HomeNDC LookupIngredientsKetorolac Tromethamine › 47335-0221-90
Ketorolac Tromethamine 5 mg/mL Solution/ Drops — NDC 47335-0221-90 package photo

Ketorolac Tromethamine 5 mg/mL Solution/ Drops

by Sun Pharmaceutical Industries, Inc. · 1 BOTTLE, DROPPER in 1 CARTON (47335-221-90) / 10 mL in 1 BOTTLE, DROPPER
NDC 47335-0221-90
🏷️ FDA NDC (as labeled) 47335-221-90 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →
⚠️
Other active recalls for Ketorolac Tromethamine (different manufacturers) — 3 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Oct 1, 2025 — Presence of Particulate Matter: Particulate matter identified as glass (Aspiro Pharma Limited) · FDA recall D-0036-2026
Class II · Sep 5, 2025 — Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns (Apotex Corp.) · FDA recall D-0677-2025
Class II · May 28, 2025 — Lack of Assurance of Sterility (Apotex Corp.) · FDA recall D-0494-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 47335-221-90
Product NDC 47335-221
11-digit billing NDC 47335022190
RxCUI 860107
UNII 4EVE5946BQ
UPC 0347335219906, 0347335220902, 0347335221909
Application # ANDA090017
SPL Set ID 2c76b8f9-5385-4c98-aebb-bdca8613d24b
Established class (EPC) Anti-Inflammatory Agents; Cyclooxygenase Inhibitor; Nonsteroidal Anti-inflammatory Drug
Mechanism of action Cyclooxygenase Inhibitors
Chemical class Non-Steroidal
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-03-13
Route OPHTHALMIC
Dosage form SOLUTION/ DROPS
Substance KETOROLAC TROMETHAMINE
Why two NDCs? The FDA registers this code as 47335-221-90 — 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 → 47335-0221-90. 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 Nonsteroidal Anti-inflammatory Drug class.

Pharmacologic class Nonsteroidal Anti-inflammatory Drug, Cyclooxygenase Inhibitor
Drug family (ATC) Sympathomimetics excl. antiglaucoma preparations, Acetic acid derivatives and related substances, Antiinflammatory agents, non-steroids
How it works Cyclooxygenase Inhibitors
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

LabelerSun Pharmaceutical Industries, Inc.
Application holderSUN PHARMACEUTICAL INDUSTRIES LTD
FDA applicationANDA090017 (ANDA)
Labeler code47335
First marketedMar 2018
Product typeHuman Prescription Drug
Portfolio889 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

📗 Our plain-language guide HelloPharmacist
  • That's actually how ketorolac has to be used — the rules say treatment must always start with an injection, either into a vein or a muscle. The oral tablets are only for continuing...
  • Why did my doctor give me a shot first instead of just pills?
  • Ketorolac is actually quite hard on your stomach, kidneys, and cardiovascular system when used beyond 5 days — the risks of serious bleeding, ulcers, and other complications go up...
  • Why can I only take this for 5 days? My pain might last longer than that.
📖 Read our full Ketorolac guide →
1
Nutrient depletion considerations

Ketorolac Tromethamine may be associated with lower levels of 1 nutrient — worth a chat with your pharmacist, not a cause for alarm.

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 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 QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 9T1C662FKS
    A synthetic detergent and emulsifier derived from octylphenol. It helps blend water and oil-based ingredients together and improves how the medicine disperses in the body, commonly used in injectable and topical formulations.
  • 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 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • 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.

7 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 DailyMedingredient 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 · Q2 2026 $2.30 $22.99 / 10 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
Ketorolac Tromethamine 5 mg/mL 65145-0140-01 Caplin 1 bottle $1.358 AT Availability likely
Ketorolac Tromethamine 5 mg/mL 42571-0137-25 Micro 5 ml $1.448 AT Availability likely
Ketorolac Tromethamine 5 mg/mL 60505-1003-01 Apotex 1 bottle $1.448 AT Availability likely
Ketorolac Tromethamine 5 mg/mL 61314-0126-05 Sandoz 5 ml $1.448 AT Availability likely
Ketorolac Tromethamine 5 mg/mL 65145-0139-01 Caplin 1 bottle $1.448 AT Availability likely
Ketorolac Tromethamine 5 mg/mL 47335-0220-90 Sun 1 bottle $1.475 FDA listed
Acular 5 mg/mL 00023-2181-05 Allergan, 1 bottle AT FDA listed
Ketorolac Tromethamine 5 mg/mL 47335-0219-90 Sun 1 bottle FDA listed
Ketorolac Tromethamine 5 mg/mLthis 47335-0221-90 Sun 1 bottle FDA listed
Ketorolac Tromethamine 5 mg/mL 50090-2746-00 A-S 5 ml AT FDA listed
Ketorolac Tromethamine 5 mg/mL 63187-0628-05 Proficient 1 bottle FDA listed
Ketorolac Tromethamine 5 mg/mL 63187-0777-05 Proficient 1 bottle AT FDA listed
Ketorolac Tromethamine 5 mg/mL 65145-0138-01 Caplin 1 bottle AT FDA listed
Ketorolac Tromethamine 5 mg/mL 65862-0770-05 Aurobindo 1 bottle FDA listed
Ketorolac Tromethamine 5 mg/mL 67296-2210-01 Redpharm 1 bottle AT FDA listed
Ketorolac Tromethamine 5 mg/mL 67296-2253-01 Redpharm 1 bottle AT FDA listed
Ketorolac Tromethamine 5 mg/mL 68071-2252-05 NuCare 5 ml AT FDA listed
Ketorolac Tromethamine 5 mg/mL 68071-2400-05 NuCare 1 bottle FDA listed
Ketorolac Tromethamine 5 mg/mL 68071-3684-05 NuCare 1 bottle AT FDA listed
Ketorolac Tromethamine 5 mg/mL 68071-3880-05 NuCare 1 bottle AT FDA listed
Ketorolac Tromethamine 5 mg/mL 68788-8549-05 Preferred 5 ml AT FDA listed
Ketorolac Tromethamine 5 mg/mL 69315-0322-03 Leading 1 bottle AT FDA listed
Ketorolac Tromethamine 5 mg/mL 70512-0790-03 SOLA 1 bottle AT FDA listed
Ketorolac Tromethamine 5 mg/mL 71205-0296-05 Proficient 5 ml AT FDA listed
Ketorolac Tromethamine 5 mg/mL 72162-2384-02 Bryant 5 ml AT FDA listed
Ketorolac Tromethamine 5 mg/mL 72189-0335-05 Direct 5 ml AT FDA listed
Ketorolac Tromethamine 5 mg/mL 67296-2318-05 Redpharm 1 bottle AT FDA listed
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
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

🏛️
2018
On the market since
Mar 2018
📍
2026
Currently FDA-listed
8 years listed
🔓
·
Generic on the market
this product is a generic
This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

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.

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

Medicare Part D (outpatient prescription) spending for Ketorolac Tromethamine — the program that covers self-administered drugs. 27 manufacturers.
⚠️ 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 Ketorolac Tromethamine. 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
$8.53M
Claims incl. refills
446K
Beneficiaries
349.6K
Spend / beneficiary
$24.38
Spend / claim
$19.12
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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Ketorolac Tromethamine — the ingredient across all brands.

Top reported reactions

Drug Hypersensitivity329
Nausea295
Headache284
Pain278
Fatigue254
Dyspnoea245
Treatment Failure213

Age at onset

Neonate1
Infant1
Child2
Adolescent12
Adult417
Elderly295

Reporter sex

5,598 reports
Male · 35%
Female · 65%
Unknown · 0%

Serious outcomes

Hospitalization1,452
Death306
Life-threatening219
Disabling159
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 564 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
47335-0221-90 You're viewing this 1 BOTTLE, DROPPER in 1 CARTON (47335-221-90) / 10 mL in 1 BOTTLE, DROPPER 2018-03-13 Active

🧭 About this NDC listing & data coverage

Finished prescription product
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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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.
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 47335-221-90, 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: 47335-0221-90, written without dashes as 47335022190. 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 47335-0221-90, the first segment (47335) is the labeler code FDA assigned to Sun Pharmaceutical Industries, Inc.; the middle segment (0221) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (90) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Sun Pharmaceutical Industries, Inc.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Sun Pharmaceutical Industries, 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 76 words

1 INDICATIONS AND USAGE Ketorolac tromethamine ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac tromethamine ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction. Ketorolac tromethamine ophthalmic solution is a nonsteroidal, anti-inflammatory indicated for: The treatment of inflammation following cataract surgery.

( 1 ) The temporary relief of ocular itching due to seasonal allergic conjunctivitis. ( 1 )

⏱️ Dosage and Administration 205 words

2 DOSAGE AND ADMINISTRATION One drop of ketorolac tromethamine ophthalmic solution should be applied to the affected eye(s) four times a day for relief of ocular itching due to seasonal allergic conjunctivitis. For the treatment of postoperative inflammation in patients who have undergone cataract extraction, one drop of ketorolac tromethamine ophthalmic solution should be applied to the affected eye four times daily beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period.

( 2.1 )

2.1Recommended Dosing Patient Dosing The recommended dose of ketorolac tromethamine ophthalmic solution is one drop four times a day to the affected eye(s) for relief of ocular itching due to seasonal allergic conjunctivitis. For the treatment of postoperative inflammation in patients who have undergone cataract extraction, one drop of ketorolac tromethamine ophthalmic solution should be applied to the affected eye four times daily beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period.

2.2Use with Other Topical Ophthalmic Medications Ketorolac tromethamine ophthalmic solution has been safely administered in conjunction with other ophthalmic medications such as antibiotics, alpha-agonists, beta blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics. Drops should be administered at least 5 minutes apart.

💊 Dosage Forms and Strengths 103 words

3 DOSAGE FORMS AND STRENGTHS Ketorolac tromethamine ophthalmic solution 0.5% is supplied sterile in white opaque LDPE dropper bottles with white opaque plug and sealed with gray pantone opaque pilfer-proof caps as follows: 5 mL size bottle filled with 3 mL of solution 5 mL size bottle filled with 5 mL of solution 10 mL size bottle filled with 10 mL of solution Ophthalmic solution containing 5 mg/mL ketorolac tromethamine. ( 3 ) 5 mL size bottle filled with 3 mL of solution 5 mL size bottle filled with 5 mL of solution 10 mL size bottle filled with 10 mL of solution

Contraindications 32 words

4 CONTRAINDICATIONS Ketorolac tromethamine ophthalmic solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation. Hypersensitivity to any component of this product. ( 4 )

⚠️ Warnings and Cautions ~2 min read

5 WARNINGS AND PRECAUTIONS Delayed healing ( 5.1 ) Cross-sensitivity or hypersensitivity ( 5.2 ) Increased bleeding time due to interference with thrombocyte aggregation ( 5.3 ) Corneal effects including keratitis ( 5.4 )

5.1Delayed Healing Topical nonsteroidal anti-inflammatory drugs (NSAIDs) may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.

5.2Cross-Sensitivity or Hypersensitivity There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs. There have been reports of bronchospasm or exacerbation of asthma associated with the use of ketorolac tromethamine ophthalmic solution in patients who have either a known hypersensitivity to aspirin/non-steroidal anti-inflammatory drugs or a past medical history of asthma. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.

5.3Increased Bleeding Time With some NSAIDs, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti- inflammatory drugs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. It is recommended that ketorolac tromethamine ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications, which may prolong bleeding time.

5.4Corneal Effects Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration, or corneal perforation. These events may be sight threatening.

Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health. Postmarketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening.

Topical NSAIDs should be used with caution in these patients. Postmarketing experience with topical NSAIDs also suggests that use more than 1 day prior to surgery or use beyond 14 days post-surgery may increase patient risk for the occurrence and severity of corneal adverse events.

5.5Contact Lens Wear Ketorolac tromethamine ophthalmic solution should not be administered while wearing contact lenses.

🤒 Adverse Reactions ~2 min read

6 ADVERSE REACTIONS The most frequent adverse reactions reported by up to 40% of patients participating in clinical trials have been transient stinging and burning on instillation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Studies Experience Because cli nical studies are conducted under wi dely var ying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to t he rates in the clinical studies of another drug and may not reflect t he rates observed in practice. The most fr equent adverse react ions reported with the use of k etorolac tro meth a mine ophthal mic solutio ns have been tra nsient stin gi ng and burni ng on instillation. These reactions were reported by up to 40% of patie nts partici pating in clinic al t rials.

Other adverse reactions occurring approxi mately 1 to 10% of the ti me during tre at ment with ketor olac tr ometh a mine ophthal mic solutio ns inc luded aller gic reactions, corneal ede ma, iritis, ocular inflammation, ocular ir rit ati on, super fici al ker atitis, and super ficial ocular in fectio ns. Other adverse reactions reported rarely with the use of ketorolac tro metha mine ophthal mic solutio ns included: c orneal infiltrates, corneal ulcer, eye dry ness, headac hes , and visual disturbance (blurry vision).

