Consumer medicine information

Acular Eye Drops

Ketorolac trometamol

BRAND INFORMATION

Brand name

Acular Eye Drops

Active ingredient

Ketorolac trometamol

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Acular Eye Drops.

What is in this leaflet

This leaflet answers some common questions about ACULAR® eye drops, including how to use the eye drops. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you using ACULAR® eye drops against the benefits they expect it will have for you.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What ACULAR® eye drops are used for

These eyedrops contain the drug ketorolac trometamol and are used to treat itchy eyes occurring in the condition called seasonal allergic conjunctivitis. They are also used for the relief of swelling and redness after cataract surgery.

Ketorolac trometamol works by decreasing prostaglandin E2 levels in the eye. Prostaglandins are normally produced by the body and are thought to be associated with pain, itching and inflammation.

ACULAR® eye drops are only available with a doctor’s prescription from pharmacies.

Ask your doctor if you have any questions about why ACULAR® eye drops have been prescribed for you.

Before you use ACULAR® eye drops

When you must not use it

Do not use ACULAR® eye drops if:

  • You have an allergy to ketorolac trometamol or to any of the ingredients listed at the end of this leaflet
  • You have ever had an allergic reaction to aspirin or certain types of medicines used for arthritis or pain relief (non steroidal anti-inflammatory drugs)
  • The seal around the cap is broken
  • The bottle/packaging shows signs of tampering
  • The product does not look quite right
  • The expiry date on the bottle has passed.

If you use this medicine after the expiry date has passed, it may not work effectively.

Do not put the eye drops into your eye(s) while you are wearing soft contact lenses as the preservative (benzalkonium chloride) in ACULAR® eye drops may be deposited and cause discoloration to soft contact lenses. Contact lenses should be removed prior to using ACULAR® eye drops. You can put your soft contact lenses back into your eyes 15 minutes after you have used ACULAR® eye drops.

Do not allow the tip of the dispensing container to contact the eye to avoid injury of the eye and contamination of the eye drops.

It is not known if ACULAR® eye drops are safe and useful for children under 12 years.

These drops are for topical use only.

Before you start to use it

Tell your doctor if:

  1. You have had an allergy to any medicines or any other substances, such as foods, preservatives or dyes.
  2. You are taking any other prescription or nonprescription medicine, particularly those which have an effect on bleeding.
  3. You have a peptic ulcer or a history of peptic ulcers.
  4. You have asthma or a history of asthma.
  5. You have defects of the cornea, sugar diabetes, diseases of the eye (e.g. dry eye syndrome), rheumatoid arthritis, or if you have had recent eye surgery.
  6. You are pregnant, or intend to become pregnant. ACULAR® eye drops are not recommended in pregnancy.
  7. You are breastfeeding or intend to breastfeed
    ACULAR® eye drops are not recommended if you are breastfeeding.
  8. You have a condition that causes you to bleed easily.

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

It is not expected that ACULAR® will interact with other medicines, however you should always ask your optical practitioner, doctor or pharmacist if you have any concerns about using ACULAR® eye drops as well as other medications.

How to use ACULAR® eye drops

How much to use

Your doctor will tell you how many drops you need to use each day. Use ACULAR® eye drops only as prescribed by your doctor.

The usual dose for itchy eyes (seasonal allergic conjunctivitis) is one drop into each eye four times daily for 2-4 weeks.

The usual dose for use before and after eye surgery for cataract removal is one or two drops into each eye four times daily, starting 24 hours before the surgery and continuing for 2-4 weeks.

Follow all directions given to you by your doctor carefully. The directions may differ from the information contained in this leaflet.

If you are using more than one eye drop product, wait 5 minutes before using the second product.

If you are being changed from one eye drop to another, follow your doctor’s instructions carefully as to when to stop the old drops and when to start the new drops.

How to use it

You may find it easier to put drops in your eye while you are sitting or lying down.

If you are wearing soft contact lenses, remove them before putting the drops in your eye.

To open a new bottle of ACULAR® eye drops first tear off the protective seal from the bottle. The contents are sterile if the seal is intact. The seal will break and you can pull it off and then throw it away.

