Podofilotoxina

Condylox

Usos autorizados

• Condylox Gel 0.5% is indicated for the topical treatment of anogenital warts (external genital warts and perianal 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 and "Bowenoid papulosis" is of particular concern.
• This product is not indicated in the treatment of mucous membrane warts (see PRECAUTIONS).

Formas y dosis

• Condylox Gel 0.5% is supplied as 3.5 grams of clear gel in aluminum tubes with an applicator tip.

Cómo se toma

• 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.

No debe usarse en caso de

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

Advertencias y precauciones

• 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.

Efectos adversos frecuentes

• 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.

Embarazo

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).

Mecanismo de acción

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

Titular de la autorización:

Allergan, Inc.

Versión de la ficha:

29 de enero de 2024

Las secciones anteriores están citadas de la ficha en inglés, porque es ese documento el que porta la autorización. Cuando una autoridad europea publica la misma información en español, el enlace figura en las fuentes. No traducimos por nuestra cuenta los textos reguladores: un error de traducción en una contraindicación sería más peligroso que una línea en otro idioma.

Esta sección recoge la ficha técnica autorizada. El texto está condensado a partir del resumen de la propia autoridad, y el documento completo figura en las fuentes.