KETOROLAC TROMETHAMINE solution/ drops

Ketorolac Tromethamine by

Drug Labeling and Warnings

Ketorolac Tromethamine by is a Prescription medication manufactured, distributed, or labeled by Aurobindo Pharma Limited, Eugia Pharma Specialities Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 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.

  • 2 DOSAGE AND ADMINISTRATION

    2.1 Recommended Dosage

    Temporary Relief of Ocular Itching Due to Seasonal Allergic Conjunctivitis
    The recommended dosage of ketorolac tromethamine ophthalmic solution is one drop four times a day to the affected eye(s) for the temporary relief of ocular itching due to seasonal allergic conjunctivitis.

    Treatment of Postoperative Inflammation in Patients Who Have Undergone Cataract Extraction
    Apply one drop of ketorolac tromethamine ophthalmic solution to the affected eye four times daily beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period for the treatment of postoperative inflammation in patients who have undergone cataract extraction.


    2.2 Use 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.

  • 3 DOSAGE FORMS AND STRENGTHS


    10 mL size bottle filled with 5 mL of ketorolac tromethamine ophthalmic solution, 0.5% (5 mg/mL).

  • 4 CONTRAINDICATIONS


    Ketorolac tromethamine ophthalmic solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation [see Adverse Reactions (6.1)].

  • 5 WARNINGS AND PRECAUTIONS

    5.1 Delayed 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.

    5.2 Cross-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.

    5.3 Increased 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.

    5.4 Corneal 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.

    5.5 Risk of Contamination

    Avoid allowing the tip of the bottle to contact the eye or surrounding structures because this could cause the tip to become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

    5.6 Contact Lens Wear


    Ketorolac tromethamine ophthalmic solution should not be administered while wearing contact lenses.

  • 6 ADVERSE REACTIONS

    The following serious adverse reactions are described elsewhere in the labeling:


    6.1 Clinical Trials Experience

    Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug and may not reflect the rates observed in practice.

    The most frequent adverse reactions reported with the use of ketorolac tromethamine ophthalmic solutions have been transient stinging and burning on instillation. These reactions were reported by up to 40% of patients participating in clinical trials.

    Other adverse reactions occurring approximately 1% to 10% of the time during treatment with ketorolac tromethamine ophthalmic solutions included allergic reactions (including eye swelling, hyperemia, and pruritus), corneal edema, iritis, ocular inflammation, ocular irritation, ocular pain, superficial keratitis, and superficial ocular infections.

    Other adverse reactions reported rarely with the use of ketorolac tromethamine ophthalmic solutions included: corneal infiltrates, corneal ulcer, eye dryness, headaches, and visual disturbance (blurry vision).

    6.2 Postmarketing Experience


    The following adverse reactions have been identified during postapproval use of ketorolac tromethamine ophthalmic solution 0.5% in clinical practice. Because these 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 the drug.

    Eye Disorders: corneal erosion, corneal perforation, corneal thinning, and epithelial breakdown.
    Respiratory, Thoracic and Mediastinal Disorders: bronchospasm or exacerbation of asthma.

  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    Risk Summary
    There are no adequate and well-controlled studies with ketorolac tromethamine ophthalmic solution in pregnant women. No evidence of teratogenicity has been observed in rats or rabbits with ketorolac tromethamine ophthalmic solution at clinically relevant doses. 

    In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

    Clinical Considerations
    Because of the known effects of prostaglandin-inhibiting drugs on the fetal cardiovascular system (closure of the ductus arteriosus), the use of ketorolac tromethamine ophthalmic solution during late pregnancy should be avoided.


    8.2 Lactation

    Risk Summary
    It is not known whether ketorolac when given topically is present in human milk. Because many drugs are excreted in human milk, caution should be exercised when ketorolac tromethamine ophthalmic solution is administered to a nursing woman.

    8.4 Pediatric Use


    The safety and effectiveness of ketorolac tromethamine ophthalmic solution have not been established in pediatric patients younger than 2 years old.

    8.5 Geriatric Use


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

  • 11 DESCRIPTION

    Ketorolac tromethamine ophthalmic solution 0.5% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for topical ophthalmic use. Its chemical name is (±)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1) and it has the following structure:

    checmial-structure
    Ketorolac tromethamine ophthalmic solution is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. Ketorolac tromethamine ophthalmic solution contains a racemic mixture of R-(+) and S-(-)- ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. The pKa of ketorolac is 3.5. This white to off-white crystalline substance discolors on prolonged exposure to light. The molecular weight of ketorolac tromethamine is 376.41. The osmolality of ketorolac tromethamine ophthalmic solution is 290 mOsmol/kg.

