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PRED FORTE prednisolone acetate 10 mg/mL Suspension/ Drops, 1 bottle — NDC 11980-0180-01 package photo

PRED FORTE prednisolone acetate 10 mg/mL Suspension/ Drops, 1 bottle

by Allergan, Inc. · 1 BOTTLE, DROPPER in 1 CARTON (11980-180-01) / 1 mL in 1 BOTTLE, DROPPER
NDC 11980-0180-01
🏷️ FDA NDC (as labeled) 11980-180-01 billing pads the product segment with a zero
This package
Contains1 bottle Pack sizes6 compare ↓
Also comes in: 5 mL 11980-0180-05 5 mL 11980-0180-06 10 mL 11980-0180-10 10 mL 11980-0180-11 15 mL 11980-0180-15
Rx only Brand Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Sep 3, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Prednisolone Acetate (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Jun 4, 2026 — Presence of Foreign Substance (Lupin Pharmaceuticals Inc.) · FDA recall D-0655-2026
Class III · May 18, 2026 — Failed Stability Specifications (AbbVie Inc.) · FDA recall D-0551-2026
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 11980-180-01
Product NDC 11980-180
11-digit billing NDC 11980018001
NCPDP billing unit ML — per mL (volume)
RxCUI 1376336, 1548724
UNII 8B2807733D
UPC 0311980180058, 0311980180157, 0311980180102
Application # NDA017011
SPL Set ID 00a5aa88-e361-4ea7-8922-530c738b726e
Established class (EPC) Corticosteroid
Mechanism of action Corticosteroid Hormone Receptor Agonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 1973-06-01
Marketing end 2027-05-31
Route OPHTHALMIC
Dosage form SUSPENSION/ DROPS
Substance PREDNISOLONE ACETATE
GPI-14 86300050101815
GPI class Pred Forte
GCN Seq No 007894
GCN 33153
HICL code 002870
Ingredient (HICL) Prednisolone Acetate
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q6
Therapeutic class — intermediate (HIC2) Ophthalmic Preparations
HIC3 code Q6P
Therapeutic class — specific (HIC3) Eye Anti-Inflammatory Agents
AHFS code 52:08.08.00
AHFS class Corticosteroids (Eent)
FDB label name PRED FORTE 1% EYE DROPS
FDB brand name Pred Forte
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 11980-180-01 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 11980-0180-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Corticosteroid class.

Pharmacologic class Corticosteroid
Drug family (ATC) Corticosteroids for local oral treatment, Corticosteroids acting locally, Corticosteroids
How it works Corticosteroid Hormone Receptor Agonists
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAllergan, Inc.
Application holderABBVIE INC
FDA applicationNDA017011 (NDA)
Labeler code11980
First marketedJun 1973
Product typeHuman Prescription Drug
Portfolio188 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name PRED FORTE 1% EYE DROPS Ingredient Prednisolone Acetate
📗 Our plain-language guide HelloPharmacist
  • Prednisolone is a steroid that calms inflammation and dials down an overactive immune system. Depending on what you're being treated for — whether that's an asthma flare, a skin co...
  • Why has my doctor prescribed prednisolone — what is it actually doing?
  • Please don't stop on your own — this is one of the most important things to know about prednisolone. When you take it for more than a short time, your adrenal glands slow down thei...
  • Can I stop taking prednisolone when I start feeling better?
📖 Read our full Prednisolone guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
8
Nutrient depletion considerations

Prednisolone may be associated with lower levels of 8 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Prednisolone nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 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.

