Oxynobetal^® (Drops) Instructions for Use

Marketing Authorization Holder

Endocrine Technologies, LLC (Russia)

Manufactured By

Moscow Endocrine Plant FSUE (Russia)

ATC Code

S01HA02 (Oxybuprocaine)

Active Substance

Oxybuprocaine (Rec.INN registered by WHO)

Dosage Form

Oxynobetal®

Eye drops 4 mg/1 ml: dropper bottles 5 ml 1 or 2 pcs.

Dosage Form, Packaging, and Composition

Eye drops as a transparent, colorless or light yellow liquid.

Excipients: disodium edetate dihydrate (disodium salt of ethylenediaminetetraacetic acid dihydrate), benzalkonium chloride 50% solution, sodium chloride, boric acid, water for injections.

5 ml – polyethylene dropper bottles (1) – cardboard packs.
5 ml – polyethylene dropper bottles (2) – cardboard packs.

Clinical-Pharmacological Group

Local anesthetic for use in ophthalmology

Pharmacotherapeutic Group

Agents used in ophthalmology; local anesthetics

Pharmacological Action

Local anesthetic for use in ophthalmology. It causes a reversible blockade of the propagation and conduction of nerve impulses through the axons of nerve cells.

Pharmacokinetics

It is easily absorbed through the mucous membranes into the corneal stroma after a single instillation into the conjunctival sac. Anesthesia occurs within 1-3 minutes.

During the subsequent 15 minutes, a quantitative decrease in the stromal concentration of oxybuprocaine is observed, which provides a 15-20 minute period of anesthesia with a single instillation.

Indications

Local anesthesia in ophthalmology (including superficial anesthesia of the cornea and conjunctiva) for tonometry, gonioscopy and other diagnostic examinations, before performing subconjunctival injections, for removal of foreign bodies and sutures from the cornea and conjunctiva, for short-term surgical interventions on the cornea and conjunctiva.

ICD codes

Dosage Regimen

Administer topically into the conjunctival sac.

For tonometry, instill one to two drops immediately prior to the procedure.

For removal of corneal foreign bodies or sutures, instill one to two drops. Administer an additional drop if required to maintain anesthesia for the duration of the procedure.

For short surgical interventions, instill one drop every two to three minutes for a total of two to three instillations.

Do not instill more than a total of 10 drops in a single session.

Avoid prolonged or repeated use beyond the immediate procedural requirement.

Protect the anesthetized eye from exposure and mechanical injury.

Discard any unused solution from the opened container after the procedure.

Adverse Reactions

From the organ of vision: sensation of burning and conjunctival hyperemia, transient tingling sensation; damage to the corneal epithelial layer, keratitis and excoriation of the corneal surface.

Allergic reactions: anaphylactic shock.

From the CNS: grand mal epileptic seizure, syncope.

From the cardiovascular system: bradycardia.

Contraindications

Hypersensitivity to oxybuprocaine; children under 2 years of age.

With caution in patients with pseudocholinesterase deficiency, malignant myasthenia, patients with epilepsy.

Use in Pregnancy and Lactation

The use of oxybuprocaine during pregnancy and breastfeeding is possible only in cases where the expected benefit of therapy for the mother outweighs the potential risk to the fetus or infant.

Pediatric Use

Contraindicated for use in children and adolescents under 2 years of age.

Special Precautions

The product should be used only for instillations into the conjunctival sac. Do not use for injections.

Prolonged, repeated and long-term use of oxybuprocaine (as well as other local anesthetics) can lead to persistent corneal clouding.

Oxybuprocaine is not intended for long-term therapy in complex eye disease.

During anesthesia, it is necessary to protect the eye from irritating chemical influences, foreign bodies and friction.

During the treatment period, alcohol consumption should be avoided.

Effect on the ability to drive vehicles and mechanisms

During the treatment period, patients should refrain from driving any vehicles and engaging in other activities that require high concentration and speed of psychomotor reactions.

Drug Interactions

Oxybuprocaine enhances the effect of succinylcholine and sympathomimetics, reduces the effect of sulfonamides and beta-blockers.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.