Cyteal^® (Solution) Instructions for Use

Marketing Authorization Holder

Pierre Fabre Medicament Production (France)

ATC Code

D08AC52 (Chlorhexidine in combination with other drugs)

Active Substances

Chlorhexidine (Rec.INN registered by WHO)

Hexamidine (Rec.INN registered by WHO)

Chlorocresol (Rec.INN registered by WHO)

Dosage Form

Cyteal^®

Solution for external use 1 mg+1 mg+3 mg/1 ml: bottle 250 ml or 1 l

Dosage Form, Packaging, and Composition

Solution for external use viscous, light yellow in color, with a characteristic odor, foams when shaken.

	100 ml
Hexamidine diisothionate	100 mg
Chlorhexidine digluconate solution 20%	0.5 ml,
Equivalent to chlorhexidine digluconate content	100 mg
Chlorocresol	300 mg

Excipients : cocamidopropyl betaine (lauramidobetaine 30%), diethanolamide of coconut oil fatty acids, edetic acid, “coniferol” flavoring, lactic acid, purified water.

250 ml – polyethylene bottles.
1 l – polyethylene bottles.

Clinical-Pharmacological Group

Antiseptic for external use

Pharmacotherapeutic Group

Antiseptic

Pharmacological Action

[I] – Instructions for medical use approved by the Pharmacological Committee of the Ministry of Health of the Russian Federation

Antiseptic agent. The action of the drug is due to the substances included in its composition: Hexamidine is a cationic antiseptic from the group of diamidines; Chlorhexidine is a cationic antiseptic, a synthetic biguanide; Chlorocresol is an antiseptic from the group of halophenols.

It has a bacteriostatic effect against gram-positive and some gram-negative bacteria, fungi, protozoa; bactericidal – against Pseudomonas aeruginosa. When applied to intact skin, it is not absorbed. The therapeutic effect persists for up to 18 hours after a single application.

Indications

Treatment of skin and mucous membranes (mycoses, eczema, acne, ulcers, intertrigo, dermatitis with concomitant bacterial infections, vulvitis, vaginitis, cervicitis, etc.);
Treatment of medical personnel’s hands;
Prevention of sexually transmitted infections.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
Z29.8	Other specified prophylactic measures

ICD-11 code	Indication
QC05.Z	Prophylactic measures, unspecified

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Externally.

Gynecology
Indications	Method of Application
Vulvitis	Undiluted solution
Microbial or fungal vaginitis Treatment Prevention	Diluted 1:10 Daily douching (plus specific treatment) Douching 2 times a week
Cervicitis	Undiluted solution or diluted 1:10
Recurrent infectious diseases of the genital organs	Undiluted solution or diluted 1:10
Antiseptic treatment of medical personnel’s hands	Undiluted solution
Dermatology
Indications	Method of Application
Mycoses Pityriasis versicolor Fungal intertrigo Tinea pedis	Undiluted solution For treatment: daily For prevention: 2 times a week
Bacterial eczema	Undiluted solution or diluted 1:10
Acne	Undiluted solution or diluted 1:10
Intertrigo in children	Diluted 1:10
Lower limb ulcers	Diluted 1:10
Primary bacterial dermatoses (furunculosis, impetigo, carbunculosis, folliculitis)	Diluted 1:10
Antiseptic treatment of medical personnel’s hands	Undiluted solution
Surgery
Indications	Method of Application
Antiseptic treatment of medical personnel’s hands	Undiluted solution

Solutions should be prepared immediately before use.

The drug is applied daily, the average course of treatment is 10-15 days; for prevention – 2 times a week for 3-6 months.

After application of the drug, the application site must be rinsed thoroughly with water.

Adverse Reactions

Tingling sensation, itching, burning, dry skin, redness (with prolonged use). Contact eczema, contact dermatitis, especially when applied to damaged or ulcerated skin.

Contraindications

Hypersensitivity;
Pregnancy;
Lactation period.

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation.

Pediatric Use

The drug should be used with caution in children.

Special Precautions

Prepared solutions of the drug are not intended for storage.

It is not recommended to use the drug in ophthalmological practice, as well as for treating the external auditory canal if perforation of the eardrum is suspected. The drug should be used with caution during repeated applications, especially on large skin areas, under occlusive dressings, on damaged skin (in particular, burned skin), in children, and on mucous membranes.

The drug is not used for antiseptic treatment of the skin before medical procedures: puncture, blood sampling.

The drug is not used for disinfecting surgical materials.

The drug is not used together with solid and liquid soaps.

After opening the bottle, there is a risk of microbial contamination of the drug.

In case of accidental ingestion, do not perform gastric lavage (foamy solution).

Drug Interactions

Incompatible with other antiseptics (mutual inactivation).

Storage Conditions

At a temperature not exceeding 25°C (77°F) in a place protected from light and out of reach of children.

Shelf Life

Shelf life — 3 years.

Do not use the drug after the expiration date.

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.

Medical Disclaimer