Zileksa sept (Solution) Instructions for Use

Marketing Authorization Holder

Tsitera LLC (Russia)

Manufactured By

Grotex, LLC (Russia)

ATC Code

D08AJ (Quaternary ammonium compounds)

Active Substance

Benzyldimethyl-myristoylamino-propylammonium (Group Name)

Dosage Form

Zileksa sept

Solution for topical application 0.01 %: bottle 50 ml or 150 ml

Dosage Form, Packaging, and Composition

Solution for topical application in the form of a colorless, transparent liquid.

Excipients : purified water – up to 1 ml.

50 ml – polyethylene bottles (1) with a urological applicator and a screw cap in a set with a gynecological nozzle in a bag or without it – cardboard packs.
50 ml – polyethylene bottles (1) with a pump with a push-type spray device with a folding cannula or without it – cardboard packs.
150 ml – polyethylene bottles (1) with a screw cap in a set with two nozzles: a pump with a push-type spray device and a pump with a push-type spray device with a folding polypropylene cannula in bags or without them – cardboard packs.

Clinical-Pharmacological Group

Topical antiseptic

Pharmacotherapeutic Group

Antiseptic

Pharmacological Action

An antiseptic agent that has antiviral and bactericidal action (hydrophobic interaction with the membranes of microorganisms leads to their destruction).

It is active against gram-positive and gram-negative, aerobic and anaerobic, spore-forming and asporogenic bacteria in the form of monocultures and microbial associations, including hospital strains with polyresistance to antibiotics.

The following microorganisms exhibit the highest sensitivity to the drug: gram-positive microorganisms (Staphylococcus spp., Streptococcus spp., Bacillus anthracoides, Bacillus subtilis); gram-negative microorganisms: Neisseria spp., Escherichia spp., Shigella spp. (including Sonne, Flexner), Salmonella spp. (typhoid fever, paratyphoid A and B, causative agents of food toxicoinfections), Vibrio spp. (including cholera, NAG, paracholera, parahaemolytic), Treponema pallidum, Corynebacterium diphtheriae; fungi (Candida albicans, Candida tropicalis, Trichophyton rubrum, Microsporum lanosum, Aspergillus niger); protozoa (Chlamydia trachomatis, Chlamydia pneumonia).

Indications

Purulent wounds in surgical and obstetric practice; burns (superficial and deep); inflammatory diseases of the female genital organs; sexually transmitted diseases (syphilis, gonorrhea, trichomoniasis, chlamydia, genital herpes); urethritis (acute and chronic), urethroprostatitis of specific (trichomoniasis, chlamydia, gonorrhea) and nonspecific nature; periodontitis, stomatitis, hygienic treatment of removable dentures; otitis (acute and chronic), sinusitis, tonsillitis, laryngitis; fungal lesions of the skin and mucous membranes.

ICD codes

Dosage Regimen

Topically and externally. For purulent wounds and burns – application of gauze dressings soaked in a 0.01% solution.

For acute and chronic urethritis and urethroprostatitis, the solution is injected into the urethra in a volume of 2-5 ml 2-3 times/day for 5-7 days (in combination with other drugs).

For prevention of infection of postpartum injuries, tampons soaked in 50 ml of the solution are inserted intravaginally with an exposure of 2 hours for 7 days.

For prevention of sexually transmitted diseases, before use, one should urinate, wash hands and genitals. Then unscrew the bottle cap and, pressing on the walls, treat the skin of the pubis, inner surfaces of the thighs, and genitals with a stream of the solution. Insert the tip of the nozzle into the external opening of the urethra and squeeze out 1.5-3 ml (men) and 1-1.5 ml (women), into the vagina – 5-10 ml. Without releasing the fingers, remove the nozzle from the urethral opening and hold the solution for 2-3 minutes.

After the procedure, it is not recommended to urinate for 2 hours. It is prophylactically effective if the procedure is performed no later than 2 hours after sexual intercourse.

Adverse Reactions

Allergic reactions. Locally – a burning sensation at the site of application (goes away on its own within 10-15 seconds and does not require discontinuation of the drug).

Contraindications

Hypersensitivity.

Drug Interactions

With simultaneous use with antibiotics, a decrease in the resistance of microorganisms to the latter has been noted.

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

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.