  • UNII F5UM2KM3W7
    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.
  • UNII R57ZHV85D4
    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.
  • UNII 7FLD91C86K
    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.
  • UNII 3NXW29V3WO
    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.
  • UNII 6OZP39ZG8H
    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.
  • UNII TZX5469Z6I
    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.
  • UNII 451W47IQ8X
    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.
  • UNII 1Q73Q2JULR
    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.
  • UNII 059QF0KO0R
    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?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 5 mL 5 mL 10 mL 10 mL 15 mL
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
prednisolone acetate 10 mg/mL 60219-2552-01 Amneal 1 bottle $4.394 AB Availability likely —
prednisolone acetate 10 mg/mL 60219-2551-01 Amneal 1 bottle $4.450 AB Availability likely —
prednisolone acetate 10 mg/mL 60219-2550-01 Amneal 1 bottle $4.589 AB Availability likely —
Prednisolone Acetate 10 mg/mL 60758-0119-05 Pacific 1 bottle $4.589 AB Availability likely —
Prednisolone Acetate 10 mg/mL 61314-0637-05 Sandoz 1 bottle $4.589 AB Availability likely —
Prednisolone Acetate 10 mg/mL 70748-0332-02 Lupin 1 bottle $4.589 AB Availability likely —
Pred Forte 10 mg/mLthis 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 —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
1973
On the market since
Jun 1973
📍
2026
Currently FDA-listed
53 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 bottle11980-0180-05 181 Rx · $30,842
1 bottle11980-0180-10 48 Rx · $14,879
1 bottle this page11980-0180-01 No Medicaid data
1 bottle11980-0180-06 No Medicaid data
1 bottle11980-0180-11 No Medicaid data
1 bottle11980-0180-15 No Medicaid data
Drug total (last 4 qtrs): 229 Rx · 1,510 units · $45,720 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Pred Forte — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Pred Forte. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$4K
Claims incl. refills
30
Beneficiaries
26
Spend / beneficiary
$153.20
Spend / claim
$132.77
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
11980-0180-01 You're viewing this 1 BOTTLE, DROPPER in 1 CARTON (11980-180-01) / 1 mL in 1 BOTTLE, DROPPER — — 1973-06-01 Discontinued by firm
11980-0180-05 1 BOTTLE, DROPPER in 1 CARTON (11980-180-05) / 5 mL in 1 BOTTLE, DROPPER $30.71 / mL $153.57 1973-06-01 Active
11980-0180-06 1 BOTTLE, DROPPER in 1 CARTON (11980-180-06) / 5 mL in 1 BOTTLE, DROPPER — — 1973-06-01 Discontinued by firm
11980-0180-10 1 BOTTLE, DROPPER in 1 CARTON (11980-180-10) / 10 mL in 1 BOTTLE, DROPPER $30.83 / mL $308.31 1973-06-01 Active
11980-0180-11 1 BOTTLE, DROPPER in 1 CARTON (11980-180-11) / 10 mL in 1 BOTTLE, DROPPER — — 1973-06-01 Discontinued by firm
11980-0180-15 1 BOTTLE, DROPPER in 1 CARTON (11980-180-15) / 15 mL in 1 BOTTLE, DROPPER — — 1973-06-01 Discontinued by firm

This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓

Pack size FAQ

What quantity is in NDC 11980-0180-01?
NDC 11980-0180-01 contains 1 bottle — 1 bottle, dropper in 1 carton / 1 ml in 1 bottle, dropper.
What NDC number is used to bill for this package of PRED FORTE prednisolone acetate 10 mg/mL Suspension/ Drops?
Bill NDC 11980-0180-01 — the 11-digit billing format is 11980018001. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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.

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 11980-180-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 11980-0180-01, written without dashes as 11980018001. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 11980-0180-01, the first segment (11980) is the labeler code FDA assigned to Allergan, Inc.; the middle segment (0180) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 5 other package presentations of this same product, including 1 bottle (11980-0180-05), 1 bottle (11980-0180-06), 1 bottle (11980-0180-10). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Allergan, Inc. is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 27 words ▾

INDICATIONS AND USAGE PRED FORTE ® 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 63 words ▾

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 72 words ▾

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

⚠️ Warnings ~1 min read ▾

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. PRED FORTE ® suspension 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 203 words ▾

ADVERSE REACTIONS 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. 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 ~1 min read ▾

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.

🧒 Pediatric Use 38 words ▾

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 17 words ▾

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

🆘 Overdosage 15 words ▾

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

🧬 Clinical Pharmacology 50 words ▾

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 120 words ▾

HOW SUPPLIED PRED FORTE ® (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: 1 mL in 5 mL bottle - NDC 11980-180-01 5 mL in 10 mL bottle - NDC 11980-180-05 10 mL in 15 mL bottle - NDC 11980-180-10 15 mL in 15 mL bottle - NDC 11980-180-15 Storage : Store at up to 25°C (77°F). Protect from freezing. Store in an upright position.

Revised : 02 / 2024 Distributed by: AbbVie, Inc. North Chicago, IL 60064 © 2024 AbbVie. All rights reserved.

Pred Forte and its design are trademarks of Allergan, Inc., an AbbVie company. v2.0USPI180 Shape Description automatically generated

📋 Description 107 words ▾

DESCRIPTION PRED FORTE ® (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: Each mL of PRED FORTE ® 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 PRED FORTE® (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 118 words ▾

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.

Contact lenses should be removed prior to application of PRED FORTE ® and may be reinserted 15 minutes following its administration.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 11980-0174-05 · Allergan, 11980-0211-05 · Allergan, →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.