Acular

DRUG DESCRIPTION

ACULAR® (ketorolac tromethamine ophthalmic solution) 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 it has the following structure:

ACULAR® (ketorolac tromethamine) structural formula illustration

ACULAR® (ketorolac tromethamine) ophthalmic solution is supplied as a sterile isotonic aqueous 0.5% solution, with a pH of 7.4. ACULAR® (ketorolac tromethamine) 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® (ketorolac tromethamine) ophthalmic solution is 290 mOsmol/kg.

Each mL of ACULAR (ketorolac tromethamine) ® 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...

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 »


Acular Consumer (continued)

SIDE EFFECTS: This medication may temporarily sting or burn your eyes for 1-2 minutes when applied. Eye redness and headache may also occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: eye swelling, eye discharge.

Tell your doctor immediately if any of these rare but very serious side effects occur: vision changes, eye pain, bleeding inside the eye.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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, other eye problems (e.g., dry eye syndrome, corneal problems), diabetes, rheumatoid arthritis, asthma, nasal polyps.

Your vision may be temporarily unstable after applying this drug. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

This medication should be used only when clearly needed during the first 6 months of pregnancy. Avoid use during the last 3 months of pregnancy due to the potential for harm to an unborn baby. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Acular Patient Information Including Side Effects

Brand Names: Acular, Acular LS, Acular PF, Acuvail

Generic Name: ketorolac ophthalmic (Pronunciation: KEE toe ROLE ak)

  • What is ketorolac ophthalmic (Acular)?
  • What are the possible side effects of ketorolac ophthalmic (Acular)?
  • What is the most important information I should know about ketorolac ophthalmic (Acular)?
  • What should I discuss with my healthcare provider before I use ketorolac ophthalmic (Acular)?
  • How should I use ketorolac ophthalmic (Acular)?
  • What happens if I miss a dose (Acular)?
  • What happens if I overdose (Acular)?
  • What should I avoid while using ketorolac ophthalmic (Acular)?
  • What other drugs will affect ketorolac ophthalmic (Acular)?
  • Where can I get more information?

What is ketorolac ophthalmic (Acular)?

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 are the possible side effects of ketorolac ophthalmic (Acular)?

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.

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

You should not use this medication if you are allergic to ketorolac or other NSAIDs (nonsteroidal anti-inflammatory drugs).

Before using ketorolac ophthalmic, tell your doctor if you are allergic to any medications, or if you have a bleeding or blood-clotting disorder, diabetes, arthritis, glaucoma, dry eye syndrome, or if you have had other recent eye surgeries.

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

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label. Using the medication for longer than prescribed may increase the risk of serious side effects on your eyes.

While you are using this medication, do not wear any contact lens that has not been approved by your doctor. Do not use any other eye medications unless your doctor has prescribed them.

Related Drug Centers
  • Acular
  • Acular LS


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