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Podofilox Topical Solution

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Podofilox Topical Solution

INDICATIONS

Podofilox (podofilox) Topical Solution 0.5% 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 (see PRECAUTIONS).

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 Podofilox (podofilox) Topical Solution 0.5%.

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 twice 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.

Podofilox (podofilox) Topical Solution 0.5% is applied to the warts with an 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 cm2 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.

HOW SUPPLIED

3.5 mL Podofilox (podofilox) Topical Solution 0.5% is supplied as a clear liquid in amber glass bottles with child-resistant screw caps. NDC 0574-0611-05. Store at controlled room temperature between 15° and 30°C (59° and 86°F). Avoid excessive heat. Do not freeze.

REFERENCES
1. Berenblum,1951.J.Natl.Cancer Inst.11:839-841
2. H.A.Kaminetsky and M.Swerdlow,1965.Am.J.Obst.Gyn.93 :486-490
3. E.A.McGrew and H.A.Kaminetsky,1961.Am.J.Clin.Pathol.35:538-545
4. F.J.C.Roe and M.H.Salaman,1955.Brit.J.Cancer.9:177-203
5. H.S.Taper,1977.Z.Krebsforsch.90:197-210
6. H.A.Kaminetsky E.A.McGrew,and R.L.Phillips,1959.Am.J.Obst.Gyn.
14:1-3
7. H.A.Kaminetsky and E.A.McGrew,1963.Arch.Path.73:481-485
8. K.Didcock,D.Jackson,and J.M.Robson,1956.Brit.J.Pharmacol.
11:437-441
9. J.Thiersch,1963.Soc.Exptl.Biol.Med.Proc.113:124-127

Paddock Laboratories,Inc.
Minneapolis,MN 55427                                                                 124159 (04-01)
www.paddocklabs.com                                                                  0611-01-0101

Last reviewed on RxList: 6/14/2005
This monograph has been modified to include the generic and brand name in many instances.

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