Instructions Benoxy eye drops 0.4% dropper container 10 ml
Composition
active ingredient: oxybuprocaine hydrochloride;
1 ml of solution contains oxybuprocaine hydrochloride 4 mg;
Excipients: boric acid, chlorhexidine diacetate, water for injection.
Dosage form
Eye drops, solution.
Main physicochemical properties: transparent colorless solution without visible mechanical particles.
Pharmacotherapeutic group
Means used in ophthalmology. Local anesthetics. ATX code S01H A02.
Pharmacological properties
Pharmacodynamics.
The active substance of the drug oxybuprocaine hydrochloride is a synthetic local anesthetic belonging to the group of esters of para-aminobenzoic acid. It is a potent surface anesthetic that exhibits a rapidly increasing effect and has a short-term local anesthetic effect (10–20 min). When it reaches sensitive nerve endings in therapeutic doses, oxybuprocaine leads to a reversible blockade of the generation and transmission of impulses and, thus, causes temporary anesthesia at the site of instillation. It does not affect the width of the pupil of the eye and the ability to accommodate. After the end of the local anesthetic effect, the sensitivity of the pupil returns to its original state. In vitro, oxybuprocaine has a weak antibacterial effect.
Pharmacokinetics.
After instillation into the conjunctival sac, oxybuprocaine is absorbed into the circulatory system in small amounts. In the blood, oxybuprocaine is immediately metabolized by plasma esterase (by breaking the ester bond) to form inactive metabolites. The main metabolite is 3-butoxy-4-aminobenzoic acid, 80% of which is excreted by the kidneys in the form of a compound with glucuronic acid.
Indication
Local short-term anesthesia of the cornea and conjunctiva: during removal of foreign particles from the cornea and conjunctiva; performing ocular tonometry, gonioscopy and other diagnostic examinations; preparation for subconjunctival and retrobulbar injections.
Contraindication
Hypersensitivity to the active substance or other components of the drug.
Severe heart failure.
Thyrotoxicosis.
Open penetrating wounds of the eye.
Hypersensitivity to other local anesthetics of the para-aminobenzoic acid ester group or the amide group.
Eye infection.
Allergic reactions.
Interaction with other medicinal products and other types of interactions
Benoxy enhances the effects of succinylcholine and sympathomimetics, weakens the effects of sulfonamides and beta-blockers.
The preparation contains the preservative chlorhexidine diacetate, which is incompatible with fluorescein solutions, as it leads to precipitation. Benoxy is also incompatible with silver nitrate, mercury salts and alkaline substances.
Application features
Only a doctor should instill the drug!
For instillation into the conjunctival sac only. Do not use for injection. The medicinal product should not be used at home.
Use drops only short-term. Due to the fact that oxybuprocaine has a bacteriostatic effect, Benoxy should not be used before taking bacteriological smears.
The patient should not touch the eye during anesthesia, as this may cause damage that will go unnoticed due to the anesthesia. The anesthetized eye should be protected from irritating chemicals, dust, and bacterial infections.
The drug should be used with caution in patients with pseudocholinesterase deficiency, myasthenia gravis, arterial hypotension, heart disease (heart failure, arrhythmia), and epilepsy.
The drug should be used with great caution in individuals with a history of bradycardia or allergic manifestations, as the development of severe bradycardia or anaphylactic shock cannot be ruled out.
Uncontrolled use of any anesthetic, even in low concentrations, can lead to damage to the corneal epithelium even after short-term use. In addition, this damage may go unnoticed due to anesthesia. Patients with persistent pain should be prescribed a systemic analgesic. Even a single use leads to the appearance of superficial areas of mild damage to the corneal epithelium. Repeated long-term use increases the damage to the epithelium. Infiltration of the corneal stroma may occur, as well as toxic damage to it, numerous erosions that heal very poorly (recurrent corneal erosions), leading to a condition similar to that observed in neuroparalytic keratitis.
Patients who wear contact lenses should remove them before using this medicine and may put them back on after the effects of the anaesthesia have fully worn off.
Systemic absorption of the drug can be reduced by pressing the lacrimal sac located in the inner corner of the eye for a minute after instillation. This will prevent the drops from entering the nasal cavity through the nasolacrimal duct.
Use during pregnancy or breastfeeding
The safety of the drug in pregnant women has not been established. The drug can be used during pregnancy only if, in the opinion of the doctor, the potential benefit to the mother outweighs the potential risk to the fetus.
Breastfeeding period
It is not known whether oxybuprocaine hydrochloride passes into breast milk. Benoxy should be used in women during breastfeeding only if, in the opinion of the physician, the potential benefit to the mother outweighs the potential risk to the infant.
