Pred Mild

Take Pred Mild exactly as prescribed.

Pred Mild comes in eyedrop form and is typically administered 2 to 4 times daily. Shake Pred Mild well before using.

If inflammation or pain persists longer than 48 hours or your eye becomes aggravated,  discontinue use of Pred Mild and consult your physician.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Pred Mild at the same time.

You should not use this medication if you are allergic to prednisolone or other steroids, or if you have certain types of infection (viral, fungal, or bacterial) that can affect your eyes.

Before using prednisolone ophthalmic, tell your doctor if you have glaucoma, herpes, or if you have recently had cataract surgery.

Do not use prednisolone ophthalmic while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses and cause discoloration. Wait at least 15 minutes after using prednisolone before putting your contact lenses in.

Shake the eye drops gently before each use.

Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

If you still have pain or swelling after 2 days of treatment, stop using this medication and call your doctor. Do not stop using prednisolone ophthalmic suddenly after long-term use without first talking to your doctor. You may need to use less and less before you stop the medication completely.

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of prednisolone ophthalmic is not expected to produce life-threatening symptoms.

PRED MILD® (prednisolone acetate ophthalmic suspension, USP) 0.12% is a sterile, topical anti-inflammatory agent for ophthalmic use. Its chemical name is 11ß,17, 21-Trihydroxypregna-1,4-diene-3, 20-dione 21-acetate and it has the following structure:

Structural Formula:

prednisolone acetate

Active: prednisolone acetate (microfine suspension) 0.12%.

Inactives: benzalkonium chloride as preservative; boric acid; edetate disodium; hypromellose; polysorbate 80; purified water; sodium bisulfite; sodium chloride; and sodium citrate. The pH during its shelf life ranges from 5.0 - 6.0.

PRED MILD® 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. PRED MILD® suspension is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.

General

The initial prescription and renewal of the medication order beyond 20 milliliters of PRED MILD® 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 2 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.

Information for Patients

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 MILD® suspension contains benzalkonium chloride, which may be absorbed by soft contact lenses. Contact lenses should be removed prior to application of PRED MILD® and may be reinserted 15 minutes following its administration.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No studies have been conducted in animals or in humans to evaluate the potential of these effects.

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. Prednisolone 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 ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast 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, 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.

Pediatric Use

The safety and effectiveness in pediatric patients have been established. Use in pediatric patients is supported by evidence from adequate and well-controlled studies of prednisolone acetate ophthalmic suspension in adults with additional data in pediatric patients.

Geriatric Use

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

The following adverse reactions have been identified during use of PRED MILD®. 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. 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 PRECAUTIONS).

Other adverse reactions reported with the use of prednisolone acetate ophthalmic suspension include: allergic reactions; dysgeusia; foreign body sensation; headache; pruritus; rash; transient burning and stinging upon instillation and other minor symptoms of ocular irritation; urticaria; and visual disturbance (blurry vision).

Keratitis, conjunctivitis, corneal ulcers, mydriasis, conjunctival hyperemia, loss of accommodation and ptosis have occasionally been reported following local use of corticosteroids. Corticosteroid-containing preparations have also been reported to cause acute anterior uveitis and perforation of the globe.

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

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).

PRED MILD® (prednisolone acetate ophthalmic suspension, USP) 0.12% is supplied sterile in opaque white LDPE plastic bottles with droppers with white high impact polystyrene (HIPS) caps as follows:

Storage: Store at 15°C -30°C (59°-86°F) in an upright position. Protect from freezing.

Revised: 05/2017

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Irvine, CA 92612
Made in the U.S.A.

71739US12

ALLERGAN

NDC 11980-174-10
Rx Only

PRED MILD®
(prednisolone
acetate ophthalmic
suspension, USP)
0.12%
sterile

10 mL