Acular

Name: Acular

What Is Ketorolac Ophthalmic?

Ketorolac is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Ketorolac works by reducing hormones that cause inflammation and pain in the body.

Ketorolac ophthalmic (for the eye) is used to relieve eye itching caused by seasonal allergies.

Ketorolac ophthalmic is also used to reduce swelling, pain, and burning or stinging after cataract surgery or corneal refractive surgery.

Ketorolac ophthalmic may also be used for other purposes not listed in this medication guide.

You should not use this medication if you are allergic to ketorolac or other NSAIDs (nonsteroidal anti-inflammatory drugs).

Before using ketorolac ophthalmic, tell your doctor if you are allergic to any medications, or if you have a bleeding or blood-clotting disorder, diabetes, arthritis, glaucoma, dry eye syndrome, or if you have had other recent eye surgeries.

Tell your doctor about all other medications you use, especially a blood thinner such as warfarin (Coumadin).

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label. Using the medication for longer than prescribed may increase the risk of serious side effects on your eyes.

While you are using this medication, do not wear any contact lens that has not been approved by your doctor. Do not use any other eye medications unless your doctor has prescribed them.

You should not use this medication if you are allergic to ketorolac or other NSAIDs.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

  • a bleeding or blood-clotting disorder;
  • diabetes;
  • arthritis;
  • glaucoma;
  • dry eye syndrome; or
  • if you have had other recent eye surgeries.

FDA pregnancy category C. It is not known whether ketorolac ophthalmic is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether ketorolac ophthalmic passes into breast milk or if it could harm a nursing baby. Do not use ketorolac ophthalmic without telling your doctor if you are breast-feeding a baby.

What should I do if I forget a dose?

Instill the missed dose as soon as you remember it. However, if is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not instill a double dose to make up for a missed one.

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

In case of emergency/overdose

If someone swallows ketorolac eye drops, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What brand names are available for ketorolac tromethamine-ophthalmic?

Acular, Acular LS, Acuvail

Indications

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.

What are some other side effects of Acular?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Eye irritation.
  • Burning.
  • Stinging.
  • Blurred eyesight.
  • Headache.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Patient Counseling Information

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).

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.

Contact Lens Wear

Patients should be advised that Acular® solution should not be administered while wearing contact lenses.

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®.

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


ALLERGAN

NDC 0023-2181-05

Acular®

(ketorolac

tromethamine

ophthalmic

solution)

0.5%

sterile Rx only

5 mL

Acular 
ketorolac tromethamine solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0023-2181
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ketorolac Tromethamine (Ketorolac) Ketorolac Tromethamine 5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
benzalkonium chloride  
edetate disodium  
octoxynol-40  
water  
sodium chloride  
hydrochloric acid  
sodium hydroxide  
Packaging
# Item Code Package Description
1 NDC:0023-2181-05 1 BOTTLE, DROPPER (1 BOTTLE) in 1 CARTON
1 5 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019700 12/01/1992
Labeler - Allergan, Inc. (144796497)
Establishment
Name Address ID/FEI Operations
Allergan, Inc. 362898611 MANUFACTURE(0023-2181)
Revised: 06/2012   Allergan, Inc.

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  • Allergy Drugs: Prescription and OTC
  • Eye Allergy
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