CONDYLOX

Israel - English - Ministry of Health

Buy It Now

Active ingredient:
PODOPHYLLOTOXIN
Available from:
TAKEDA ISRAEL LTD
ATC code:
D06BB04
Pharmaceutical form:
SOLUTION
Composition:
PODOPHYLLOTOXIN 5 MG/ML
Administration route:
GENITAL
Prescription type:
Required
Manufactured by:
TAKEDA AUSTRIA GMBH
Therapeutic group:
PODOPHYLLOTOXIN
Therapeutic area:
PODOPHYLLOTOXIN
Therapeutic indications:
Treatment of external genital warts (Condyloma Acuminatum).
Authorization number:
050 14 26541 00
Authorization date:
2020-07-31

Documents in other languages

Patient Information leaflet Patient Information leaflet - Arabic

25-01-2021

Patient Information leaflet Patient Information leaflet - Hebrew

07-06-2017

1133448

1703 7

Code 1295

- 1 -

PRESCRIBING INFORMATION

CONDYLOX

solution

1.

NAME OF THE MEDICINAL PRODUCT

CONDYLOX 0.5% solution for external application

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

1ml contains:

Podophyllotoxin 5mg

in buffered ethanol solution.

For a full list of other excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Clear colourless solution for application on the skin

4.

CLINICAL PARTICULARS

4.1 Therapeutic indications

Treatment of external genital warts (Condylomata Acuminatum).

4.2

Posology, method and duration of administration

Treatment is carried out twice daily (at an interval of 12 hours) on three consecutive days. Then a

treatment-free interval of four days should be observed. Therapy should be repeated until the

condylomata disappear; the maximum duration of administration is four weeks.

If no success in treatment can be achieved after four treatment cycles, a different from of therapy

must be chosen.

Prior to application, the body parts to be treated must be washed carefully with water and soap

and subsequently dried with caution. The solution is applied with a cotton tipped applicator on

the condylomata. The cotton pad may be used only once!

Take care that podophyllotoxin does not reach the surrounding healthy skin and/or mucosa.

Condylox should not be applied to non-genital warts.

After application, let it dry for a few minutes.

Condylox 0.5% solution is left at the site of application and must not be washed off again. The

treated spots must have dried before coming in contact with clothing.

After each treatment hands should be cleaned thoroughly.

- 2 -

Therapy with Condylox 0.5% solution may be carried out at home by the patients themselves.

However, lesions in the female and lesions greater than 4cm² in the male should be treated under

direct medical supervision.

Children

Condylox 0.5% solution is contraindicated in children under the age of 12 (See Section 4.3).

4.3

Contraindications

Over- sensibility to podophyllotoxin or another excipient of Condylox 0.5% solution.

Inflamed or bleeding pointed condylomata, or open wounds following surgical procedures.

Simultaneous administration of other preparations containing podophylline.

Pregnancy and lactation.

Children under the age of 12.

4.4

Special warnings and precautions for use

There are no data available on the administration of Condylox 0.5% solution in young adults

between 12 and 18 years.

Condylox 0.5% must not come in contact with the eyes. However, if podophyllotoxin gets into

the eye, immediate rinsing with water should be carried out and a doctor should be consulted.

Condylox 0.5% is exclusively used for the therapy of condylomata and must not be applied to

other warts or naevi. Contact with healthy skin is to be avoided.

Lesions in the female and lesions greater than 4 cm2 in the male should be treated under direct

medical supervision.

Male patients should wear condoms until healed completely. The partners should be requested to

have themselves examined by a doctor.

4.5

Interactions with other medicinal products and other forms of interaction

Simultaneous treatment with other preparations containing podophylline should be avoided,

since these also contain podophyllotoxin.

4.6

Pregnancy and lactation

Condylox 0.5% solution causes serious damage to the unborn child if used during pregnancy.

Condylox 0.5% solution is contraindicated during pregnancy and lactation (see 4.3)

4.7

Effects on ability to drive and use machines

Condylox 0.5% solution has no or negligible influence on the ability to drive and the ability to

use machines

- 3 -

4.8

Side effects

Disorders of the reproductive system and breast:

Podophyllotoxin may induce balanoposthitis

Skin and subcutaneous

tissue disorders:

Local irritation symptoms of the area treated such as itching, burning.

Phimoses, erosions and ulcerations have been observed.

The frequency of these side effects is unknown.

