Instructions Medrolgin eye drops solution 5 mg/ml dropper bottle 5 ml
Composition
active ingredient: ketorolac;
1 ml of solution contains ketorolac tromethamine 5 mg;
Excipients: octoxynol 40, disodium edetate, sodium chloride, benzalkonium chloride, sodium hydroxide or hydrochloric acid, purified water.
Dosage form
Eye drops, solution.
Main physicochemical properties: transparent solution from colorless to pale yellow, practically free of mechanical impurities.
Pharmacotherapeutic group
Nonsteroidal anti-inflammatory drugs. Ketorolac.
ATX code S01B C05.
Pharmacological properties
Pharmacodynamics
Medrolgin is a nonsteroidal anti-inflammatory drug.
Ketorolac tromethamine has analgesic, anti-inflammatory and antipyretic effects, which are due to its ability to inhibit prostaglandin biosynthesis. When applied topically to the eye, ketorolac reduces the level of prostaglandin E2 in the aqueous humor of the eye.
Ketorolac tromethamine has no significant effect on intraocular pressure, however, changes in intraocular pressure are possible after cataract surgery.
Pharmacokinetics
Ketorolac tromethamine has no significant effect on intraocular pressure. The very low or undetectable plasma levels of ketorolac after instillation into the conjunctival sac indicate minimal absorption of the drug into the systemic circulation after topical administration.
Indication
Pain and inflammation after cataract surgery.
Contraindication
Hypersensitivity to any of the components of the drug.
Interaction with other medicinal products and other types of interactions
Concomitant ophthalmic medications should be applied at least 5 minutes after instillation of Medrolgin.
Topical corticosteroids are also known to slow or delay wound healing. Concomitant treatment with topical NSAIDs and topical steroids may increase the risk of healing problems.
There is a risk of cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives and other NSAIDs.
Application features
Slow wound healing
Topical nonsteroidal anti-inflammatory drugs (NSAIDs) may slow or delay wound healing. Patients should be advised of the possibility of slowing or delaying healing with NSAIDs.
Occurrence of cross-sensitivity
The drug should be used with caution in the treatment of individuals who have previously shown sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs.
Increased bleeding time
There is a risk of increased bleeding time with some NSAIDs due to interference with platelet aggregation. NSAIDs used in the eye have been reported to cause increased bleeding into ocular tissues (including hemorrhages into the anterior chamber of the eye) in conjunction with ocular surgery.
It is recommended to use Medrolgin with caution in patients who have a tendency to bleed or are taking other medications that may increase bleeding time.
Corneal effects
Topical NSAIDs may cause keratitis. In some susceptible patients, prolonged use of topical NSAIDs may result in epithelial detachment, corneal thinning, corneal erosion, corneal ulceration, and corneal perforation. This may be a threat to vision. Patients with signs of corneal epithelial detachment should immediately discontinue topical NSAIDs and have their corneas examined.
Intercurrent eye conditions
Patients should be advised that in the event of intercurrent ocular conditions (e.g., trauma or infection) or ophthalmic surgery, they should consult an ophthalmologist to determine the possibility of continued treatment with the drug.
Concomitant local therapy
Medrolgin can be used with other topical ophthalmic drugs such as alpha-agonists, beta-blockers, drugs for the treatment of accommodation paralysis, and mydriatics.
If the patient is using more than one ophthalmic drug, an interval of at least 5 minutes should be observed between instillations.
Application when using contact lenses
The drug should not be used when wearing contact lenses.
Prevention of microbial contamination of the drug
Do not allow the tip of the bottle to touch your eyes or the surface around your eyes, as this may contaminate the tip with bacteria that cause eye infections. Serious eye damage with subsequent loss of vision may result from the use of contaminated solutions.
Use during pregnancy or breastfeeding
Due to the effect of prostaglandin inhibitors on the fetal cardiovascular system (closure of the ductus arteriosus), the use of the drug should be avoided in late pregnancy.
Since most drugs are excreted in breast milk, caution should be exercised when using Medrolgin in nursing women.
Ability to influence reaction speed when driving vehicles or other mechanisms
No adverse effects are expected when driving or using other mechanisms, although patients should be warned about the possibility of blurred vision when using Medrolgin.
Method of administration and doses
For topical use only.
One drop of the drug is instilled into the affected eye twice a day, starting one day before cataract surgery, continuing on the day of surgery and for the first 2 weeks of the postoperative period.
Children
The safety and efficacy of the drug in children have not been studied, therefore Medrolgin should not be used in pediatric practice.
Overdose
Usually, an overdose does not lead to serious consequences.
Adverse reactions
The most common adverse reactions, occurring in 1-6% of patients, were increased intraocular pressure, conjunctival hyperemia and/or hemorrhage, corneal edema, eye pain, headache, tearing, and blurred vision. Some of these effects may be secondary to cataract surgery.
Expiration date
2 years. After opening the bottle, the drug can be used for 4 weeks.
Storage conditions
Store at a temperature not exceeding 25 °C out of the reach of children.
Packaging
5 ml in a dropper bottle; 1 dropper bottle in a cardboard box.
Vacation category
According to the recipe.
Producer
K.O. Rompharm Company SRL, Romania / SC Rompharm Company SRL, Romania.
Applicant
WORLD MEDICINE LTD / WORLD MEDICINE LTD.
Location of the manufacturer and its business address
Otopeni city, Eroilor str. № 1A, 075100, jud. Ilfov.
