KONDILIN

Active material: Podophyllotoxin
When ATH: D06BB04
CCF: The drug is a cauterizing and mummified action
ICD-10 codes (testimony): A63.0
When CSF: 29.11
Manufacturer: ASTELLAS PHARMA EUROPE B.V. (Netherlands)

Pharmaceutical form, composition and packaging

The solution for outdoor applications 0.5% colorless, clear.

Excipients: lactic acid, Sodium lactate, ethanol, Purified water.

3.5 ml – vials of dark glass (1) complete with applicator (30 PC.) – packs cardboard.

Pharmacological action

The drug is a cauterizing and mummified action. The active substance Kondilina^® – podofillotoksin – It is the most active component of podophyllin, obtained from plant extracts. Kondilin^® It contains purified standardized podofillotoksin, purity of the preparation is 99%.

It has a cytostatic effect. When applied topically, it causes necrosis of external genital warts due to caustic and mummified action.

Pharmacokinetics

Applique 0.01-0.05 ml 0.5% podophyllotoxin solution leads to the appearance in serum of small amounts of active substance through 30-60 min after application.

When using 0.1 ml (warts area of 4 cm²) serum levels of podophyllotoxin reached 5 ng / mL in 1-2 h and is reduced to 3 ng / mL in 4 h after application. When using 0.15 ml podophyllotoxin pharmacokinetic parameters differ from a previous dose of a sustained breeding (through 12 h in serum is determined less 1 ng / ml).

T_1/2 podofillotoksina ranges from 1 to 4.5 no. No cases of cumulation of the active substance.

Testimony

- Topical treatment of genital warts (Acuminate condylomata).

Dosage regimen

For the application of the drug necessary to moisten the plastic applicator in the product so, to loop hole filled with liquid. With the solution is applied to the loop condyloma. Then repeat the appliqué, wetting liquid all other warts, but not more 50 time. Kondilin^® to be discharged only warts, since the drug on healthy skin or mucous membranes may cause severe irritation and ulceration. After application the place applying the solution must dry thoroughly to avoid irritation of the skin healthy, contact with acuminata.

Kondilin^® apply 2 times / day for 3 days, What follows is a 4-day break; possible re-3-day course of treatment. The total duration of treatment should not exceed 5 weeks.

Side effect

Local reactions: may cause redness, slightly severe pain, ulceration of the epithelium warts (usually at the beginning of treatment, often on 2-3 daily use of the drug). If you have large warts in the preputial area may develop swelling and balanoposthitis.

There are allergic reactions.

Contraindications

- Pregnancy;

- Lactation;

- Children up to age 12 years;

- The use of other drugs, containing podophyllotoxin;

- Hypersensitivity to the drug.

Pregnancy and lactation

Kondilin^® contraindicated during pregnancy and lactation.

Cautions

Kondilin^® should be used with caution. After contact with the eyes to prevent irritation expressed an urgent need to rinse the eyes with plenty of water.

Before applying Kondilina^® should wash the affected areas with soap and water and dry well.

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

Irritation, ulceration of the skin and mucous membranes around warts can be prevented by protective ointment, neutral creams, Vaseline, zinc ointment, which is applied to the tissue surrounding the warts before applique Kondilina^®.

With the development of edema and a balanoposthitis is possible to use anti-inflammatory drugs (eg, Glucocorticosteroids in form of an ointment).

Applying the product to a larger surface (more 10 cm²) can lead to reactions, associated with the resorptive effect of podophyllotoxin.

It is advisable to survey and, in case of need, treatment of sexual partners. During treatment should eliminate sex or consider using this period of barrier contraceptives.

Overdose

The local application of the drug in high doses, it should be washed off with soap and water. When taking random Kondilina^® should be washed inside the stomach, monitor electrolyte, gas balance, peripheral blood picture, the functional state of the liver.

Drug Interactions

Drug Interactions drug Kondilin^® not disclosed.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The drug should be stored in the dark, inaccessible to children at temperature from 15 ° to 25 ° C. Term life – 4 year.