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Podofilox

Medically reviewed by Drugs.com. Last updated on Jun 29, 2020.

Pronunciation

(poe DOF il oks)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Gel, External:

Condylox: 0.5% (3.5 g)

Solution, External:

Condylox: 0.5% (3.5 mL [DSC]) [contains alcohol, usp]

Generic: 0.5% (3.5 mL)

Brand Names: U.S.

  • Condylox

Pharmacologic Category

  • Keratolytic Agent
  • Topical Skin Product

Pharmacology

Exact mechanism of action is unknown; causes necrosis of visible wart tissue

Absorption

No detectable serum levels

Use: Labeled Indications

Genital warts: Treatment of external genital warts

Perianal warts: Treatment of perianal warts (gel only)

Off Label Uses

Molluscum contagiosum

Data from a randomized, multicenter, double-blind, placebo-controlled study support the use of podofilox in the treatment of molluscum contagiosum [Syed 1994].

Contraindications

Hypersensitivity or intolerance to any component of the formulation

Dosing: Adult

Genital warts: Topical: Solution: Apply twice daily (morning and evening) for 3 consecutive days, then withhold use for 4 consecutive days; this cycle may be repeated up to 4 times until there is no visible wart tissue; maximum dose: 0.5 mL daily (or ≤10 cm2 of wart tissue). Note: Discontinue after 4 treatment cycles if incomplete response and consider alternative treatment; do not repeat use.

Genital and perianal warts: Topical: Gel: Apply twice daily (morning and evening) for 3 consecutive days, then withhold use for 4 consecutive days; this cycle may be repeated up to 4 times until there is no visible wart tissue; maximum dose: 0.5 g daily (or ≤10 cm2 of wart tissue). Note: Discontinue after 4 treatment cycles if incomplete response and consider alternative treatment; do not repeat use.

Molluscum contagiosum (off-label use): Topical: Gel or solution: Apply twice daily (morning and evening) for 3 consecutive days, then withhold use for 4 consecutive days; this cycle may be repeated up to 4 times until lesion resolution (Syed 1994)

Dosing: Geriatric

Refer to adult dosing.

Administration

For external use only. Do not apply to mucous membrane warts. Wash hands before and after application. Apply to warts using either the applicator supplied with the drug (gel, solution) or with finger (gel only) while minimizing exposure to surrounding normal tissue. Dispose applicator tip carefully after use. Allow the gel or solution to dry before allowing return of opposing skin surfaces to their normal positions; wash hands after application.

Storage

Store at 20°C to 25°C (68°F to 77°F); do not freeze. Flammable; avoid excessive heat and flame.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

Gel, topical:

>10%:

Central nervous system: Localized burning (12% to 37%), local pain (12% to 24%)

Dermatologic: Skin erosion (9% to 27%)

Hematologic & oncologic: Local hemorrhage (<1% to 19%)

Local: Local inflammation (9% to 32%), local pruritus (8% to 32%)

1% to 10%:

Central nervous system: Headache (7%)

Dermatologic: Stinging of the skin (7%), erythema (5%)

<1%, postmarketing, and/or case reports: Crusted skin, dermal ulcer, desquamation, edema, skin blister, skin discoloration, skin fissure, skin rash, skin tenderness, tingling of skin, xeroderma

Solution, topical:

>10%:

Central nervous system: Localized burning (female 78%; male 64%), local pain (female 72%; male 50%)

Dermatologic: Skin erosion (67%)

Local: Local inflammation (male 71%; female 63%), local pruritus (female 65%; male 50%)

<1%, postmarketing, and/or case reports: Body odor, dermal ulcer, dizziness, hematuria, insomnia, local hemorrhage, localized edema, localized vesiculation, pain, skin tenderness, tingling of skin, vomiting, xeroderma

Warnings/Precautions

Concerns related to adverse effects:

• Skin reactions: Most skin reactions are mild to moderate and did not increase during the treatment period, however severe skin reactions can occur. Severe reactions are most frequent within the first two weeks of treatment.

Dosage form specific issues:

• Topical gel and solution: Flammable; keep away from fire or flame.

Other warnings/precautions:

• Appropriate use: For cutaneous use only; avoid contact with eyes. If product comes in contact with the eyes, flush with water and seek medical attention. Not intended for treatment of mucous membrane warts.

Monitoring Parameters

Treated areas for adequate healing; tolerability of treatment

Pregnancy Considerations

Podofilox should not be used during pregnancy (CDC [Workowski 2015]).

Patient Education

What is this drug used for?

• It is used to treat genital warts.

• It is used to treat perianal warts.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache

• Burning

• Stinging

• Itching

• Short-term pain

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Severe or persistent skin irritation or pain

• Application site swelling or bleeding

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.