Acular - Ketorolac Tromethamine solution/ Drops
(Ketorolac Tromethamine)Acular - Ketorolac Tromethamine solution/ Drops Prescribing Information
Warnings and Precautions (
Risk of Contamination
ACULAR is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. ACULAR is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.
- For temporary relief of ocular itching due to seasonal allergic conjunctivitis, apply one drop of ACULAR to the affected eye(s) four times a day.
- For the treatment of postoperative inflammation in patients who have undergone cataract extraction, apply one drop of ACULARto the affected eye four times daily beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period. ()
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Recommended DosageTemporary Reliefof Ocular ItchingDueto Seasonal Allergic ConjunctivitisThe recommended dosage of ACULAR is one drop four times a day to the affected eye(s) for the temporary relief of ocular itching due to seasonal allergic conjunctivitis.
Treatmentof Postoperative Inflammationin Patients Who Have Undergone Cataract ExtractionApply one drop of ACULAR 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.
10 mL size bottle filled with 5 mL of ketorolac tromethamine ophthalmic solution, 0.5% (5 mg/mL).
There are no adequate and well-controlled studies with ACULAR in pregnant women. No evidence of teratogenicity has been observed in rats or rabbits with ACULAR 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.
Because of the known effects of prostaglandin-inhibiting drugs on the fetal cardiovascular system (closure of the ductus arteriosus), the use of ACULAR during late pregnancy should be avoided.
ACULAR solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation
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).