Acular

Name: Acular

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

Is ketorolac tromethamine-ophthalmic available as a generic drug?

GENERIC AVAILABLE: Yes

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

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

How should I use Acular (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.

Before Using Acular

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.

What are some things I need to know or do while I take Acular?

  • Tell all of your health care providers that you take Acular. This includes your doctors, nurses, pharmacists, and dentists.
  • Tell your doctor if you have an eye infection, eye injury, or will be having eye surgery.
  • If you have an eye wound or irritation that does not heal, talk to your doctor.
  • Use care when driving or doing other tasks that call for clear eyesight.
  • Do not take this medicine for more than 2 weeks unless told to do so by your doctor.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Acular while you are pregnant.
  • Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

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.

Indications and Usage for Acular

Acular® ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Acular® ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Ketorolac tromethamine was not carcinogenic in either rats given up to 5 mg/kg/day orally for 24 months or in mice given 2 mg/kg/day orally for 18 months. These doses are approximately 125 times and 50 times higher respectively than the maximum recommended human topical ophthalmic daily dose given as QID for itching to affected eyes on a mg/kg basis.

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 an in 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 9 mg/kg/day and 16 mg/kg/day, respectively. These doses are respectively 225 and 400 times higher than the typical human topical ophthalmic daily dose.

What is ketorolac ophthalmic (acular, acular ls, acular pf, acuvail)?

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.

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].

Read the entire FDA prescribing information for Acular (Ketorolac Tromethamine)

Read More »

Ketorolac ophthalmic Breastfeeding Warnings

Caution is recommended; according to some experts, use is not recommended. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: -This drug is present in breast milk following oral administration. -Placing pressure over the tear duct by the corner of the eye for at least 1 minute and removing excess solution with an absorbent tissue substantially reduces the amount of drug that reaches breast milk after using eye drops.

Ketorolac Levels and Effects while Breastfeeding

Summary of Use during Lactation

Limited data indicate that milk levels of ketorolac are low with the usual oral dosage, but milk levels have not been measured after higher injectable dosages. Use caution when using ketorolac in nursing mothers, especially with the injectable drug. To substantially diminish the amount of drug that reaches the breastmilk after using eye drops, place pressure over the tear duct by the corner of the eye for 1 minute or more, then remove the excess solution with an absorbent tissue.

Drug Levels

Maternal Levels. Ten women who were 2 to 6 days postpartum and were taking ketorolac 10 mg orally four times daily had their milk ketorolac levels measured at various times during 2 days of drug administration. Milk levels were undetectable (<5 mcg/L) in 4 of the patients at all collection times. In the other 6 patients, ketorolac was detectable 2 hours after the first dose of the day in concentrations from 5.2 to 7.3 mcg/L on day 1 and from 5.9 to 7.9 mcg/L on day 2. Ketorolac was not detectable in milk in any patient 10 hours after the last dose.[1] The paper erroneously states that the breastfed infant would receive an estimated 3.16 to 7.9 mg daily based on a calculation error. The correct calculation yields an estimated maximum daily intake of 7.9 mcg or 0.18% of the maternal weight-adjusted dosage.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

Alternate Drugs to Consider

Acetaminophen, Flurbiprofen, Ibuprofen, Indomethacin, Naproxen, Piroxicam

References

1. Wischnik A, Manth SM, Lloyd J et al. The excretion of ketorolac tromethamine into breast milk after multiple oral dosing. Eur J Clin Pharmacol. 1989;36:521-4. PMID: 2787750

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