Ivinac eye drops with an emphasis 0.09%, 5ml
Expiration Date: 05/2027
Russian Pharmacy name:
Ивинак капли глазные с упором 0,09%, 5мл
Instillation into the conjunctival sac.
1-2 drops of the drug in the conjunctival sac twice a day for no more than 15 days.
If a dose of the drug is missed, it should be used as soon as possible in the dosage specified in the instructions for use. If the missed dose of a drug is about 24 hours, the drug should be used at the next scheduled time, without doubling the dose to compensate for the missed dose.
Treatment of postoperative inflammation: one drop once a day. Treatment begins 1 day before surgery and continues for the first 14 days of the postoperative period (including the day of surgery).
Treatment of non-infectious inflammatory diseases of the anterior segment of the eye: one drop twice a day. The course of treatment is determined by the doctor depending on the severity of the condition.
How to work with a bottle equipped with an emphasis:
Get the stop and the bottle out of the pack.
Using counterclockwise rotating movements, open the bottle with the stop and remove the cap.
Carefully, without touching the tip of the bottle with your fingers, fix the stop on the neck of the bottle.
Tilt your head back, set the stop on the eyelid so that the tip of the bottle is opposite the eyeball, slightly press on the bottle and drip the required amount of the drug.
Remove the stop from the neck of the bottle, put the cap on the bottle and close it with rotating movements clockwise.
After opening the bottle, the drug can be used within 1 month. After this period, the drug should be discarded.
In case of visible damage to the vial, the drug should not be used.
Active substance:
Bromfenac sodium sesquihydrate 1.035 mg
in terms of bromfenac 0.9 mg
Excipients:
Benzalkonium chloride 0.01 mg
Hydroxypropylbetadex 20.0 mg
Boric acid 12.5 mg
Sodium tetraborate decahydrate 12.5 mg
Polysorbate 80 1.5 mg
Disodium edetate dihydrate 0.2 mg
Sodium hydroxide solution 10 M or hydrochloric acid solution 1 M to pH 8.3
Water for injection up to 1 ml
The drug is contraindicated in patients who have a history of hypersensitivity to any component of the drug.
The drug is contraindicated in patients in whom attacks of bronchial asthma, urticaria and symptoms of acute rhinitis are aggravated by taking acetylsalicylic acid and other NSAIDs.
Age up to 18 years (the safety and efficacy of the drug in children have not been studied).
Pharmacological properties
Pharmacodynamics
Bromfenac is a non-steroidal anti-inflammatory drug (NSAID), the anti-inflammatory effect of which is realized by blocking the synthesis of prostaglandins by inhibiting cyclooxygenase 1 and 2.
In in vitro studies, bromfenac inhibited the synthesis of prostaglandins in the rabbit ciliary body. The half-maximal inhibition concentration (IC50) for bromfenac (1.1 µmol) was lower than for indomethacin (4.2 µmol) and pranoprofen (11.9 µmol).
In an experimental model of uveitis in rabbits, bromfenac at concentrations of 0.02%, 0.05%, 0.1% and 0.2% inhibited almost all symptoms of ocular inflammation.
Pharmacokinetics
Suction
Bromfenac effectively penetrates the cornea of ??patients with cataracts: with a single administration, the average peak concentration in aqueous humor is 79 ± 68 ng / ml 150-180 minutes after application. This concentration is maintained for 12 hours in aqueous humor while maintaining measurable concentration levels in the major tissues of the eye, including the retina, for up to 24 hours. Plasma concentrations were not measurable with bromfenac eye drops twice daily.
Distribution
Bromfenac actively binds to plasma proteins. According to an in vitro study, binding to proteins in human blood plasma was 99.8%.
In vitro studies did not reveal biologically significant binding to melanin.
According to a study in rabbits using radiolabeled bromfenac, the maximum concentration after topical application is observed in the cornea, and high in the conjunctiva and aqueous humor of the eye. Low - in the lens and vitreous.
Metabolism
According to the results of an in vitro study, the main metabolism of bromfenac is carried out by the enzyme CYP2C9, which is absent in the iridociliary zone, retina and choroid. The level of this enzyme in the cornea is less than 1% compared to the corresponding hepatic level.
When taken orally in humans, the unchanged parent substance is mainly found in plasma. Several conjugated and unconjugated metabolites have been isolated, the main of which is cyclic amide, which is excreted in the urine.
