Composition, form of production and packaging
Solution for external use 0.5% colorless, transparent.
podophyllotoxin 5 mg
Excipients: lactic acid - 51.67 mg, sodium lactate - 7.79 mg, ethanol - 735 mg, purified water - 30.6 mg.
3.5 ml - bottles of dark glass (1) complete with applicators (30 pcs.) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
Locally necrotizing drug. Active substance Kondilina - podophyllotoxin - is the most active component of podophyllin derived from plant extracts. Condilin В® contains purified standardized podophyllotoxin, the purity of which in the preparation is 99%.
It has a cytostatic effect. When topical application causes necrosis of external condylomas due to cauterizing and mummifying effect.
Application 0.01-0.05 ml of a 0.5% solution of podophyllotoxin results in the appearance of small amounts of active substance in the serum 30-60 minutes after its application.
When 0.1 ml (warts more than 4 cm 2 in area ) is used, 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 a slower elimination (after 12 hours in serum, less than 1 ng / ml is determined).
T 1/2 podophyllotoxin ranges from 1 to 4.5 hours. No cases of cumulation of the active substance have been described.
- local treatment of genital warts (Condylomata acuminata).
To apply the drug, moisten the plastic applicator in the preparation so that the hole in the loop is filled with liquid. Using a loop, the solution is applied to the condyloma. Then the application should be repeated, wetting with liquid all other warts, but not more than 50 times. Condylin В® should only fall on the condyloma, tk.getting the drug on healthy areas of the skin or mucous membranes can lead to severe irritation and ulceration. 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.
Condilin В® is applied 2 times / day for 3 days, then a 4-day break is made; a repeated 3-day course of treatment is possible. The total duration of treatment should not exceed 5 weeks.
Local reactions: there may be redness, slight pain, ulceration of the epithelial cover of condyloma (usually at the beginning of treatment, usually 2-3 days 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 .
- children's age till 12 years;
- use of other drugs containing podophyllotoxin;
- Hypersensitivity to the components of the drug.
PREGNANCY AND LACTATION
Condilin В® is contraindicated in pregnancy and lactation.
APPLICATION FOR CHILDREN
Contraindicated in children under 12 years.
Condilin В® must be used with caution. If the product gets into the eyes, in order to avoid pronounced irritation, rinse immediately with plenty of water.
Before using Condilin, wash affected areas with soap and water and dry well.
When using Condilin, it should be avoided on healthy skin and mucous membranes surrounding the condyloma. Particular caution should be exercised in the localization of genital warts in the area of вЂ‹вЂ‹the foreskin.
Irritation, ulceration of the skin and mucous membrane 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 Condilin.
With the development of edema and balanoposthitis, it is possible to use anti-inflammatory drugs (for example, GCS in the form of ointment).
Application of the drug on a large surface (more than 10 cm 2 ) 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.
Impact on the ability to drive vehicles and manage mechanisms
The effect of the drug on the ability to drive vehicles and work with mechanisms has not been noted.
When topical application of the drug in high doses, it should be washed off with soap and water. If you accidentally take Condilin inside, you must wash your stomach, control the electrolyte, gas balance, picture of peripheral blood, the functional state of the liver.
Drug interaction of the drug Condilin В® is not described.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a place protected from light, inaccessible to children, at a temperature of no higher than 25 В° C. The shelf life is 3 years.