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Acular

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Acular

ACULAR®
(ketorolac tromethamine) Ophthalmic Solution

DRUG DESCRIPTION

ACULAR® (ketorolac tromethamine ophthalmic solution) 0.5% is a member of the pyrrolopyrrole 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 it has the following structure:

ACULAR® (ketorolac tromethamine) Structural Formula Illustration

ACULAR® ophthalmic solution is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. ACULAR® ophthalmic solution is 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 molecular weight of ketorolac tromethamine is 376.41. The osmolality of ACULAR® ophthalmic solution is 290 mOsmol/kg.

Each mL of ACULAR® ophthalmic solution contains: Active: ketorolac tromethamine 0.5%. Preservative: benzalkonium chloride 0.01%. Inactives: edetate disodium 0.1%; octoxynol 40; purified water; sodium chloride; hydrochloric acid and/or sodium hydroxide to adjust the pH.

What are the possible side effects of ketorolac ophthalmic (Acular, Acular LS, Acular PF, Acuvail)?

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,...

Read All Potential Side Effects and See Pictures of Acular »

What are the precautions when taking ketorolac tromethamine (Acular)?

Before using ketorolac, tell your doctor or pharmacist if you are allergic to it; or to aspirin, other NSAIDs (e.g., ibuprofen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, previous eye surgery,...

Read All Potential Precautions of Acular »

Last reviewed on RxList: 6/29/2012
This monograph has been modified to include the generic and brand name in many instances.

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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