Ivysolone Ophthalmic Suspension

PRED FORTE ® is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.

• Shake well before using
• Instill one to two drops into the conjunctival sac two to four times daily
• During the initial 24 to 48 hours, the dosing frequency may be increased if necessary
• Care should be taken not to discontinue therapy prematurely
• If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated (see PRECAUTIONS )

• The safety and effectiveness
• Pediatric patients have been established
• Pediatric patients is supported by evidence from adequate and well-controlled studies of prednisolone acetate ophthalmic suspension
• Adults with additional data
• Pediatric patients

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

• Information for P atients Advise patients that if eye inflammation or pain persists longer than 48 hours or becomes aggravated, they should consult a physician
• Advise patients that to prevent eye injury or 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
• Advise patients that PRED FORTE ® suspension contains benzalkonium chloride, which may be absorbed by soft contact lenses. …

PRED FORTE ® suspension is contraindicated in acute untreated purulent ocular infections, 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. …

Prolonged use of corticosteroids may result in posterior subcapsular cataract formation and may increase intraocular pressure in susceptible individuals, resulting in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Prolonged use may also suppress the host immune response and thus increase the hazard of secondary ocular infections. If this product is used for 10 days or longer, intraocular pressure should be routinely monitored even though it may be difficult in children and uncooperative patients. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be checked frequently. …

The following adverse reactions have been identified during use of PRED FORTE ® . Because reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Adverse reactions include 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 (bacterial, fungal, and viral) has occurred. …

Pregnancy 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. …

Overdosage will not ordinarily cause acute problems. If accidentally ingested, drink fluids to dilute.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.