Acular LS

Name: Acular LS

What is Acular LS (ketorolac ophthalmic)?

Ketorolac is a nonsteroidal anti-inflammatory drug (NSAID) that 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 purposes not listed in this medication guide.

Acular LS (ketorolac ophthalmic) side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe burning, stinging, or itching of your eyes;

  • a wound that will not heal;

  • eye pain, redness, or watering;

  • vision changes, increased sensitivity to light;

  • white patches on your eyes; or

  • crusting or drainage from your eyes.

Common side effects may include:

  • mild eye pain, stinging, or redness;

  • blurred vision;

  • watery eyes;

  • swollen or puffy eyelids; or

  • headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Acular LS Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Itching, redness, tearing, or other sign of eye irritation not present before use of this medicine or becoming worse during use
  • redness of the clear part of the eye
  • sensitivity to light
  • swelling of the eye
  • tearing
  • throbbing pain
Rare
  • Blurred vision or other change in vision
  • eye irritation or redness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Stinging or burning of the eye when medicine is applied
Rare
  • Dry eyes
  • headache

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Use in specific populations

Pregnancy

Risk Summary

There are no adequate or well-controlled studies with Acular LS® in pregnant women. No evidence of teratogenicity has been observed in rats or rabbits with Acular LS® at clinically relevant doses.

Lactation

Risk Summary

It is not known whether ketorolac when given topically is present in human milk. Because many drugs are excreted in human mik, caution should be exercised when Acular LS® is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of ketorolac tromethamine in pediatric patients below the age of 3 have not been established.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

Acular LS - Clinical Pharmacology

Mechanism of Action

Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug which, when administered systemically, has demonstrated analgesic, anti-inflammatory, and anti-pyretic activity. The mechanism of its action is thought to be due to its ability to inhibit prostaglandin biosynthesis.

Pharmacokinetics

One drop of 0.5% ketorolac tromethamine ophthalmic solution was instilled into one eye and one drop of vehicle into the other eye TID in 26 healthy subjects. Five of 26 subjects had detectable concentrations of ketorolac in their plasma (range 11 to 23 ng/mL) at day 10 during topical ocular treatment.

Two drops of 0.5% ketorolac tromethamine ophthalmic solution instilled into the eyes of patients 12 hours and 1 hour prior to cataract extraction achieved a mean ketorolac concentration of 95 ng/mL in the aqueous humor of 8 of 9 eyes tested (range 40 to 170 ng/mL).

Patient Counseling Information

Slow or Delayed Healing

Inform patients of the possibility that slow or delayed healing may occur while using nonsteroidal anti-inflammatory drugs (NSAIDs).

Avoiding Contamination of the Product

Instruct patients 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

Advise patients that Acular LS® solution should not be administered while wearing contact lenses.

Intercurrent Ocular Conditions

Advise patients 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 LS®.

Concomitant Topical Ocular Therapy

Advise patients that if more than one topical ophthalmic medication is being used, the medicines should be administered at least 5 minutes apart.

© 2016 Allergan. All rights reserved.
Irvine, CA 92612, U.S.A.
All trademarks are the property of their respective owners.
Patented: See: www.allergan.com/products/patents
Made in the U.S.A.

71654US15

ALLERGAN

NDC 0023-9277-05

Acular LS®

(ketorolac tromethamine
ophthalmic solution) 0.4%

sterile Rx only

5 mL

Acular LS  
ketorolac tromethamine solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0023-9277
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ketorolac tromethamine (ketorolac) ketorolac tromethamine 4 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
edetate disodium  
octoxynol-40  
water  
sodium chloride  
benzalkonium chloride  
hydrochloric acid  
sodium hydroxide  
Packaging
# Item Code Package Description
1 NDC:0023-9277-05 1 BOTTLE, DROPPER 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 NDA021528 08/19/2003
Labeler - Allergan, Inc. (144796497)
Establishment
Name Address ID/FEI Operations
Allergan, Inc. 362898611 MANUFACTURE(0023-9277)
Revised: 06/2016   Allergan, Inc.
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