Virotek intim

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT VIROTEK INTIM

Composition:

Active substance: 100 g of solution contains benzalkonium chloride (calculated as 100% dry substance) 0.02 g;

Excipients: phenoxyethanol, disodium edetate (Trilon B), sodium hydroxide, purified water.

Pharmaceutical form. Solution for external use.

Main physico-chemical properties: clear colorless liquid which slightly foams when shaken.

Pharmacotherapeutic group.

Antiseptics and disinfectants. Quaternary ammonium compounds. Benzalkonium. ATC code D08AJ01.

Pharmacological Properties

Pharmacodynamics

The drug exerts bacteriostatic and bactericidal effects against Gram-positive and Gram-negative, aerobic and anaerobic bacteria, including Staphylococcus, Streptococcus, Escherichia coli, Klebsiella, Proteus, Pseudomonas aeruginosa, Clostridium, and Bacillus subtilis. It is more effective against Gram-positive bacteria. The drug also exerts fungistatic and fungicidal effects against pathogenic fungi, particularly Candida species. It reduces bacterial and fungal resistance to antibiotics. It is effective against hospital-acquired microorganisms exhibiting multidrug resistance to chemotherapeutic agents. It is also effective against pathogens of sexually transmitted infections (Treponema spp., Neisseria gonorrhoeae, Trichomonas spp., Chlamydia spp., Ureaplasma spp.), as well as against certain viruses, including human immunodeficiency virus (HIV) and Herpes simplex. The antimicrobial activity is preserved in the presence of blood, pus, various secretions, and organic substances.

The drug exerts a spermicidal effect: the effect develops in two stages—first, disruption of the spermatozoa flagellum, followed by rupture of the sperm head, thereby preventing fertilization.

Pharmacokinetics

When applied topically, benzalkonium chloride is not absorbed through the skin or the mucous membranes of the vagina and urethra and does not produce any systemic (resorptive) effects. It is adsorbed onto the walls of the vagina and urethra and is excreted with physiological secretions or removed by washing with water.

Clinical characteristics.

Indications.

Individual prevention of sexually transmitted diseases (syphilis, gonorrhea, trichomoniasis, genital herpes, genital candidiasis, human immunodeficiency virus).

Complex treatment of acute and chronic urethritis and urethral-prostatitis.

Contraindications.

Increased individual sensitivity to the components of the drug, vaginitis, ulcers and irritation of the vaginal and cervical mucosa.

Interaction with other medicinal products and other forms of interaction.

When used simultaneously with systemic antibiotics, enhances their antimicrobial activity and promotes reduction of microbial resistance to antibiotics.

Chemically incompatible with soaps and other anionic surfactants (surface-active agents), as well as with iodine-containing preparations. Non-ionic surfactants reduce or eliminate the antimicrobial effect of benzalkonium chloride.

Special precautions for use.

The medicinal product contains benzalkonium chloride, which may cause irritation and skin reactions. Avoid contact with the eyes. In case of accidental exposure to the eyes, thoroughly rinse with boiled water and consult a doctor.

Use during pregnancy or breastfeeding.

The medicinal product may be used during pregnancy or breastfeeding.

Ability to influence reaction speed when driving or operating machinery.

Does not affect.

Method of Administration and Dosage

The drug is applied externally to the skin or affected surface and locally to mucous membranes.

Before use, unscrew the screw cap, bring the nozzle to the affected area or insert it into the cavity, and press the walls of the bottle. Depending on the pressure applied, the solution is dispensed from the bottle as drops or a stream. After treatment, the cap is screwed back onto the bottle. Before the first use, the tamper-evident seal must be broken.

For prevention of venereal diseases, the drug is effective if used no later than 2 hours after sexual intercourse.

Before using the drug for prevention of venereal diseases, it is recommended to urinate, and wash hands and genital organs. If soap or shampoo is used for washing, it should be thoroughly and completely rinsed off with running water. After that, spray the solution onto the skin of the inner surfaces of the thighs, pubic area, and external genital organs. Then, using the nozzle, introduce the 0.02% solution into the urethra for 2–3 minutes: in men – 2–3 ml; in women – 1–2 ml into the urethra and 5–10 ml into the vagina. Urination should be avoided for 2 hours after the procedure.

The drug is used in the complex treatment of acute and chronic urethritis of specific and non-specific etiology via endourethral instillations of 2–3 ml of solution 1–2 times daily. The treatment course lasts 10 days.

Children

The drug should not be used in children under 14 years of age.

Overdose

No cases of acute intoxication have been reported following excessive single topical application of the drug over a large skin or mucous membrane surface (vagina and urethra). If any adverse local reactions occur, the drug should be washed off with water.

In case of accidental oral ingestion, lethal doses of benzalkonium chloride in humans are considered to be 1–3 g, equivalent to 5–15 L of the 0.02% drug solution. Oral intake may lead to adverse effects including vomiting, collapse, and coma. Toxic doses may result in paralysis of respiratory muscles, dyspnea, and cyanosis. In case of accidental oral ingestion of large doses of benzalkonium chloride, vomiting should be induced, the stomach should be washed out with water, and activated charcoal should be administered.

Adverse reactions.

The risk of adverse effects during use of the drug is minimal. However, in patients with increased sensitivity to benzalkonium chloride, local irritant effects may occur after prolonged skin contact, and in rare cases, hypersensitivity reactions. With intravaginal administration, allergic reactions, irritation, pricking sensations, warmth at the application site, contact dermatitis, itching, burning in the vagina or in the partner's penis, and dysuria may occur.

In individual cases, a mild burning sensation at the site of application on mucous membranes may occur, which usually resolves spontaneously and does not require discontinuation of the drug. If necessary, the drug can be washed off with water.

If any adverse reactions occur, use of the medicinal product should be discontinued and medical advice must be sought immediately.

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Do not freeze.

Packaging. 50 g in a bottle; 1 bottle per carton.

Availability. Over-the-counter (without prescription).

Manufacturer.

Limited Liability Company "Multispray".

Manufacturer's address and location of business operations.

24, Valeriy Petrosov St., lit. A-2, Kharkiv, Kharkiv Oblast, 61052, Ukraine.

Marketing Authorization Holder.

LLC "VALARTIN PHARMA".

Address of the Marketing Authorization Holder.

60, Hrushevskoho St., village of Chayky, Kyiv-Sviatoshynskyi District, Kyiv Oblast, 08135, Ukraine.