Properties
What is it?
International Nonproprietary Name - ketorolac tromethamine Clinical-pharmacological group: Ophthalmology → Anti-inflammatory agents for topical use in ophthalmology Dosage form Eye drops Description: A clear solution from colorless to pale yellow. Composition 1 ml of the preparation contains Active substance: ketorolac tromethamine 5 mg. Excipients: octoxynol 40, disodium edetate, sodium chloride, benzalkonium chloride, hydrochloric acid, purified water. Pharmacotherapeutic group Non-steroidal anti-inflammatory drug for topical use in ophthalmology. Pharmacological properties Medrolgin is a non-steroidal anti-inflammatory drug with analgesic and anti-inflammatory effects, due to the inhibition of cyclooxygenase, the main enzyme in the metabolism of arachidonic acid, by ketorolac tromethamine. With topical application, it reduces the concentration of prostaglandins in the aqueous humor. Medrolgin does not significantly affect intraocular pressure. After instillation into the conjunctival sac, very low or negligible levels of ketorolac in plasma indicate minimal absorption of the drug into the systemic circulation. Indications for use - Prevention and treatment of inflammation and related symptoms developing after cataract and other ophthalmic surgeries on the anterior segment of the eye; - Relief of eye itching in seasonal allergic conjunctivitis. Method of administration and dosage For topical use only. The duration of treatment should not exceed two weeks. For inflammatory processes developing after ophthalmic surgery, instill one drop 4 times a day for 2 weeks, starting within 24 hours after surgery. In seasonal allergic conjunctivitis, instill one drop into the conjunctival sac 4 times a day. Avoid touching the dropper tip to any surface to prevent microbial contamination of the vial contents. Medrolgin eye drops should not be used while wearing contact lenses. Contraindications - Hypersensitivity to the components of the preparation; - Pregnancy and lactation; - Children under 12 years of age. Side effects Temporary burning and irritation of the eyes after instillation, conjunctival hyperemia, corneal infiltration, superficial punctate keratitis, headache, eye swelling, eye itching, superficial eye infections, eye pain. Rarely – corneal ulcer (ulcerative keratitis), corneal infiltration, blurred vision, dry eyes, increased tearing. Effect on ability to drive and operate machinery Due to possible visual disturbances that develop immediately after instillation, refrain from driving vehicles and operating other potentially dangerous machinery until vision normalizes. Use during pregnancy and lactation The use of Medrolgin eye drops during pregnancy and lactation is contraindicated. Use in pediatrics The safety and efficacy of Medrolgin eye drops in children under 12 years of age have not been established. Interaction with other drugs Medrolgin can be used together with eye drops containing antibiotics, beta-blockers, carbonic anhydrase inhibitors, and mydriatics, in which case an interval of at least 5 minutes between instillations must be observed. When Medrolgin is used together with other non-steroidal anti-inflammatory drugs, pentoxifylline, anticoagulants, there may be an increased risk of postoperative bleeding. Overdose Not established. Dosage form Medrolgin eye drops are available in a 5 ml polyethylene bottle with a dropper and a screw-on cap. The bottle is placed in a cardboard box with instructions for use.