Instructions for use Elipa eye drops solution 5mg/ml bottle 10 ml
Composition
active ingredient: ketorolac tromethamine;
1 ml of solution contains ketorolac tromethamine 5 mg;
Excipients: sodium chloride, disodium edetate, benzalkonium chloride 50% solution, hydrochloric acid 10% or sodium hydroxide 40%, water for injections.
Dosage form
Eye drops, solution.
Main physicochemical properties: transparent, colorless, odorless solution.
Pharmacotherapeutic group
Drugs used in ophthalmology. Nonsteroidal anti-inflammatory drugs. Ketorolac. ATX code S01B C05.
Pharmacological properties
Pharmacodynamics
Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug (NSAID) that has analgesic and anti-inflammatory effects. Ketorolac tromethamine inhibits the enzyme cyclooxygenase, which is required for the biosynthesis of prostaglandins. Topical application of Elipa to the eye has been shown to reduce the level of prostaglandins in the aqueous humor.
When used systemically with ketorolac tromethamine, it does not cause mydriasis. Clinical studies have shown that Elipa has no significant effect on intraocular pressure.
Pharmacokinetics
As demonstrated in clinical studies, higher levels of ketorolac in aqueous humor and very low or undetectable levels in plasma following ocular administration indicate that topical application of ketorolac tromethamine for the treatment of ocular diseases results in extremely low systemic absorption in patients.
Indication
The drug Elipa is indicated for the prevention and reduction of inflammation and associated symptoms after ophthalmic surgery.
The drug Elipa is indicated for use in adults.
Contraindication
Hypersensitivity to the active substance or to any of the excipients of the drug.
There is a risk of cross-sensitization to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs. Elipa is contraindicated in patients with a history of hypersensitivity to these drugs.
Interaction with other medicinal products and other types of interactions
Interaction studies have not been conducted.
Elipa has been safely used with ophthalmic and systemic drugs such as antibiotics, sedatives, beta-blockers, carbonic anhydrase inhibitors, miotics, mydriatics, and cycloplegics.
Ellipta 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 risk of healing problems (see section 4.4).
Application features
It is recommended that Elipa be used with caution in patients with a known tendency to bleed or those receiving other medications that may prolong bleeding time.
Like other anti-inflammatory drugs, Elipa may mask the usual signs of infection.
All NSAIDs can slow or delay wound healing. Concomitant use of NSAIDs and topical steroids may increase the risk of healing problems.
Caution should be exercised when administering Ellipta and topical corticosteroids concomitantly to patients susceptible to corneal epithelial damage.
Topical NSAIDs may cause keratitis. In some patients, prolonged use of topical NSAIDs may result in epithelial damage, corneal thinning, erosion, ulceration, or corneal perforation. These events may be vision-threatening. Patients with signs of corneal epithelial damage should discontinue topical NSAIDs immediately and have their corneas monitored closely.
Topical NSAIDs should be used with caution in patients with complications following ophthalmic surgery, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g. dry eye syndrome), rheumatoid arthritis, or in the case of repeated ophthalmic surgeries within a short period, as this may increase the risk of corneal adverse events that may be vision-threatening.
Post-marketing experience with topical NSAIDs also suggests that use more than 24 hours before surgery or more than 14 days after surgery may increase the patient's risk of corneal adverse events and their severity.
In the post-marketing period, there have been reports of bronchospasm or exacerbation of bronchial asthma in patients with known hypersensitivity to acetylsalicylic acid/NSAIDs or with a history of bronchial asthma, which were associated with the use of the drug Elipa, which may be a contributing factor. It is recommended to use the drug Elipa with caution in such patients (see section "Adverse reactions").
Patients should be advised to avoid contact of the dropper tip with the eye or surrounding tissues to avoid injury or contamination of the eye drops.
Undesirable effects can be minimized by using the lowest effective dose for the shortest period necessary to control symptoms.
