Podocon-25

Topical Antivirals

Topical Liquid 
Podophyllum is to be applied only by a physician.
Avoid contact with the eyes.
Do not use if wart or surrounding tissue is inflamed or irritated.
Do not use on bleeding warts, moles, birthmarks, or unusual warts with hair growing from them.
Thoroughly cleanse the affected area prior to use.
Shake well and use the supplied applicator to apply sparingly to the lesion.
Allow to thoroughly dry.
Avoid contact with healthy tissue.
The first application should only be left on the lesion for 30—40 minutes to determine the patient's sensitivity. Thereafter, lesional contact should be kept to the minimum time necessary to produce the desired result (1—4 hours depending on the condition of the lesion and the patient).
Large areas and numerous warts should not be treated at one time.
After the treatment, thoroughly remove the podophyllum with alcohol or soap and water.

ileus / Delayed / Incidence not known
coma / Early / Incidence not known

neuritis / Delayed / Incidence not known
thrombocytopenia / Delayed / Incidence not known
leukopenia / Delayed / Incidence not known

paresthesias / Delayed / Incidence not known
fever / Early / Incidence not known

Podocon-25

Rx

Topical cytotoxic agent that arrests mitosis in the metaphase
For the treatment of genital warts (condylomata acuminata)
Systemic toxicity possible with topical use; use sparingly

To be applied only by a physician to intact lesions. Initially, podophyllum should be left in contact for no more than 30 to 40 minutes to determine patient sensitivity. Thereafter, lesional contact should be kept to the minimum time to produce the desired result (1 to 4 hours). Large areas and numerous warts should not be treated at 1 time. Remove the dried resin with alcohol or soap and water. Podophyllin resin is not recommended by guidelines because of the number of safer regimens available and the severe systemic toxicity associated with podophyllin resin when applied to large areas of friable tissue and not washed off within 4 hours. If use is necessary, guidelines recommend that the application be limited to intact lesions (i.e., free of wounds or friable tissue) with an area of less than 10 cm2 of warts per session. Treatment must be restricted to less than 0.5 mL and washed off within 1 to 4 hours; application may be repeated once weekly if needed.

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are 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 podophyllum resin. Therefore, imiquimod cream administration is not recommended until skin is healed from any previous topical drug treatments or surgery.
Podofilox: (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.

Podocon-25/Podophyllum Resin Topical Sol: 25%

The FDA-approved labeling does not specify a maximum dose; however, the CDC recommends the application should be limited to less than 0.5 mL of podophyllum or an area less than 10 cm2 of warts per session.

The FDA-approved labeling does not specify a maximum dose; however, the CDC recommends the application should be limited to less than 0.5 mL of podophyllum or an area less than 10 cm2 of warts per session.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Podophyllum is a powdered mixture of resins and is a cytotoxic agent that arrests mitosis in the metaphase by interacting with microtubule proteins. The active agent is podophyllotoxin, which varies in concentration depending on what type of podophyllum is used. Topically, podophyllum has caustic and escharotic properties. Neurotoxicity may be due to direct nonspecific effects on the neurons and glial cells; however, podophyllum may impair axoplasmic flow via its effects on the microtubules in a similar manner to the vinca alkaloids.

Podophyllum is administered topically. Pharmacokinetic data have not been clearly defined. Podophyllotoxin, the active compound, is water-soluble and may have a small volume of distribution. Metabolism of podophyllotoxin may occur rapidly; however, metabolites and half-life have not been determined. In a study of 69 patients who received podophyllum, in an ethanolic preparation, topically once or twice daily for 3 days, the serum half-life of podophyllotoxin ranged from 1—4.5 hours.

Podophyllum absorption has not been fully defined; however, systemic adverse events have been identified with topical use. In a study of 69 patients who received podophyllum, in an ethanolic preparation, topically once or twice daily for 3 days, serum concentrations obtained 1—2 hours after application ranged from 0—17 ng/ml and were not directly proportional to the dose used.

Podophyllum is contraindicated in pregnancy. There have been reports of complications associated with the topical use of podophyllum on condylomata of pregnant patients including birth defects, fetal death, and stillbirth. There are no well controlled studies in pregnant patients.

Podophyllum is contraindicated for use in patients who are breast-feeding. It is not known if podophyllum is excreted in human breast milk and there are no controlled studies. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition.