PREDNISOLONE ACETATE 10 mg/mL Suspension/ Drops
Other active recalls for Prednisolone Acetate (different manufacturers) — 2 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Corticosteroid class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Ophthalmic prednisolone reduces the irritation, redness, burning, and swelling of eye inflammation caused by chemicals, heat, radiation, infection, allergy, or foreign bodies in the eye. It sometimes is used after eye surgery. Prednisolone is in a class of medications called steroids. It prevents swelling and redness by changing the way the immune system works.
Read the full MedlinePlus article ↗- Pred Mild is a corticosteroid eye drop used to calm inflammation and allergic reactions in the eye — specifically in the eyelid, the white of the eye, and the clear structures on t...
- Shake the bottle well before every use. Then tilt your head back, pull down your lower eyelid gently, and place one to two drops into that small space between the eyelid and your e...
- It's really important not to stop early without talking to your doctor first, even if your eye feels much better. Stopping too soon can allow the inflammation to come back. If you...
- Can I stop using the drops once my eye feels better?
Patient education
Supplement & herbal interactions
Prednisolone may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
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Boric acid is a weak acid derived from boron. In medicines, it typically serves as a buffer to help maintain the product's pH level and may act as a preservative in certain formulations.
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Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
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Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
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Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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Sodium bisulfite is a chemical salt used as a preservative and antioxidant in medicines. It prevents discoloration and degradation of active ingredients, especially in liquid formulations and injectables.
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Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
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Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
9 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $4.394 | $65.91 / 15 ml |
| Medicaid paysCMS SDUD · 12 mo | $6.05 | $90.69 / 15 ml |
| Medicare drug plans payPart D · Q2 2026 | $5.35 | $80.18 / 15 ml |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| prednisolone acetate 10 mg/mL 60219-2552-01 | Amneal | 1 bottle | $4.394 | AB | Availability likely | — |
| Prednisolone Acetate 10 mg/mLthis 60758-0119-15 | Pacific | 1 bottle | $4.394 | AB | Availability likely | — |
| prednisolone acetate 10 mg/mL 60219-2551-01 | Amneal | 1 bottle | $4.450 | AB | Availability likely | +1% |
| prednisolone acetate 10 mg/mL 60219-2550-01 | Amneal | 1 bottle | $4.589 | AB | Availability likely | +4% |
| Prednisolone Acetate 10 mg/mL 61314-0637-05 | Sandoz | 1 bottle | $4.589 | AB | Availability likely | +4% |
| Prednisolone Acetate 10 mg/mL 70748-0332-02 | Lupin | 1 bottle | $4.589 | AB | Availability likely | +4% |
| Pred Forte 10 mg/mL 11980-0180-01 | Allergan, | 1 bottle | — | AB | Discontinued | — |
| Prednisolone Acetate 10 mg/mL 50090-0559-00 | A-S | 1 bottle | — | AB | FDA listed | — |
| Prednisolone Acetate 10 mg/mL 50090-1912-00 | A-S | 1 bottle | — | AB | FDA listed | — |
| Prednisolone Acetate 10 mg/mL 50090-5275-00 | A-S | 1 bottle | — | AB | FDA listed | — |
| Prednisolone Acetate 10 mg/mL 50090-7539-00 | A-S | 1 bottle | — | AB | FDA listed | — |
| Prednisolone Acetate 10 mg/mL 67296-2176-05 | Redpharm | 1 bottle | — | AB | FDA listed | — |
| Prednisolone Acetate 10 mg/mL 68071-2222-05 | NuCare | 1 bottle | — | AB | FDA listed | — |
| Prednisolone Acetate 10 mg/mL 76420-0204-05 | Asclemed | 1 bottle | — | AB | FDA listed | — |
| Prednisolone Acetate 10 mg/mL 85766-0124-05 | Sportpharm | 1 bottle | — | AB | FDA listed | — |
| Prednisolone Acetate 10 mg/mL 85766-0258-05 | Sportpharm | 1 bottle | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Where does this data come from?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
Where does this data come from?
