HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ACULAR ® safely and effectively. See full prescribing information for ACULAR ®.
ACULAR ® (ketorolac tromethamine ophthalmic solution) 0.5%
Initial U.S. Approval: 1991
INDICATIONS AND USAGE
ACULAR® 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
One drop of ACULAR® 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 ACULAR® 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)
DOSAGE FORMS AND STRENGTHS
Ophthalmic solution containing 5 mg/mL ketorolac tromethamine. (3)
10 mL size bottle filled with 5 mL of solution
CONTRAINDICATIONS
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)
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 Allergan at 1-800-433-8871 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 12/2011
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosing 2.2 Use with Other Topical Ophthalmic Medications 3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Delayed Healing 5.2 Cross-Sensitivity or Hypersensitivity 5.3 Increased Bleeding Time 5.4 Corneal Effects 5.5 Contact Lens Wear 6 ADVERSE REACTIONS
6.1 Clinical Studies Experience 6.2 Postmarketing Experience 8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy 8.3 Nursing Mothers 8.4 Pediatric Use 8.5 Geriatric Use 11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
17.1 Slow or Delayed Healing 17.2 Avoiding Contamination of the Product 17.3 Contact Lens Wear 17.4 Intercurrent Ocular Conditions 17.5 Concomitant Topical Ocular Therapy * Sections or subsections omitted from the full prescribing information are not listed. Close
1 INDICATIONS AND USAGE
ACULAR® ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. ACULAR® 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 Dosing
Patient Dosing
The recommended dose of ACULAR® ophthalmic so