Acuvail

Name: Acuvail

How should I use ketorolac ophthalmic?

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Ketorolac ophthalmic is used 2 to 4 times per day, depending on the condition you are treating. Follow your doctor's dosing instructions very carefully. Prolonged use of NSAID eye drops can lead to serious damage to your eyesight.

For cataract surgery you will begin using the eye drops 1 day before surgery and continue for up to 2 weeks afterward. For corneal refractive surgery the usual dosage is 4 times daily for up to 4 days after surgery.

Do not use ketorolac ophthalmic while you are wearing contact lenses.

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 tip down. Look up and away from the dropper and squeeze out a drop.

  • Close your eyes for 2 or 3 minutes with your head tipped down, without blinking or squinting. Gently press your finger to the inside corner of the eye for about 1 minute, to keep the liquid from draining into your tear duct.

  • Use only the number of drops your doctor has prescribed. If you use more than one drop, wait about 5 minutes between drops.

  • If using this medicine after single-eye surgery, use the drops only in the eye you are having surgery on.

  • Wait at least 10 minutes before using any other eye drops your doctor has prescribed.

Do not touch the tip of the eye dropper or place it directly on your eye. A contaminated dropper can infect your eye, which could lead to serious vision problems.

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

Each single-use vial (bottle) of this medicine is for use in one eye only. Throw away after one use, even if there is still some medicine left in the vial.

Store at room temperature away from moisture, heat, and light. Do not freeze. Keep the bottle tightly closed when not in use. If your medicine vials come in a foil pouch, store the vials inside the pouch and fold the ends closed.

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.

Before Using Acuvail

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of Acular LS® eye drops in children younger than 3 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of Acular® eye drops in children younger than 2 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ketorolac eye drops in the elderly.

Pregnancy

Pregnancy Category Explanation
1st Trimester C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
2nd Trimester C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
3rd Trimester D Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

Breast Feeding

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Allergy to NSAIDs (eg, aspirin, diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Voltaren®) or
  • Asthma, or history of or
  • Bleeding problems or
  • Bronchospasm (breathing problem)—Use with caution. May make these conditions worse.
  • Corneal (front part of the eye) denervation or
  • Corneal (front part of the eye) epithelial defects or
  • Diabetes or
  • Ocular (eye) surface diseases (eg, dry eye syndrome) or
  • Ocular (eye) surgeries, complicated or
  • Ocular (eye) surgeries, multiple within a short period of time or
  • Rheumatoid arthritis—Use with caution. May increase the risk of having serious eye problems.

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 Acuvail. 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.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Change in eyesight, eye pain, or very bad eye irritation.
  • Bleeding in the eye.

Acuvail Dosage and Administration

Recommended Dosing

Patient Dosing

One drop of Acuvail® should be applied to the affected eye twice daily beginning 1 day prior to cataract surgery, continued on the day of surgery, and through the first 2 weeks of the postoperative period.

Use With Other Topical Ophthalmic Medications

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

Dosage Forms and Strengths

4.5 mg/mL ketorolac tromethamine solution (0.45%) in a single-use vial.

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 600 times and 1700 times higher respectively than the typical human topical ophthalmic daily dose of 0.35 mg (4.5 mg/mL x 0.04 mL/drop, twice daily) to an affected eye 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 300 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. Acuvail® 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 Acuvail® solution during late pregnancy should be avoided.

Nursing Mothers

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

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

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

Clinical Studies

Two multicenter, randomized, double-masked, parallel group comparison studies including approximately 500 patients were conducted to evaluate the effects of Acuvail® on anterior chamber cell and flare, and ocular pain relief following cataract extraction with posterior chamber intraocular lens (IOL) implantation. Results of these studies indicated that patients receiving Acuvail® had a significantly higher incidence of clearing of anterior chamber inflammation 53% (167/318) versus patients receiving vehicle 26% (41/155) at day 14.

Acuvail® was also significantly superior to vehicle in resolving ocular pain. On Day 1 post cataract surgery, 72% (233/322) of patients in the Acuvail® group were pain free compared to 40% (62/156) of patients in the vehicle group.

Results from clinical studies indicate that ketorolac tromethamine has no significant effect upon intraocular pressure; however, changes in intraocular pressure may occur following cataract surgery.

How Supplied/Storage and Handling

Acuvail® (ketorolac tromethamine ophthalmic solution) 0.45% is available as a sterile solution supplied in clear, LDPE, single-use vials packaged in 6 foil pouches, 5 vials per pouch:

30 Single-Use Vials 0.4 mL each: NDC 0023-3507-30

Storage: Store at 15°-30° C (59°-86° F). Store the vials in the pouch, protected from light. Fold pouch ends closed.

Patient Counseling Information

Slow or Delayed Healing

Patients should be informed of the possibility that slow or delayed healing may occur while using nonsteroidal anti-inflammatory drugs (NSAIDs).

Avoiding Contamination of the Product

Patients should be instructed that the solution from one individual single-use vial is to be used immediately after opening for administration to the affected eye. The remaining vial contents should be discarded.

The use of the same single-use vial of topical eye drops for both eyes following bilateral ocular surgery is not recommended. In these circumstances, advise patients to use one vial for each eye immediately after opening and discard the remaining contents after use.

Patients should be instructed to avoid allowing the tip of the vial to contact the eye or surrounding structures because this could cause the tip to become contaminated by common bacteria known to cause ocular infections or cause injury to the eye. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

Store the vials in the pouch, protected from light. Fold pouch ends closed.

Contact Lens Wear

Patients should be advised that Acuvail® solution should not be administered while wearing contact lenses.

Intercurrent Ocular Conditions

Patients should be advised that if they develop an intercurrent ocular condition (e.g., trauma or infection) or have ocular surgery, they should immediately seek their physician's advice concerning the continued use of Acuvail®.

Concomitant Topical Ocular Therapy

Patients should be advised that if more than one topical ophthalmic medication is being used, the medicines should be administered at least 5 minutes apart.

© 2014 Allergan, Inc., Irvine, CA 92612, U.S.A.
® marks owned by Allergan, Inc.
Patented. See: www.allergan.com/products/patent_notices
Made in the U.S.A.

72555US12

ALLERGAN NDC 0023-3507-30

Acuvail®

(ketorolac tromethamine
ophthalmic solution) 0.45%

Preservative-Free

FOR SINGLE-USE ONLY

Rx only

sterile

30 Single-Use Vials 0.4 mL Each

Acuvail 
ketorolac tromethamine solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0023-3507
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ketorolac tromethamine (ketorolac) ketorolac tromethamine 4.5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
carboxymethylcellulose sodium  
sodium chloride  
trisodium citrate dihydrate  
water  
sodium hydroxide  
hydrochloric acid  
Packaging
# Item Code Package Description
1 NDC:0023-3507-05 5 VIAL, SINGLE-USE in 1 CARTON
1 0.4 mL in 1 VIAL, SINGLE-USE
2 NDC:0023-3507-30 30 VIAL, SINGLE-USE in 1 CARTON
2 0.4 mL in 1 VIAL, SINGLE-USE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA022427 08/01/2009
Labeler - Allergan, Inc. (144796497)
Establishment
Name Address ID/FEI Operations
Allergan, Inc. 362898611 MANUFACTURE(0023-3507)
Revised: 12/2014   Allergan, Inc.
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