  1. Wash your hands well with soap and water.
  2. Remove the lid/cap
  3. Hold the bottle upside down in one hand between your thumb and forefinger or index finger.
  4. Using your other hand, gently pull down your lower eyelid to form a pouch or pocket.
  5. Tilt your head back and look up.
  6. Put the tip of the bottle close to your lower eyelid. Do not let it touch your eye.
  7. Release one drop into the pouch or pocket formed between your eye and eyelid by gently squeezing the bottle.
  8. Close your eye. Do not blink or rub your eye.
  9. While your eye is closed, place your index finger against the inside corner of your eye and press against your nose for about two minutes. This will help to stop the medicine from draining through the tear duct to the nose and throat, from where it can be absorbed into other parts of your body. Ask your doctor for more specific instructions on this technique.
  10. Replace the lid/cap, sealing it tightly.
  11. Wash your hands again with soap and water to remove any residue.

Wait 15 minutes before replacing your contact lenses.

Be careful not to touch the dropper tip against your eye, eyelid or anything else to avoid contaminating the eye drops.

How long to use it

Continue using ACULAR® eye drops for as long as your doctor prescribes. The usual length of use is 2-4 weeks.

If you forget to use it

If it is almost time for your next dose, skip the dose you missed and use your next dose when you are meant to. Otherwise, use the drops as soon as you remember, and then go back to using them as you would normally.

If you are not sure whether to skip the dose, talk to your doctor or pharmacist.

Do not use double the amount to make up for the dose that you missed.

If you use too much (overdose)

If you accidentally put several drops in your eye(s), immediately rinse your eye(s) with warm water.

If you think that you or anyone else may have swallowed any or all of the contents of a bottle of ACULAR® eye drops, drink fluids to dilute and immediately telephone your doctor or Poisons Information Centre (Australia: telephone 13 11 26; New Zealand: telephone 0800 POISON or 0800 764 766) for advice, or go to casualty at your nearest hospital. Do this even if there are no signs of discomfort or poisoning.

While you are using ACULAR® eye drops

Things you must do

If you develop an eye infection, receive an eye injury, or have eye surgery tell your doctor.

Your doctor may tell you to use a new container of ACULAR® eye drops because of possible contamination of the old one or may advise you to stop your treatment with ACULAR® eye drops.

If you become pregnant while using ACULAR® eye drops tell your doctor immediately.

If you wear soft contact lenses, remove them before using ACULAR® eye drops. Leave your lenses out for at least 15 minutes after putting in the eye drops.

Tell your doctor if your condition gets worse or does not get better while using ACULAR® eye drops.

If you are about to start any new medicine tell your doctor and pharmacist that you are using ACULAR® eye drops.

Things you must not do

Do not give ACULAR® eye drops to anyone else, even if they have the same condition as you.

Do not stop using ACULAR® eye drops without first talking to your doctor.

Things to be careful of

Your vision may blur for a short time after you put in your ACULAR® eye drops. If this happens you should wait until you can see well again before you drive or use machinery.

ACULAR® eye drops are not expected to cause any problems with your ability to drive a car or operate machinery. However, as a general precaution be careful driving or operating machinery until you know how ACULAR® eye drops affect you.

Side effects

Tell your optical practitioner, doctor or pharmacist as soon as possible if you do not feel well while you are using ACULAR® eye drops.

Check with your doctor as soon as possible if you have any problems while taking ACULAR® eye drops, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them. Ask your doctor or pharmacist to answer any questions you may have.

Some side effects of ACULAR® eye drops are:

  • burning and stinging of the eye on instillation
  • blurring of vision
  • infection of the eye or surrounding areas
  • inflammation of the front layer of the eyeball or the coloured part of the eye
  • conjunctivitis (scratching, foreign body sensation, itching, redness)
  • local allergic reactions, such as red eye, stinging of the eye
  • irritation of the surface of the eye or feeling of having something in the eye
  • pain in the eye
  • drooping of the upper eyelid
  • swollen eyelid
  • uncomfortable sensitivity to light
  • eye dryness
  • a lesion on the front layer of the eyeball
  • increased pressure in the eye
  • white spots on the surface of the eye
  • headaches
  • visual disturbance
  • hypersensitivity.

