| PODOFILM® |
|Podophyllum Resin |
|Wart Remover |
|Indications And Clinical Uses: For the removal of benign epithelial growths such as venereal warts (condylomata acuminata), common warts (verruca vulgaris), and benign papillomas such as granuloma inguinale and plantar warts.
Contra-Indications: Hypersensitivity to podophyllin. The consumption of alcoholic beverages for several hours after treatment, is to be avoided.
Precautions: Podophyllin is an extremely potent vesicant and is to be applied only by the doctor. It is recommended that care be used in the selection of patients to be treated with the product and method used, the doctor developing his own experience and technique. To avoid toxicity, it is recommended that applications be limited to small areas of intact skin. Do not use on tongue or any mucosal tissue. Do not use if growth or surrounding tissue is inflamed or irritated. Do not use on diabetics or people with poor blood circulation, nor on moles, birth-marks, or unusual warts with hair growing from them. Do not use in circumstances where the genital warts are either florid with a large surface area or so hemorrhagic that absorption of the toxin is probable. If vaginal condylomata are very extensive it is probably best to treat them on just one half of the vagina at a time to prevent severe inflammation and interference with micturition. Large areas should not be treated all at once since discomfort may be excessive and systemic absorption may result.
Pregnancy and Lactation: Use during pregnancy and or in nursing mothers is not recommended since there have been no adequate and well-controlled studies in the use of podophyllin in pregnant women or nursing mothers. It is recommended that the patient be advised of the effect and the possible results of treatment.
Adverse Reactions: Systemic effects from topical use of podophyllum resin includes urticaria, transient fever, paresthesia, polyneuritis, paralytic ileus, pyrexia leukopenia, thrombocytopenia, coma, and death. Local effects include severe necrosis and scarring of the anogenital area, paraphimosis requiring circumcision and pseudoepitheliomatous hyperplasia.
Note: Podophyllin is a strong vesicant and may produce blisters if it comes in contact with normal skin or mucous membrane. If spilled on skin, wipe off at once, using acetone, alcohol or tape remover. Then wash vigorously with warm soapy water and rinse well. If spilled on mucous membrane or eyes, flush with water, remove the precipitated film, and flush with water for an additional 15 minutes. Patients vary in their sensitivity to podophyllin and in rare cases tingling, burning or extreme tenderness may develop. In these cases, patient should remove tape and soak the area in cool water for 10 to 15 minutes, repeating as required for relief. If soreness persists, puncture blister using sterile technique, apply antiseptic and cover with a Band-Aid. It is advisable to treat only 1 or 2 lesions on the first visit, until the sensitivity of the patient is known. For external use only.
Dosage And Administration: Care must be exercised when applying the drug so that the adjacent area is not affected. Normal skin adjacent to the lesion should be protected with petrolatum. Apply no more than 1 to 2 mL of podophyllin during 1 treatment.
Moist anogenital warts (condylomata acuminata): Treatment should be an office procedure and should be carried out by the physician. Using a cotton applicator or toothpick, apply the drug carefully to the lesion. Allow to dry before adding the next application. It should be allowed to dry before the patient leaves the office.
The initial application should be allowed to remain in place for 1 hour then washed off. If the initial application is not unusually inflammatory or painful, the product may be subsequently left on for 4 to 6 hours before being washed off. The medication should then be carefully removed with soap and water. Reapplication can be carried out at weekly intervals, if necessary.
It has been reported that use of podophyllum for cervical warts can lead to a false-positive PAP smear for as long as 6 months after the application of the podophyllum resin. Common warts: Method A (no curettage): No cutting or prior treatment is required. Occasionally nails must be trimmed to expose subungual warts to medication. Using a Q-Tip or applicator stick, apply podophyllin (1 layer only) to the wart and a 1 to 3 mm margin around the wart. Allow to dry for a few minutes. Cover with a piece of nonporous plastic adhesive tape. Instruct patient to keep the tape on for at least 4 hours (up to 24 hours). Within 24 hours a blister forms which is often painful and inflamed. Have the patient return for observation in 1 to 2 weeks. Remove necrotic tissue and treat as before if any viable wart tissue remains. Allow tissue to re-epithelialize before retreatment.
Method B (with curettage) Proceed as in Method A except have patient return in 1 day for curettage. (Local anesthesia may be necessary). There are several advantages to this method: Treatment with podophyllin prior to curettage enhances identification of tissue planes, increases separability of wart tissue and retreatment is rarely necessary. Have the patient return for observation in 4 weeks. (The lesion normally heals completely within 1 to 3 weeks.) The use of a mild antibacterial agent until area heals is recommended.
Plantar warts: Pare away keratin covering the wart, avoid bleeding, avoid cutting viable tissue. Using a Q-Tip or applicator stick, apply podophyllin to both the wart and a 1 to 3 mm margin around the wart. Allow a few minutes to dry. Secure with nonporous plastic adhesive tape. Leave in place for 48 hours, then debride. If any viable wart tissue remains after debridement, reapply a small amount of podophyllin and bandage as above. Repeat treatments over several weeks are often necessary. When destruction of wart is complete, the healed site will appear smooth, with normal skin lines.
Pain Management: Warn the patient that the blister may be painful. Prescribe a mild analgesic, e.g. ASA with codeine, or acetaminophen with codeine. The tape may be removed and the area soaked in cool water for 10 to 15 minute periods, as needed, provided sufficient time has been allowed for the medication to penetrate. Local anesthesia may be needed during curettage (Method B).
Molluscum contagiosum: Coat each lesion with a thin film of podophyllin. After 1 week, treat any new lesions the same way and retreat any resistant lesions with podophyllum, this time covering with a small piece of occlusive tape. The tape should be removed in 6 to 8 hours.
Availability And Storage: Each bottle contains: podophyllum resin 25% in an adherent film forming vehicle (tincture of benzoin compound). Bottles of 25 mL. Keep away from heat, fire and flame. Close tightly immediately after use. Store at room temperature.