4.9 Overdosage

The risk of systemic toxicity after topical administration is increased with large-area treatment

using excessive quantities for a longer period, or when treating bleeding or recently eliminated

pointed condylomata, and with unintentional administration on intact skin or mucosa.

Symptoms include nausea, vomiting, abdominal pain and diarrhoea; thrombocytopenia,

leukopenia, hepatotoxicity or renal failure may occur. CNS-related adverse events are delayed in

onset and prolonged in duration and include acute psychotic reactions, hallucinations, confusion,

dizziness, stupor, ataxia, hypotonia, seizures and coma. Peripheral and autonomic neuropathies

develop later and may result in paraesthesias, reduced reflexes, muscle weakness, tachycardia,

apnoea, orthostatic hypotension, paralytic ileus and urinary retention.

After topical overdosage the skin is to be cleaned thoroughly with soap and water, Eyes are to be

rinsed thoroughly with water

or if available, with an appropriate eye-cleaning solution. If accidentally

ingested, give stomach washout and monitor electrolyte balance, blood gases, liver function and blood

picture.

5.

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: chemotherapeutic agent for topical administration, antiviral agent

ATC-code: D06BB04

Podophyllotoxin is the therapeutically active constituent of podophylline, the resin extracted

from the rootstock of pododphyllum species (berberidaceae).

Podophyllotoxin has a clearly antimitotic effect. Due to the attachment to tubeline, the formation

of microtubuli and thus the formation of spindles in the metaphasis of cell division is impeded. A

necrosis of the wart tissue is triggered as a consequence of the blocked cell division.

It is also caustic to normal skin if applied to it and can be absorbed into the systemic circulation with

resultant toxic effects, in particular nausea, vomiting and thrombocytopenia.

In addition, podophyllotoxin has a tumor destructing and anti-inflammatory effect.

5.2

Pharmacokinetic properties

- 4 -

Absorption

Since

podophyllotoxin with local administration is absorbed only to a minor degree, systemic

effects are not to be expected during the recommended administration and dosage. The

quantity absorbed of topically applied podophyllotoxin depends on the volume of application.

Quantities up to 50µl and 0.5% ethanol solution (corresponding to Condylox) could not be

verified in the serum. Patients treated with 100-1500µl showed serum peak values of 1-

17ng/ml within 1 to 2 hours. There was no cumulation of the substance in the serum.

The administration of up to 250µl twice daily for three days is to be considered safe and does not

lead to systemic toxicity.

Distribution

Owing to its high lipid solubility, it is distributed through the body including the CNS.

Metabolism

No data are available on the metabolism of podophyllotoxin.

Elimination

The half-life of podophyllotoxin is 1 – 4.5 hours.

5.3

Preclinical safety data

The LD

of Condylox 0.5% in mice is 33 mg.kg

and in rats is 15 mg.kg

. In both species, therapy

produced an acute leukopenia. As a cytotoxic agent it has teratogenic potential and has been associated

with intrauterine deaths in mice and rats.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Sodium lactate

Lactic acid

Ethanol 96%

6.2

Incompatibilities

Not applicable

6.3

Shelf life

Two years. Shelf life after first opening

:

6 weeks

or expiry date whichever comes first.

6.4

Special precautions for storage

Do not store above 25°C. Light protection required.

- 5 -

6.5

Nature and contents of container

The amber glass vial with child-proof screw top made of polypropylene contains a 3.5ml

solution. The pack is supplied with disposable plastic applicators which have a small hole in one

end that holds the solution.

6.6

Special precautions for disposal and other handling instructions

Unused pharmaceutical products or waste material must be disposed of in accordance with local

requirements.

Condylox 0.5% Solution is flammable and should be kept away from naked flames.

A patient information leaflet is provided with the product giving details on the use and handling

of the product.

Manufacturer:

Takeda Austria GmbH, Linz, Austria

License Holder:

Takeda Israel Ltd., 25 Efal St., POB 4140, Petach - Tikva 4951125

The format of this leaflet was determined by the Ministry of Health and its content was

checked and approved in February 2014.