The following side effects were observed in one patient during a controlled clinical study:

  • white deposit on the underside of the front part of the eye
  • bleeding of the retina
  • swelling of the central area of the retina
  • burning eye
  • itchy eye
  • eye injury.

After using ACULAR® eye drops

Storage

Keep your eye drops in a cool place where the temperature stays below 25°C, and out of the light.

Keep the medicine where children cannot reach it.

Do not leave the top/lid off the bottle for any length of time to avoid contaminating the eye drops.

Disposal

If your doctor tells you to stop using the eye drops or they have passed their expiry date, ask your pharmacist what to do with any remaining solution.

Product description

What ACULAR® eye drops look like:

Clear, colourless to pale yellow, sterile solution, supplied in a white opaque plastic bottle with a dropper tip.

Ingredients

Active ingredient:
Ketorolac trometamol 5.0mg/mL

Preservative:
Benzalkonium chloride

Inactive ingredients:
sodium chloride,
edetate disodium
octoxinol 40
purified water
sodium hydroxide and/or
hydrochloric acid may be added to adjust pH

Manufacturer/Supplier

AbbVie Pty Ltd
241 O’Riordan Street
Mascot NSW 2020
AUSTRALIA
Ph: 1800 043 460

AbbVie Limited
6th Floor, 156-158 Victoria St
Wellington, 6011
NEW ZEALAND
PH: 0800 900 030

ACULAR® eye drops can be identified by registration number: AUST R 63539

Date of preparation: August 2023

©2023 AbbVie. All rights reserved.
ACULAR® and its design are trademarks of Allergan, Inc., an AbbVie company.

Published by MIMS October 2023

BRAND INFORMATION

Brand name

Acular Eye Drops

Active ingredient

Ketorolac trometamol

Schedule

S4

 

1 Name of Medicine

Ketorolac trometamol.

2 Qualitative and Quantitative Composition

Acular contains ketorolac trometamol 5 mg/mL.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Acular Eye Drops is a clear, colourless to pale yellow, sterile, isotonic aqueous solution.

4 Clinical Particulars

4.1 Therapeutic Indications

Acular Eye Drops are indicated for the short term (2-4 weeks) relief of symptoms of seasonal allergic conjunctivitis.
Acular Eye Drops are also indicated for the short term (2-4 weeks) prophylaxis and reduction in inflammation in patients undergoing cataract extraction.

4.2 Dose and Method of Administration

Seasonal allergic conjunctivitis.

The recommended dose of Acular Eye Drops for the relief of symptoms of seasonal allergic conjunctivitis is one drop (0.25 mg) instilled in the eye four times daily. Treatment may be continued for up to four weeks.

Postoperative inflammation.

The recommended dose of Acular Eye Drops for the prophylaxis and treatment of inflammation in patients who have undergone cataract extraction is one to two drops (0.25-0.5 mg) four times daily, starting 24 hours before surgery and continuing for 2-4 weeks.

4.3 Contraindications

Acular Eye Drops are contraindicated in patients hypersensitive to any of the components of the medication.
The potential exists for cross sensitivity to acetylsalicylic acid, phenylacetic acid derivatives and other nonsteroidal anti-inflammatory medicines. Acular Eye Drops are contraindicated in patients who have previously exhibited sensitivities to these drugs.

4.4 Special Warnings and Precautions for Use

Patients with bleeding tendencies.

With some nonsteroidal anti-inflammatory drugs a potential exists for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti-inflammatory drugs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. Acular Eye Drops should be used with care in patients with known bleeding tendencies, or in patients who are receiving other medications which may prolong bleeding time, or patients with a known history of peptic ulceration.

Cross-sensitivity.

There exists the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other nonsteroidal anti-inflammatory agents. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
There have been post-marketing reports of bronchospasm or exacerbation of asthma in patients, who have either a known hypersensitivity to aspirin/ nonsteroidal anti-inflammatory drugs or a past medical history of asthma associated with the use of Acular, which may be contributory. Caution is recommended in the use of Acular in these individuals.

Delayed healing.

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

Corneal effects.

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.
Topical NSAIDs should be used with caution in 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 as they may be at increased risk for corneal adverse events which may become sight threatening.
Post-marketing 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.

Masking of infections.

