Acular 0.4 % Eye Drops

ACULAR 0,4 % ophthalmic solution is indicated for the reduction of ocular pain and burning/stinging following corneal refractive surgery.

The recommended dose is one drop four times a day in the operated eye. It can be instilled for up to 4 days following corneal refractive surgery.

Special populations

Elderly
No dosage adjustment is required for elderly patients.

Paediatric population
Safety and efficacy of ACULAR 0,4 % in children have not been established.

Method of administration
Avoid touching the dropper tip against the eye or any other surface (see section 4.4). ACULAR 0,4 % ophthalmic solution should not be administered while wearing contact lenses (see section 4.4).

ACULAR 0,4 % ophthalmic solution is contraindicated in patients with previously demonstrated hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Safety and efficacy in pregnancy and lactation have not been established (see section 4.6).

There is a potential for cross-sensitivity to acetylsalicylic acid, phenylacetic derivatives and other non-steroidal anti-inflammatory drugs (NSAIDs). There have been reports of bronchospasm or exacerbation of asthma associated with the use of ketorolac tromethamine 0,5 % ophthalmic solution in patients who have either a known hypersensitivity to aspirin or NSAIDs, or a past medical history of asthma. Caution should be exercised when treating patients who have previously exhibited sensitivities to these medicines. Use of ACULAR 0,4 %, may result in keratitis in susceptible patients. Continued use of ACULAR 0,4 % may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. These events may lead to blindness. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of ACULAR 0,4 % and should be closely monitored for corneal health. There is a risk of increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly-applied non-steroidal anti-inflammatory medicine, like ACULAR 0,4 %, may cause increased bleeding of ocular tissue (including hyphaemas) in conjunction with ocular surgery. ACULAR 0,4 % should be used with caution in patients with known bleeding tendencies or who are receiving other medicines which may prolong bleeding time (see section 4.5). Post-marketing experience with topical NSAIDs such as ACULAR 0,4 % 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 lead to blindness. ACULAR 0,4 % should be used with caution in these patients. Post-marketing experience with topical NSAIDs such as ACULAR 0,4 % also suggest 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. As the possibility of adverse effects on the corneal permeability and the danger of disruption of the corneal epithelium with prolonged or repeated usage of benzalkonium chloride preserved ophthalmological preparations such as ACULAR 0,4 % cannot be excluded, regular ophthalmological examination is required. Caution should be exercised in the use of benzalkonium chloride preserved topical medication, like ACULAR 0,4 %, over an extended period in patients with extensive ocular surface disease. 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. ACULAR 0,4 % should not be administered while wearing contact lenses. ACULAR 0,4 % 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 0,4 % and may be reinserted 15 minutes following administration.

Medicines containing anticoagulants, coumarin- or indandione-derivative, heparin or platelet aggregation inhibitors may interact with ACULAR 0,4 %. Concurrent use with these medicines may increase the risk of post-operative bleeding. ACULAR 0,4 % may slow or delay healing. Topical corticosteroids are known to slow or delay healing. Concomitant use of ACULAR 0,4 % and topical steroids may therefore increase the potential for delayed healing problems. There have been no reports of interactions of ketorolac tromethamine ophthalmic solution 0,5 % with topical or injectable medicines used in ophthalmology, used pre-, intra-, or post- operatively, including:

• antibiotics (e.g gentamicin, tobramycin, neomycin, polymyxin),
• sedatives (e.g diazepam, hydroxyzine, lorazepam, promethazine HCl),
• miotics, mydriatics, cycloplegics (e.g acetylcholine, atropine, epinephrine, physostigmine, phenylephrine, timolol maleate),
• hyaluronidase,
• local anaesthetics (e.g bupivacaine HCl, cyclopentolate HCl, lidocaine HCl, tetracaine), or
• corticosteroids.

Pregnancy
Safety in pregnancy and lactation has not been established. Because of the known effects of NSAIDs on the foetal cardiovascular system of rats (delayed closure of the ductus arteriosus), ACULAR 0,4 % should not be used during pregnancy (see section 4.3). There are no adequate and well-controlled studies in pregnant women. ACULAR 0,4 % should therefore not be administered in pregnant women.

Breastfeeding
It is not known whether ketorolac tromethamine is excreted in human milk following administration of ACULAR 0,4 %. Therefore, mothers using ACULAR 0,4 % should not breastfeed their infants (see section 4.3).

Transient blurring of vision may occur at instillation. The patient should wait until their vision clears before driving or using machinery.

Tabulated list of adverse reactions
The frequency of adverse reactions documented during clinical trials and through post-marketing experience is given below and is defined as follows: Very Common (u2265 1/10); Common (u22651/100 to <1/10); Uncommon (u22651/1,000 to <1/100); Rare (u22651/10,000 to <1/1,000); Very Rare (<1/10,000); Not Known (cannot be estimated from available data).

System organ class Frequency Adverse Reaction / Side Effect
Eye disorders Very common Stinging or burning on instillation
Common Conjunctival hyperaemia, corneal infiltrates, ocular oedema, ocular pain, iritis, ocular inflammation, corneal oedema, ocular irritation, superficial keratitis and superficial ocular infections
Unknown Corneal erosion, corneal perforation, corneal thinning, epithelial breakdown, ulcerative keratitis, eye swelling, eyelid oedema and ocular hyperaemia
Nervous system Common Headache
Skin and subcutaneous tissue disorders Common Allergic reactions (itching, rash, redness or swelling of skin)

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicine is important. It allows continued monitoring of the benefit/risk balance of the medicine. Health care providers are asked to report any suspected adverse reactions to SAHPRA via the u201c6.04 Adverse Drug Reactions Reporting Formu201d, found online under SAHPRAu2019s publications: https://www.sahpra.org.za/Publications/Index/8

See section 4.8. In the event of topical overdose, wash the eye with water. If accidentally ingested, drink fluids to dilute. Treatment is symptomatic and supportive.