6.2Postmarketing Experience The following adverse reactions have been identified during postmarketing use of ketorolac tromethamine ophthalmic solution 0.5% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to topical ketorolac tromethamine ophthalmic solution 0.5% or a combination of these factors, include bronchospasm or exacerbation of asthma, corneal erosion, corneal perforation, corneal thinning, and epithelial breakdown [see Warnings and Precautions ( 5.2 , 5.4 )].

👥 Use in Specific Populations ~1 min read

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Teratogenic Effects. P regnancy Category C Pregnancy Category C: Ketorolac tr o metha min e, ad ministered during organogenesis, was not teratogenic in rabbits and rats at oral doses of 3.6 mg/kg/day and 10 mg/ kg/day, respectively. These doses are approxi mately 100 ti mes and 250 ti mes higher respectively than the max i m um recom mended hu man topical op hthal mic daily d ose of 2 mg (5 mg / mL x 0.05 mL/drop, x 4 drops x 2 eyes) to affected eyes on a mg/kg basis.

Additionally, when ad ministered to rats after Day 17 of gestation at oral doses up to 1.5 mg/ k g/day (approxi mately 40 ti mes the typical hu man topical ophthal mic daily dose), ketorolac tro me tha mine resulted in dystocia and increased pup mortality. There are no adequate a nd well-controlled studies in pregnant w o men. Keto ro lac t ro met ham ine op htha lm ic so lut i on should be used during pregnancy only if the potential bene fit j usti fies the p otential risk to the fetus.

Nonterato genic Effect s: Because of the known effects of prostaglandin-inhibiting drugs on the fetal c ardio vascul ar syst em (closure of the ductus art eriosu s), the use of keto ro lac t ro met ham ine op htha lm ic so lut i on during late pregnancy should be avoided.

8.3Nursing Mothers Because many drugs are excreted in human milk, caution should be exercised when ketorolac tromethamine ophthalmic solution is administered to a nursing woman.

8.4Pediatric Use Safety and efficacy in pediatric patients bel ow t he age of 2 have not been esta blished.

8.5Geriatric Use No overall clinical di fferences in sa fety or effectiveness have been observed between elderly and other ad ult patie nts.

🤰 Pregnancy ~1 min read

8.1Pregnancy Teratogenic Effects. P regnancy Category C Pregnancy Category C: Ketorolac tr o metha min e, ad ministered during organogenesis, was not teratogenic in rabbits and rats at oral doses of 3.6 mg/kg/day and 10 mg/ kg/day, respectively. These doses are approxi mately 100 ti mes and 250 ti mes higher respectively than the max i m um recom mended hu man topical op hthal mic daily d ose of 2 mg (5 mg / mL x 0.05 mL/drop, x 4 drops x 2 eyes) to affected eyes on a mg/kg basis.

Additionally, when ad ministered to rats after Day 17 of gestation at oral doses up to 1.5 mg/ k g/day (approxi mately 40 ti mes the typical hu man topical ophthal mic daily dose), ketorolac tro me tha mine resulted in dystocia and increased pup mortality. There are no adequate a nd well-controlled studies in pregnant w o men. Keto ro lac t ro met ham ine op htha lm ic so lut i on should be used during pregnancy only if the potential bene fit j usti fies the p otential risk to the fetus.

Nonterato genic Effect s: Because of the known effects of prostaglandin-inhibiting drugs on the fetal c ardio vascul ar syst em (closure of the ductus art eriosu s), the use of keto ro lac t ro met ham ine op htha lm ic so lut i on during late pregnancy should be avoided.

🧒 Pediatric Use 21 words

8.4Pediatric Use Safety and efficacy in pediatric patients bel ow t he age of 2 have not been esta blished.

🧓 Geriatric Use 24 words

8.5Geriatric Use No overall clinical di fferences in sa fety or effectiveness have been observed between elderly and other ad ult patie nts.

🧬 Clinical Pharmacology ~1 min read

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Ketorolac tr o metha mine is a nonsteroidal ant i-inflammatory drug which, when a d ministered syste micall y, has de monstrated anal gesic, a nti-inflam matory, and anti-pyretic activity. The mechani sm of its action is thought to be due to i ts ability to inhibit prostaglandin biosynthesis.

12.3Pharmacokinetics Two drops of 0.5% ketorolac tro metha mine ophthal mic solution instilled into the eyes of patients 12 hours and 1 hour prior to cataract extraction achieved a mean ketorolac concentration of 95 ng/ mL in the aqueous h u mor of 8 of 9 eyes tested (range 40 to 170 ng/mL). One drop of 0.5% ketorolac tro metha mine ophthal mic solution was instilled into 1 eye and 1 drop of vehicle into the other eye TID in 26 healthy subjects. Five (5) of 26 subjects had dete ctable concent ratio ns of ketorol ac in th eir plas ma (range 11 to 23 ng/mL) at Day 10 during topical ocular treat ment.