In common with other anti-inflammatory drugs, Acular Eye Drops may mask the usual signs of infections.

Use in the elderly.

No data available.

Paediatric use.

Safety and efficacy have not been demonstrated in children aged less than 12 years.

Effects on laboratory tests.

No data available.

Information for patients.

Acular should not be administered while wearing contact lenses. Acular contains the preservative benzalkonium chloride, which may be absorbed and cause discoloration to soft contact lenses. Contact lenses should be removed prior to administration of Acular and may be reinserted 15 minutes following administration.
Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures to avoid injury and contamination of eye drops.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No specific clinical studies on interactions with other drugs have been conducted with Acular Eye Drops. There were no reports in the controlled studies of interactions of Acular Eye Drops with systemic and ophthalmic medications such as antibiotics, sedatives, beta blockers, carbonic anhydrase inhibitors, miotics, mydriatics, cycloplegics, local anaesthetics and corticosteroids.
Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems (see Section 4.4 Special Warnings and Precautions for Use, Delayed healing).

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Impairment of fertility did not occur in male or female rats at oral doses of 9 mg/kg (1.2 times human parenteral AUC) and 16 mg/kg (2.1 times the human parenteral AUC) respectively.
(Category C)
Ketorolac trometamol and its metabolites have been shown to pass into the foetus. Safety in human pregnancy has not been established. Not recommended in pregnancy.
Reproduction studies have been performed in rabbits and rats at oral doses of 3.6 and 10 mg/kg/day, respectively. The results from these studies did not reveal any significant evidence of harm to the foetus. However, studies in rabbits have shown a small increase in the incidence of major vessel anomalies.
Ketorolac trometamol is excreted in the milk of lactating rats and rabbits, and has been detected in human breast milk. A peri/ postnatal study in rats showed reductions in postnatal growth and survival of the offspring when ketorolac trometamol was administered to lactating rats at oral dose levels greater than 4.8 mg/kg/day. Thus, use of ketorolac trometamol in lactating mothers is not recommended.

4.7 Effects on Ability to Drive and Use Machines

As Acular Eye Drops may cause transient blurring on instillation, caution is required with the use of hazardous machinery or driving, which are not recommended unless vision is clear. The patient should wait until their vision clears before driving or using machinery.

4.8 Adverse Effects (Undesirable Effects)

In controlled clinical studies, the most frequently reported adverse events with the use of Acular Eye Drops have been transient stinging and burning on instillation (eye pain). These events were reported by up to 40% of subjects treated with Acular. Other adverse events reported in controlled clinical studies (at an incidence of ≥ 1%) included conjunctivitis (scratching, foreign body sensation, itching, erythema), local allergic reactions, superficial keratitis, keratic precipitates (1%), haemorrhage retinal (1%), cystoid macular edema (1%), burning eye (1%), pruritus eye (1%), eye trauma (1%), intraocular pressure (2%), corneal oedema, eye infection, eye inflammation, eye irritation and hypersensitivity. Ptosis, blepharitis, photophobia, blurred vision, eye dryness, corneal lesion, iritis, and glaucoma were also reported in > 1% of patients in some studies. Uncommon (> 0.1% and < 1%) adverse events reported were eye dryness, corneal infiltrates, ulcerative keratitis, visual disturbance and headaches.

Note.

The frequency of 1% represents 1 patient.

Post-marketing experience.

The following adverse reactions have been identified during post-marketing use. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
In post-marketing experience ocular burning and stinging, eye irritation, local allergic reactions, superficial ocular infections, superficial keratitis, eye oedema, ocular hyperaemia, conjunctival hyperaemia, eye swelling, eye pain, eye pruritus and ulcerative keratitis were the most frequently reported adverse reactions. Systemic allergic reactions have been reported very rarely. There have been post-marketing reports of bronchospasm or exacerbation of asthma in patients who have either a known hypersensitivity to aspirin/ nonsteroidal anti-inflammatory drugs or a past medical history of asthma, associated with the use of Acular which may be contributory (see Section 4.4 Special Warnings and Precautions for Use).

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

There is no experience of overdose by the ophthalmic route. If accidentally ingested, fluids should be taken to dilute the effects, if any.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Class.

