Action And Clinical Pharmacology: Necrosis of visible tissue is observed following treatment of genital warts with podofilox. The exact mechanism of action is unknown.
Podofilox is a metaphase inhibitor of dividing cells. Podofilox binds to at least one binding site on tubulin. This binding prevents the tubulin polymerization required for microtubule assembly. At higher concentrations podofilox also inhibits nucleoside transport through the cell membrane. The chemotherapeutic action of podofilox is assumed to be due to inhibition of growth and the ability to invade the tissue of the virus-infected cells. Podofilox prevents cell division in the virus-infected cells of the condylomata acuminata.
Indications And Clinical Uses: For the topical treatment of external genital warts (condylomata acuminata) confined to the penile and vulvar regions.
Contra-Indications: Patients who develop hypersensitivity to podofilox or to any component in the formulation. Open wounds following surgical procedures should not be treated with podofilox.
Manufacturers’ Warnings In Clinical States: For topical use only.
Podofilox is a potent vesicant and is to be used only as directed by a physician. Extreme care should be taken to avoid contact with eyes, tongue or mucosal tissue of the vagina or cervix. If accidental contact with the eyes occurs, bathe eyes immediately and thoroughly with large amounts of water and contact a physician immediately.
Precautions: Diagnosis: Although condylomata (genital warts) have a characteristic appearance, histopathological confirmatory tests should be obtained if there is any question of the diagnosis. Differential diagnosis from squamous cell carcinoma (so-called “Bowenoid papulosis”) is of particular concern. Squamous cell carcinoma may also be associated with human papillomaviruses but should not be treated with podo-filox.
General: The recommended method of application, frequency of application and duration of treatment should not be exceeded (see Dosage). If the solution is accidentally spilled on healthy skin, wipe off at once, wash vigorously with soap and water and rinse well. The solution should not be applied to any open cuts or abrasions. Self-treatment of genital warts with surface areas greater then 10 cmshould not be permitted.
Genital warts may be contagious, and the patient should be instructed to abstain from sexual intercourse. If this is not possible, a latex condom must be used until the infected partner is declared cured by the physician.
Children: There is no clinical experience; therefore, use in children cannot presently be recommended.
Pregnancy and Lactation: Not recommended for use in pregnant or lactating women.
Patients with Special Diseases and Conditions: Do not use if growth of surrounding tissue is inflamed or irritated. Do not use on moles, birth marks or unusual warts with hair growing from them.
Podofilox should not be used on tissues which were recently exposed to laser surgery or cryosurgery.
Drug Interactions: No interaction with other medications is known.
Adverse Reactions: Local irritations might occur on the second or third day of application associated with the start of wart necrosis. In the majority of cases the reactions are mild and they will disappear in a few days.
In clinical trials with podofilox 0.5% solution, the following have been shown to be the most common local adverse events which were reported at some time during treatment: erythema 32%, burning 30%, erosion 20%, tenderness 30%, itching 15%, pruritus 11%, and other 3% including pain and balanoposthitis.
If severe cases of local irritations occur, this can be treated with local anti-inflammatory drugs. To alleviate acute pain, analgesics may be used.
Symptoms And Treatment Of Overdose: Symptoms and Treatment: Topical: In the event of accidental spillage on healthy skin, burning or extreme tenderness of treated areas, wash the area copiously with soap and cold water and rinse with water as required. If required, an analgesic, ASA or acetaminophen, may be administered for pain management. Local discomfort may be alleviated by the use of topical anti-inflammatory therapy (e.g., hydrocortisone acetate).
Systemic: An excessive oral ingestion of podofilox (>0.5 mg/kg, 2 bottles) may cause systemic toxicity. Initial symptoms are general malaise, weakness, drowsiness and dizziness. Later symptoms may be coma with risk of respiratory failure, ileus and vascular crisis.
In the event of accidental ingestion, gastric lavage or induction of emesis should be instituted. Treatment of overdosage is symptomatic and in severe oral overdose ensure the airway is clear, provide fluids, correct electrolyte balance, monitor blood gases and liver function. Blood count should be monitored for at least 5 days.
Symptomatic treatment and hemoperfusion through coal filter may prevent a fatal outcome.
Dosage And Administration: Apply twice daily, morning and evening, for 3 consecutive days followed by 4 days without treatment.
Preferably the physician should perform the first application for the patient as an office procedure.
The affected area should be thoroughly washed with soap and water, and dried prior to application.
Using the applicator provided, the warts should be painted with the solution. The treated area should be allowed to dry. If an area in the occluded prepuce (under the foreskin) is being treated, care should be taken to allow the solution to dry before letting the foreskin return to its normal position. If residual warts persist, further treatment may be repeated after an interval of 7 days. The treatment may be repeated 3 times. If there is incomplete response after 4 treatment cycles, alternative treatment should be considered.
The majority of patients will not require in excess of 30 loops for each application; however, a maximum of 50 loops per application (equivalent to 250 L of solution) may be applied. Treatment should be limited to less than 10 cmof wart tissue and to no more than 500 g (0.5 mL) of solution per day.
Availability And Storage: Each mL of solution for topical application contains: podofilox 0.5%. Nonmedicinal ingredients: ethanol 70% and phosphoric acid. Screw-capped amber glass bottles of 3 mL. Each pack contains a bottle of 3 mL and a tube of double-ended applicators. The applicators include a loop end for the treatment of separate warts and a spatula end for the treatment of large or fused warts. Store at controlled room temperature in light-resistant and tightly closed containers.
WARTEC® Pharmascience Podofilox Antimitotic Agent
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