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Podofilox
Overview
What is Podofilox?
Podofilox is an antimitotic drug which can be chemically synthesized or purified from the plant families
and
(e.g. species of and ). 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:
What does Podofilox look like?
What are the available doses of Podofilox?
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What should I talk to my health care provider before I take Podofilox?
Sorry No records found
How should I use Podofilox?
Podofilox 0.5% solution is indicated for the topical treatment of external genital warts (Condyloma acuminatum). This product is indicated in the treatment of perianal or mucous membrane warts (see ).
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 1 week cycle of treatment may be repeated up to four times until there is no visible wart tissue.
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.
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.
What interacts with Podofilox?
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What are the warnings of Podofilox?
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What are the precautions of Podofilox?
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What are the side effects of Podofilox?
Sorry No records found
What should I look out for while using Podofilox?
Podofilox 0.5% solution is contraindicated for patients who develop hypersensitivity or intolerance to any component of the formulation.
Correct diagnosis of the lesions to be treated is essential. See the “” subsection of the statement.
Podofilox 0.5% solution is intended for cutaneous use only.
What might happen if I take too much Podofilox?
Topically applied podofilox may be absorbed systemically (see section). Toxicity reported following systemic administration of podofilox in investigational use for cancer treatment included: nausea, vomiting, fever, diarrhea, bone marrow depression, and oral ulcers. Following 5 to 10 daily intravenous doses of 0.5 to 1 mg/kg/day, significant hematological toxicity occurred but was reversible. Other toxicities occurred at lower doses. Toxicity reported following systemic administration of podophyllum resin included: nausea, vomiting, fever, diarrhea, peripheral neuropathy, altered mental status, lethargy, coma, tachypnea, respiratory failure, leukocytosis, pancytosis, hematuria, renal failure, and seizures. Treatment of topical overdosage should include washing the skin free of any remaining drug and symptomatic and supportive therapy.
How should I store and handle Podofilox?
StorageStore in a well-closed container at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature].StorageStore in a well-closed container at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [see USP Controlled Room Temperature].3.5 mL of podofilox 0.5% solution is supplied as a clear liquid in amber glass bottles with child-resistant screw caps. Store at 20-25°C (68-77°F). [See USP controlled room temperature.] Keep out of reach of children.3.5 mL of podofilox 0.5% solution is supplied as a clear liquid in amber glass bottles with child-resistant screw caps. Store at 20-25°C (68-77°F). [See USP controlled room temperature.] Keep out of reach of children.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Treatment of genital warts with podofilox results in necrosis of visible wart tissue. The exact mechanism of action is unknown.
Non-Clinical Toxicology
Podofilox 0.5% solution is contraindicated for patients who develop hypersensitivity or intolerance to any component of the formulation.Correct diagnosis of the lesions to be treated is essential. See the “” subsection of the statement.
Podofilox 0.5% solution is intended for cutaneous use only.
Thiazides may add to or potentiate the action of other antihypertensive drugs.
The thiazides may decrease arterial responsiveness to norepinephrine. This diminution is not sufficient to preclude effectiveness of the pressor agent for therapeutic use. Thiazides have also been shown to increase the responsiveness to tubocurarine.
Lithium generally should not be given with diuretics because they reduce its renal clearance and add a high risk of lithium toxicity. Refer to the package insert on lithium before use of such concomitant therapy.
Acute renal failure has been reported in a few patients receiving indomethacin and formulations containing triamterene and hydrochlorothiazide. Caution is therefore advised when administering non-steroidal anti-inflammatory agents with triamterene and hydrochlorothiazide.
Potassium-sparing agents should be used very cautiously, if at all, in conjunction with angiotensin-converting enzyme (ACE) inhibitors due to a greatly increased risk of hyperkalemia. Serum potassium should be monitored frequently.
Data are not available on the safe and effective use of this product for treatment of warts occurring in the perianal area or on mucous membranes of the genital area (including the urethra, rectum and vagina). The recommended method of application, frequency of application, and duration of usage should not be exceeded (see ).
In clinical trials, the following local adverse reactions were reported at some point during treatment.
Reports of burning and pain were more frequent and of greater severity in women than in men.
Adverse effects reported in less than 5% of the patients included pain with intercourse, insomnia, tingling, bleeding, tenderness, chafing, malodor, dizziness, scarring, vesicle formation, crusting edema, dryness/peeling, foreskin irretraction, hematuria, vomiting and ulceration.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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