WARTEC LIQUID

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PODOPHYLLOTOXIN

Available from:

STIEFEL LABORATORIES (IRELAND) LIMITED

ATC code:

D06BB04

INN (International Name):

PODOPHYLLOTOXIN

Dosage:

5MG

Pharmaceutical form:

LIQUID

Composition:

PODOPHYLLOTOXIN 5MG

Administration route:

TOPICAL

Units in package:

3ML

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:

2015-04-30

Summary of Product characteristics

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_Page 1 of 19_
PRODUCT MONOGRAPH
PR
WARTEC
®
PODOFILOX TOPICAL SOLUTION 0.5% W/V
ANTIMITOTIC AGENT
Stiefel Laboratories (Ireland) Limited
Date of Revision:
Finisklin Industrial Estate
December 24, 2013
Sligo, IRELAND
Control # 170147
_®_
_WARTEC is a registered trademark of Stiefel Laboratories, Inc., used
under license by GlaxoSmithKline Inc._
_ _
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PRODUCT MONOGRAPH
PR
WARTEC
®
Podofilox topical solution 0.5% w/v
THERAPEUTIC CLASSIFICATION
Antimitotic Agent
ACTIONS
Necrosis of visible tissue is observed following treatment of genital
warts with Podofilox.
The exact mechanism of action is_ _unknown.
Podofilox is_ _a metaphase inhibitor of dividing cells. Podofilox
binds to at least one
binding site on tubulin. This binding prevents the tubulin
polymerisation required for
microtubule assembly. At higher concentrations Podofilox also inhibits
nucleoside
transport through the cell membrane.
The chemotherapeutic action of Podofilox is assumed to be due to
inhibition of growth
and the ability to invade the tissue of the virus-infected cells.
Podofilox prevents cell
division in the virus infected cells of the condylomata acuminata.
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INDICATIONS
WARTEC
® (Podofilox 0.5% topical solution) is indicated for the topical
treatment of
external genital warts (Condylomata acuminata) confined to the penile
and vulvar
regions.
CONTRAINDICATIONS
WARTEC
®
(Podofilox 0.5% topical solution) is contraindicated for patients who
develop
or have known hypersensitivity to Podofilox or to any component in the
formulation
(ethanol, phosphoric acid)
_(SEE _
_PHARMACEUTICAL INFORMATION DESCRIPTION SECTION)._
Open or bleeding wounds should not be treated with WARTEC
® (Podofilox).
WARNINGS
WARTEC
® (PODOFILOX TOPICAL SOLUTION 0.5%) IS INTENDED FOR
TOPICAL USE ONLY.
PODOFILOX IS A POTENT VESICANT AND IS TO BE USED ONLY AS
DIRECTED BY A PHYSICIAN.
EXTR