225 and 400 times higher than the typical human topical ophthalmic daily dose.
14 CLINICAL STUDIES
Two controlled clinical studies showed that ketorolac tromethamine ophthalmic solution was significantly more effective than its vehicle in relieving ocular itching caused by seasonal allergic conjunctivitis.
Two controlled clinical studies showed that patients treated for two weeks with ketorolac tromethamine ophthalmic solution were less likely to have measurable signs of inflammation (cell and flare) than patients treated with its vehicle.
Results from clinical studies indicate that ketorolac tromethamine has no significant effect upon intraocular pressure; however, changes in intraocular pressure may occur following cataract surgery.
16 HOW SUPPLIED/STORAGE AND HANDLING
ACULAR® (ketorolac tromethamine ophthalmic solution) 0.5% is supplied sterile, in white opaque plastic LDPE bottles with white droppers, with gray high impact polystyrene (HIPS) caps as follows:
5 mL in 10 mL bottle NDC 0023-2181-05
Storage: Store at 15°-25°C (59°-77°F). Protect from light.
17 PATIENT COUNSELING INFORMATION
17.1 Slow or Delayed Healing Patients should be informed of the possibility that slow or delayed healing may occur while using nonsteroidal anti-inflammatory drugs (NSAIDs).
17.2 Avoiding Contamination of the Product Patients should be instructed to avoid allowing the tip of the bottle to contact the eye or surrounding structures because this could cause the tip to become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
Also, to avoid the potential for cross-contamination, the patient should be advised to use one bottle for each eye following bilateral ocular surgery. The use of the same bottle of topical eye drops for both eyes following bilateral ocular surgery is not recommended.
17.3 Contact Lens Wear Patients should be advised that ACULAR® solution should not be administered while wearing contact lenses.
17.4 Intercurrent Ocular Conditions Patients should be advised that if they develop an intercurrent ocular condition (e.g., trauma or infection) or have ocular surgery, they should immediately seek their physician's advice concerning the continued use of ACULAR®.
17.5 Concomitant Topical Ocular Therapy Patients should be advised that if more than one topical ophthalmic medication is being used, the medicines should be administered at least 5 minutes apart.
© 2012 Allergan, Inc., Irvine, CA 92612, U.S.A.
ACULAR® is manufactured and distributed by Allergan, Inc. under license from its developer, Roche Palo Alto LLC, Palo Alto, CA, U.S.A.
® marks owned by Allergan, Inc.
Made in the U.S.A.
72379US10
PRINCIPAL DISPLAY PANEL
ALLERGAN
NDC 0023-2181-05
ACULAR®
(ketorolac
tromethamine
ophthalmic
solution)
0.5%
sterile Rx only
5 mL
INGREDIENTS AND APPEARANCE
ACULAR
ketorolac tromethamine solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0023-2181
Route of Administration OPHTHALMIC
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ketorolac Tromethamine (UNII: 4EVE5946BQ) (Ketorolac - UNI
