Piclonord^® (Drops) Instructions for Use

Marketing Authorization Holder

Severnaya Zvezda NAO (Russia)

Contact Information

SEVERNAYA ZVEZDA NAO (Russia)

ATC Code

S01AX16 (Picloxydine)

Active Substance

Picloxydine (Rec.INN registered by WHO)

Dosage Form

Piclonord®

Eye drops 0.5 mg/1 ml: 5 ml or 10 ml dropper bottles

Dosage Form, Packaging, and Composition

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

Excipients: anhydrous dextrose (glucose), polysorbate 80, purified water.

5 ml – dropper bottles (1) – cardboard boxes.
10 ml – dropper bottles (1) – cardboard boxes.

Clinical-Pharmacological Group

Drug with antimicrobial action for topical use in ophthalmology

Pharmacotherapeutic Group

Drugs used in ophthalmology; antimicrobial drugs; other antimicrobial drugs

Pharmacological Action

Picloxydine is a derivative of biguanides, an antimicrobial agent with antiseptic action.

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

Pharmacokinetics

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

Indications

For adults and children from 0 years with

• Bacterial infections of the anterior segment of the eye;
• Dacryocystitis;
• For the 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

Bacterial infections

1 drop 2-6 times/day. The duration of treatment is 10 days.

The appropriateness and necessity of extending the treatment period >10 days should be determined by a doctor.

Postoperative period

1 drop 3-4 times/day.

For the prevention of postoperative complications (preoperative preparation)

1-2 drops of the drug immediately before surgery.

Special patient groups

Elderly patients

Dose adjustment is not required.

Patients with renal impairment

Dose adjustment is not required.

Patients with hepatic impairment

Dose adjustment is not required.

Children

The dosing regimen for children does not differ from the dosing regimen for adults.

Method of administration

For topical use as instillations into the conjunctival sac of the affected eye (eyes).

To instill the eye drops, the patient’s head should be tilted slightly backward, and the patient’s gaze should be directed upward.

The drug is instilled into the lower conjunctival sac, gently pulling down the lower eyelid. To prevent contamination of the drug solution during instillation, patients should avoid contact of the dropper tip with the eye and skin.

If it is necessary to instill several medicinal products into the conjunctival sac, the drugs should be applied separately with an interval of at least 15 minutes. Eye ointments should be applied last.

Adverse Reactions

Rarely allergic reactions manifested by conjunctival injection.

Reporting of suspected adverse reactions

It is important to report suspected adverse reactions after registration of the medicinal product to ensure continuous monitoring of the benefit-risk ratio of the medicinal product.

Healthcare professionals are recommended to report any suspected adverse drug reactions through the national adverse reaction reporting system of the member states of the Eurasian Economic Union.

Contraindications

• Hypersensitivity to picloxydine or to any of the excipients included in the drug.

Use in Pregnancy and Lactation

Pregnancy

Data on the use of picloxydine in pregnant women are absent or limited. The drug Piclonord^® is not recommended for use during pregnancy.

Breastfeeding period

There are no data on whether Picloxydine and/or metabolites pass into human milk. When treating with Piclonord^®, breastfeeding is recommended to be discontinued.

Fertility

No studies have been conducted to evaluate the effect of the ophthalmic drug picloxydine on human fertility.

Use in Hepatic Impairment

Dose adjustment is not required.

Use in Renal Impairment

Dose adjustment is not required.

Pediatric Use

Used according to indications from 0 years.

Geriatric Use

Dose adjustment is not required.

Special Precautions

The drug Piclonord^® must not be used for subconjunctival injections or introduced into the anterior chamber of the eye.

The drug Piclonord^® does not change the color of contact lenses (including soft hydrophilic ones), however, wearing contact lenses is contraindicated in infectious diseases.

Effect on the ability to drive vehicles and mechanisms

The drug Piclonord^® affects the ability to drive vehicles and work with mechanisms.

If clarity of vision decreases during treatment with the drug, patients should refrain from driving vehicles and working with mechanisms.

Overdose

In case of local overdose of the drug, the eyes should be rinsed with warm water.

Drug Interactions

Interaction studies have not been conducted.

Storage Conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C (77°F).

Shelf Life

Shelf life – 3 years.

Shelf life after first opening of the dropper bottle – 28 days.

Dispensing Status

The drug is available without a 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.