Acular

Name: Acular

Ketorolac Ophthalmic Side Effects

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

Call your doctor at once if you have a serious side effect such as:

  • severe burning, stinging, or itching of your eyes;
  • eye pain, redness, or watering;
  • vision changes, increased sensitivity to light;
  • white patches on your eyes; or
  • crusting or drainage from your eyes.

Less serious side effects may include:

  • mild burning, stinging, or itching of your 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 (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.

Commonly used brand name(s)

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

Uses For Acular

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.

Uses of Acular

  • It is used to treat eye irritation due to allergies.
  • It is used to treat swelling and pain after cataract surgery.

Contraindications

Acular® solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation.

Warnings and Precautions

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® 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® should not be administered while wearing contact lenses.

What happens if i miss a dose (acular, acular ls, acular pf, acuvail)?

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

For the Consumer

Applies to ketorolac ophthalmic: ophthalmic solution

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

Ketorolac ophthalmic Pregnancy Warnings

Avoid use during third trimester of pregnancy. Prior to third trimester: Use only if the potential benefit justifies the potential risk to the fetus. AU TGA pregnancy category: C US FDA pregnancy category: C (0.45% and 0.5% ophthalmic solutions); Not assigned (0.4% ophthalmic solution) Risk summary (0.4% ophthalmic solution): No data available on use of this drug in pregnant women to inform a drug-related risk.

Animal studies have revealed evidence of dystocia and increased pup mortality at oral doses of 1.5 mg/kg/day (about 40 times the typical human ophthalmic daily dose). Prostaglandin inhibitors used during late pregnancy have demonstrated adverse effects on the fetal cardiovascular system, including closure of the fetal ductus arteriosus. There are no controlled data in human pregnancy. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

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