Microsoft word - horostenum_eng.doc

APPROVED
Order of the Ministry of Health
Care of Ukraine
___07.07.09__ № ___487__
Registration certificate
№ _ UA/2048/01/01
INSTRUCTION
for medical use
HOROSTENUM®
Composition:
active component: decametoxin;
100 ml of the solution contains 0.025 g decametoxin;
auxiliary components: 96% ethanol, glycerin, 1% citral alcoholic solution, purified water.

Pharmaceutical form. Solution for external application. Colorless, slightly opalescent liquid
with lemon odor.

Manufacturer name and location.
Yuria-Pharm Ltd.
10 M.Amosova st., 03680 Kyiv, Ukraine.
Tel./fax: (044) 275-01-08; 275-92-42.
Pharmacotherapeutic group. Antiseptic and disinfecting agents.
ATC code D08A J10.
Horostenum® antiseptic substance has antimicrobial, antiviral and antifungal effect. The effect of
decametoxin is based on influencing the microbial cell membranes: decametoxin ruins the above-
membrane layer, loosens the membrane and increases its penetrability for large molecular
substances. Since the majority of enzymes are retained on membrane structures, decametoxin
changes the enzymatic activity of the cell, inhibiting enzymatic systems. The hydrophobic
decametoxin radical facilitates maximum binging of the drug with the micro-organisms’ cellular
membranes. The decametoxin cationic radical first decrease and then neutralizes the microbial
cellular wall charge. Decametoxin has no influence on the human cell membranes, as they have a
much larger lipid radical length, so hydrophobic interaction with them does not occur. Decametoxin
has a pronounced bactericide effect on gram-positive, gram-negative and anaerobic microorganisms:
staphylococci, streptococci, diphtheria bacilli, E. Coli, salmonella, Protea, Klebsiella, Shigella,
pseudomonades, Clostridia,
Decametoxin also has a fungicidal effect on yeast-like fungi, agents of epidormophytosis, trichophytia, microsporia and erythrasma, certain mold fungi (aspergilli, penicilli); and an antiviral effect on lipophilic viruses, including AIDS and hepatitis. Horostenum® is highly active against antibiotic-resistant microorganisms (resistant to penicillin, chloramphenicol, tetracycline, streptomycin, gentamycin, neomycin, novobiocin, oleandomycin, cephalosporin, fluoroquinolones, etc.). Prolonged therapy with Horostenum® does not lead to creation of drug-resistant strains of microorganisms. Bacteriostatic (fungistatic) concentrations are similar to its bactericidal (fungicidal), virusocidal and sporocidal concentrations. The sensitivity of antibiotic-resistant microorganisms to antibiotics is increased during therapy with
Horostenum®.
Glycerin included in Horostenum® softens the skin, therefore preventing irritation even in case of
frequent application on sensitive skin.
Absorption of the drug by mucous membranes, skin and wound surface is virtually absent. It does
not dye the skin, and citral lends it a pleasant lemon odor.
Indications for use.
- Disinfection of hand skin in medical personnel, treatment of hand skin in medical personnel - Treatment of skin areas affected by staphylococcal and streptococcal impetigo, and the - Disinfection of hand skin in any cases associated with the increased risk of infection and proliferation of hazardous microorganisms. - Treatment of microtraumas, treatment of skin after depilation and shaving. - Hygienic skin disinfection.
Contraindications. Individual sensitivity to the drug components.
Special precautions.
Avoid contact of the drug with the conjunctiva. In case of accidental contact with the eyes, wash with
plenty of running water.
Use during pregnancy and lactation.
No known contraindications for use during pregnancy. Not recommended for nipple cleaning during
lactation.
Impact on the reaction time for driving or operating of machinery.
The drug is prescribed for external use only, therefore, it does not influence the reaction time during
driving or operating of other machinery.
Use in children.
Do not use for children under one year of age.
Administration and doses.
Used externally as wipes or poultices.
Wash hands thoroughly with running water and soap, remove soap residue, wipe hands. Pour 3-5 ml
of Horostenum® onto a palm and thoroughly spread it over the inner and outer hand surface,
interdigital and periungular areas, and the lower third of the arm, during 1-2 minutes. Dry the skin.
If hands had not been washed with soap, Horostenum® treatment is used twice.
In case of risk of bedsores, Horostenum® is rubbed into the skin with a cotton wad. In cases of
bedsores, Horostenum® is used as an application.
For use after shaving, wipe the facial skin with the solution applied onto a cotton wad or the palm of
hand.

Overdosing. Due to the lack of systemic absorption, overdosing is not observed.
Side effects. Skin rash and irritation may appear, alleviated after the solution use is ceased.
In case of any side effects, seek medical aid!
Interaction with other drugs and other forms of interaction.
Horostenum® is a cationic surface-active agent, so it is incompatible with soap and other anionic
compounds (sodium laurylsulfate, saponins). Because of this, soap must be washed off
thoroughly before the solution is applied to the skin.
Horostenum® is compatible with drugs that contain cationic surface-active agents (benzalkonium
chloride, aethonium, etc.)
Decametoxin included in Horostenum® increases the antibiotic sensitivity of antibiotic-resistant
microorganisms.
Heating of Horostenum® up to 37-38°C before administration increases its antimicrobial
efficiency.
Shelf life. 2 years.
Storage conditions. Store in a dry, dark place at temperatures not exceeding 30°C. Keep out of
reach of children.

Packaging. 2 ml in disposable containers. 30 ml, 100 ml and 400 ml plastic jars.
Sales list. Over-the-counter.

Date of latest review.

Source: http://uf.ua/upload/iblock/3c0/3c008b298b6ddc4b0845310276021efe.pdf