העדוה העדוה

לע לע

הרמחה הרמחה

(

(

עדימ עדימ

ןולעב )תוחיטב ןולעב )תוחיטב

ןכרצל ןכרצל

ןכדועמ( ןכדועמ(

05.2013

05.2013

ךיראת

19.01.14

םש

רישכת

תילגנאב

רפסמו

םושירה

Condylox 5014.26541

םש

לעב

םושירה

וגירפ

לארשי

תויונכוס

מ"עב

ספוט

הז

דעוימ

טורפל

תורמחהה

דבלב

תורמחהה

תושקובמה

קרפ

ןולעב טסקט

יחכונ טסקט

שדח ינפל שומישה

הפורתב יתמ

ןיא

שמתשהל

?רישכתב לא

ישמתשת

רישכתב

רשאכ

ךניה

ןוירהב וא

.הקינמ

ןיא

שמתשהל

םא

העודי תושיגר

דחאל

יביכרממ

.רישכתה ןיא

שמתשהל

לע

רוע

םמדמ

וא

יתקלד

וא לע

םיעצפ

םיחותפ

ורבעש

לופיט

.יגרוריכ רישכתה

וניא

דעוימ

םידליל

תחתמ

ליגל

ןיא .

שמתשהל

דחיב

םע

רישכת

ףסונ ליכמה

Podophyllotoxin

ןיא

שמתשהל

תב הפור

:םא

תא

ןוירהב

וא

הקינימ

העודי

תושיגר

דחאל

יביכרממ

תה .רישכ

ןיא

שמתשהל

לע

רוע

םמדמ

וא

יתקלד

וא לע

םיעצפ

םיחותפ

ורבעש

לופיט

.יגרוריכ

רישכתה

וניא

דעוימ

םידליל

תחתמ

ליגל

ןיא

שמתשהל

דחיב

םע

רישכת

ףסונ

ליכמה

Podophyllotoxin

ןיא

שמתשהל

רישכתב

לע

רוע

םייניע ,אירב וא

לע

םינפה

רחאמ

לוכיו

םרגהל

יוריג רומח

תורהזא תודחוימ תועגונה שומישל

:

הפורתב :תורהזא םא

ךניה

ה/שיגר

ןוזמל

והשלכ

וא

הפורתל ךילע ,יהשלכ

עידוהל

ךכ-לע

אפורל

ינפל שומישה

.רישכתב שי

ענמיהל

עגממ

רישכתה

םע

רוע

,אירב תויריר

.םייניעהו הרקמב

לש

עגמ

םע

שי ,םייניעה

ףוטשל ןתוא

תומכב

הלודג

לש

םימ

ץעייתהלו

םע שי .אפורה

ענמיהל

תחירממ

הפורתה

לע םיחטש

ןיא .םיבחרנ

שמתשהל

רישכתב לופיטל

תולביב

גוסמ

רחא

וא

שי .תומושב ענמיהל

ןוירהמ

ןמזב

לופיטה

,סקולידנוקב רחאמ

העפשההש

לע

רבועה

הניא

.העודי ןיא

תותשל

תוניי

וא

תואקשמ

םיפירח תפוקתב

.לופיטה תורהזא

תודחוימ

תועגונה

שומישל :הפורתב

ינפל

לופיטה

רפס ,סקולידנוקב אפורל

:םא םא

ךניה

שיגר

ןוזמל

והשלכ

וא

הפורתל .יהשלכ

שי

ענמיהל

עגממ

הפורתה

םע

רוע

,אירב תויריר

הרקמב .םייניעהו

לש

עגמ

םע שי ,םייניעה

ףוטשל

ןתוא

תומכב

הלודג

לש םימ

ץעייתהלו

םע

.אפורה

שי

ענמיהל

תחירממ

הפורתה

לע

םיחטש .םיבחרנ

שי -םישנל

שמתשהל

הפורתב

תחת

החגשה תיאופר

.הדומצ

םא -םירבגל

ךניה

לבוס

תולבימ

,תובר ערתשמה תו

לע

חטש

לוד

,מ"ס שי

שמתשהל

הפורתב

תחת

החגשה תיאופר

הדומצ

ןיא

שמתשהל

הפורתב

לופיטל

תולביב

גוסמ רחא

וא

.תומושב שי

ענמיהל

ןוירהמ

ןמזב

לופיטה רחאמ ,סקולידנוקב

העפשההש

לע רבועה

הניא

.העודי ןוירה

הקנהו

ןיא

שמתשהל

סקולידנוקב

םא

תא

,ןוירהב הסנמ

תורהל

וא

.הקינימ שומיש :ןונימ דציכ

שמתשת

?הפורתב

:

