Ketorolac Drops Pharma-Q 5 mg/ mL. Eye drops, solution.

Ketorolac Drops Pharma-Q is indicated for the relief of inflammation following ocular surgery.

Posology
One drop instilled into the eye three times daily starting 24 hours before surgery and continuing post-operatively.
Special populations
Paediatric Population:
The safety and efficacy of Ketorolac Drops Pharma-Q in children have not been established (see section 4.3).
Method of administration
Ophthalmic 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 used with other eye drops there must be an interval of 5 minutes between applications.

• Known hypersensitivity to ketorolac trometamol 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 medicines.
• Ketorolac Drops Pharma-Q is contraindicated in individuals who have previously exhibited sensitivities to these medicines.
• Safety and effectiveness in children have not been established.
• Safety of use in pregnant women has not been established (see section 4.6).
• Ketorolac Drops Pharma-Q is not recommended for nursing mothers. Ketorolac trometamol is secreted in human milk after systemic administration (see section 4.6).
• Ketorolac Drops Pharma-Q should not be used while wearing soft contact lenses.

Benzalkonium chloride
Ketorolac Drops Pharma-Q contains the preservative benzalkonium chloride, which may be absorbed by soft contact lenses. Contact lenses should be removed prior to instillation of Ketorolac Drops Pharma-Q and may be reinserted 15 minutes following administration. Benzalkonium chloride has been reported to cause eye irritation, symptoms of dry eyes and may affect the tear film and corneal surface. Ketorolac Drops Pharma-Q should be used with caution in dry eye patients and in patients where the cornea may be compromised. Patients should be monitored in case of prolonged use. As the possibility of adverse effects on the corneal permeability and danger of disruption of the corneal epithelium with prolonged or repeated usage of benzalkonium chloride preserved preparations cannot be excluded, regular ophthalmological examination is required. Caution should be exercised in the use of benzalkonium chloride preserved topical medication over an extended period in patients with extensive ocular surface disease.
Asthma patients with hypersensitivity to aspirin/NSAIDs
There have been post-marketing reports of bronchospasm or exacerbation of asthma in patients, who have either a known hypersensitivity to aspirin/NSAIDS or a past medical history of asthma associated with the use of Ketorolac 0,5 %, which may be contributory (see section 4.8).
Risk of bleeding
With Ketorolac Drops Pharma-Q, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied NSAIDs may cause increased bleeding of ocular tissues (including hyphaemas) in conjunction with surgery. It is recommended that Ketorolac Drops Pharma-Q be used with caution in patients with known bleeding tendencies or who are receiving other medicines which may prolong bleeding time and in patients with known history of peptic ulceration.
Infections
In common with other anti-inflammatory medicines, Ketorolac Drops Pharma-Q may mask the usual signs of infection.
General:
Ketorolac Drops Pharma-Q may slow or delay healing.
Keratitis
Use of Ketorolac Drops Pharma-Q may result in keratitis (see section 4.8). In such patients continued use of Ketorolac Drops Pharma-Q 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 Ketorolac Drops Pharma-Q and should be closely monitored for corneal health.
Corneal Adverse Events
Ketorolac Drops Pharma-Q 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 (see section 4.8). Post-marketing experience with topical NSAIDs, such as Ketorolac Drops Pharma-Q, 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. Ketorolac drops may cause the risk of anastomotic leakage.

Ketorolac Drops Pharma-Q has been safely administered with systemic and ophthalmic medicines such as antibiotics, sedatives, beta-blockers, carbonic anhydrase inhibitors, miotics, mydriatics, local anaesthetics and cycloplegics. Ketorolac Drops Pharma-Q 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.

Pregnancy
Safety and efficacy in human pregnancy have not been established (see section 4.3).
Breastfeeding
Ketorolac trometamol, the active ingredient in Ketorolac Drops Pharma-Q, is secreted in human milk after systemic administration. Therefore, mothers using Ketorolac Drops Pharma-Q should not be breastfeeding their infants (see section 4.3).
Fertility
There are no adequate data from the use of ketorolac trometamol on fertility in humans.

Upon instillation, patients may experience transient blurred vision which may impair the ability to drive or use machinery. If affected, patients should not drive or use machinery until their vision has cleared.

a. Summary of the safety profile
The most frequent adverse events reported with the use of Ketorolac Drops Pharma-Q are transient stinging and burning on instillation.
b. Tabulated summary of adverse reactions
MedDRA system organ class Frequency Adverse reactions
Immune system disorders Frequent Hypersensitivity including localised allergic reactions.
Nervous system disorders Frequent Headache.
Eye disorders Frequent Eye irritation (including burning sensation), eye pain (including stinging), superficial (punctate) keratitis, eye and/or eyelid oedema, ocular pruritus, conjunctival hyperaemia, eye infection, eye inflammation, iritis, keratic precipitates, retinal haemorrhage, cystoid macular oedema, eye trauma, increased intraocular pressure, blurred and/or diminished vision.
Less frequent Corneal ulcer, corneal infiltrates, eye dryness, epiphora.
Frequency unknown Corneal damage, e.g. thinning, erosion, epithelial breakdown and perforation*, ulcerative keratitis, eye swelling, ocular hyperaemia.
Gastrointestinal disorders Frequency unknown Anastomotic leakage
Respiratory, thoracic and mediastinal disorders Frequency unknown Bronchospasm or exacerbation of asthma**.
*Occasional post marketing reports of corneal damage including corneal thinning, corneal erosion, epithelial breakdown and corneal perforation have been received. These occurred mainly in patients using concomitant topical corticosteroids and/or with predisposing co-morbidity (see section 4.4).
**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 Ketorolac Drops Pharma-Q which may be contributory. None of the typical adverse reactions reported with the systemic non-steroidal anti-inflammatory medicines (including ketorolac trometamol) have been observed at the doses used in topical ophthalmic therapy.

No case of overdose has been reported. Overdose is unlikely to occur via the recommended method of administration. In the event of topical overdosage, rinse the eye with water. If accidentally ingested, drink fluids to dilute.