INDICATIONS & USAGE SECTION.

INDICATIONS:. Podocon-25(R) (25% podophyllin in benzoin tincture) is indicated for the removal of soft genital (venereal) warts (condylomata acuminata)(4).

NURSING MOTHERS SECTION.

Nursing Mothers:. It is not known whether podophyllin is excreted in human milk following topical application. In the absence of controlled safety studies, podophyllin remains contraindicated for use on nursing patients.

PRECAUTIONS SECTION.

PRECAUTIONS:. Do not use Podocon- 25(R) 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.

PREGNANCY SECTION.

Pregnancy:. There have been reports of complications associated with the topical use of podophyllin on condylomata of pregnant patients including birth defects, fetal death and stillbirth (6). In the absence of controlled safety studies, podophyllin remains contraindicated for use on pregnant patients.

WARNINGS SECTION.

WARNINGS:. Podophyllin is powerful caustic and severe irritant. Keep away from the eyes; if eye contact occurs, flush with copious amounts of warm water and consult physician or poison control center immediately for advice.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY:. Podophyllin is cytotoxic agent that has been used topically in the treatment of genital warts. It arrests mitosis in metaphase, an effect it shares with other cytotoxic agents such as the vinca alkaloids(2). The active agent is podophyllotoxin, whose concentration varies with the type of podophyllin used; the American source normally containing one-fourth the amount of podophyllotoxin as the Indian source(3).NOTE: PODOCON-25(R) IS TO BE APPLIED ONLY BY PHYSICIAN. IT IS NOT TO BE DISPENSED TO THE PATIENT.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS:. Podocon-25(R) is contraindicated in diabetics, patients using steroids or with poor blood circulation. Podocon-25(R) should not be used on bleeding warts, moles, birthmarks or unusual warts with hair growing from them. It is recommended that Podocon- 25(R) not be used during pregnancy (see Pregnancy warning below).

DESCRIPTION SECTION.

DESCRIPTION:. Podocon-25(R) is composed of Podophyllin (Podophyllum Resin, American) 25% in Benzoin Tincture. Podophyllum Resin is the powdered mixture of resins removed from the May apple or Mandrake (PodophyllumpeltatumLinne ), perennial plant of northern and middle United States(1). The podophyllin resin used in this product is exclusively the American podophyllin (rather than the Indian resin). American podophyllin typically has reduced level of podophyllotoxin (see below).

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION:. PODOCON-25(R) IS TO BE APPLIED ONLY BY PHYSICIAN. IT IS NOT TO BE DISPENSED TO THE PATIENT. SHAKE WELL. Thoroughly cleanse affected area. Use supplied applicator to apply Podocon-25(R) sparingly to lesion. Avoid contact with healthy tissue. Allow to dry thoroughly. Only intact (no bleeding) lesions should be treated. As podophyllin is powerful caustic and severe irritant, it is recommended the first application of Podocon-25(R) be left in contact for only short time (30-40 minutes) to determine patients sensitivity. To avoid systemic absorption, time of contact should be minimum time necessary to produce the desired result (1 to hours, depending on condition of lesion and of patient), the physician developing his/her own experience and technique. Large areas or numerous warts should not be treated at once.After treatment time has elapsed, remove dried Podocon-25(R) thoroughly with alcohol or soap and water.

HOW SUPPLIED SECTION.

HOW SUPPLIED. Podocon-25(R) is available in 15-mL bottles with tapered tip applicator attached inside cap. NDC 63629-8699-1Store at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature] in tight, light-resistant containers.Rx Only.

ADVERSE REACTIONS SECTION.

ADVERSE REACTIONS:. The use of topical podophyllin has been known to result in paresthesia, polyneuritis, paralytic ileus, pyrexia, leukopenia, thrombocytopenia, coma and death(5).. Pregnancy:. There have been reports of complications associated with the topical use of podophyllin on condylomata of pregnant patients including birth defects, fetal death and stillbirth (6). In the absence of controlled safety studies, podophyllin remains contraindicated for use on pregnant patients.. Nursing Mothers:. It is not known whether podophyllin is excreted in human milk following topical application. In the absence of controlled safety studies, podophyllin remains contraindicated for use on nursing patients.