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Condylox Gel (podofilox 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).
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 and "Bowenoid papulosis" is of particular concern. Squamous cell carcinoma may also be associated with human papillomavirus which should not be treated with Condylox Gel (podofilox gel) 0.5%.
DOSAGE AND ADMINISTRATION
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 (podofilox 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 0.5 g 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 (podofilox gel) 0.5% is supplied as 3.5 g of clear gel in aluminum tubes with an applicator tip. NDC 52544-045-13. Store at controlled room temperature between 15 - 30°C (59 - 86° F). Avoid excessive heat. Do not freeze.
Keep out of reach of children.
Mfd. for: Watson Pharmaceuticals, Inc. Corona, CA 92880 USA by DPT Laboratories, Ltd. San Antonio, TX 78215. Revised: November 2007. FDA rev date: 3/13/1997
Last reviewed on RxList: 11/24/2008
This monograph has been modified to include the generic and brand name in many instances.
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