Piclosept (Drops) Instructions for Use

Marketing Authorization Holder

Sentiss Pharma, Pvt. Ltd. (India)

Contact Information

SENTISS RUS LLC (Russia)

ATC Code

S01AX16 (Picloxydine)

Active Substance

Picloxydine (Rec.INN registered by WHO)

Dosage Form

Piclosept

Eye drops 0.5 mg/1 ml: bottle 10 ml with dropper cap

Dosage Form, Packaging, and Composition

Eye drops as a transparent, colorless solution.

Excipients: polysorbate 80, dextrose monohydrate, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), water for injections.

10 ml – polyethylene bottles (1) with dropper cap – cardboard packs.

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, Chlamidia 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 impaired renal function

Dose adjustment is not required.

Patients with impaired liver function

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 avoid contamination of the eyes or eye drops, contact of the bottle tip with any surfaces should be avoided.

If it is necessary to instill several medications 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 drug in order to ensure continuous monitoring of the benefit-risk ratio of the drug.

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. Piclosept is not recommended for use during pregnancy.

Breastfeeding period

There are no data on whether Picloxydine and/or metabolites pass into human milk. Piclosept should not be used during breastfeeding.

Fertility

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

Special Precautions

Piclosept must not be used for subconjunctival injections or introduced into the anterior chamber of the eye.

Piclosept does not change the color of contact lenses (including soft hydrophilic ones), however, wearing contact lenses is contraindicated in infectious diseases.

Effect on ability to drive vehicles and mechanisms

The drug Piclosept affects the ability to drive vehicles and work with mechanisms.

After instillation, temporary blurred vision may occur, which may affect the ability to drive a car or operate machinery.

If such symptoms appear after instillation, the patient should wait until vision clarity is restored before driving a car or operating machinery.

Overdose

Symptoms

There are no data on drug overdose.

Treatment

If an excessive amount of the drug gets into the eyes, the eyes should be rinsed with sterile saline.

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 – 2 years.

After opening the bottle, store at a temperature not exceeding 25°C (77°F) for no more than 45 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.