Acular

Name: Acular

Ketorolac Ophthalmic Dosage

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.

Ketorolac ophthalmic is usually given 24 hours before cataract surgery, and continued for up to 14 days after surgery. Using the medication for longer than prescribed may increase the risk of serious side effects on your eyes.

Wash your hands before using the eye drops.

To apply the eye drops:

  • Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.
  • Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct.
  • Use the eye drops only in the eye you are having surgery on.
  • Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your doctor for a new prescription.

Store the drops at room temperature away from heat and moisture. Keep the bottle tightly closed when not in use.

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.

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

Proper Use of ketorolac

This section provides information on the proper use of a number of products that contain ketorolac. It may not be specific to Acular. Please read with care.

Your eye doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to. This medicine is not for long-term use.

This medicine can be used with other ophthalmic (eye) medicines. Wait at least 5 minutes before using another eye medicine.

If you or your child are wearing contact lenses, remove them while you are using this medicine. Talk to your eye doctor about this if you have questions.

If you are using this medicine after an eye surgery, use one bottle for each eye only. Use of the same bottle of eye drops for both eyes is not recommended.

To use the eye drops:

  • First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed for 1 or 2 minutes to allow the medicine to be absorbed by the eye.
  • Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.
  • If you think you did not get the drop of medicine into your eye properly, use another drop.
  • To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, always keep the container tightly closed.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For ophthalmic dosage form (eye drops):
    • For relief of eye itching caused by seasonal allergic conjunctivitis:
      • Adults and children 2 years of age and older—Use one drop in the affected eye(s) 4 times a day.
      • Children younger than 2 years of age—Use and dose must be determined by your doctor.
    • For eye swelling following cataract surgery:
      • Adults and children 2 years of age and older—Use one drop in the affected eye(s) 4 times a day beginning 24 hours after surgery and for 2 weeks after the surgery.
      • Children younger than 2 years of age—Use and dose must be determined by your doctor.
    • For eye pain, burning, or stinging following corneal refractive surgery:
      • Adults and children 3 years of age and older—Use one drop in the affected eye(s) 4 times a day for up to 4 days after the surgery.
      • Children younger than 3 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Acular

Your eye doctor will check your or your child's eyes at regular visits to make sure it is working properly and is not causing unwanted effects.

If your or your child's symptoms do not improve within a few days or if they become worse, check with your doctor.

Slow or delayed healing may occur while you or your child are using this medicine. Ask your doctor before using this medicine together with a topical corticosteroid (eg, betamethasone, hydrocortisone).

Using this medicine may increase risk of having corneal (front part of the eye) problems, including keratitis. Check with your eye doctor right away if you or your child have blurred vision, changes in vision, or eye redness, irritation, or pain while using this medicine.

Make sure your doctor knows if you are pregnant. Do not use this medicine during the later part of a pregnancy, unless your doctor tells you to.

If you hurt your eye, develop an eye infection, or need to have eye surgery, talk with your doctor right away. You may need to change your medicine or stop using it.

While applying this medicine, your eyes will probably sting or burn for a short time. This is to be expected.

Do not use other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side effects

Clinical Studies Experience

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.

The most frequent adverse reactions reported with the use of ketorolac tromethamine ophthalmic solutions have been transient stinging and burning on instillation. These reactions were reported by up to 40% of patients participating in clinical trials.

Other adverse reactions occurring approximately 1 to 10% of the time during treatment with ketorolac tromethamine ophthalmic solutions included allergic reactions, corneal edema, iritis, ocular inflammation, ocular irritation, superficial keratitis, and superficial ocular infections.

Other adverse reactions reported rarely with the use of ketorolac tromethamine ophthalmic solutions included: corneal infiltrates, corneal ulcer, eye dryness, headaches, and visual disturbance (blurry vision).

Postmarketing Experience

The following adverse reactions have been identified during post-marketing use of ketorolac tromethamine ophthalmic solution 0.5% 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 solution 0.5% or a combination of these factors, include bronchospasm or exacerbation of asthma, corneal erosion, corneal perforation, corneal thinning, and epithelial breakdown [see WARNINGS AND PRECAUTIONS].

What do I need to tell my doctor BEFORE I take Acular?

