Proxocarpine^® (Drops) Instructions for Use

Marketing Authorization Holder

Moscow Endocrine Plant FSUE (Russia)

Contact Information

MOSCOW ENDOCRINE PLANT FSUE (Russia)

ATC Code

S01EX (Other antiglaucoma drugs)

Active Substances

Pilocarpine (BAN)

Proxodolol (DAB)

Dosage Form

Proxocarpine®

Eye drops 10 mg+10 mg/1 ml: 1.3 ml, 1.5 ml, 2 ml, 5 ml or 10 ml dropper tube 5 or 10 pcs., 5 or 10 ml dropper bottle 1 pc., 5 ml bottle 1 pc.

Dosage Form, Packaging, and Composition

Eye drops as a transparent, colorless or slightly colored liquid.

Excipients: citric acid, sodium citrate for injection, sodium chloride, benzethonium chloride, purified water.

1.3 ml – dropper tubes (5) – cardboard packs.
1.3 ml – dropper tubes (10) – cardboard packs.
1.5 ml – dropper tubes (5) – cardboard packs.
1.5 ml – dropper tubes (10) – cardboard packs.
2 ml – dropper tubes (5) – cardboard packs.
2 ml – dropper tubes (10) – cardboard packs.
5 ml – dropper tubes (5) – cardboard packs.
5 ml – dropper tubes (10) – cardboard packs.
5 ml – dropper bottle (1) – cardboard packs.
10 ml – dropper bottle (1) – cardboard packs.
5 ml – bottle (1) with a dropper – cardboard packs.

Clinical-Pharmacological Group

Antiglaucoma drug

Pharmacotherapeutic Group

Antiglaucoma agent

Pharmacological Action

Combined antiglaucoma drug.

Proxodolol is a non-selective beta-adrenergic blocker, which also has a selective alpha-adrenergic blocking effect. It suppresses the production of aqueous humor.

Pilocarpine is an m-cholinomimetic, it increases the outflow of intraocular fluid due to the opening of the anterior chamber angle and unblocking of the Schlemm’s canal.

The active substances have an additive effect.

The effect of the drug begins 1 hour after instillation, reaches a maximum after 4-6 hours and lasts more than 24 hours.

The drug does not have a damaging effect on the eye tissues.

Indications

• Various forms of glaucoma (primary open-angle, angle-closure, congenital, juvenile, secondary);
• Insufficient effectiveness of monotherapy with proxodolol or pilocarpine.

ICD codes

Dosage Regimen

Instill one drop into the conjunctival sac of the affected eye(s) twice daily.

Maintain a consistent 12-hour interval between administrations to ensure stable therapeutic effect.

Strictly adhere to the prescribed frequency; do not increase or decrease the number of instillations without medical supervision.

Wash hands thoroughly before the procedure.

Avoid contact between the dropper tip and any surface, including the eye, to prevent contamination.

If using other topical ophthalmic agents, administer them at least 5-10 minutes apart.

Apply gentle pressure to the lacrimal sac (inner corner of the eye) for 1-2 minutes after instillation to minimize systemic absorption.

Blot excess solution around the eye with a clean tissue.

Regularly monitor intraocular pressure as directed by an ophthalmologist to assess treatment efficacy.

Immediately report any adverse reactions or lack of effect to the prescribing physician.

Adverse Reactions

From the organ of vision: burning, miosis, accommodation spasm, lacrimation, short-term visual impairment due to pupil constriction, eye pain, allergic conjunctivitis, eyelid skin dermatitis.

Systemic side effects: headache, rhinorrhea; rarely – bronchospasm, salivation, decreased heart rate, decreased blood pressure.

Contraindications

• Bronchial asthma;
• Broncho-obstructive lung diseases;
• Chronic heart failure;
• Bradycardia;
• Arterial hypotension;
• AV block of II-III degree;
• Inflammation of the anterior part of the vascular membrane of the eye (iris, ciliary body) – iritis, iridocyclitis;
• Pregnancy;
• Individual hypersensitivity to any component of the drug.

Use in Pregnancy and Lactation

Due to lack of experience, the use of the drug during pregnancy and lactation is not recommended.

The use of Proxocarpine^® during these periods is possible only in cases where the expected therapeutic effect outweighs the risk of side effects.

Special Precautions

Proxocarpine^® combines well with beta-blockers and other drugs for the treatment of glaucoma.

In case of an acute attack of angle-closure glaucoma, pilocarpine can be used separately or in combination with carbonic anhydrase inhibitors.

During the period of drug use, wearing soft contact lenses is not recommended. When using hard lenses, they should be removed before instillation and put back on 15-20 minutes after drug instillation.

Treatment should be carried out with regular monitoring of intraocular pressure.

Influence on the ability to drive vehicles and mechanisms

Patients who experience blurred vision after instillation are not recommended to drive a car or work with complex machinery requiring clear vision immediately after instillation of the drug.

Overdose

Symptoms: nausea and bradycardia.

Treatment: symptomatic. Atropine can be used as a specific antidote. For severe bradycardia due to overdose of the m-cholinomimetic, 0.5-2 mg of atropine is administered parenterally.

Drug Interactions

Antagonists of pilocarpine are atropine and other m-cholinergic blockers.

The m-cholinostimulating activity of pilocarpine decreases when combined with tricyclic antidepressants, phenothiazine derivatives, chlorprothixene, clozapine; it increases when combined with anticholinesterase agents.

The development of bradycardia and decreased blood pressure is possible during general anesthesia with halothane.

Storage Conditions

List B. The drug should be stored in a light-protected place, out of reach of children, at a temperature not exceeding 25°C (77°F) (in bottles), not exceeding 15°C (59°F) (in dropper tubes).

Shelf Life

Shelf life – 2 years.

Dispensing Status

The drug is dispensed by prescription.

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.