Coral ophthalmic solution is indicated for the relief of pruritus, conjunctival hyperemia and foreign body sensation that accompany allergic conjunctivitis. In post-surgical states, chronic non-infectious inflammations such as conjunctivitis, keratoconjunctivitis and episcleritis.
Coral contains Ketorolac trometamol, a non-steroidal anti-inflammatory drug, which, administered systemically, has been shown to have analgesic, anti-inflammatory and antipyretic activity, due to the inhibition of prostaglandin biosynthesis. Ocular administration of Ketorolac tromethamine reduces prostaglandin E2 levels in aqueous humor.
Prostaglandins have been shown to mediate various types of eye inflammation. In studies conducted in animal eyes, prostaglandins cause breakdown of the blood-water barrier, vasodilation, increased vascular permeability, leukocytosis, and increased intraocular pressure. Likewise, prostaglandins seem to participate in the miotic response produced during eye surgery, by contracting the iris through non-cholinergic mechanisms.
The administration of two drops (0.1 ml) of 0.5% Ketorolac tromethamol ophthalmic solution 12 hours before and 1 hour before cataract surgery produces in the eyes of the patients average ketorolac concentrations of 95 ng / ml in the aqueous humor. (range between 40 and 170 ng / ml).
Ketorolac trometamol 0.5% ophthalmic solution has no significant effect on intraocular pressure; however, changes in intraocular pressure may occur after the cataract operation.
Ketorolac trometamol 0.5% ophthalmic solution has been used safely with other ophthalmic medications, such as antibiotics, beta-blockers, carbonic anhydrase inhibitors, cycloplegics and mydriatics.
Known hypersensitivity to any component of the formula.
Each ml contains:
Ketorolac trometamol 5 mg
Excipients and purified water C.S.P. 1 ml
Posology and administration
For the relief of pruritus, conjunctival hyperemia and foreign body sensation in allergic conjunctivitis: instill one or two drops four times a day.
For the treatment of post-operative inflammation in cataract operated patients, the dosage is 1 drop in the eye (s) four times per day; the application should start 24 hours after the operation, continuing it for a period of 2 weeks.
Administration route: Ophthalmic.
Store at a temperature between 15 ° C and 25 ° C. Protect from freezing.
Box containing dropper bottle with 5 ml solution.
Concomitant use of topical corticosteroids may increase the potential wound healing problem. Coral has a very low probability of presenting pharmacological interactions, so it can be administered together with other ophthalmic medications, such as antibiotics, beta-adrenergic blocking agents, carbonic anhydrase inhibitors, cycloplegics and / or mydriatics.
Cross sensitivity may occur with acetylsalicylic acid, phenylacetic acid derivatives, and other non-steroidal anti-inflammatory agents.
It is recommended that Coral be used with caution in patients with a known tendency to bleed or who were receiving other medications that could prolong the bleeding time.
Precautions or restrictions on use during pregnancy and lactation
There are no adequate and well-controlled studies in pregnant women. Ketorolac trometamol should be used during pregnancy if the benefit justifies the potential risk to the fetus. Caution should be exercised when Coral is administered to lactating women.
Due to the known effects of prostaglandin inhibitors on the fetal cardiovascular system (premature closure of the ductus arteriosus), the use of Coral should be avoided during the last stage of pregnancy.
Employment in pediatrics
The safety and efficacy of Ketorolac trometamol 0.5% ophthalmic solution have not been established in children under 12 years of age.
Temporary burning, eye irritation, superficial eye infections and superficial keratitis, dry eye, corneal infiltrates, corneal ulceration and blurred vision.
Laboratory test abnormalities
They have not been reported to date.