Condylox sol

Condylox sol Information

Brand Name: Condylox

Generic Names: Podofilox

Other Common Names: Podofilia #2

Condylox Topical Solution 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.

Condylox Topical Solution is the brand name of podofilox, an antimitotic drug which can be chemically synthesized or purified from the plant families Coniferae and Berberidaceae (e.g. species of Juniperus and Podophyllum).

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 Topical Solution.

Condylox sol Ingredients and Composition

How Does Condylox sol 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 sol and Condylox sol Dosage and Administration

In order to ensure that the patient is fully aware of the correct method of therapy and to identify which specific warts should be treated, the technique for initial application of the medication should be demonstrated by the prescriber.

Apply Condylox Topical Solutiontwice daily morning and evening (every 12 hours), for 3 consecutive days, then withhold use for 4 consecutive days. This one week cycle of treatment may be repeated up to four times until there is no visible wart tissue. If there is incomplete response after four treatment weeks, alternative treatment should be considered. Safety and effectiveness of more than four treatment weeks have not been established.

Condylox 0.5% Solution is applied to the warts with a cotton-tipped applicator supplied with the drug. The drug-dampened applicator should be touched to the wart to be treated, applying the minimum amount of solution necessary to cover the lesion. Treatment should be limited to less than 10 cm 2 of wart tissue and to no more than 0.5 mL of the solution per day. 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.

Care should be taken to allow the solution to dry before allowing the return of opposing skin surfaces to their normal positions. After each treatment, the used applicator should be carefully disposed of and the patient should wash his or her hands.

If you suspect a Condylox sol Overdose

Topically applied Condylox Topical Solutionmay 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 sol Side Effects

Condylox sol Warnings

Condylox sol 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.

Pregnancy

Pregnancy Category C: Podofilox, the active ingredient in Condylox Topical Solution was not teratogenic in the rabbit following topical application of up to 0.21 mg/kg (5 times the maximum human dose) once daily for 13 days. The scientific literature contains references that podofilox is embryotoxic in rats when administered systemically in a dose approximately 250 times the recommended maximum human dose. 8,9 Teratogenicity and embryotoxicity have not been studied with intravaginal application. Many antimitotic drug products are known to be embryotoxic. There are no adequate and well-controlled studies in pregnant women. Podofilox should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

Taking Condylox sol during Pregnancy or Breast-feeding

It is not known whether this drug is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from podofilox, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Contraindications to Condylox sol

Condylox Topical Soltion is contraindicated for patients who develop hypersensitivity or intolerance to any components of the formulation.

Condylox sol Clinical Trials and Studies

Condylox sol Pill Identification / ID and Appearance

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

Storing Condylox sol

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

Avoid excessive heat. Do not freeze.

Additional Patient Information for Condylox sol

Patients using Condylox 0.5% Solution should receive the following information and instructions. This information is intended to aid in the safe and effective use of his 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.