Podofilox

Podofilox
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Deepika Beereddy, MBBS [2]

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Overview

Podofilox is an antimitotic agent that is FDA approved for the treatment of treatment of anogenital warts. Common adverse reactions include pruritus, superficial ulcer of skin, pain, burning sensation, Inflammatory disorder.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Anogenital warts

• Condylox Gel 0.5% is indicated for the topical treatment of anogenital warts (external genital warts and perianal warts). This product is not indicated in the treatment of mucous membrane warts.

• Dosing information:

• Condyloma acuminatum, External: apply 0.5% solution or gel TOPICALLY every 12 hours in the morning and evening for 3 days, then withhold for 4 days; repeat cycle up to 4 times.
• Condyloma acuminatum, perianal: apply 0.5% gel TOPICALLY for 3 days, then withhold for 4 days, repeat cycle up to 4 times

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Podofilox in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Podofilox in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Podofilox FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Podofilox in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Podofilox in pediatric patients.

Contraindications

• Condylox Gel 0.5% is contraindicated for patients who develop hypersensitivity or intolerance to any components of the formulation.

Warnings

• Correct diagnosis of the lesions to be treated is essential. See the Diagnosis subsection of the INDICATIONS AND USAGE section. Condylox Gel 0.5% is intended for cutaneous use only. Avoid contact with the eyes. If contact with the eyes occurs, patients should immediately flush the eyes with copious quantities of water and seek medical advice.

• Drug Product is Flammable.

• Keep Away From Open Flame.

PRECAUTIONS

General

• Data are not available on the safe and effective use of this product for treatment of warts occurring 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.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Podofilox Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Podofilox Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Podofilox Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Podofilox in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Podofilox in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Podofilox during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Podofilox in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Podofilox in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Podofilox in geriatric settings.

Gender

There is no FDA guidance on the use of Podofilox with respect to specific gender populations.

Race

There is no FDA guidance on the use of Podofilox with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Podofilox in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Podofilox in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Podofilox in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Podofilox in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Podofilox Administration in the drug label.

Monitoring

There is limited information regarding Podofilox Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Podofilox and IV administrations.

Overdosage

There is limited information regarding Podofilox overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Podofilox Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Podofilox Mechanism of Action in the drug label.

Structure

There is limited information regarding Podofilox Structure in the drug label.

Pharmacodynamics

There is limited information regarding Podofilox Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Podofilox Pharmacokinetics in the drug label.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis and Impairment of Fertility

• An 80-week carcinogenicity study in the mouse was performed using a 0.5% podofilox solution applied dermally at 0.04, 0.2 and 1.0 mg/kg/day. There were no differences between the podofilox treated mice at any dose level and vehicle control in the incidence of neoplasia. Published animal studies, in general, have not shown the drug substance, podofilox, to be carcinogenic.2,3,4,5,6 There are published reports that, in mouse studies, crude podophyllin resin (containing podofilox) applied topically to the cervix produced changes resembling carcinoma in situ.7 These changes were reversible at five weeks after cessation of treatment. In one reported experiment, epidermal carcinoma of the vagina and cervix was found in 1 out of 18 mice after 120 applications of podophyllin8 (the drug was applied twice weekly over a 15-month period).

• Podofilox was not mutagenic in the Ames plate reverse mutation assay at concentrations up to 5 mg/plate, with and without metabolic activation. No cell transformation related to potential oncogenicity was observed in BALB/3T3 cells after exposure to podofilox at concentrations up to 0.008 μg/mL, without metabolic activation and 12 μg/mL podofilox with metabolic activation. Results from the mouse micronucleus in vivo assay using podofilox 0.5% solution at doses up to 25 mg/kg (75 mg/m2), indicate that podofilox should be considered a potential clastogen (a chemical that induces disruption and breakage of chromosomes).

• Daily topical application of 0.5% podofilox solution at doses up to the equivalent of 0.2 mg/kg (1.18 mg/m2, approximately equivalent to the human daily dose) to rats throughout gametogenesis, mating, gestation, parturition and lactation for two generations demonstrated no impairment of fertility.

Clinical Studies

There is limited information regarding Podofilox Clinical Studies in the drug label.

How Supplied

There is limited information regarding Podofilox How Supplied in the drug label.

Storage

There is limited information regarding Podofilox Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Podofilox Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Podofilox interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Podofilox Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Podofilox Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.