Picloxydine (Drops) Instructions for Use

Marketing Authorization Holder

Kosmofarm, LLC (Russia)

Manufactured By

Slavic Pharmacy, LLC (Russia)

ATC Code

S01AX16 (Picloxydine)

Active Substance

Picloxydine (Rec.INN registered by WHO)

Dosage Form

Picloxydine

Eye drops 0.05%: dropper bottle 10 ml

Dosage Form, Packaging, and Composition

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

Excipients: dextrose monohydrate, polysorbate 80, hydrochloric acid solution 1M or sodium hydroxide solution 1M, water for injections.

10 ml – polymeric dropper bottles (1) – cardboard packs.

Clinical-Pharmacological Group

Topical antiseptic for use in ophthalmology

Pharmacotherapeutic Group

Antimicrobial agent

Pharmacological Action

An antimicrobial agent for use in ophthalmology, a derivative of biguanides. It has an antiseptic effect.

Picloxydine is active against Staphylococcus aureus, Streptococcus faecalis, Escherichia coli, Eberthella typhosa, Klebsiella pneumoniae, Proteus vulgaris, Shigella dysenteriae, Bacillus subtilis, Chlamydia trachomatis, some viruses and fungi.

Pharmacokinetics

With topical application, the systemic absorption of picloxydine is low.

Indications

Bacterial infections of the anterior segment of the eye, dacryocystitis; prevention of infectious complications in the postoperative period after surgical interventions in the area of the anterior segment of the eye.

ICD codes

Dosage Regimen

Use topically for ophthalmic infections and postoperative prophylaxis.

Instill one to two drops into the affected eye.

Apply two to six times daily, depending on infection severity.

For postoperative prophylaxis, use for the duration specified by the surgeon.

Administer for a maximum of 10 days unless otherwise directed.

Wash hands thoroughly before use.

Avoid contact between the dropper tip and the eye or any other surface to prevent contamination.

If using other ophthalmic products, maintain an interval of at least 15 minutes between instillations.

After instillation, press a finger on the inner corner of the eye for 2 minutes to minimize systemic absorption.

Do not use for subconjunctival injection or introduction into the anterior chamber of the eye.

Discontinue use and consult a physician if symptoms persist or worsen.

Adverse Reactions

Possible development of allergic reactions, manifested by conjunctival hyperemia.

Contraindications

Hypersensitivity to picloxydine.

Use in Pregnancy and Lactation

Use during pregnancy and breastfeeding is not recommended.

Pediatric Use

Can be used in children from 0 years of age as indicated.

Special Precautions

If other medicinal products in the form of eye drops are used along with picloxydine, it is necessary that the interval between their instillations is at least 15 minutes.

To prevent picloxydine from entering the systemic circulation through the nasal mucosa, it is recommended to press a finger on the inner corner of the eye for 2 minutes after instillation.

Picloxydine must not be used for subconjunctival injections or for introduction into the anterior chamber of the eye.

Effect on the ability to drive vehicles and mechanisms

After application of picloxydine, temporary blurred vision is possible. If such symptoms occur, the patient must wait for complete restoration of visual clarity before driving vehicles or working with mechanisms.

Storage Conditions

Store at 15°C (59°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.