Instruction for use: Condyline

Active substance Podophyllotoxin

ATX code D06BB04 Podophyllotoxin

Pharmacological group

dermotropic means

Nosological classification (ICD-10)

A63.0 Anogenital (venereal) warts

Anogenital warts, Venereal warts, Condylomata genital, Condyloma pointed, Externally pointed genital warts, Externally pointed condyloma, Pointed Condyloma, Flat condyloma

Composition and form of release

Solution for external use 1 ml

podophyllotoxin 5 mg

auxiliary substances: lactic acid - 51.67 mg; sodium lactate - 7.79 mg; ethanol 735 mg; purified water 30.6 mg

in bottles of dark brown glass of 3.5 ml (complete with applicators); in the box 1 set.

Description of dosage form

Colorless, clear solution.

pharmachologic effect

Pharmacological action - cauterizing, mummifying.

Local antimitotic and cytotoxic. It blocks mitotic division of cells at the metaphase stage.

Pharmacodynamics

Active substance Condyline ® - podophyllotoxin - is the most active component of podophyllin derived from plant extracts. Condyline® contains purified standardized podophyllotoxin, the purity of which in the preparation is 99%.

It has a cytostatic effect. With topical application it causes necrosis of external condylomas, has cauterizing and mummifying effect.

Pharmacokinetics

Application 0,01-0,05 ml of a 0.5% solution of podophyllotoxin results in the appearance of a small amount of active substance in the serum 30-60 minutes after its application.

Using 0.1 ml (condyloma with an area> 4 cm2), the level of podophyllotoxin in the serum reaches 5 ng / ml after 1-2 hours and decreases to 3 ng / ml 4 hours after the application.

When 0.15 ml is used, the pharmacokinetic parameters of podophyllotoxin differ from the previous dose by slower elimination (after 12 hours in serum <1 ng / ml is determined).

T1 / 2 podophyllotoxin ranges from 1 to 4.5 hours. No cases of cumulation of the active substance have been described.

Indications

Local treatment of genital warts (Condylomata acuminata).

Contraindications

hypersensitivity to the components of the drug;

pregnancy;

breast-feeding;

children's age till 12 years;

use of other drugs containing podophyllotoxin.

pregnancy and lactation

Contraindicated. For the duration of treatment, breastfeeding should be discontinued.

Side effects

Local reactions: redness may appear, slight pain, ulceration of the epithelium of condyloma (usually at the beginning of treatment, usually on the 2-3rd day of application of the drug). In the presence of large condylomas in the preputial region, the development of edema and balanoposthitis is possible.

Allergic reactions are possible.

Interaction

Not described.

Dosing and Administration

Outwardly. The plastic applicator is wetted in the preparation so that the hole in the loop is filled with liquid. With the help of the loop, the solution is applied to the condyloma, the procedure is repeated, wetting all other warts, but not more than 50 times per procedure. Apply 2 times a day for 3 days, then make a 4-day break. It is possible to conduct a three-day course again. The total duration of treatment is no more than 5 weeks.

Condyline® should only be used on condyloma. The drug on the healthy areas of the skin or mucous membranes can lead to irritation and ulceration, which can be prevented with protective ointments, neutral creams, vaseline, zinc ointment. They are applied to the surrounding warts of the tissue before application. After application, the place of application of the solution should dry well, in order to avoid irritation of healthy skin, which is in contact with condyloma.

Overdose

Treatment: with topical application of large doses of the drug, it should be washed off with soap and water. If you accidentally take Condyline® inside, you must wash your stomach, control the electrolyte, gas balance, picture of peripheral blood, and the functional state of the liver.

Precautionary measures

Use a completely dry applicator. It is necessary to avoid getting the drug on the healthy skin and mucous membranes surrounding the condyloma, especially in the foreskin area. It is recommended to use protective ointments, neutral creams, Vaseline, zinc ointment to protect the skin and mucous membrane around the condyloma before application. Application in large areas (more than 10 cm2) can lead to reactions associated with the resorptive action of podophyllotoxin.

special instructions

Condyline® should be used with caution. If the product gets into the eyes, in order to avoid pronounced irritation, rinse immediately with plenty of water.

Before applying Condyline ®, wash affected areas with soap and water and dry well.

When using Condyline®, avoid contact with healthy skin and mucous membranes surrounding the condyloma. Particular caution should be exercised in the localization of genital warts in the area of the foreskin.

Irritation, ulceration of the skin and mucosa around the condyloma can be prevented with protective ointments, neutral creams, Vaseline, zinc ointment, which are applied to the surrounding warts of the tissue before the application of Condyline®.

With the development of edema and balanoposthitis, it is possible to use anti-inflammatory drugs (for example, glucocorticoids in the form of ointments).

Application of the drug on a large surface (> 10 cm2) can lead to reactions associated with the resorptive action of podophyllotoxin.

It is advisable to examine and, if necessary, treat sexual partners. During treatment, sexual intercourse should be excluded or the use of barrier contraceptives should be considered during this period.

storage Conditions

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life

4 years.

Do not use after the expiry date printed on the package.