הפורתב ןונימ

יפל

תוארוה

אפורה

.דבלב

ןיא רובעל

לע

הנמה

.תצלמומה םירבגל לופיטל -

ימצע

תיבב

םאתהב תוארוהל

ןונימה ,אפורה

ץלמומה

:אוה םיימעפ

רקובב ,םויב

ברעבו

לדבהב

לש

ךשמב ,תועש

השולש

םימי

.םיפוצר םישנל

לופיטל -

י"ע

אפורה

,ותאפרמב

ןונימה

ץלמומה

םעפ :אוה

םויב

ךשמב השולש

םימי

.םיפוצר שי

תוכחל

האפרמב

דע

רמוחהש

שבייתי .ירמגל לופיטה

םירבגל

םישנלו

לוכי

שדחתהל

ידמ עובש

דע

םומיסקמל

לש

תועובש םיפוצר

עובש(

לופיטה

בכרומ

ימי םאתהב ,לופיט

-ו ,תויחנהל

ימי

.)החונמ י/םיש

בל

אל

הפורת !עולבל

וז

תדעוימ שומישל

ינוציח

.דבלב ןפוא

:שומישה ינפל

תליחת

שי ,לופיטה

ףוטשל

בטיה

תא רוזיאה

עוגנה

ןובסב

םימו

שביילו

שי .בטיה חורמל

תא

רמוחה

תועצמאב

ןולקמה תיתדוקנ ,קייודמב

לע

רהזיהל ,תלביה רמוחהש

אל

אובי

עגמב

םע

רוע

אירב אדוולו

רחאלש

שומישה

קובקבה

רוגס ןיא .בטיה

שמתשהל

ותואב

ןולקמ

רתוי םעפמ

רחאל .תחא

החירמה

שי

תתל רמוחל

שבייתהל

ךשמב

רפסמ

ינפל ,תוקד ואוב

עגמב

םע

שי .םידגבה

דיפקהל ףוטשל

בטיה

םיידי

םימב

ןובסו

רחאל

לכ שומיש

.סקולידנוקב דציכ

י/לכות

עייסל

תחלצהל

?לופיטה ךילע

םילשהל

תא

לופיטה

ץלמוהש

די-לע

.אפורה םג

םא

לח

רופיש

בצמב

ךתואירב

ןיא קיספהל

לופיטה

רישכתב

אלל

תוצעייתה םע

.אפור תולבי

ירבאב

ןימה

ןה

שי ,ןכל .תוקבדמ חיטבהל

תב/ןבש

גוזה

וקדבי

י"ע

.אפורה שי

שמתשהל

םודנוקב

יעצמאכ

ןגמ

ינפמ תקבדה

תב/ןב

גוזה

דע

יופירל

.טלחומ

דימת

שי

שמתשהל

יפל

תוארוה

.אפורה

ךילע קודבל

םע

אפורה

וא

חקורה

םא

ךניא

.חוטב ןונימה

ןפואו

לופיטה

ועבקי

לע

ידי

אפורה

דבלב

ןונימה

לבוקמה ךרדב

ללכ

:אוה םירבגל לופיטל -

ימצע

תיבב

םאתהב

תוארוהל ןונימה ,אפורה

םיימעפ :ץלמומה

רקובב ,םויב ברעבו

לדבהב

לש

ךשמב ,תועש

השולש םימי

.םיפוצר םישנל

לופיטל -

י"ע

אפורה

,ותאפרמב ןונימה

םעפ :ץלמומה

םויב

ךשמב השולש

םימי

שי .םיפוצר

תוכחל

האפרמב

דע רמוחהש

שבייתי

.ירמגל ןיא

רובעל

לע

הנמה

תצלמומה

.

םיש

בל

:

