Acuvail

Name: Acuvail

What is 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.

What is the most important information I should know about ketorolac ophthalmic?

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.

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

Indications and Usage for Acuvail

Acuvail® ophthalmic solution is indicated for the treatment of pain and inflammation following cataract surgery.

Adverse Reactions

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 the rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Clinical Studies Experience

The most common adverse reactions were reported in 1-6% of patients and included increased intraocular pressure, conjunctival hyperemia and/or hemorrhage, corneal edema, ocular pain, headache, tearing and vision blurred. Some of these reactions may be the consequence of the cataract surgical procedure.

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, exacerbation of asthma, corneal erosion, corneal perforation, corneal thinning and corneal melt, epithelial breakdown [see Warnings and Precautions (5.2, 5.4)], and ulcerative keratitis.

Acuvail Description

Acuvail® (ketorolac tromethamine ophthalmic solution) 0.45% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its chemical name is (±)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid, compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1), and its molecular weight is 376.40. Its molecular formula is C19H24N2O6. Its chemical structure is:

Acuvail® solution is supplied as a sterile isotonic aqueous 0.45% preservative-free solution, with a pH of approximately 6.8. Acuvail® solution contains a racemic mixture of R-(+) and S-(-)- ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. The pKa of ketorolac is 3.5. This white to off-white crystalline substance discolors on prolonged exposure to light. The osmolality of Acuvail® solution is approximately 285 mOsml/kg.

Each mL of Acuvail® ophthalmic solution contains: Active: ketorolac tromethamine 0.45%. Inactives: carboxymethylcellulose sodium; sodium chloride; sodium citrate dihydrate; and purified water with sodium hydroxide and/or hydrochloric acid to adjust pH.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of ketorolac is not likely to cause life-threatening symptoms.

For the Consumer

Applies to ketorolac ophthalmic: ophthalmic solution

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