ACUVAIL
Generic: KETOROLAC TROMETHAMINE
Basic Information
Manufacturer
Allergan, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
OPHTHALMIC
FDA Set ID
3cea5803-a446-4d2c-9747-f3fb034332c8
Indications & Usage
1 INDICATIONS AND USAGE ACUVAIL ® is indicated for the treatment of pain and inflammation following cataract surgery.
ACUVAIL is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of pain and inflammation following cataract surgery.
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ACUVAIL is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of pain and inflammation following cataract surgery.
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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 )] Most common adverse reactions occurring in 1% to 6% of patients were increased intraocular pressure, conjunctival hemorrhage, and vision blurred.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-678-1605 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 common adverse reactions were reported in 1% to 6% of patients and included increased intraocular pressure, conjunctival hyperemia and/or hemorrhage, corneal edema, ocular pain, headache, tearing and vision blurred.
Some of these reactions may be the consequence of the cataract surgical procedure.
Other adverse reactions occurring during treatment with ketorolac tromethamine ophthalmic solutions included allergic reactions (including eye swelling, hyperemia, and pruritis).
6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of ketorolac tromethamine ophthalmic solutions 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 corneal melt, epithelial breakdown [see Warnings and Precautions ( 5.2 , 5.4 )] , and ulcerative keratitis.
Respiratory, Thoracic and Mediastinal Disorders : Bronchospasm, exacerbation of asthma.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-678-1605 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 common adverse reactions were reported in 1% to 6% of patients and included increased intraocular pressure, conjunctival hyperemia and/or hemorrhage, corneal edema, ocular pain, headache, tearing and vision blurred.
Some of these reactions may be the consequence of the cataract surgical procedure.
Other adverse reactions occurring during treatment with ketorolac tromethamine ophthalmic solutions included allergic reactions (including eye swelling, hyperemia, and pruritis).
6.2 Postmarketing Experience The following adverse reactions have been identified during postapproval use of ketorolac tromethamine ophthalmic solutions 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 corneal melt, epithelial breakdown [see Warnings and Precautions ( 5.2 , 5.4 )] , and ulcerative keratitis.
Respiratory, Thoracic and Mediastinal Disorders : Bronchospasm, exacerbation of asthma.