Properties
What is it?
Composition: Active substance is Ketorolac Tromethamine. Excipients are: Sodium Chloride, Disodium Edetate, Benzalkonium Chloride 0.1 mg/ml as preservative and highly purified water. Pharmacotherapeutic group: Non-steroidal anti-inflammatory drug. Indications: In ophthalmology for the treatment of inflammatory conditions, pain control, pre- and post-operative periods. To suppress miosis during surgery. Dosage and administration: Recommended dose is: In preparation for surgery: 1 drop every half hour in the pupil, for two hours before surgical intervention (total 4 drops). Post-operative period: Medical criteria should determine the dosage for a period of 3 weeks. For other indications: Recommended average dose is 1 drop 4 times a day. Treatment should not exceed one week without doctor's advice. The efficacy and safety of this preparation have not been studied in children under 12 years of age. The bottle must not be used for other purposes. Side effects: Stinging and burning sensation in the eyes and eyelids, especially in patients with allergic conjunctivitis. Allergic reactions, eye irritation, superficial eye infections and superficial keratitis. After instillation, vision may be temporarily blurred. Other possible side effects include flu-like symptoms, nausea, vomiting, and bruising. Contraindications: Hypersensitivity to the active substance or any of the excipients; there is a potential for cross-sensitivity with acetylsalicylic acid and other non-steroidal anti-inflammatory drugs. Elipa is contraindicated in patients who have previously experienced hypersensitivity to this preparation. Elipa must not be used with contact lenses. Interactions with other drugs: Elipa was well tolerated when administered with ophthalmic and systemic preparations such as antibiotics, sedatives, beta-blockers, carbonic anhydrase inhibitors, miotics, mydriatics, cycloplegics, and corticosteroids. Use with caution in patients prone to bleeding or undergoing anticoagulant therapy. Special instructions: This preparation must not be used with contact lenses. When using contact lenses, glasses should be worn during the period of Elipa administration. Caution is recommended when using Elipa in patients prone to hemorrhages or undergoing anticoagulant therapy. Elipa contains benzalkonium chloride. May cause eye irritation. Do not contact soft contact lenses. Before instillation, the patient should remove contact lenses and put them back on 15 minutes after instillation. Benzalkonium chloride is known to discolor soft contact lenses. If the patient forgets to take Elipa and the time for the next instillation has not yet approached, it should be instilled immediately. Do not take a double dose to make up for a missed one. Pregnancy and lactation: Consult a doctor before taking this preparation during pregnancy and breastfeeding. Driving and operating machinery: No effects were observed. Overdose: No cases of overdose were observed with ocular use. Appearance and packaging: Elipa eye drops, solution is presented in a sterile low-density polyethylene dropper bottle with a volume of 10 ml. Storage conditions: Store in a place protected from light and moisture and inaccessible to children. At a temperature not exceeding 30C. Elipa should be used within 28 days after the first opening of the bottle. Expiration date: Indicated on the packaging. Pharmacy dispensing conditions: Over-the-counter. Manufacturer: Laboratorios Edol-Produtos Farmaceuticos, S.A. Portugal