Condylox

Topical Antivirals

For storage information, see the specific product information within the How supplied section.

•Podofilox is for external topical use to the affected skin only; do not ingest and do not get in the eyes.

•Topical gel: Apply gel using the applicator supplied or by fingertip. May be used in the genital or perianal area.
•Topical solution: Apply solution using the applicator supplied or a cotton-tipped applicator. Touch the drug-dampened applicator to the wart to be treated, applying the minimum amount of solution necessary to cover the lesion. Allow the solution to dry before allowing the return of opposing skin surfaces to their normal positions. After each treatment, dispose of the used applicator and wash hands. Podofilox solution is not suitable for use in the perianal area.

phimosis / Delayed / 0-5.0

skin erosion / Delayed / 0-67.0
bleeding / Early / 0-19.0
hematuria / Delayed / 0-5.0
dyspareunia / Delayed / 0-5.0
edema / Delayed / 0-5.0
skin ulcer / Delayed / 0-5.0
erythema / Early / 5.0-5.0

pruritus / Rapid / 0-65.0
headache / Early / 7.0-7.0
skin discoloration / Delayed / 0-5.0
xerosis / Delayed / 0-5.0
rash / Early / 0-5.0
nausea / Early / 0-5.0
vomiting / Early / 0-5.0
dizziness / Early / 0-5.0
insomnia / Early / 0-5.0
skin irritation / Early / Incidence not known

Condylox

Rx

Topical mitotic agent used to treat external genital and perianal warts (i.e., condylomata acuminata) caused by human papillomavirus (HPV); does not eradicate HPV; included by the CDC as a first-line therapy for external genital warts; self-administered by patient.

Apply topically to wart(s) twice daily for 3 consecutive days, followed by 4 days of no therapy. May repeat this 1-week cycle until there is no visible wart tissue or for a maximum of 4 cycles. Max: 0.5 mL/day. Limit treatment area to 10 cm2 or less of wart tissue. If there is incomplete response after 4 treatment cycles, discontinue treatment and consider alternative treatment.

Apply topically to wart(s) twice daily for 3 consecutive days, followed by 4 days of no therapy. May repeat this 1-week cycle until there is no visible wart tissue or for a maximum of 4 cycles. Max: 0.5 mL/day. Limit treatment area to 10 cm2 or less of wart tissue. If there is incomplete response after 4 treatment cycles, discontinue treatment and consider alternative treatment.

Apply topically to wart(s) twice daily for 3 consecutive days, followed by 4 days of no therapy. May repeat this 1-week cycle until there is no visible wart tissue or for a maximum of 4 cycles. Max: 0.5 g gel/day. Limit treatment area to 10 cm2 or less of wart tissue. If there is incomplete response after 4 treatment cycles, discontinue treatment and consider alternative treatment.

Apply topically to wart(s) twice daily for 3 consecutive days, followed by 4 days of no therapy. May repeat this 1-week cycle until there is no visible wart tissue or for a maximum of 4 cycles. Max: 0.5 g gel/day. Limit treatment area to 10 cm2 or less of wart tissue. If there is incomplete response after 4 treatment cycles, discontinue treatment and consider alternative treatment.

Apply topically to molluscum lesions twice daily for 3 consecutive days, then discontinue for 4 consecutive days; repeat this 1-week cycle as necessary until clearance for up to 4 weeks.

Apply topically to molluscum lesions twice daily for 3 consecutive days, then discontinue for 4 consecutive days; repeat this 1-week cycle as necessary until clearance for up to 4 weeks.

†Indicates off-label use

No dosage adjustment is needed.

No dosage adjustment is needed.

Imiquimod: (Minor) While no drug interactions have been reported with imiquimod, there is no clinical experience with imiquimod cream therapy immediately following the treatment of genital/perianal warts with other cutaneously applied drugs, such as podofilox. Therefore, imiquimod cream administration is not recommended until skin is healed from any previous topical drug treatments or surgery.
Podophyllum: (Minor) No drug interactions of clinical significance have been noted for podofilox. While no drug interactions have been reported, there is no clinical experience with podofilox immediately following the treatment of genital/perianal warts with other cutaneously applied drugs like podophyllum resin. Therefore, podofilox administration is not recommended until genital and/or perianal tissue is healed from any previous topical drug treatment or surgery.

Condylox/Podofilox Topical Gel: 0.5%
Condylox/Podofilox Topical Sol: 0.5%

0.5 g/day for topical gel or 0.5 ml/day for topical solution; limit treatment area to <= 10 cm2 of wart tissue (gel or solution).

0.5 g/day for topical gel or 0.5 ml/day for topical solution; limit treatment area to <= 10 cm2 of wart tissue (gel or solution).

Safety and efficacy have not been established; 0.5 g/day for topical gel or 0.5 ml/day for topical solution has been used off-label.

Safety and efficacy have not been established; 0.5 g/day for topical gel or 0.5 ml/day for topical solution has been used off-label.

Mechanism of Action: The exact mechanism of action of podofilox in treating condylomata acuminata is not known, but it causes visible necrosis of the wart tissue. Podofilox potently inhibits cell mitosis. It acts by binding to tubulin to prevent the formation of microtubules, which results in mitotic arrest. It exerts a variety of biological effects including attenuation of nucleoside transport damage to the endothelium of small blood vessels, reduction of the lymphocyte response to mitogens, induction of interleukin-1 and interleukin-2, enhancement of macrophage growth, stifling of immune responses, and inhibition of macrophage metabolism.

Podofilox is for external topical use only.  The elimination half-life of podofilox ranges from 1.0 to 4.5 hours. Podofilox does not accumulate after multiple treatments.

When applied topically at a dosage of 0.1—1.5 ml of the 0.5% solution, peak serum concentrations of 1—17 ng/ml occur within 1—2 hours after application. Topical application of 0.5 ml of the 0.5% solution to the external genitalia does not result in detectable podofilox serum concentrations.

Guidelines recommend against use of podofilox during pregnancy. The manufacturer recommends use only if the potential benefits justify the potential risks to the fetus. No adequate and well-controlled studies have been conducted in pregnant women. In animal studies, use of systemic podofilox was found to be embryotoxic in rats at doses 19-times the maximum recommended human dose (RHD); however, the drugs was not teratogenic when given topically to pregnant rabbits at doses 2-times the RHD for 13 days. Because genital warts can proliferate and become friable during pregnancy, consideration can be given to their removal during pregnancy. HPV types 6 and 11 can cause respiratory papillomatosis in infants and children. The route of transmission (i.e., transplacental, perinatal, or postnatal) is not completely understood. In rats, podofilox did not appear to impair fertility when administered topically at doses corresponding to the recommended human daily dose.

According to the manufacturer, a decision should be made whether to discontinue podofilox or to discontinue nursing, taking into account the importance of the drug to the mother. It is not known if podofilox is distributed into the human milk. However, in pharmacokinetic studies, topical application of podofilox to external genitalia did not result in detectable serum levels and the drug did not accumulate after multiple treatments. Therefore, it is unlikely that a clinically significant amount of drug would be present in breast-milk. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.