ןיא

הפורת !עולבל

וז

תדעוימ שומישל

ינוציח

.דבלב ינפל

תליחת

שי ,לופיטה

ףוטשל

בטיה

תא רוזיאה

עוגנה

ןובסב

םימו

שביילו

שי .בטיה חורמל

תא

רמוחה

תועצמאב

ןולקמה

,קייודמב תיתדוקנ

לע

רהזיהל ,תלביה

רמוחהש

אל

אובי עגמב

םע

רוע

אירב

אדוולו

רחאלש

שומישה קובקבה

רוגס

ןיא .בטיה

שמתשהל

ותואב ןולקמ

רתוי

םעפמ

רחאל .תחא

החירמה

שי תתל

רמוחל

שבייתהל

ךשמב

רפסמ

,תוקד ינפל

ואוב

עגמב

םע

שי .םידגבה

דיפקהל ףוטשל

בטיה

םיידי

םימב

ןובסו

רחאל

לכ

שומיש .סקולידנוקב לופיטה

םירבגל

םישנלו

לוכי

שדחתהל

ידמ עובש

דע

םומיסקמל

לש

תועובש

םיפוצר עובש(

לופיטה

בכרומ

ימי

םאתהב ,לופיט -ו ,תויחנהל

ימי

.)החונמ םא

תלטנ

תועטב

ןונימ

רתי

וא

םא

תועטב

עלב דלי

ןמ

הפורתה

הנפ

דימ

אפורל

וא

רדחל ןוימ

לש

תיב

םילוח

אבהו

תזירא

הפורתה .ךתיא םא

תחכש

שמתשהל

סקולידנוקב

ןמזב

,שורדה שי

חורמל

תא

הפורתה

עגרב

םא .תרכזנש

ןמז הנמה

האבה

גלד ,ברקתמ

לע

לופיטה תרסחהש

ךשמהו

שמתשהל

יפל

תוארוה .אפורה שי

דימתהל

לופיטב

יפכ

ץלמוהש

לע

ידי

.אפורה םג

םא

לח

רופיש

בצמב

ךתואירב

ןיא

קיספהל לופיטה

רישכתב

אלל

תוצעייתה

םע

.אפור תולבי

ירבאב

ןימה

ןה

שי ,ןכל .תוקבדמ חיטבהל

תב/ןבש

גוזה

וקדבי

י"ע

.אפורה שי

שמתשהל

םודנוקב

יעצמאכ

ןגמ

ינפמ תקבדה

תב/ןב

גוזה

דע

יופירל

.טלחומ םא

שי

ךל

תולאש

תופסונ

עגונב

שומישל ץעוויה ,הפורתב

אפורב

וא

.חקורב ב"צמ

ובש ,ןולעה

נמוסמ תו

תורמחהה

תושקובמה

לע

עקר

בוהצ

םייוניש

םניאש

רדגב

תורמחה

ונמוס

ןולעב עבצב )

שי .הנוש

ןמסל

קר

ןכות

יתוהמ

אלו

םייוניש םוקימב

.טסקטה רבעוה

ראודב

ינורטקלא

ךיראתב

19.01.14

העדוה העדוה

לע לע

הרמחה הרמחה

(

(

עדימ עדימ

ןולעב )תוחיטב ןולעב )תוחיטב

ל

ל

אפור אפור ןכדועמ( ןכדועמ(

05.2013

05.2013

ךיראת

19.01.14

םש

רישכת

תילגנאב

רפסמו

םושירה

Condylox 5014.26541

םש

לעב

םושירה

וגירפ

לארשי

תויונכוס

מ"עב

ספוט

הז

דעוימ

טורפל

תורמחהה

דבלב

תורמחהה

תושקובמה קרפ

ןולעב טסקט

יחכונ טסקט

שדח

Posology, method

and duration of

administration

Treatment is carried out twice

daily (at an interval of 12 hours)

on three consecutive days. Then a

treatment-free interval of four

days should be observed. Therapy

should be repeated until the

condylomata disappear; the

maximum duration of

administration is four weeks.

If no success in treatment can be

achieved after four treatment

cycles, a different from of therapy

must be chosen.

Prior to application, the body

parts to be treated must be washed

carefully with water and soap and

subsequently dried with caution.

The solution is applied with a

cotton tipped applicator on the

condylomata. The cotton pad may

be used only once!

Take care that podophyllotoxine

does not reach the surrounding

healthy skin and/or mucosa.

Condylox should not be applied to

other warts.

After application, let it dry for a

few minutes.

Treatment is carried out twice daily (at an

interval of 12 hours) on three consecutive days.

Then a treatment-free interval of four days

should be observed. Therapy should be

repeated until the condylomata disappear; the

maximum duration of administration is four

weeks.

If no success in treatment can be achieved after

four treatment cycles, a different from of

therapy must be chosen.

Prior to application, the body parts to be treated

must be washed carefully with water and soap

and subsequently dried with caution. The

solution is applied with a cotton tipped

applicator on the condylomata. The cotton pad

may be used only once!