Use during pregnancy or breastfeeding
Pregnancy
There are no adequate data from the use of ketorolac tromethamine eye drops in pregnant women. Animal studies have shown reproductive toxicity. Inhibition of prostaglandin synthesis may adversely affect pregnancy and/or embryonal/fetal development and/or postnatal development. Although very low systemic exposure is expected with ketorolac eye drops, Elipa is not recommended for use during pregnancy.
Breast-feeding
Elipa is not recommended for use in breast-feeding women. Ketorolac tromethamine is excreted in breast milk after systemic administration.
Fertility
There are no adequate data on the effects of ketorolac tromethamine on human fertility.
Ability to influence reaction speed when driving vehicles or other mechanisms
When instilling eye drops, temporary blurred vision may occur. You should not drive or operate dangerous machinery until clear vision is restored.
Method of administration and doses
Dosage
Instill 1 drop into the eye 3 times a day, starting 24 hours before surgery and continuing for 3 weeks after surgery.
Method of application
For use in the eye.
Instill 1 drop of the solution into the lower conjunctival sac of the eye being treated, slightly pulling the lower eyelid downward and looking upward.
If Elipa is used simultaneously with other topical ophthalmic medicinal products, there should be an interval of at least 5 minutes between the application of the two medicinal products.
Children.
The drug is not used in children.
Overdose
No cases of overdose have been recorded with the use of the drug Elipa. Overdose is unlikely when used as recommended.
In case of accidental ingestion, drink the liquid to dilute the drug.
Adverse reactions
The most common adverse reactions reported with Elipa were temporary tingling and burning during instillation.
Adverse reactions are listed by system organ class and frequency. The frequency is defined as follows: very common (≥1/10); common (≥1/100,
On the part of the immune system
Common: hypersensitivity, including localized allergic reactions.
From the nervous system
Common: headache.
From the organs of vision
Very common: eye irritation (including burning sensation); eye pain (including stinging).
Common: superficial keratitis, eye and/or eyelid swelling, eye pruritus, conjunctival hyperemia, eye infection, eye inflammation, iritis, keratotic precipitates, retinal hemorrhage, cystoid macular edema, eye injury, increased intraocular pressure, blurred and/or impaired vision.
Uncommon: corneal ulcer, corneal infiltrates, dry eye, lacrimation (epiphora).
Frequency unknown: corneal damage (reduction in corneal thickness, corneal erosion, epithelial tear, corneal perforation)*, ulcerative keratitis, eye swelling, ocular hyperemia.
Respiratory, thoracic and mediastinal disorders
Frequency unknown: bronchospasm or exacerbation of bronchial asthma**.
* Isolated reports of corneal damage, including corneal thinning, corneal erosion, epithelial damage and corneal perforation, have been received in the post-marketing period. These events occurred mainly in patients receiving concomitant topical corticosteroids and/or in patients with concomitant diseases (see section 4.4).
** In the post-marketing period, bronchospasm or exacerbation of bronchial asthma has been reported in patients with known hypersensitivity to acetylsalicylic acid/NSAIDs or with a history of bronchial asthma, which were associated with the use of Elipa, which may be a contributing factor.
When using the drug at doses recommended for topical ophthalmic treatment, none of the typical adverse reactions reported with systemic use of NSAIDs (including ketorolac tromethamine) were observed.
Reporting of suspected adverse reactions after the marketing authorisation of a medicinal product is important. This allows for continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national pharmacovigilance system.
Expiration date
36 months.
The shelf life after first opening the dropper bottle is 28 days.
Storage conditions
Store at a temperature not exceeding 30 ° C. Store in the original packaging in order to protect from light and moisture. Keep out of the reach of children.
Packaging
10 ml in a dropper bottle; 1 dropper bottle in a cardboard box.
Vacation category
According to the recipe.
Producer
Laboratorio Edol - Pharmaceutical Products, S.A.
Location of the manufacturer and address of its place of business.
Ave. 25 de Abril, No. 6 - 6A, Linda-a-Velha, 2795 - 225, Portugal.