    Each mL of ketorolac tromethamine ophthalmic solution contains: Active: ketorolac tromethamine USP 0.5%. Preservative: benzalkonium chloride 0.01%. Inactives: edetate disodium 0.1%; octoxynol 40; water for injection; sodium chloride; hydrochloric acid and/or sodium hydroxide to adjust pH.

  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action


    Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug which, when administered systemically, has demonstrated analgesic, anti-inflammatory, and anti-pyretic activity. The mechanism of its action is thought to be due to its ability to inhibit prostaglandin biosynthesis.

    12.3 Pharmacokinetics

    Two drops of 0.5% ketorolac tromethamine ophthalmic 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 humor of 8 of 9 eyes tested (range 40 to 170 ng/mL).

    One drop of 0.5% ketorolac tromethamine ophthalmic 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 detectable concentrations of ketorolac in their plasma (range 11 to 23 ng/mL) at Day 10 during topical ocular treatment. The range of concentrations following TID dosing of 0.5% ketorolac tromethamine ophthalmic solution are approximately 4 to 8% of the steady state mean minimum plasma concentration observed following four times daily oral administration of 10 mg ketorolac in humans (290 ± 70 ng/mL).

  • 14 CLINICAL STUDIES

    Two controlled clinical studies showed that ketorolac tromethamine ophthalmic solution was significantly more effective than its vehicle in relieving ocular itching caused by seasonal allergic conjunctivitis.

    Two controlled clinical studies showed that patients treated for two weeks with ketorolac tromethamine ophthalmic solution were less likely to have measurable signs of inflammation (cell and flare) than patients treated with its vehicle.

    Results from clinical studies indicate that ketorolac tromethamine has no significant effect upon intraocular pressure; however, changes in intraocular pressure may occur following cataract surgery.

  • 16 HOW SUPPLIED/STORAGE AND HANDLING


    Ketorolac tromethamine ophthalmic solution 0.5% is a clear colorless to slightly yellow solution supplied sterile, in a white opaque (LDPE) bottle with white opaque LDPE nozzle and gray color HDPE cap with a tamper evident ring as follows:

    5 mL in 10 mL bottle                        NDC: 65862-770-05

    Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.

  • 17 PATIENT COUNSELING INFORMATION

    Slow or Delayed Healing
    Advise patients of the possibility that slow or delayed healing may occur while using nonsteroidal anti-inflammatory drugs (NSAIDs).

    Avoiding Contamination of the Product
    Instruct patients to avoid allowing the tip of the bottle to contact the eye or surrounding structures because this could cause the tip to become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

    Contact Lens Wear
    Advise patients that ketorolac tromethamine ophthalmic solution should not be administered while wearing contact lenses.

    Intercurrent Ocular Conditions
    Advise patients that if they develop an intercurrent ocular condition (e.g., trauma or infection) or have ocular surgery, they should immediately seek their physician’s advice concerning the continued use of ketorolac tromethamine ophthalmic solution.

    Concomitant Topical Ocular Therapy
    Advise patients that if more than one topical ophthalmic medication is being used, the medicines should be administered at least 5 minutes apart.


    Distributed by:
    Aurobindo Pharma USA, Inc.
    279 Princeton-Hightstown Road
    East Windsor, NJ 08520

    Manufactured by:
    Eugia Pharma Specialities Limited
    Hyderabad - 500032
    India

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.5% (5 mL) - Container Label

    NDC: 65862-770-05
    Ketorolac
    Tromethamine
    Ophthalmic Solution
    0.5%
    For Topical Application in the Eye
    RX only  AUROBINDO

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.5% (5 mL) - Container Label

  • PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.5% (5 mL) - Container-Carton

    NDC: 65862-770-05
    Ketorolac
    Tromethamine
    Ophthalmic Solution
    0.5%
    For Topical Application in the Eye
    5 mL
    RX only    AUROBINDO

    PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 0.5% (5 mL) - Container-Carton

  • INGREDIENTS AND APPEARANCE
    KETOROLAC TROMETHAMINE 
    ketorolac tromethamine solution/ drops
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 65862-770
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    KETOROLAC TROMETHAMINE (UNII: 4EVE5946BQ) (KETOROLAC - UNII:YZI5105V0L) KETOROLAC TROMETHAMINE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    OCTOXYNOL-40 (UNII: 9T1C662FKS)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 65862-770-051 in 1 CARTON12/03/2020
    15 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20519012/03/2020
    Labeler - Aurobindo Pharma Limited (650082092)
    Establishment
    NameAddressID/FEIBusiness Operations
    EUGIA PHARMA SPECIALITIES LIMITED650498244ANALYSIS(65862-770) , MANUFACTURE(65862-770)
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