Ketorolac trometamol 5 mg/ml.
ACULAR is indicated for the prophylaxis and reduction of inflammation and associated symptoms following ocular surgery.
ACULAR is indicated in adults.
Posology
Post-operative inflammation:
One drop instilled into the eye three times daily starting 24 hours pre-operatively and continuing for up to three weeks post-operatively.
Paediatric population
There is no relevant use of ACULAR in the paediatric population in the indication: For the prophylaxis and reduction of inflammation following cataract surgery.
Method of administration
Ocular use.
Instil one drop of the solution into the inferior conjunctival sac of the eye to be treated, while pulling the lower eyelid gently downwards and looking upwards.
If ACULAR is used concomitantly with other topical eye medications there must be an interval of at least 5 minutes between the two medications.
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
The potential exists for cross-sensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs. ACULAR is contraindicated in individuals who have previously exhibited sensitivities to these drugs.
Special warnings and precautions for use
It is recommended that ACULAR be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.
In common with other anti-inflammatory drugs, ACULAR may mask the usual signs of infection.
All non-steroidal anti-inflammatory drugs (NSAIDs) may slow down or delay wound healing. Concomitant use of NSAIDs and topical steroids can increase the potential for healing problems.
Concomitant use of ACULAR and topical corticosteroids should be exercised with caution in patients susceptible to corneal epithelial breakdown.
Use of topical NSAIDS may result in keratitis. In some 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 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.
The preservative in ACULAR, benzalkonium chloride, may cause eye irritation. Contact lenses must be removed prior to application, with at least a 15-minute wait before reinsertion. Benzalkonium chloride is known to discolour soft contact lenses. Contact with soft contact lenses must be avoided.
There have been post-marketing reports of bronchospasm or exacerbation of asthma in patients, who have either a known hypersensitivity to aspirin/non-steroidal 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 (see section 4.8).
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.
Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
ACULAR has been safely administered with systemic and ophthalmic medications such as antibiotics, sedatives, beta blockers, carbonic anhydrase inhibitors, miotics, mydriatics, local anaesthetics and cycloplegics.
ACULAR may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical corticosteroids may increase the potential for healing problems (see section 4.4).
4.6. Fertility, pregnancy and lactation
Pregnancy
There are no adequate data from the use of eye drops containing ketorolac trometamol in pregnant women. Studies in animals have shown reproductive toxicity. Inhibition of prostaglandin synthesis may negatively affect pregnancy and/or embryonal/foetal development and/ or postnatal development. Although a very low systemic exposure is expected after the use of ketorolac eye drops, ACULAR is not recommended during pregnancy.
Breast-feeding
ACULAR should not be used during breast-feeding. Ketorolac trometamol is excreted in human milk after systemic administration.
Fertility
There are no adequate data from the use of ketorolac trometamol on fertility in humans.
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