Product Description.:
Solution , clear , clear
Condylox 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). Condylox 0.5% Solution is formulated for topical administration. Each milliliter of solution contains 5 mg of podofilox, in a vehicle containing lactic acid and sodium lactate in alcohol 95%, USP.
INDICATIONS AND USAGE
Condylox 0.5% Solution 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 (seePRECAUTIONS).
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 Condylox 0.5% Solution.
CONTRAINDICATIONS
Condylox 0.5% Solution is contraindicated for patients who develop hypersensitivity or intolerance to any component of the formulation.
WARNINGS
Correct diagnosis of the lesions to be treated is essential. See the Diagnosis subsection of theINDICATIONS AND USAGE statement.
Condylox 0.5% Solution is intended for cutaneous use only. Avoid contact with the eye. If eye contact occurs, patients should immediately flush the eye with copious quantities of water and seek medical advice.
PRECAUTIONS
General
Data are not available on the safe and effective use of this product for treatment of warts occurring in the perianal area or 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 (seeDOSAGE AND ADMINISTRATION).
Information for Patients
The patient should be provided with a Patient Information leaflet when a Condylox prescription is filled.
OVERDOSAGE
Topically applied podofilox may be absorbed systemically (seeCLINICAL 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. Other toxicities occurred at lower doses. Toxicity reported following systemic administration of podophyllum resin included: nausea, vomiting, fever, diarrhea, peripheral neuropathy, altered mental status, lethargy, coma, tachypnea, respiratory failure, leukocytosis, pancytosis, hematuria, renal failure, and seizures. Treatment of topical overdosage should include washing the skin free of any remaining drug and symptomatic and supportive therapy.
