KETOROLAC TROMETHAMINE
Generic: KETOROLAC TROMETHAMINE
Basic Information
Manufacturer
Sandoz Inc
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
OPHTHALMIC
FDA Set ID
79e29a86-1b44-4d95-8d84-5a2e8f23ddcf
Indications & Usage
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 drug (NSAID) indicated for: • The temporary relief of ocular itching due to seasonal allergic conjunctivitis.
( 1 ) • The treatment of inflammation following cataract surgery.
( 1 ) •
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 drug (NSAID) indicated for: • The temporary relief of ocular itching due to seasonal allergic conjunctivitis.
( 1 ) • The treatment of inflammation following cataract surgery.
( 1 ) •
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: • Delayed Healing [see Warnings and Precautions ( 5.1 )] • Cross-Sensitivity or Hypersensitivity [see Warnings and Precautions ( 5.2 )] • Increased Bleeding Time [see Warnings and Precautions ( 5.3 )] • Corneal Effects [see Warnings and Precautions ( 5.4 )] 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 Sandoz Inc., at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc., at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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.