(poe DOF il oks)
Treatment of external genital warts (solution and gel) and perianal warts (gel only)
Hypersensitivity or intolerance to any component of the formulation
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.
Refer to adult dosing.
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.
Store at 20 ‚ °C to 25 ‚ °C (68 ‚ °F to 77 ‚ °F); do not freeze. Flammable; avoid excessive heat and flame.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Gel, External:
Condylox: 0.5% (3.5 g)
Solution, External:
Condylox: 0.5% (3.5 mL) [contains alcohol, usp]
Generic: 0.5% (3.5 mL)
There are no known significant interactions.
Treated areas for adequate healing; tolerability of treatment
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% (Limited to important or life-threatening): 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% (Limited to important or life-threatening): Dermal ulcer, hematuria, insomnia, local hemorrhage, localized edema, localized vesiculation, pain, skin tenderness, tingling of skin, xeroderma
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.
C
Teratogenic events have not been observed in animal reproduction studies with topical administration. Podofilox should not be used during pregnancy (CDC [Workowski 2015])
Exact mechanism of action is unknown; causes necrosis of visible wart tissue
No detectable serum levels
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience burning, itching, or short-term pain. Have patient report immediately to prescriber severe skin irritation, severe pain, edema, or bleeding (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.