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 60758-0119-05 | 1 BOTTLE, DROPPER in 1 CARTON (60758-119-05) / 5 mL in 1 BOTTLE, DROPPER | $4.59 / mL | $22.94 | 1997-08-19 | Active |
| 60758-0119-10 | 1 BOTTLE, DROPPER in 1 CARTON (60758-119-10) / 10 mL in 1 BOTTLE, DROPPER | $4.45 / mL | $44.50 | 1997-08-19 | Active |
| 60758-0119-15 You're viewing this | 1 BOTTLE, DROPPER in 1 CARTON (60758-119-15) / 15 mL in 1 BOTTLE, DROPPER | $4.39 / mL | $65.91 | 1997-08-19 | Active |
This pack has the lowest per-mL cost of the 3 priced pack sizes ($4.39 NADAC).
This pack accounts for about 1.5% of this product's recent Medicaid fills; most go to a different pack size. See all packs ↓
Pack size FAQ
What quantity is in NDC 60758-0119-15?
What NDC number is used to bill for this package of PREDNISOLONE ACETATE 10 mg/mL Suspension/ Drops?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Prednisolone acetate ophthalmic suspension 1% is indicated for the treatment of steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION 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 ).
⛔ Contraindications ▾
CONTRAINDICATIONS Prednisolone acetate ophthalmic suspension 1% 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. Prednisolone acetate ophthalmic suspension 1% is also contraindicated in individuals with known or suspected hypersensitivity to any of the ingredients of this preparation and to other corticosteroids.
⚠️ Warnings ▾
WARNINGS 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. Various ocular diseases and long-term use of topical corticosteroids have been known to cause corneal and scleral thinning.
Use of topical corticosteroids in the presence of thin corneal or scleral tissue may lead to perforation. Acute purulent infections of the eye may be masked or activity enhanced by the presence of corticosteroid medication. The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation.
Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution; frequent slit lamp microscopy is recommended. Prednisolone acetate ophthalmic suspension 1% contains sodium bisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people.
The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The following adverse reactions have been identified during use of prednisolone acetate ophthalmic suspension 1%. 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; eye pain; 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.
🤰 Pregnancy ▾
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.
🧒 Pediatric Use ▾
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 ▾
Geriatric Use No overall differences in safety or effectiveness have been observed between elderly and younger patients.
🆘 Overdosage ▾
OVERDOSAGE Overdosage will not ordinarily cause acute problems. If accidentally ingested, drink fluids to dilute.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Prednisolone acetate is a glucocorticoid that, on the basis of weight, has 3 to 5 times the anti-inflammatory potency of hydrocortisone. Glucocorticoids inhibit the edema, fibrin deposition, capillary dilation, and phagocytic migration of the acute inflammatory response, as well as capillary proliferation, deposition of collagen, and scar formation.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Prednisolone acetate ophthalmic suspension, USP 1% is supplied sterile in opaque white LDPE plastic bottles with droppers with pink high impact polystyrene (HIPS) caps as follows: 5 mL in 10 mL bottle - NDC 60758-119-05 10 mL in 15 mL bottle - NDC 60758-119-10 15 mL in 15 mL bottle - NDC 60758-119-15 Pacific Pharma Storage : Store at up to 25°C (77°F). Protect from freezing. Store in an upright position.
Revised: 0 3 /202 4 Distributed by: AbbVie Inc. North Chicago, IL 60064 © 2024 AbbVie. All rights reserved.
PACIFIC PHARMA and its design are trademarks of Allergan, Inc., an AbbVie company. v2.0USPI0119
📦 Storage and Handling ▾
Storage : Store at up to 25°C (77°F). Protect from freezing. Store in an upright position. Revised: 0 3 /202 4 Distributed by: AbbVie Inc. North Chicago, IL 60064 © 2024 AbbVie. All rights reserved. PACIFIC PHARMA and its design are trademarks of Allergan, Inc., an AbbVie company. v2.0USPI0119
📋 Description ▾
DESCRIPTION Prednisolone acetate ophthalmic suspension, USP 1% 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 Each mL of Prednisolone acetate ophthalmic suspension 1% contains: Active : prednisolone acetate (microfine suspension) 1% 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. The following structure for Prednisolone acetate ophthalmic suspension, USP 1% 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.
💬 Information for Patients ▾
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 prednisolone acetate ophthalmic suspension 1% contains benzalkonium chloride, which may be absorbed by soft contact lenses.
Contact lenses should be removed prior to application of prednisolone acetate ophthalmic suspension 1% and may be reinserted 15 minutes following its administration.