Condylox® Gel 0.5% is indicated for the topical treatment of anogenital warts (external genital warts and perianal warts). This product is not indicated in the treatment of mucous membrane warts (see PRECAUTIONS).

Diagnosis

Although anogenital warts have a characteristic appearance, histopathologic confirmation should be obtained if there is any doubt of the diagnosis. Differentiating warts from squamous cell carcinoma "Bowenoid papulosis" is of particular concern. Squamous cell carcinoma may also be associated with human papillomavirus which should not be treated with Condylox® Gel 0.5%.

The prescriber should ensure that the patient is fully aware of the correct method of therapy and identify which specific warts should be treated.

Apply twice daily for 3 consecutive days, then discontinue for 4 consecutive days. This one week cycle of treatment may be repeated until there is no visible wart tissue or for a maximum of four cycles. If there is incomplete response after four treatment cycles, discontinue treatment and consider alternative treatment. Safety and effectiveness of more than four treatment cycles has not been established. There is no evidence to suggest that more frequent application will increase efficacy, but additional applications would be expected to increase the rate of local adverse reactions and systemic absorption.

Condylox® Gel 0.5% should be applied to the warts with the applicator tip or finger. Application on the surrounding normal tissue should be minimized. Treatment should be limited to 10 cm² or less of wart tissue and to no more than 0.5g of the gel per day.

Care should be taken to allow the gel to dry before allowing the return of opposing skin surfaces to their normal positions. Patients should be instructed to wash their hands thoroughly before and after each application.

Condylox® Gel 0.5% is supplied as 3.5g of clear gel in aluminum tubes with an applicator tip. NDC55515-102-01.

Store at controlled room temperature between 15°- 30°C (59°- 86° F ).

Avoid excessive heat. Do not freeze.

Caution: Federal (U. S. A.) law prohibits dispensing without prescription.

References

1. von Krogh G. Podophyllotoxin in serum: Absorption subsequent to three day repeated applications of a 0.5% ethanolic preparation on condylomata acuminata. Sex Trans Disease 1982: 9: 26-33.

2. Berenbium I.The effect of podophyllotoxin on the skin of the mouse, with reference to carcinogenic, cocarcinogenic, and anticarcino-genic action. J Cancer lnst 11:839-841, 1951.

3. Kaminetzky HA, Swerdlow M. Podophyllin and the mouse cervix: assessment of carcinogenic potential. Am J Obst Gyn 95:486-490, 1965.

4. McGrew EA, Kaminetzky HA. The genesis of experimental cervical epithelial dysplasia. Am J Clin Path 35:538-545, 1961.

5. Roe FJC, Salaman MH. Further studies on incomplete carcinogen-esis: triethylene melamine (T.E.M.) 1,2 benzanthracene and beta-propiolactone as initiators of skin tumor formation in the mouse. Brit J Cancer 9:177-203, 1955.

6. Taper HS. Induction of the deficient acid DNAase activity in mouse interfollicular epidermis by croton oil as a possible tumor promot-ing mechanism. Zeitschrift fur Krebsforschung and Klinisch Onkologie (Cancer Research and Clinical Oncology, Berlin) 90:197- 210,1977.

7. Kaminetzky HA, McGrew EA, Phillips RL. Experimental cervical epithe-lial dysplasia. J Obst Gyn 14: 1 -10,l959.

8. Kaminetzky HA, McGrew EA: Podophyllin and mouse cervix: Effect of long term application. Arch Path 73:481-485, 1962.

9. Thiersch JB. Effect of podophyflin (P) and podophylotoxine (PT.) on the rat litter in utero. Soc Exptl Biol Med Proc 113:124-127, 1963.

10 Savel H.: Clinical experience with intravenous podophyllotoxin. Proc Amer Assoc Cancer Res, 1964; 5: 56.

11. Cassidy DE, Dewry J and Fanning JP: Podophyllum toxicity: A report of a fatal case and a review of the literature. J Toxicol Clinic Toxicol 1982: 19: 35-44.

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