Condylox

Patients using C Condylox® Gel 0.5% should receive the following information and instructions. This information is intended to aid in the safe and effective use of this medication. It is not intended to disclose all possible adverse or intended effects.

1) This medication should be used only as directed by the health care provider. Patients should be instructed to wash their hands thor-oughly before and after each application. It is for external use only. Avoid contact with the eyes.

2) Patients should be advised not to use this medication for any disorder other than for which it was prescribed.

3) Patients should report any signs of adverse reactions to the health care provider.

4) If no improvement is observed after 4 weeks of treatment, discontinue the medication and consult the health care provider.

Patients should report any signs of adverse reactions to the health care provider.

Carcinogenesis, Mutagenesis and Impairment of Fertility

An 80-week carcinogenicity study in the mouse was performed using a 0.5% podofilox solution applied dermally at 0.04, 0.2 and 1.0 mg/kg/day. There were no differences between the podofilox treated mice at any dose level and vehicle control in the incidence of neoplasia. Published animal studies, in general, have not shown the drug substance, podofilox, to be carcinogenic.2,3,4,5,6 There are published reports that, in mouse studies, crude podophyllin resin (containing podofilox) applied topically to the cervix produced changes resembling carcinoma in situ.7 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 podophyllina (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 5mg/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. 008ug/mL, without metabolic activation and 12ug/mL podofilox with metabolic activation. Results from the mouse micronucleus in vivo assay using podofilox 0.5% solution at doses up to 25 mg/ kg (75 mg/m2 ) , indicate that podofilox should be considered a potential clastogen (a chemical that induces disruption and breakage of chromosomes).

Daily topical application of 0.5% podofilox solution at doses up to the equivalent of 0.2mg/kg (1.18 mg/m2 , approximately equivalent to the human daily dose) to rats throughout gametogenesis, mating, gestation, parturition and lactation for two generations demonstrated no impairment of fertility.

Pregnancy

Pregnancy Category C: 0.5% podofilox solution was not teratogenic in the rabbit following topical application of up to 0.21 mg/ kg (2.85 mg/m2, approximately 2 times the maximum human dose) once daily for 13 days. The scientific literature contains references that podofilox is embryotoxic in rats when administered intraperitoneally at a dose of 5mg/kg (29.5 mg/m2, approximately 19 times the recommended maximum human dose).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. Condylox® Gel 0.5% should be used during pregnancy only if the potential benefit Justifies the potential risk to the fetus.

Nursing Mothers

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 mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Condylox to understand an ancient culture that had an appreciation of the beautiful yet have had so much horror in its heart?

CORONA, Calif., March 17, 1997 -- The U.S. Food and Drug Administration (FDA) has approved to market Condylox(R) Gel 0.5% (podofilox) for the treatment of external genital and perianal warts (condyloma acuminata). The product is expected to be launched in the second quarter of fiscal 1997.

It is believed that Condylox(R) Gel offers two important advancements over Condylox topical solution, introducedin 1991: easy, finger-tip application and an expanded perianal wart indication.

Oclassen Pharmaceuticals, Inc., a wholly-owned subsidiary of Watson Pharmaceuticals, is dedicated to the development and acquisition of unique proprietary dermatological products.

Watson Pharmaceuticals, Inc., headquartered in Corona, CA, is engaged in the manufacture and sale of off-patent medications and branded pharmaceutical products.

Condylox

t