Take care that podophyllotoxin does not reach

the surrounding healthy skin and/or mucosa.

Condylox should not be applied to other non-

genital warts.

After application, let it dry for a few minutes.

Condylox 0.5% solution is left at the site of

application and must not be washed off again.

The treated spots must have dried before

coming in contact with clothing.

After each treatment hands should be cleaned

thoroughly.

Condylox 0.5% solution is left at

the site of application and must

not be washed off again. The

treated spots must have dried

before coming in contact with

clothing.

After each treatment hands should

be cleaned thoroughly.

Therapy with Condylox 0.5%

solution may be carried out at

home by the patients themselves.

However, lesions in the female

and lesions greater than 4cm² in

the male should be treated under

direct medical supervision.

Condylox 0.5% solution is

contraindicated in children under

the age of 12 (See Section 4.3).

Therapy with Condylox 0.5% solution may be

carried out at home by the patients themselves.

However, lesions in the female and lesions

greater than 4cm² in the male should be treated

under direct medical supervision.

Children

Condylox 0.5% solution is contraindicated in

children under the age of 12 (See Section 4.3).

Contraindications

Over- sensibility to

podophyllotoxine or another

excipient of Condylox 0.5%

solution

Inflamed or bleeding pointed

condylomata

Simultaneous administration of

other preparations containing

podophylline

Pregnancy and lactation.

Children under the age of 12

Over- sensibility to podophyllotoxin or another

excipient of Condylox 0.5% solution.

Inflamed or bleeding pointed condylomata, or

open wounds following surgical procedures.

Simultaneous administration of other

preparations containing podophylline.

Pregnancy and lactation.

Children under the age of 12.

Special warnings

and precautions for

use

There are no data available on the

administration of Condylox 0.5%

solution in young adults between

12 and 18 years.

Condylox 0.5% must not come in

contact with the eyes. However, if

podophyllotoxine gets into the

eye, immediate rinsing with water

should be carried out and a doctor

should be consulted.

Condylox 0.5% is exclusively

used for the therapy of

condylomata and must not be

applied to other warts or naevi.

Contact with healthy skin is to be

avoided.

Alcohol consumption is to be

avoided during treatment. The

There are no data available on the

administration of Condylox 0.5% solution in

young adults between 12 and 18 years.

Condylox 0.5% must not come in contact with

the eyes. However, if podophyllotoxin gets into

the eye, immediate rinsing with water should be

carried out and a doctor should be consulted.

Condylox 0.5% is exclusively used for the

therapy of condylomata and must not be

applied to other warts or naevi. Contact with

healthy skin is to be avoided.

Lesions in the female and lesions greater than 4 cm

in the male should be treated under direct medical

supervision.

Alcohol consumption is to be avoided during

treatment. The ingestion of alcohol during

therapy may lead to massive increase of

ingestion of alcohol during

therapy may lead to massive

increase of undesired effects.

Male patients should wear

condoms until healed completely.

The partners should be requested

to have themselves examined by a

doctor.

undesired effects.

Male patients should wear condoms until

healed completely. The partners should be

requested to have themselves examined by a

doctor.

Overdosage

The risk of systemic toxicity after

topical administration is increased

with large-area treatment using

excessive quantities for a longer

period, or when treating bleeding

or recently eliminated pointed

condylomata, and with

unintentional administration on

intact skin or mucosa.

After topical overdosage the skin

is to be cleaned thoroughly with

soap and water, Eyes are to be

rinsed thoroughly with water.

The risk of systemic toxicity after topical

administration is increased with large-area

treatment using excessive quantities for a

longer period, or when treating bleeding or

recently eliminated pointed condylomata, and

with unintentional administration on intact skin

or mucosa.

Symptoms include nausea, vomiting,

abdominal pain and diarrhoea;

thrombocytopenia, leukopenia, hepatotoxicity

or renal failure may occur. CNS-related

adverse events are delayed in onset and

prolonged in duration and include acute

psychotic reactions, hallucinations, confusion,

dizziness, stupor, ataxia, hypotonia, seizures

and coma. Peripheral and autonomic

neuropathies develop later and may result in

paraesthesias, reduced reflexes, muscle

weakness, tachycardia, apnoea, orthostatic

hypotension, paralytic ileus and urinary

retention.