Ability to influence reaction speed when driving vehicles or other mechanisms
Since oxybuprocaine is absorbed, albeit in small amounts, into the blood after topical administration into the conjunctival sac, systemic effects may develop. Taking into account the above, driving, operating other machinery, or working at height should be allowed no earlier than 1 hour after application of the drops and after vision has returned.
Method of administration and doses
The drug is intended for adults and children aged 2 years and over.
Instill into the conjunctival sac. The eyes should be closed between successive instillations of the drug.
Corneal and conjunctival anesthesia.
Removal of foreign particles on the surface: instill 1 drop 3 times with an interval of 5 minutes.
Removal of deeply embedded foreign particles: 5–10 times 1 drop at intervals of 30–60 seconds.
Before subconjunctival or retrobulbar injection: 1 drop 3 times with an interval of 5 minutes.
Ocular tonometry, gonioscopy and other examinations: 1–2 drops once.
As with any eye drops, it is recommended to press lightly on the lacrimal sac area in the inner corner of the eye and release after 1 minute to reduce systemic absorption. This should be done immediately after instillation of each drop.
Contact lenses should be removed before using the eye drops; they can be put back on after the effects of anesthesia have fully worn off.
When using two or more ophthalmic agents, the interval between their administration should be at least 5 minutes.
Children.
The drug is not intended for use in children under 2 years of age.
Overdose
Systemic adverse reactions may occur with excessive doses or prolonged use. Systemic toxicity affects, in particular, the central nervous system and the cardiovascular system. Irritability, insomnia, sedation, confusion, agitation, euphoria, disorientation, hearing, vision or speech disorders, paresthesia, nausea, vomiting, muscle twitching, convulsions, respiratory disorders, coma, tachycardia, arrhythmia, hypotension, shock and cardiac arrest require symptomatic treatment. No specific antidote is known.
Side effects
From the organs of vision.
After instillation of the drug, a temporary tingling and burning sensation, redness, and discomfort may occur, which usually disappear quickly.
Allergic reactions of the eyelids and conjunctiva may develop. As a result of prolonged or frequent use, the following may develop: stromal infiltration, edema, moderate damage to the corneal epithelium, keratitis (including toxic, superficial small-spotted, discoid, superinfectious candidiasis), iris fibrinosis, periorbital contact dermatitis (including allergic), suppression of the precorneal film (only for blue eyes), change in corneal thickness, decreased corneal sensitivity, keratopathy (including striate, bullous, keratopathy, toxic keratopathy, necrotizing ulcerative keratopathy, postoperative keratopathy), wrinkling of Descemet's membrane of the eye, increase in the size of endothelial cells, restriction of iris translucency, decrease in endothelial cell density, extracellular melanosome, subsequent decrease in normal cytokinetic and mitotic activity in eye cells, formation of peripheral corneal rings, development of tolerance, epithelial cell damage, irreversible superficial cell damage at the level of corneal endothelial cells, direct cytotoxic effect on corneal cells (including a significant decrease in oxygen consumption by the corneal epithelium), chemosis, development of hypopyon or corneal perforation, corneal or conjunctival necrosis. Possible occurrence of corneal ulcers, recurrent corneal ulcers, delayed healing of the cornea, irreversible corneal opacity, decreased intraocular pressure, decreased spontaneous blinking, spontaneous eye movements, pseudopositive reactions, decreased tear film stability, cataract. Cases of fibrinous iritis have been reported.
From the cardiovascular system.
Bradycardia.
From the nervous system.
Sedation, confusion, excitement, euphoria, disorientation, hearing, vision, or speech impairment, paresthesia, muscle cramps, fainting, and in severe overdose, convulsions, respiratory arrest, coma.
From the gastrointestinal tract.
Nausea, vomiting, dysphagia.
From the immune system.
Allergic reactions, including itching, flushing, eyelid edema, contact allergy, urticaria, angioedema, angioedema, anaphylactic shock.
Expiration date
18 months.
After first opening, store for no more than 28 days.
Storage conditions
Store out of the reach of children, at a temperature not exceeding 25 °C in the original packaging. Do not freeze. After first opening, store for no more than 28 days.
Packaging
10 ml in a dropper container. 1 dropper container together with instructions for medical use in a cardboard box.
Vacation category
According to the recipe.
Producer
LLC "UNIMED PHARMA"/"UNIMED PHARMA Ltd".
Address
Orieskova 11, 821 05 Bratislava, Slovak Republic.
