Condilin - instructions for use, dose, side effects, contraindications

Active substancePodophyllotoxinPodophyllotoxin

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Vartek

cream externally

GlaxoSmithKline Trading, ZAO Russia

Condilin®

solution externally

Astellas Farma Europe BV Netherlands

Dosage form: & nbspsolution for external use

Composition:

1 ml of the preparation contains:

active substance: podophyllotoxin 5.0 mg;

Excipients: lactic acid 51.67 mg, sodium lactate 7.79 mg, ethanol 735.0 mg, purified water 30.6 mg.

Description:Colorless, clear solution.

Pharmacotherapeutic group:Local necrotizing agent

ATX: & nbsp

D.06.B.B Antiviral drugs

D.06.B.B.04 Podophyllotoxin

Pharmacodynamics:

Active substance Kondilin - podophyllotoxin - is the most active component of podophyllin derived from plant extracts. Condylline 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 of 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 using 0.1 ml (warts more than 4 cm in area²) 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 applying 0.15 ml pharmacokinetic parameters of podophyllotxin differ from the previous dose by slower elimination (after 12 hours in serum is determined less than 1 ng / ml).

The half-life of 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:

- Pregnancy;

- lactation;

- children's age (up to 12 years);

- use of other drugs containing podophyllotoxin;

- hypersensitivity to the components of the drug.

Pregnancy and lactation:

Condilin is contraindicated for use during pregnancy and lactation.

Dosing and Administration:

To apply the drug, moisten the plastic applicator in the preparation, so that the hole of 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. Condilin should only fall on the condyloma, since 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 is applied 2 times / day for 3 days, then a 4-day break is done; a repeated 3-day course of treatment is possible. The total duration of treatment should not exceed 5 weeks.

Side effects:

Local Reactions: possibly the appearance of redness, mild 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.

Overdose:

When topical application of large doses of the drug 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.

Interaction:

Drug interaction of the drug Condilin is not described.

Special instructions:

Condilin 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 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 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 Condilin.

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

Application of the preparation on a large surface (more than 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.

Effect on the ability to drive transp. cf. and fur:The effect of the drug on the ability to drive vehicles and work with mechanisms has not been noted.

Form release / dosage:

Solution for external use, 0,5%.

Packaging:

For 3.5 ml of the drug in bottles of dark brown glass with a capacity of 5 ml, closed by screw caps with a child lock.

Each vial is placed in a cardboard bundle together with a set of plastic sticks (30 pcs.) For applying the drug and instructions for use.

Storage conditions:

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

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N013828 / 01

Date of registration:11.12.2008 / 24.03.2017

Expiration Date:Unlimited

The owner of the registration certificate:Astellas Farma Europe BVAstellas Farma Europe BV Netherlands

Manufacturer: & nbsp

ASTELLAS PHARMA EUROPE, B.V. Netherlands

Representation: & nbspASTELLAS PHARMA YUROP BV ASTELLAS PHARMA YUROP BV Netherlands

Information update date: & nbsp16.01.2018

Illustrated instructions

Instructions

Condilin® (Condyline®)