CONDYLINE SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PODOPHYLLOTOXIN

Available from:

SANOFI-AVENTIS CANADA INC

ATC code:

D06BB04

INN (International Name):

PODOPHYLLOTOXIN

Dosage:

0.5%

Pharmaceutical form:

SOLUTION

Composition:

PODOPHYLLOTOXIN 0.5%

Administration route:

TOPICAL

Units in package:

3.5ML

Prescription type:

Prescription

Therapeutic area:

MISC. SKIN AND MUCOUS MEMBRANE AGENTS

Product summary:

Active ingredient group (AIG) number: 0123181001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2021-08-25

Summary of Product characteristics

PRODUCT MONOGRAPH
Pr
CONDYLINE
®
Podofilox Topical Solution
0.5%
Antimitotic Agent
sanofi-aventis Canada Inc.
2905 Place Louis-R.-Renaud
Laval, Quebec H7V 0A3
DATE OF PREPARATION:
July 14, 2021
Submission
Control No.: 246341
PRODUCT MONOGRAPH
NAME OF DRUG
Pr
CONDYLINE
®
Podofilox Topical Solution
0.5%
THERAPEUTIC CLASSIFICATION
Antimitotic Agent
ACTIONS
Necrosis of visible tissue is observed following
treatment of genital warts with CONDYLINE
(Podofilox Topical Solution
0.5%). The exact mechanism of action is unknown. CONDYLINE
(Podofilox Topical solution
0.5%) is believed to exert its antimitotic
effect by binding
to tubulin,
at a site close to but not identical to the binding
site of colchicine; it is thought that this
antimitotic
effect causes necrosis of wart tissue, the observed clinical effect.
In addition,
podofilox
is known to interfere with nucleoside transport which may also
contribute to its action
(1). Crude podophyllum
resin, from which podofilox
is extracted, has been shown to produce
mitotic arrest and necrosis of wart tissue.
INDICATIONS
CONDYLINE (Podofilox Topical Solution 0.5%) is indicated for the
topical treatment of
external genital warts (Condylomata acuminata) confined to the penile
and vulvar regions. The
effectiveness of podofilox in the treatment of perianal or mucous
membrane warts has not been
established.
CONTRAINDICATIONS
CONDLYINE (Podofilox Topical Solution 0.5%) is contraindicated in:

Patients who have hypersensitivity to podofilox
or intolerance to any component of the
formulation.

Patients with open wounds, inflamed or bleeding lesions.

Pregnant or breast-feeding women.

Children under 12 years of age.

In combination
with other podophyllin
containing preparations.
WARNINGS
Condyline (podofilox topical solution 0.5%) is intended for topical
use only.
Women of child-bearing
age should be using effective contraception before being administered
CONDYLINE.
The consumption of alcoholic beverages for several hours after
treatment is to be avoided.
Condyline is a p