DailyMed Label: PREDNISOLONE ACETATE

DailyMed Label: prednisolone acetate

2006

DailyMed Prescription

prednisolone acetate

prednisolone acetate

Alcon Laboratories, Inc.

NDC: 0998-0635

NDC: 0998-0637

ECONOPRED® and ECONOPRED® Plus (Prednisolone Acetate) are adrenocortical steroid products prepared as sterile ophthalmic suspensions. The active ingredient is represented by the chemical structure: Each mL contains: Active: Prednisolone Acetate 1.0% or 0.125%. Preservative: Benzalkonium Chloride 0.01%. Vehicle: Hydroxypropyl Methylcellulose. Inactive: Dibasic Sodium Phosphate, Polysorbate 80, Edetate Disodium, Glycerin, Citric Acid and/or Sodium Hydroxide (to adjust pH), Purified Water. DM-02, DM-03

Steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe such as allergic conjunctivitis, acne rosacea, superficial punctate keratitis, herpes zoster keratitis, iritis, cyclitis, selected infective conjunctivitides, when the inherent hazard of steroid use is accepted to obtain an advisable diminution in edema and inflammation; corneal injury from chemical, radiation, or thermal burns, or penetration of foreign bodies.

SHAKE WELL BEFORE USING . Two drops topically in the eye(s) four times daily. In cases of bacterial infections, concomitant use of anti-infective agents is mandatory. 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 ). The dosing of ECONOPRED and ECONOPRED Plus may be reduced, but care should be taken not to discontinue therapy prematurely. In chronic conditions, withdrawal of treatment should be carried out by gradually decreasing the frequency of applications.

ECONOPRED and ECONOPRED Plus are contraindicated in most viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. ECONOPRED and ECONOPRED Plus are also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

The initial prescription and renewal of the medication order should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. If signs and symptoms fail to improve after two days, the patient should be re-evaluated. As fungal infections of the cornea are particularly prone to develop coincidentally with long-term local corticosteroid applications, fungal invasion should be suspected in any persistent corneal ulceration where a corticosteroid has been used or is in use. Fungal cultures should be taken when appropriate. If this product is used for 10 days or longer, intraocular pressure should be monitored (SEE WARNINGS ). If inflammation or pain persists longer than 48 hours or becomes aggravated, the patient should be advised to discontinue use of the medication and consult a physician. This product is sterile when packaged. To prevent contamination, care should be taken to avoid touching the bottle tip to eyelids or to any other surface. The use of this bottle by more than one person may spread infection. Keep bottle tightly closed when not in use. Keep out of the reach of children. No studies have been conducted in animals or in humans to evaluate the potential of these effects. Pregnancy Category C. 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 and well controlled studies in pregnant women. ECONOPRED® and ECONOPRED® Plus should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 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 other untoward effects. Because of the potential for serious adverse reactions in nursing infants from prednisolone acetate, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Safety and effectiveness in pediatric patients have not been established.

5mL and 10mL in plastic DROP-TAINER® dispensers.        1/8% ECONOPRED:                1% ECONOPRED Plus: 5 mL       NDC 0998-0635-05    5 mL      NDC 0998-0637-05 10 mL     NDC 0998-0635-10   10 mL     NDC 0998-0637-10 STORAGE: STORE at 8° - 24°C (46° - 75°F) in an UPRIGHT position. Rx Only

Corticosteroids inhibit the inflammatory response to a variety of inciting agents and probably delay or slow healing. They inhibit the edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation. There is no generally accepted explanation for the mechanism of action of ocular corticosteroids. However, corticosteroids are thought to act by the induction of phospholipase A 2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A 2 . Corticosteroids are capable of producing a rise in intraocular pressure.