Withdrawal
When instilled into the eyes, the half-life of bromfenac elimination from the aqueous humor of the eye is about 1.4 hours, which indicates a rapid elimination.
After oral administration of 14C-bromfenac by healthy volunteers, it was found that the drug is predominantly excreted in the urine (about 82% of the administered dose), while about 13% of the administered dose is excreted in the feces.
Application during pregnancy and during breastfeeding
There are no sufficient data on the use of bromfenac in pregnant women. Animal studies have shown reproductive toxicity. The potential risk to humans is unknown. Since the systemic exposure after treatment with the drug in non-pregnant women is negligible, the risk during pregnancy can be considered low.
However, due to the known effects of drugs that inhibit prostaglandin biosynthesis on the fetal cardiovascular system (closure of the duct), this drug should be avoided in the third trimester of pregnancy. In general, the use of this drug during pregnancy is not recommended unless the benefit outweighs the potential risk.
Overdose
At the moment, there is no information on overdose with topical application in humans.
According to foreign reports, patients who took the drug bromfenac sodium orally in a total dose exceeding 1500 mg for a long period of time more than 1 month, there were serious liver dysfunctions (including deaths). In this regard, if abnormalities are found that are presumably associated with early symptoms of liver failure, it is necessary to discontinue treatment with this drug and take appropriate measures.
Use in patients with hepatic and renal impairment
The effect of the drug in patients with hepatic and renal insufficiency has not been studied.
Interaction with other medicinal products
Interaction studies of bromfenac with other drugs have not been conducted.
special instructions
The drug should be used as part of symptomatic treatment, and not for etiotropic therapy.
The drug should only be used as eye drops.
All topical NSAIDs can slow or delay healing similar to topical glucocorticosteroids. Using NSAIDs and topical steroids together can increase the likelihood of healing problems.
Cross sensitivity
There is a possibility of cross-sensitivity to acetylsalicylic acid, phenylacetylic acid derivatives and other NSAIDs. Therefore, caution should be exercised when treating individuals who have previously been susceptible to these drugs, and the potential risks and benefits should be carefully evaluated.
Special patient groups
In susceptible patients, long-term use of topical NSAIDs, including bromfenac, can lead to epithelial rupture, corneal thinning, corneal erosion, corneal ulceration, or corneal perforation. These events can threaten with loss of vision. Patients with signs of destruction of the corneal epithelium should immediately discontinue the use of topical NSAIDs and should closely monitor the health of the cornea. Consequently, in patients at risk, concomitant use of ophthalmic corticosteroids with NSAIDs may lead to an increased risk of corneal adverse events.
Post-registration experience of application
Post-marketing experience with topical NSAIDs indicates that patients with complications after ophthalmic surgery, corneal denervation, corneal epithelial defects, diabetes mellitus and superficial eye diseases, rheumatoid arthritis or repeated ophthalmic surgical interventions performed within a short period of time may experience increased the risk of corneal adverse events that can become threatening loss of vision. Topical NSAIDs should be used with caution in these patients.
It has been reported that ophthalmic NSAIDs can cause increased bleeding in the tissues of the eye (including hyphema) in combination with ophthalmic surgery. Topical NSAIDs should be used with caution in patients with a history of bleeding tendencies, or if patients are receiving other medications that may increase blood clotting time.
Eye infections
The use of the drug should be carefully monitored and it should be prescribed with caution to patients with inflammation caused by infections, since the drug can mask the symptoms of infectious eye diseases.
Using contact lenses
In general, wearing contact lenses during drug treatment is not recommended. In this regard, patients are not advised to wear contact lenses unless explicitly instructed by the attending physician.
Excipients
Benzalkonium chloride, which is often used as a preservative in ophthalmic preparations, can cause punctate keratopathy and / or toxic ulcerative keratopathy. Since the drug contains benzalkonium chloride, careful monitoring is necessary in case of frequent or prolonged use in patients with dry eye syndrome or in cases of corneal damage. Benzalkonium chloride can discolor soft contact lenses. It is necessary to remove soft contact lenses before using the drug and put them on again 15 minutes after instillation.
Influence on the ability to drive vehicles and mechanisms
After instillation, transient blurred vision may occur. In the case of the development of blurred vision after instillation, it is necessary to refrain from driving vehicles and mechanisms until the clarity of vision is restored.