Ketorolac trometamol is a member of the pyrrolo-pyrolle group of nonsteroidal anti-inflammatory drugs for ophthalmic use.

Mechanism of action.

Ketorolac trometamol is a nonsteroidal anti-inflammatory agent demonstrating analgesic and anti-inflammatory activity. It is believed to inhibit the cyclo-oxygenase enzyme essential for prostaglandin biosynthesis. Ocular administration of ketorolac trometamol reduces prostaglandin E2 levels in the aqueous humour. Ketorolac trometamol given systemically does not cause pupil constriction. Results from clinical studies indicate that Acular Eye Drops has no significant effect upon intraocular pressure.

Clinical trials.

Allergic conjunctivitis.

A total of 203 patients with seasonal allergic conjunctivitis were evaluable for efficacy in two randomised, controlled clinical trials of Acular (ketorolac) eye drops against placebo. The patients who received ketorolac demonstrated significant decreases in itching and conjunctival inflammation over the 7 day treatment period.

Post-operative inflammation.

A total of 206 patients who had undergone cataract surgery participated in two randomised, controlled clinical trials of Acular (ketorolac) eye drops against placebo. The patients who received ketorolac showed significantly greater decreases in anterior chamber cells and anterior chamber flare over the two weeks of treatment. 39% of ketorolac patients achieved a zero score for anterior cells and flare after 2 weeks of treatment compared to 12% of placebo patients.

5.2 Pharmacokinetic Properties

Absorption.

Two drops (0.1 mL) of 0.5% Acular Eye Drops instilled into the eyes of patients 12 hours and 1 hour prior to cataract extraction achieved measurable levels in 8 of 9 patients' eyes (mean ketorolac concentrations 95 nanogram/mL aqueous humour, range 40-170 nanogram/mL). One drop (0.05 mL) of 0.5% ketorolac trometamol solution was instilled into one eye and one drop of the vehicle into the other eye three times a day for 21 days in 26 normal subjects.

Distribution.

Only 4 of 13 subjects had detectable amounts of ketorolac in their plasma (range 10.7 to 22.5 nanogram/mL) after 15 minutes at Day 10 during topical ocular treatment. Average peak plasma level following intramuscular administration of 30 mg ketorolac trometamol was 2.2 microgram/mL 50 minutes after administration.

5.3 Preclinical Safety Data

Genotoxicity.

Ketorolac trometamol was not genotoxic in a series of assays for gene mutations and DNA damage. Ketorolac trometamol did not cause chromosome breakage in the mouse micronucleus test in vivo at 1590 microgram/mL, approximately 1000 times the average human plasma levels, but increased the incidence of chromosomal aberrations in Chinese hamster ovarian cells in vitro at higher concentrations.

Carcinogenicity.

An 18-month study in mice at oral doses of ketorolac trometamol of 2 mg/kg/day (equal to 1.2 times the human systemic exposure at the maximum recommended IM dose of 90 mg/day, based on AUC) and a 24-month study in rats at oral doses of 5 mg/kg (0.7 times the human parenteral AUC) showed no evidence of tumours.

6 Pharmaceutical Particulars

6.1 List of Excipients

Benzalkonium chloride 0.01% (w/v), disodium edetate 0.1% (w/v), octoxinol 40, sodium chloride, sodium hydroxide/hydrochloric acid (to adjust pH) and purified water.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

24 months.

6.4 Special Precautions for Storage

Store below 25°C. Protect from light.

6.5 Nature and Contents of Container

Acular (ketorolac trometamol) eye drops is supplied in white opaque plastic dropper bottles with dropper applicators.
Eye drops: 3 mL, 5 mL and 10 mL (3 mL and 10 mL pack sizes are not marketed).

6.6 Special Precautions for Disposal

Discard any unused contents 28 days after opening the bottle.

6.7 Physicochemical Properties

Chemical structure.

Ketorolac trometamol is a white to off-white crystalline substance, which is a racemic mixture. It may exist in three crystalline forms, all of which are equally soluble in water.
Chemical name: (±)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-1-carboxylic acid compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:1).
Empirical formula: C19H24N2O6.
Molecular weight: 376.41.
pKa: 3.54.

CAS number.

74103-07-4.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription Only Medicine.

Summary Table of Changes