Podophyllin Cream 0.15% w/w

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 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 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 cm 2 or less of wart tissue and to no more than 0.5 g ram 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

• Safety and effectiveness
• In pediatric patients have not been established

• Patients using 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 thoroughly 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. …

Condylox Gel 0.5% is contraindicated for patients who develop hypersensitivity or intolerance to any components of the formulation.

Correct diagnosis of the lesions to be treated is essential. See the Diagnosis subsection of the INDICATIONS AND USAGE section. Condylox Gel 0.5% is intended for cutaneous use only. Avoid contact with the eyes. If contact with the eyes occurs, patients should immediately flush the eyes with copious quantities of water and seek medical advice. Drug Product is Flammable. Keep Away f rom Open Flame.

In clinical trials with Condylox Gel 0.5%, the following local adverse reactions were reported during the treatment of anogenital warts. The severity of local adverse reactions were predominantly mild or moderate and did not increase during the treatment period. Severe reactions were most frequent within the first 2 weeks of treatment. Adverse Reaction Mild Moderate Severe Inflammation 32.2% 30.4% 9.3% Burning 37.1% 25.9% 11.5% Erosion 27.0% 20.8% 8.9% Pain 23.7% 20.4% 11.5% Itching 32.2% 16.0% 7.8% Bleeding 19.2% 3.0% 0.7% Other local adverse reactions reported included stinging (7%), and erythema (5%); less commonly reported local adverse events included desquamation, scabbing, discolorati …

Pregnancy 0.5% podofilox solution was not teratogenic in the rabbit following topical application of up to 0.21 mg/kg (2.85 mg/m 2 , 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 5 mg/kg (29.5 mg/m 2 , approximately 19 times the recommended maximum human dose). …

Topically applied podofilox may be absorbed systemically (see CLINICAL PHARMACOLOGY section). Toxicity reported following systemic administration of podofilox in investigational use for cancer treatment included: nausea, vomiting, fever, diarrhea, bone marrow depression, and oral ulcers. Following 5 to 10 daily intravenous doses of 0.5 to 1 mg/kg/day, significant hematological toxicity occurred but was reversible. 10 Other toxicities occurred at lower doses. …

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