  • If you have an allergy to ketorolac tromethamine or any other part of Acular (ketorolac eye drops).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are more than 24 weeks pregnant.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

How is this medicine (Acular) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • For the eye only.
  • Wash your hands before and after use.
  • Do not wear contact lenses while using Acular.
  • Do not touch the container tip to the eye, lid, or other skin.
  • Tilt your head back and drop drug into the eye.
  • If more than 1 drug is being used in the same eye, use each drug at least 5 minutes apart.
  • If this medicine is being used after surgery on both eyes, do not use the same bottle for both eyes. Your doctor may order 2 eye drop bottles; one for each eye. Make sure you do not mix the 2 bottles up.

What do I do if I miss a dose?

  • Use a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not use 2 doses or extra doses.

If OVERDOSE is suspected

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.

How do I store and/or throw out Acular?

  • Store at room temperature.
  • Protect from light.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Acular Dosage and Administration

Recommended Dosing

Patient Dosing

The recommended dose of Acular® ophthalmic solution is one drop four times a day to the affected eye(s) for relief of ocular itching due to seasonal allergic conjunctivitis.

For the treatment of postoperative inflammation in patients who have undergone cataract extraction, one drop of Acular® ophthalmic solution should be applied to the affected eye four times daily beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period.

Use with Other Topical Ophthalmic Medications

Acular® ophthalmic solution has been safely administered in conjunction with other ophthalmic medications such as antibiotics, alpha-agonists, beta blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics. Drops should be administered at least 5 minutes apart.

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 frequent adverse reactions reported with the use of ketorolac tromethamine ophthalmic solutions have been transient stinging and burning on instillation. These reactions were reported by up to 40% of patients participating in clinical trials.

Other adverse reactions occurring approximately 1 to 10% of the time during treatment with ketorolac tromethamine ophthalmic solutions included allergic reactions, corneal edema, iritis, ocular inflammation, ocular irritation, superficial keratitis, and superficial ocular infections.

Other adverse reactions reported rarely with the use of ketorolac tromethamine ophthalmic solutions included: corneal infiltrates, corneal ulcer, eye dryness, headaches, and visual disturbance (blurry vision).

Postmarketing Experience

The following adverse reactions have been identified during post-marketing use of ketorolac tromethamine ophthalmic solution 0.5% 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 solution 0.5% or a combination of these factors, include bronchospasm or exacerbation of asthma, corneal erosion, corneal perforation, corneal thinning, and epithelial breakdown [see Warnings and Precautions (5.2, 5.4)].

Use in specific populations

Pregnancy

Teratogenic Effects. Pregnancy Category C

Ketorolac tromethamine, administered during organogenesis, was not teratogenic in rabbits and rats at oral doses of 3.6 mg/kg/day and 10 mg/kg/day, respectively. These doses are approximately 100 times and 250 times higher respectively than the maximum recommended human topical ophthalmic daily dose of 2 mg (5 mg/mL x 0.05 mL/drop, x 4 drops x 2 eyes) to affected eyes on a mg/kg basis. Additionally, when administered to rats after Day 17 of gestation at oral doses up to 1.5 mg/kg/day (approximately 40 times the typical human topical ophthalmic daily dose), ketorolac tromethamine resulted in dystocia and increased pup mortality. There are no adequate and well-controlled studies in pregnant women. Acular® solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nonteratogenic Effects: Because of the known effects of prostaglandin-inhibiting drugs on the fetal cardiovascular system (closure of the ductus arteriosus), the use of Acular® solution during late pregnancy should be avoided.

Nursing Mothers

Because many drugs are excreted in human milk, caution should be exercised when Acular® is administered to a nursing woman.

Pediatric Use

Safety and efficacy in pediatric patients below the age of 2 have not been established.

Geriatric Use

No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.

What should i discuss with my healthcare provider before i use ketorolac ophthalmic (acular, acular ls, acular pf, acuvail)?

You should not use this medication if you are allergic to ketorolac or other NSAIDs.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

  • a bleeding or blood-clotting disorder;
  • diabetes;
  • arthritis;
  • glaucoma;
  • dry eye syndrome; or
  • if you have had other recent eye surgeries.

FDA pregnancy category C. It is not known whether ketorolac ophthalmic is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether ketorolac ophthalmic passes into breast milk or if it could harm a nursing baby. Do not use ketorolac ophthalmic without telling your doctor if you are breast-feeding a baby.

Ketorolac Identification

Substance Name

Ketorolac

CAS Registry Number

74103-06-3

Drug Class

Analgesic Agents

Nonsteroidal Antiinflammatory Agents

Administrative Information

LactMed Record Number

153

Last Revision Date

20150310

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

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