Correct diagnosis of the lesions to be treated is
essential. See the “Diagnosis” subsection of the INDICATIONS
AND USAGE statement.
Condylox 0.5% Solution is intended for cutaneous use
only. Avoid contact with the eye. If eye contact occurs , patients should
immediately flush the eye with copious quantities of water and seek medical
Data are not available on the safe and effective use of
this product for treatment of warts occurring in the perianal area or on mucous
membranes of the genital area (including the urethra, rectum and vagina). The
recommended method of application, frequency of application, and duration of
usage should not be exceeded (see DOSAGE AND ADMINISTRATION).
Information for Patients
The patient should be provided with a PATIENT INFORMATION leaflet when a Condylox prescription is filled.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Reports of lifetime carcinogenicity studies in mice are
not available. Published animal studies, in general, have not shown the drug
substance, podofilox, to be carcinogenic.1,2,3,4,5 There are
published reports that, in mouse studies, crude podophyllin resin (containing
podofilox) applied topically to the cervix produced changes resembling
carcinoma in situ.6 These changes were reversible at five
weeks after cessation of treatment. In one reported experiment, epidermal
carcinoma of the vagina and cervix was found in 1 out of 18 mice after 120
applications of podophyllin7 (the drug was applied twice weekly over
a 15-month period).
Podofilox was not mutagenic in the Ames plate reverse
mutation assay at concentrations up to 5 mg/plate, with and without metabolic
activation. No cell transformation related to potential oncogenicity was
observed in BALB/3T3 cells after exposure to podofilox at concentrations up to
0.008 μg/mL without metabolic activation and 12 μg/mL podofilox with
metabolic activation. Results from the mouse micronucleus in vivo assay using
podofilox 0.5% solution in concentrations up to 25 mg/kg, indicate that podofilox
should be considered a potential clastogen (a chemical that induces disruption
and breakage of chromosomes).
Daily topical application of Condylox 0.5% Solution at
doses up to the equivalent of 0.2 mg/kg (5 times the recommended maximum human
dose) to rats throughout gametogenesis, mating, gestation, parturition and
lactation for two generations demonstrated no impairment of fertility.
Podofilox was not teratogenic in the rabbit following
topical application of up to 0.21 mg/kg (5 times the maximum human dose) once
daily for 13 days. The scientific literature contains references that podofilox
is embryotoxic in rats when administered systemically in a dose approximately
250 times the recommended maximum human dose.8,9 Teratogenicity and
embryotoxicity have not been studied with intravaginal application. Many
antimitotic drug products are known to be embryotoxic. There are no adequate
and well-controlled studies in pregnant women. Podofilox should be used in
pregnancy only if the potential benefit justifies the potential risk to the
It is not known whether this drug is excreted in human
milk. Because of the potential for serious adverse reactions in nursing infants
from podofilox, a decision should be made whether to discontinue nursing or to
discontinue the drug, taking into account the importance of the drug to the
Safety and effectiveness in pediatric patients have not
1. Berenblum I. The effect of podophyllotoxin on the skin
of the mouse, with reference to carcinogenic, cocarcinogenic, and
anticarcinogenic action. J Cancer Inst 11:839-841, 1951.
2. Kaminetzky HA, Swerdlow M. Podophyllin and the mouse
cervix: assessment of carcinogenic potential. Am J Obst Gyn 95:486-490, 1965.
3. McGrew EA, Kaminetzky HA. The genesis of experimental
cervical epithelial dysplasia. Am J Clin Path 35:538-545, 1961.
4. Roe FJC, Salaman MH. Further studies on incomplete
carcinogenesis: triethylene melamine (T.E.M.) 1,2 benxanthracene and
beta-propiolactone as initiators of skin tumor formation in the mouse. Brit J Cancer,
5. Taper HS. Induction of the deficient acid DNAase
activity in mouse interfollicular epidermis by croton oil as a possible tumor
promoting mechanism. Zeitschrift fur Krebsforschung and Klinisch Onkologie
(Cancer Research and Clinical Oncology, Berlin). 90:197-210, 1977.
6. Kaminetzky HA, McGrew EA, Phillips RL. Experimental
cervical epithelial dysplasia. J Obst Gyn 14:1-10, 1959.
7. Kaminetzky HA, McGrew EA: Podophyllin and mouse cervix:
Effect of long term application. Arch Path 73:481-485, 1962.
8. Didcock K, Jackson D, Robson JM. The action of some
nucleotoxic substances on pregnancy. Brit J Pharmacol 11:437-441, 1956.
9. Thiersch JB. Effect of podophyllin (P) and
podophylotoxine (PT) on the rat litter in utero. Soc Exptl Biol Med Proc.