Acular LS

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

It is not likely that other drugs you take orally or inject will have an effect on ketorolac used in the eyes. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

In the U.S.

• Acular
• Acular LS
• Acular PF
• Acuvail

In Canada

• Apo-Ketorolac
• Ratio-Ketorolac

Available Dosage Forms:

• Solution

Therapeutic Class: Ophthalmologic Agent

Pharmacologic Class: Ketorolac

Chemical Class: Ketorolac

This section provides information on the proper use of a number of products that contain ketorolac. It may not be specific to Acular LS. Please read with care.

Your eye doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to. This medicine is not for long-term use.

This medicine can be used with other ophthalmic (eye) medicines. Wait at least 5 minutes before using another eye medicine.

If you or your child are wearing contact lenses, remove them while you are using this medicine. Talk to your eye doctor about this if you have questions.

If you are using this medicine after an eye surgery, use one bottle for each eye only. Use of the same bottle of eye drops for both eyes is not recommended.

To use the eye drops:

• First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed for 1 or 2 minutes to allow the medicine to be absorbed by the eye.
• Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.
• If you think you did not get the drop of medicine into your eye properly, use another drop.
• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, always keep the container tightly closed.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For ophthalmic dosage form (eye drops):
  • For relief of eye itching caused by seasonal allergic conjunctivitis:
    • Adults and children 2 years of age and older—Use one drop in the affected eye(s) 4 times a day.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
  • For eye swelling following cataract surgery:
    • Adults and children 2 years of age and older—Use one drop in the affected eye(s) 4 times a day beginning 24 hours after surgery and for 2 weeks after the surgery.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
  • For eye pain, burning, or stinging following corneal refractive surgery:
    • Adults and children 3 years of age and older—Use one drop in the affected eye(s) 4 times a day for up to 4 days after the surgery.
    • Children younger than 3 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Recommended Dosing

The recommended dose of Acular LS® ophthalmic solution is one drop four times a day in the operated eye as needed for pain and burning/stinging for up to 4 days following corneal refractive surgery.

Use With Other Topical Ophthalmic Medications

Acular LS® has been safely administered in conjunction with other topical ophthalmic medications such as alpha-agonists, antibiotics, beta-blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics. Drops should be administered at least 5 minutes apart.

Delayed Healing

Topical nonsteroidal anti-inflammatory drugs (NSAIDs) may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.

Cross-Sensitivity or Hypersensitivity

There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs. There have been reports of bronchospasm or exacerbation of asthma associated with the use of ketorolac tromethamine ophthalmic solution in patients who have either a known hypersensitivity to aspirin/non-steroidal anti-inflammatory drugs or a past medical history of asthma. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.

Increased Bleeding Time

With some NSAIDs, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti-inflammatory drugs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery.

It is recommended that Acular LS® ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications, which may prolong bleeding time.

Corneal Effects

Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration, or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health.

Postmarketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening. Topical NSAIDs should be used with caution in these patients.

Postmarketing experience with topical NSAIDs also suggests that use more than 1 day prior to surgery or use beyond 14 days post-surgery may increase patient risk for the occurrence and severity of corneal adverse events.

Contact Lens Wear

Acular LS® should not be administered while wearing contact lenses.

The following serious adverse reactions are described elsewhere in the labeling:

• Delayed Healing [see Warnings and Precautions (5.1)]
• Cross-Sensitivity or Hypersensitivity [see Warnings and Precautions (5.2)]
• Increased Bleeding Time [see Warnings and Precautions (5.3)]
• Corneal Effects[see Warnings and Precautions (5.4)]

Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

The most frequently reported adverse reactions for Acular LS® ophthalmic solution occurring in approximately 1 to 5% of the overall study population were conjunctival hyperemia, corneal infiltrates, headache, ocular edema, and ocular pain.

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 in 1 to 10% of the time during treatment with other ketorolac tromethamine ophthalmic solutions included allergic reactions, corneal edema, iritis, ocular inflammation, ocular irritation, superficial keratitis, and superficial ocular infections.

Other adverse reactions reported rarely with the use of ketorolac tromethamine ophthalmic solutions included: corneal ulcer, eye dryness, and visual disturbance (blurry vision).

Postmarketing Experience

The following adverse reactions have been identified during postmarketing use of ketorolac tromethamine ophthalmic solutions in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reactions, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to topical ketorolac tromethamine ophthalmic solutions or a combination of these factors, include bronchospasm or exacerbation of asthma, corneal erosion, corneal perforation, corneal thinning and corneal melt, and epithelial breakdown [see Warnings and Precautions (5.2, 5.4)].

Applies to ketorolac ophthalmic: ophthalmic solution

Along with its needed effects, ketorolac ophthalmic (the active ingredient contained in Acular LS) 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 while taking ketorolac ophthalmic:

• 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

• Blurred vision or other change in vision
• eye irritation or redness

Some side effects of ketorolac ophthalmic 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:

• Stinging or burning of the eye when medicine is applied

• Dry eyes
• headache

Applies to ketorolac ophthalmic: ophthalmic solution

General

The most frequently reported side effects were transient stinging and burning on instillation.[Ref]

Ocular

Common (1% to 10%): Intraocular pressure increased, conjunctival hyperemia, conjunctival hemorrhage, corneal edema, ocular pain, tearing, vision blurred, corneal infiltrates, ocular edema, iritis, ocular inflammation, ocular irritation, superficial keratitis, superficial ocular infection, conjunctivitis, ocular pruritus, keratic precipitates, retinal hemorrhage, cystoid macular edema, eye trauma, ptosis, blepharitis, photophobia, corneal lesion, glaucoma
Uncommon (0.1% to 1%): Ulcerative keratitis, eye dryness, epiphora, corneal ulcer
Postmarketing reports: Corneal erosion, corneal perforation, corneal thinning, corneal melt, epithelial breakdown[Ref]

Local

Very common (10% or more): Transient stinging (up to 40%), burning (up to 40%)
Common (1% to 10%): Local allergic reaction[Ref]

Nervous system

Common (1% to 10%): Headache[Ref]

Respiratory

Postmarketing reports: Bronchospasm, asthma exacerbated[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity reaction[Ref]

Some side effects of Acular LS may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.