days 10 through 13 of gestation. A significant increase in the incidence of cleft palate was observed in the fetuses of the treated mice. There are no adequate well-controlled studies in pregnant women. PRED-G® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. Because of the potential for serious adverse reactions in nursing infants from PRED-G® a decision should be made whether to discontinue nursing or to discontinue the medication.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Adverse Reactions: 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.
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 infection has occurred after use of combinations containing steroids and antimicrobials. Fungal 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.
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.
How Supplied: PRED-G® (gentamicin and prednisolone acetate ophthalmic ointment, USP) 0.3%/0.6% is supplied in ophthalmic ointment tubes of the following size:
3.5 g--NDC 0023-0066-04
Note: Store at 15°-25°C (59°-77°F).