Kelopt

Anti-inflammatory

Kelopt® Ophthalmic solution

Ketorolac Tromethamine 5,0 mg/ml.

5 ml Ophthalmic Solution

S3 Reg. No. 45/15.4/1033

Package Insert

KELOPT Ophthalmic Solution contains: Ketorolac Tromethamine
5,0 mg/ml.
Other ingredients are:
Disodium Phosphate Anhydrous
Monosodium Phosphate Dihydrate
Sodium Chloride
Purified Water
Preservatives: Benzalkonium Chloride 0,01 % m/v
Disodium Edetate Dihydrate 0,05 % m/v

A 15.4 Ophthalmic preparations, others.

Pharmacodynamic properties:
Ketorolac tromethamine is a non-steroidal anti-inflammatory agent, demonstrating both anti-inflammatory and analgesic activity.
The mechanism of action of ketorolac tromethamine is believed to
be due to its ability to inhibit the cyclo-oxygenase enzymes, which
are essential for the biosynthesis of certain prostaglandins in the
arachidonic acid pathway.
Ketorolac tromethamine has been shown to reduce aqueous
humour concentrations of these prostaglandins (PGE2) following
topical application to the eye. Ketorolac tromethamine has no
significant effect on intraocular pressure.
Systemic administration of ketorolac tromethamine does not cause
pupil constriction.

Following topical administration of one drop (0,05 ml) of 0,5 %
ketorolac tromethamine ophthalmic solution into one eye and
one drop of vehicle into the other eye, 3 times a day in 26 normal
individuals, it was noted that only some of the individuals had
a detectable amount of ketorolac in their plasma (range: 10,7 to
22,5 ng/ml) at day 10. Steady state plasma levels of about
960 ng/ml is achieved when 10 mg of ketorolac tromethamine is
administered systemically every 6 hours.

KELOPT is indicated for the relief of inflammation following ocular surgery.

KELOPT is contraindicated in patients who are hypersensitive to
ketorolac tromethamine, benzalkonium chloride or any ingredient in the formulation.
There is a potential for cross-sensitivity to aspirin and other non-steroidal anti-inflammatory drugs (NSAIDs). KELOPT is contraindicated in individuals who have previously exhibited sensitivities to these components (See WARNINGS AND SPECIAL PRECAUTIONS).
Pregnancy and lactation.
Safety and effectiveness of KELOPT in children have not been established.
KELOPT should not be administered while wearing soft (hydrophilic)
contact lenses.

Since there is potential for cross-sensitivity between KELOPT and other NSAIDs [including aspirin (acetylsalicylic acid)], KELOPT should be used with caution in patients in whom asthma, rhinitis or urticaria is precipitated by aspirin or other NSAIDs.
KELOPT may mask the usual signs of infection.
KELOPT has the potential to increase bleeding time due to interference with thrombocyte aggregation and may cause increased bleeding of ocular tissue (including hyphemas) in conjunction with ocular surgery.
KELOPT should be used with caution in patients with a known history of peptic ulceration, in patients who have bleeding tendencies or who are receiving other medication which may prolong the bleeding time.
Keratitis may result from the use of KELOPT. Continued use of KELOPT may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or cornea perforation in some susceptible patients. These events may threaten vision.

KELOPT should be immediately discontinued in patients with evidence of
corneal epithelial breakdown and these patients should be closely monitored for corneal health.
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 become sight threatening.
It is therefore recommended that KELOPT be used with caution in these patients.
The use of KELOPT for 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.
KELOPT may slow or delay the healing process.
Benzalkonium chloride is known to cause eye irritation and discolour soft contact lenses. Patients that wear soft contact lenses should be instructed to remove their lenses prior to using KELOPT and to wait at least 15 minutes before reinserting them (See DOSAGE AND DIRECTIONS FOR USE).
In view of KELOPT’s inherent potential to cause fluid retention, heart
failure may be precipitated in some compromised patients.
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 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.

KELOPT may cause transient burning on instillation. Patients should
be advised not to drive or use machines unless vision is clear.

Concomitant use with medication containing anticoagulants, coumarin- or indandione-derivatives, heparin or platelet aggregation inhibitors may increase the risk of post-operative bleeding.
Since KELOPT and topical corticosteroids slow or delay healing, concomitant use of these agents may increase the potential for healing problems.
KELOPT has been safely administered with systemic and ophthalmic medication such as carbonic anhydrase inhibitors, cycloplegics, betablockers, antibiotics, miotics and mydriatrics.

 

Concomitant use with medication containing anticoagulants, coumarin- or indandione-derivatives, heparin or platelet aggregation inhibitors may increase the risk of post-operative bleeding.
Since KELOPT and topical corticosteroids slow or delay healing, concomitant use of these agents may increase the potential for healing problems.
KELOPT has been safely administered with systemic and ophthalmic medication such as carbonic anhydrase inhibitors, cycloplegics, betablockers, antibiotics, miotics and mydriatrics.

Benzalkonium chloride is known to cause eye irritation and discolour soft contact lenses. Patients that wear soft contact lenses should be instructed to remove their lenses prior to using KELOPT and to wait at least 15 minutes before reinserting them (See WARNINGS AND SPECIAL PRECAUTIONS).
The recommended dose is one drop of KELOPT into the affected eye(s) four times daily starting 24 hours before surgery and continuing post-operatively.
Post marketing experience with topical NSAIDs such as KELOPT suggest that use of these medications for more than 24 hours prior to surgery or use beyond 14 days post-surgery may increase the risk for the occurrence and severity of corneal adverse events (See WARNINGS AND SPECIAL PRECAUTIONS).

Eye disorders:
Frequent:
Stinging or burning upon instillation. Minor symptoms of ocular irritation.
Superficial ocular infections, corneal infiltrates, superficial keratitis, ocular irritation, conjunctival hyperaemia, ocular inflammation, ocular pain, ocular oedema, iritis, corneal oedema.
Less frequent:
Dry eyes, corneal ulceration.
Frequency unknown:
Blurring/visual disturbances.
Corneal perforation, corneal erosion, corneal thinning and epithelial breakdown.
Immune system disorders:
Frequent:
Allergic reactions such as rash, itching, redness or swelling of the skin.
Nervous system disorders:
Frequent:
Headache.

(See SIDE EFFECTS, WARNINGS AND SPECIAL PRECAUTIONS).
In the event of topical overdosage, flush the eye with water.
Treatment is symptomatic and supportive.

Clear, transparent, yellowish solution without suspending particles.

KELOPT ophthalmic solution is supplied in an opaque white sterile dropper bottle with a white sterile capillary plug and white sterile cap, containing 5 ml solution.

Store at or below 30 °C. Do not use more than 28 days after opening.
Discard any unused portion. Protect from light. Keep the container in the outer carton.

Do not refrigerate or freeze.

KEEP OUT OF REACH OF CHILDREN.

45/15.4/1033

Actor Pharma (Pty) Ltd
Unit 7, Royal Palm Business Estate
646 Washington Street, Halfway House, Midrand, 1685
Gauteng

25 August 2015

® – KELOPT is a registered trademark of Actor Pharma (Pty) Ltd
1 Company Registration number: 2008/008787/07