Podofilox Topical Solution

Podofilox (podofilox) Topical Solution 0.5% is indicated for the topical treatment of external genital warts (Condyloma acuminatum).This product is not indicated in the treatment of perianal or mucous membrane warts (see PRECAUTIONS).

Diagnosis
Although genital warts have a characteristic appearance,histopathologic confirmation should be obtained if there is any doubt of the diagnosis.Differentiating warts from squamous cell carcinoma (so-called †Bowenoid papulosis†) is of particular concern. Squamous cell carcinoma may also be associated with human papillomavirus but should not be treated with Podofilox (podofilox) Topical Solution 0.5%.

Mechanism of Action

Treatment of genital warts with podofilox (podofilox) results in necrosis of visible wart tissue.The exact mechanism of action is unknown.

Pharmacokinetics

In systemic absorption studies in 52 patients, topical application of 0.05 mL of 0.5% podofilox (podofilox) solution to external genitalia did not result in detectable serum levels.Applications of 0.1 to 1.5 mL resulted in peak serum levels of 1 to 17 ng/mL one to two hours after application. The elimination half-life ranged from 1.0 to 4.5 hours. The drug was not found to accumulate after multiple treatments.

CLINICAL STUDIES

In clinical studies with podofilox (podofilox) solution,the test product and its vehicle were applied in a double-blind fashion to comparable patient groups.Patients were treated for two to four weeks, and reevaluated at a two-week follow-up examination. Although the number of patients and warts evaluated at each time period varied,the results among investigators were relatively consistent.

The following table represents the responses noted in terms of frequency of response by lesions treated and the overall response by patients. Data are presented for the 2-week follow-up only for those patients evaluated at that time point.

*Cleared and clearing mean no visible wart tissue remained at the treated sites

You should not use podofilox topical if you are allergic to it.

Do not use this medication on any warts or skin growths that have not been checked by your doctor.

FDA pregnancy category C. It is not known whether podofilox topical will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication..

It is not known whether podofilox topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

PODOFILOX (po do FIL ox) is a medication used to remove genital warts. The topical solution should only be used to treat genital warts located on the outside skin of the genitals (i.e., penis or vagina). The solution should not be used to treat warts near the rectal area.

This drug also comes in other forms, including Topical gel

This drug can cause serious side effects. See which side effects you should report to your doctor right away.

Know how to use your medication, and learn what might happen if you miss a dose.

Talk to your healthcare provider if you have any of these conditions.

Know what to watch for and get tips for reducing your risks while taking this drug.