After topical overdosage the skin is to be

cleaned thoroughly with soap and water,

Eyes are to be rinsed thoroughly with

water

or if available, with an appropriate

eye-cleaning

solution.

accidentally

ingested, give stomach washout and monitor

electrolyte

balance,

blood

gases,

liver

function and blood picture.

Pharmacodynamic

properties

Pharmacotherapeutic group:

chemotherapeutic agent for

topical administration, antiviral

agent

ATC-code: D06BB04

Podophyllotoxine is the

therapeutically active constituent

of podophylline, the resin

extracted from the rootstock of

pododphyllum species

(berberidaceae).

Pharmacotherapeutic group: chemotherapeutic

agent for topical administration, antiviral agent

ATC-code: D06BB04

Podophyllotoxin is the therapeutically active

constituent of podophylline, the resin extracted

from the rootstock of pododphyllum species

(berberidaceae).

Podophyllotoxin has a clearly antimitotic

effect. Due to the attachment to tubeline, the

formation of microtubuli and thus the formation

of spindles in the metaphasis of cell division is

Podophyllotoxine has a clearly

antimitotic effect. Due to the

attachment to tubeline, the

formation of microtubuli and thus

the formation of spindles in the

metaphasis of cell division is

impeded. A necrosis of the wart

tissue is triggered as a

consequence of the blocked cell

division.

In addition, podophyllotoxine has

a tumor destructing and anti-

inflammatory effect.

impeded. A necrosis of the wart tissue is

triggered as a consequence of the blocked cell

division.

It is also caustic to normal skin if applied to it and

can be absorbed into the systemic circulation with

resultant toxic effects, in particular nausea,

vomiting and thrombocytopenia.

In addition, podophyllotoxin has a tumor

destructing and anti-inflammatory effect.

Pharmacokinetic

properties

Since podophyllotoxine with local

administration is absorbed only to

a minor degree, systemic effects

are not to be expected during the

recommended administration and

dosage. The quantity absorbed of

topically applied

podophyllotoxine depends on the

volume of application. Quantities

up to 50µl and 0.5% ethanol

solution (corresponding to

Condylox) could not be verified in

the serum. Patients treated with

100-1500µl showed serum peak

values of 1-17ng/ml within 1 to 2

hours. There was no cumulation

of the substance in the serum. The

half-life of podophyllotoxine is 1

– 4.5 hours.

The administration of up to 250µl

twice daily for three days is to be

considered safe and does not lead

to systemic toxicity.

Absorption

Since podophyllotoxin with local

administration is absorbed only to a minor

degree, systemic effects are not to be

expected during the recommended

administration and dosage. The quantity

absorbed of topically applied

podophyllotoxin depends on the volume of

application. Quantities up to 50µl and 0.5%

ethanol solution (corresponding to

Condylox) could not be verified in the

serum. Patients treated with 100-1500µl

showed serum peak values of 1-17ng/ml

within 1 to 2 hours. There was no

cumulation of the substance in the serum

The administration of up to 250µl twice daily

for three days is to be considered safe and does

not lead to systemic toxicity.

Distribution

Owing to its high lipid solubility, it is distributed

through the body including the CNS.

Metabolism

No data are available on the metabolism of

podophyllotoxin.

Elimination

The half-life of podophyllotoxin is 1 – 4.5

hours.

Preclinical safety

data

Preclinical data for the active

substance podophyllotoxine are

not known. Due to many years of

clinical experience, however, no

other undesired effects are to be

expected than those described in

other sections of the summary of

Preclinical data for the active substance

podophyllotoxin are not known. Due to many

years of clinical experience, however, no other

undesired effects are to be expected than those

described in other sections of the summary of

product characteristics.

The LD

of Condylox 0.5% in mice is 33 mg.kg

product characteristics.

and in rats is 15 mg.kg

. In both species, therapy

produced an acute leukopenia. As a cytotoxic agent

it has teratogenic potential and has been associated

with intrauterine deaths in mice and rats.

ב"צמ

ובש ,ןולעה

נמוסמ תו

תורמחהה

שקובמה תו

לע

עקר

.בוהצ םייוניש

םניאש

רדגב

תורמחה

ונמוס

)ןולעב( עבצב

שי .הנוש

ןמסל

קר

ןכות

יתוהמ

אלו

םייוניש םוקימב

.טסקטה רבעוה

ראודב

ינורטקלא

ךיראתב

19.01.14

Similar products

Search alerts related to this product

View documents history

Share this information