Acular

Name: Acular

Before using ketorolac eye drops

To make sure this is the right treatment for you, before you start using the eye drops it is important that your doctor knows:

  • If you have ever had an allergic reaction to a medicine. It is particularly important that you tell your doctor if you know you are allergic to an NSAID such as naproxen, diclofenac or ibuprofen, or if you have ever had a bad reaction to aspirin.
  • If you have a tendency to bleed easily.
  • If you know you have an eye infection.
  • If you have sugar diabetes or rheumatoid arthritis.
  • If you are pregnant or breast-feeding.
  • If you are taking any other medicines or using any other eye drops. This includes any medicines or creams which are available to buy without a prescription, as well as herbal and complementary medicines.

How to use ketorolac eye drops

Before you start the treatment, read the manufacturer's printed information leaflet from inside the pack. It will give you more information about the eye drops and will also provide you with a full list of the side-effects which you could experience from using them.

How to use eye drops

  1. First wash your hands.
  2. Remove the cap.
  3. Tilt your head back a little and pull the lower lid of your eye downwards to form a pocket.
  4. Hold the bottle upside down near to your eye. Try not to touch your eye as you do this.
  5. Gently apply enough pressure to release one drop into your eye.
  6. Close your eye for a minute or two, and press gently on the side of your nose where the corner of your eye meets your nose. This helps to stop the drop from draining away and keeps it in your eye.
  7. Repeat the process in your other eye if you have been told to use the drops in both eyes.
  8. Replace the cap.

What should I discuss with my healthcare provider before I use Acular (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.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What other drugs will affect Acular (ketorolac ophthalmic)?

It is not likely that other drugs you take orally or inject will have an effect on ketorolac used in the eyes. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Acular Side Effects

Along with its needed effects, a medicine 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:

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 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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Acular, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Acular. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Acular.

Review Date: October 4, 2017

How Supplied/Storage and Handling

Acular® (ketorolac tromethamine ophthalmic solution) 0.5% is supplied sterile, in white opaque plastic LDPE bottles with white droppers, with gray high impact polystyrene (HIPS) caps as follows:

5 mL in 10 mL bottle          NDC 0023-2181-05

Storage: Store at 15°-25°C (59°-77°F). Protect from light.

Dosing & Uses

Dosage Forms & Strengths

ophthalmic solution

  • 0.4% (Acular LS)
  • 0.45% (Acuvail)
  • 0.5% (Acular)

Allergic Conjunctivitis

Indicated for temporary relief of ocular itching caused by seasonal allergic conjunctivitis

Acular: Instill 1 gtt in affected eye(s) q6hr

Ocular Pain & Inflammation

Indicated for pain and inflammation following catarac surgery

Acuvail: Instill 1 gtt to affected eye(s) twice daily beginning 1 day before surgery and on day of surgery and continue through the first 2 weeks postoperatively

Acular: Instill 1 gtt in affected eye(s) four times daily starting 24 hr after surgery and continue up to 4 days after surgery

Ocular Pain & Burning/Stinging

Indicated to reduce ocular pain and burning/stinging following corneal refractive surgery

Acular LS: Instill 1 gtt in the operated eye PRN for up to 4 days postoperatively

Cystoid Macular Edema (Off-label)

Prevention of postoperatvie cystoid macular edema

1-2 gtt in affected eye(s) q6-8hr beginning 24 hr pre-op and continuing 3-4 wk postoperatively

Dosage Forms & Strengths

ophthalmic solution

  • 0.4% (Acular LS)
  • 0.45% (Acuvail)
  • 0.5% (Acular)

Allergic Conjunctivitis

Indicated for temporary relief of ocular itching caused by seasonal allergic conjunctivitis

<2 years: Safety and efficacy not established

>2 years: Instill 1 gtt in affected eye(s) q6hr (Acular)

Ocular Pain & Inflammation

Indicated for pain and inflammation following catarac surgery

<2 years: Safety and efficacy not established

>2 years: Instill 1 gtt (Acular) in affected eye(s) q6hr starting 24 hr after surgery and continue through the first 2 weeks postoperatively

Ocular Pain & Burning/Stinging

Indicated to reduce ocular pain and burning/stinging following corneal refractive surgery

<2 years: Safety and efficacy not established

>2 years: Instill 1 gtt (Acular LS) in operated eye PRN for up to 4 days postoperatively

Warnings

Contraindications

Hypersensitivity to ASA or NSAIDs

Cautions

Ocular infection possible following surgery; patients should use two bottles should not use the same bottle for both eyes

Safety and efficacy of Acular LS not established in postcataract surgery patients

NSAIDs may delay healing

Cross-sensitivity or hypersensitivity may occur between other NSAIDs, acetylsalicylic acid, and phenylacetic acid derivatives

Increased bleeding time due to interference with thrombocyte aggregation; reports that ocularly applied NSAIDs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery

May cause keratitis, and in some susceptible patients, chronic use may cause epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration, or corneal perforation

Do not administer while wearing contact lenses

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