Acular PF

Name: Acular PF

Uses For Acular PF

Ketorolac eye drops is used to treat itching caused by seasonal allergic conjunctivitis (an allergy that occurs at only certain times of the year). It is also used to treat pain, burning, and inflammation of the eye following cataract surgery or corneal refractive surgery. This medicine is a topical nonsteroidal anti-inflammatory drug (NSAID).

This medicine is available only with your doctor's prescription.

Acular PF 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.

Acular PF - Clinical Pharmacology

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. Ketorolac tromethamine given systemically does not cause pupil constriction.

One drop (0.05 mL) of ketorolac tromethamine (preserved) was instilled into one eye and one drop of vehicle into the other eye TID in 26 normal subjects. Only 5 of 26 subjects had a detectable amount of ketorolac in their plasma (range 10.7 to 22.5 ng/mL) at day 10 during topical ocular treatment. When ketorolac tromethamine 10 mg is administered systemically every 6 hours, peak plasma levels at steady state are around 960 ng/mL.

In two double-masked, multi-centered, parallel-group studies, 340 patients who had undergone incisional refractive surgery received ACULAR® PF or its vehicle QID for up to 3 days. Significant differences favored ACULAR® PF for the treatment of ocular pain and photophobia.

Results from clinical studies indicate that ketorolac tromethamine has no significant effect upon intraocular pressure.

Indications and Usage for Acular PF

ACULAR® PF ophthalmic solution is indicated for the reduction of ocular pain and photophobia following incisional refractive surgery.

Warnings

There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other nonsteroidal anti-inflammatory agents. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.

With some nonsteroidal anti-inflammatory drugs, 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.

Adverse Reactions

The most frequent adverse events reported with the use of ketorolac tromethamine ophthalmic solutions have been transient stinging and burning on instillation. These events were reported by approximately 20% of patients participating in clinical trials.

Other adverse events occurring approximately 1 - 10% of the time during treatment with ketorolac tromethamine ophthalmic solutions included allergic reactions, corneal edema, iritis, ocular inflammation, ocular irritation, superficial keratitis, and superficial ocular infections.

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

Clinical Practice: The following events have been idientified during postmarketing use of ketorolac tromethamine ophthalmic solution 0.5% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to topical ketorolac tromethamine ophthalmic solution 0.5%, or a combination of these factors, include corneal erosion, corneal perforation, corneal thinning, and epithelial breakdown (see PRECAUTIONS, General).

How is Acular PF Supplied

ACULAR® PF (ketorolac tromethamine ophthalmic solution) 0.5% Preservative-Free is available as a sterile solution supplied in clear, LDPE, single-use vials as follows:

  ACULAR® PF 12 Single-Use Vials 0.4 mL each: NDC 0023-9055-04

Store ACULAR® PF at 15°C-30°C (59°F - 86°F) with protection from light.

Rx only

© 2004 Allergan
Irvine, CA 92612, U.S.A.

ACULAR® is a registered trademark of Roche L.L.C. ACULAR® PF is manufactured and distributed by ALLERGAN under license from its developer, Roche Palo Alto L.L.C., Palo Alto, California, U.S.A.

8718X
70899US13P

Acular PF 
ketorolac tromethamine solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0023-9055
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ketorolac tromethamine (ketorolac tromethamine) ketorolac tromethamine 5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
water  
sodium chloride  
sodium hydroxide  
hydrochloric acid  
Packaging
# Item Code Package Description
1 NDC:0023-9055-04 12 VIAL, SINGLE-USE (12 VIAL) in 1 CARTON
1 0.4 mL (0.4 MILLILITER) in 1 VIAL, SINGLE-USE
Labeler - Allergan
Revised: 02/2006   Allergan

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of Acular LS® eye drops in children younger than 3 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of Acular® eye drops in children younger than 2 years of age. Safety and efficacy have not been established.

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.

For the Consumer

Applies to ketorolac ophthalmic: ophthalmic solution

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

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 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:

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

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