Acular PF

Name: Acular PF

Commonly used brand name(s)

In the U.S.

  • Acular
  • Acular LS
  • Acular PF
  • Acuvail

In Canada

  • Apo-Ketorolac
  • Ratio-Ketorolac

Available Dosage Forms:

  • Solution

Therapeutic Class: Ophthalmologic Agent

Pharmacologic Class: Ketorolac

Chemical Class: Ketorolac

Before Using Acular PF

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 Acular PF. 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 PF

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.

Acular PF Description

ACULAR® PF (ketorolac tromethamine ophthalmic solution) Preservative-Free 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® PF 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® PF is 290 mOsml/kg.

Each ml of ACULAR® PF contains: Active: ketorolac tromethamine 0.5%. Inactives: purified water; sodium chloride; hydrochloric acid and/or sodium hydroxide to adjust the pH to 7.4.

Contraindications

ACULAR® PF ophthalmic solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation.

Precautions

General:

All topical nonsteroidal anti-inflammatory drugs (NSAIDs) may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.

Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health.

Postmarketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening. Topical NSAIDs should be used with caution in these patients.

Postmarketing experience with topical NSAIDs also suggests that use more than 24 hours prior to surgery or use beyond 14 days post-surgery may increase patient risk for the occurrence and severity of corneal adverse events.

It is recommended that ACULAR® PF ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.

Information for Patients:

ACULAR® PF should not be administered while wearing contact lenses.

The solution from one individual single-use vial is to be used immediately after opening for administration to one or both eyes, and the remaining contents should be discarded immediately after administration. To avoid contamination, do not touch tip of unit-dose vial to eye or any other surface.

Carcinogenesis, Mutagenesis, and Impairment of Fertility:

Ketorolac tromethamine was not carcinogenic in rats given up to 5 mg/kg/day orally for 24 months (151 times the maximum recommended human topical ophthalmic dose, on a mg/kg basis, assuming 100% absorption in humans and animals) nor in mice given 2 mg/kg/day orally for 18 months (60 times the maximum recommended human topical ophthalmic dose, on a mg/kg basis, assuming 100% absorption in humans and animals).

Ketorolac tromethamine was not mutagenic in vitro in the Ames assay or in forward mutation assays. Similarly, it did not result in an in vitro increase in unscheduled DNA synthesis or anin vivo increase in chromosome breakage in mice. However, ketorolac tromethamine did result in an increased incidence in chromosomal aberrations in Chinese hamster ovary cells.

Ketorolac tromethamine did not impair fertility when administered orally to male and female rats at doses up to 272 and 484 times the maximum recommended human topical ophthalmic dose, respectively, on a mg/kg basis, assuming 100% absoprtion in humans and animals.

Pregnancy:

Teratogenic Effects: Pregnancy Category C. Ketorolac tromethamine, administered during organogensis, was not teratogenic in rabbits or rats at oral doses up to 109 times and 303 times the maximum recommended human topical ophthalmic dose, respectively, on a mg/kg basis assuming 100% absorption in humans and animals. When administered to rats after Day 17 of gestation at oral doses up to 45 times the maximum recommended human topical ophthalmic dose, respectively, on a mg/kg basis, assuming 100% absorption in humans and animals, ketorolac tromethamine resulted in dystocia and increased pup mortality. There are no adequate and well-controlled studies in pregnant women. ACULAR® PF ophthalmic 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® PF ophthalmic solution during late pregnancy should be avoided.

Nursing Mothers:

Caution should be exercised when ACULAR® PF is administered to a nursing woman.

Pediatric Use:

Safety and efficacy in pediatric patients below the age of 3 years have not been established.

Geriatric Use:

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Acular PF Dosage and Administration

The recommended dose of ACULAR® PF is one drop (0.25 mg) four times a day in the operated eye as needed for pain and photophobia for up to 3 days after incisional refractive surgery.

For Healthcare Professionals

Applies to ketorolac ophthalmic: ophthalmic solution

General

The most frequently reported side effects were transient stinging and burning on instillation.[Ref]

Ocular

Common (1% to 10%): Intraocular pressure increased, conjunctival hyperemia, conjunctival hemorrhage, corneal edema, ocular pain, tearing, vision blurred, corneal infiltrates, ocular edema, iritis, ocular inflammation, ocular irritation, superficial keratitis, superficial ocular infection, conjunctivitis, ocular pruritus, keratic precipitates, retinal hemorrhage, cystoid macular edema, eye trauma, ptosis, blepharitis, photophobia, corneal lesion, glaucoma
Uncommon (0.1% to 1%): Ulcerative keratitis, eye dryness, epiphora, corneal ulcer
Postmarketing reports: Corneal erosion, corneal perforation, corneal thinning, corneal melt, epithelial breakdown[Ref]

Local

Very common (10% or more): Transient stinging (up to 40%), burning (up to 40%)
Common (1% to 10%): Local allergic reaction[Ref]

Nervous system

Common (1% to 10%): Headache[Ref]

Respiratory

Postmarketing reports: Bronchospasm, asthma exacerbated[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity reaction[Ref]

Some side effects of Acular PF may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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