The range of concent rations following TID dosing of 0.5% ketorolac tro metha mi ne ophthal mic solution are approxi mately 4 to 8% of the steady state mean min i m um plas ma concentration observed following four ti mes daily oral a d ministration of 10 mg ketorolac in hu mans (290 ± 70 ng/mL).

🧬 Mechanism of Action 53 words

12.1Mechanism of Action Ketorolac tr o metha mine is a nonsteroidal ant i-inflammatory drug which, when a d ministered syste micall y, has de monstrated anal gesic, a nti-inflam matory, and anti-pyretic activity. The mechani sm of its action is thought to be due to i ts ability to inhibit prostaglandin biosynthesis.

📦 How Supplied / Storage and Handling 82 words

16 HOW SUPPLIED/STORAGE AND HANDLING Ketorolac tromethamine ophthalmic solution 0.5% is supplied sterile in white opaque LDPE dropper bottles with white opaque plug and sealed with gray pantone opaque pilfer-proof caps as follows: 3 mL in 5 mL bottle NDC 47335-219-90 5 mL in 5 mL bottle NDC 47335-220-90 10 mL in 10 mL bottle NDC 47335-221-90 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature]. Protect from light.

📋 Description ~1 min read

11 DESCRIPTION Keto ro lac t ro met ham ine op htha lm ic so lut i on 0.5% is a m ember of the pyrrolo-­pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthal mic use. Its che mical na me is (±)-5-Benzoyl-2, 3-dihydro-1H pyrrolizi ne-1-carboxylic acid co m pound with 2-a mino-2-(hydroxy methyl)-1,3-propanediol ( 1:1) and it has the following structure: Keto ro lac t ro met ham ine op htha lm ic so lut i on is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. Keto ro lac t ro met ham ine op htha lm ic so lut i on is a race mic m ixture of R-(+) and S-(-)- ketor olac tro metha mine.

Ketorol ac tro methamine may exist in t hree cr ystal for ms. All for ms are equally soluble in water. The pKa of ketorolac is 3.5.

This white to o ff-white c rystalline su bstance discolors on prolonged exposure to light. The m o lecular weight of ketorolac tro metha mine is 376.41. The os molality of keto ro lac t ro met ham ine op htha lm ic so lut i on is 290 m O s mol/kg.

Each mL of ketorolac tromethamine ophthalmic solution contains: Active: ketorolac tromethamine USP 0.5%. Preservative: benzalkonium chloride solution (50%) NF 0.02%. Inactives: edetate disodium USP 0.1%; octoxynol 40; water for injection USP; sodium chloride USP; hydrochloric acid NF and/or sodium hydroxide NF to adjust the pH. ketorolac-structure

💬 Information for Patients ~1 min read

17 PATIENT COUNSELING INFORMATION

17.1Slow or Delayed Healing Patie nts sh ould be in fo r med of the possibility that slow or delayed healing may occur while using nonsteroidal anti-inflammatory drugs (NSAIDs).

17.2Avoiding Contamination of the Product Patie nts sh ould be in str ucted to avoid allow ing the tip of the bottle to co ntact the eye or surrounding structures because this could cause the tip to beco me cont a m inated by common bacteria kn own to cause ocular infections. Serious da mage to the eye and subsequent loss of vision may result from using contaminated solutions. Also, to avoid the potential for cross-conta mina tion, the patient should be advised to use one bottle for e ach eye foll owing bil ate ral ocular s u rgery.

The use of the s a me bottle of topic al eye drops for both eyes following bilateral ocular surgery is not recom mend ed.

17.3Contact Lens Wear Patients should be advised that keto ro lac t ro met ham ine op htha lm ic so lut i on should not be ad ministered while wearing contact lenses.

17.4Intercurrent Ocular Conditions Patients should be advised that if they develop an intercurrent ocular condition (e.g., trau ma or infection) or have ocular surgery, they should i mmediately seek their physician’s advice concerning the continued use of keto ro lac t ro met ham ine op htha lm ic so lut i on.

17.5Concomitant Topical Ocular Therapy Patie nts sh ould be advi sed that if m ore than one topical op ht hal mic medication is being used, the medicines should be ad ministered at least 5 minutes apart. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 PJPI0496A ISS. 07/2017

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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.