Condylox Gel

Condylox Gel Information

Brand Name: Condylox

Generic Names: Podofilox

Other Common Names: Podofilia #2

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.

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%.

Condylox Gel Ingredients and Composition

How Does Condylox Gel Work?

Mechanism of Action

Treatment of anogenital warts with podofilox results in necrosis of visible wart tissue. The exact mechanism of Condylox action is unknown.

Pharmacokinetics

In systemic absorption studies in 52 patients, topical application of 0.05mL of an ethanolic solution containing 0.5% podofilox to external genitalia did not result in detectable serum levels. Applications of 0.1 to 1.5mL 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.

How To Take Condylox Gel and Condylox Gel 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 Condylox 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 Condylox 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 Condylox application.

If you suspect a Condylox Gel Overdose

Topically applied Condylox may be absorbed systemically. Toxicity reported following systemic administration of Condylox 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. Other toxicities occurred at lower doses. Treatment of topical overdosage should include washing the skin free of any remaining drug and symptomatic and supportive therapy.

Condylox Gel Side Effects

Condylox Gel Warnings

Condylox Gel Precautions and Contraindications

General

Data is not available on the safe and effective use of Condylox for treatment of warts occurring on mucous membranes of the genital area (including the urethra, rectum and vagina). The recommended method of application, frequency of application, and duration of usage should not be exceeded.

Contraindications to Condylox Gel

Condylox Gel 0. 5% is contraindicated for patients who develop hypersensitivity or intolerance to any components of the formulation.

Condylox Gel Clinical Trials and Studies

Condylox Gel Pill Identification / ID and Appearance

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

Storing Condylox Gel

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

Avoid excessive heat. Do not freeze.

Additional Patient Information for Condylox Gel

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.

Condylox 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.

Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
Patients should report any signs of adverse reactions to the health care provider.
If no improvement is observed after 4 weeks of treatment, discontinue Condylox and consult the health care provider.