FDA

Ketorolac Tromethamine

Approved 5 Nov 2009EyeSolution/drops

The FDA lists this product in 60 strengths and forms.

Indications

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

Contraindications

Ketorolac tromethamine 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 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.

At a glance

Brand name: Ketorolac Tromethamine
Route: Eye
Dosage form: Solution/drops
Applicant: Apotex
Status: Prescription
FDA approval: 5 Nov 2009
Application: ANDA076109-001

Indications

The treatment of inflammation following cataract surgery.
The temporary relief of ocular itching due to seasonal allergic conjunctivitis ( 1 ).

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

5.2Cross-Sensitivity or Hypersensitivity

5.3Increased Bleeding Time

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 Apotex Corp. at 1-800-706-5575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies 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, corneal edema, iritis, ocular inflammation, ocular irritation, 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).

6.2Postmarketing Experience

The following adverse reactions have been identified during post-marketing 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 )] .

Ketorolac Tromethamine

Indications

Contraindications

Warnings and precautions

5.1Delayed Healing

5.2Cross-Sensitivity or Hypersensitivity

5.3Increased Bleeding Time

At a glance

Two medicines in one question?

Ketorolac Tromethamine

Indications

Contraindications

Warnings and precautions

5.1Delayed Healing

5.2Cross-Sensitivity or Hypersensitivity

5.3Increased Bleeding Time

At a glance

Two medicines in one question?

5.4Corneal Effects Use

5.5Contact Lens Wear

Pregnancy and breastfeeding

8.1Pregnancy Teratogenic Effects. Pregnancy Category C Pregnancy Category C:

Adverse reactions

6.1Clinical Studies Experience

6.2Postmarketing Experience

Composition

Strengths and forms

Official product information