Acuvail

Name: Acuvail

Why is this medication prescribed?

Ophthalmic ketorolac is used to treat itchy eyes caused by allergies. It also is used to treat swelling and redness (inflammation) that can occur after cataract surgery. Ketorolac is in a class of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). It works by stopping the release of substances that cause allergy symptoms and inflammation.

Do I need a prescription for ketorolac tromethamine-ophthalmic?

Yes

Side effects

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] and ulcerative keratitis.

What should I discuss with my healthcare provider before I use ketorolac ophthalmic?

You should not use this medicine if you are allergic to ketorolac. Tell your doctor if you are allergic to any other NSAIDs, such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

To make sure ketorolac ophthalmic is safe for you, tell your doctor if you have:

  • a bleeding or blood-clotting disorder;

  • diabetes;

  • arthritis;

  • glaucoma;

  • dry eye syndrome; or

  • a condition for which you take a blood thinner such as warfarin (Coumadin, Jantoven).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant.

It is not known whether ketorolac ophthalmic passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medicine to a child without medical advice.

Uses of Acuvail

  • It is used to treat swelling and pain after cataract surgery.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Ketorolac tromethamine was not carcinogenic in either rats given up to 5 mg/kg/day orally for 24 months or in mice given 2 mg/kg/day orally for 18 months. These doses are approximately 900 times and 300 times higher respectively than the typical human topical ophthalmic daily dose given as twice daily to an affected eye on a mg/kg basis.

Ketorolac tromethamine was not mutagenic in vitro in the Ames assay or in forward mutation assays. Similarly, it did not result in an in vitro increase in unscheduled DNA synthesis or an in vivo increase in chromosome breakage in mice. However, ketorolac tromethamine did result in an increased incidence in chromosomal aberrations in Chinese hamster ovary cells.

Ketorolac tromethamine did not impair fertility when administered orally to male and female rats at doses up to 9 mg/kg/day and 16 mg/kg/day, respectively. These doses are respectively 1500 and 2700 times higher than the typical human topical ophthalmic daily dose.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

  • Hemophilia or other bleeding problems—The possibility of bleeding may be increased.
  • Viral eye infection (epithelial herpes simplex keratitis), or a history of having a viral eye infection—It is possible that a current infection could be made worse or an old infection could return.
  • Use of soft contact lenses—Eye irritation, such as redness and burning of the eyes, may occur.

What is ketorolac ophthalmic (acular, acular ls, acular pf, acuvail)?

Ketorolac is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Ketorolac 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 other purposes not listed in this medication guide.

What other drugs will affect Acuvail?

Tell your doctor about all other medications you use, especially a blood thinner such as warfarin (Coumadin).

This list is not complete and there may be other drugs that can interact with Acuvail. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

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