Podofilox Solution
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Questions & Answers
Side Effects & Adverse Reactions
Correct diagnosis of the lesions to be treated is essential. See the “Diagnosis” subsection of the INDICATIONS AND USAGE statement.
Podofilox 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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Podofilox 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 (see PRECAUTIONS).
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 0.5% Solution.
History
There is currently no drug history available for this drug.
Other Information
Podofilox is an antimitotic drug which can be chemically synthesized or purified from the plant families Coniferae and Berberidaceae (e.g. species of Juniperus and Podophyllum). Podofilox 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.
Podofilox has a molecular weight of 414.4 daltons, and is soluble in alcohol and sparingly soluble in water. Its chemical name is 5,8,8a,9-Tetrahydro-9-hydroxy-5-(3,4,5-trimethoxyphenyl)furo[3',4':6,7] naphtho[2,3,d]-1, 3-dioxol-6(5aH)-one. Podofilox has the following structural formula:
Sources
Podofilox Solution Manufacturers
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Physicians Total Care, Inc.
![Podofilox Solution [Physicians Total Care, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Podofilox Solution | Physicians Total Care, Inc.
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 0.5% Solution is applied to the warts with a cotton-tipped 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.
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Metacon Labs
Podofilox Solution | Metacon Labs
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 Topical Solution 0.5% is applied to the warts with the applicator supplied with the drug (see HOW SUPPLIED). 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.
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Watson Laboratories, Inc.
Podofilox Solution | Midway Advanced Products, Llc
tear open packet and apply entire amount of gel to unsoiled hands. rub in thoroughly until hands are dry. do not wipe or use water rinse.
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Paddock Laboratories, Llc
Podofilox Solution | Paddock Laboratories, Llc
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 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.
![Podofilox Solution [Metacon Labs]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=aa85b56c-da8c-47db-bda4-db4d05788721&name=podofilox-figure-2-podofilox-figure-2-pkg_podofilox_label_(2).jpg)
![Podofilox Solution [Watson Laboratories, Inc.]](https://www.recallguide.org/wp-content/themes/bootstrap/assets/img/drug-image-placeholder.jpg)
![Podofilox Solution [Paddock Laboratories, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6af07697-5203-43e0-ba35-83683af851c3&name=0374a375-639c-439d-914c-538b1e790c07-02.jpg)
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