Podophyllum Resin

Generic Name: podophyllum resin

Over-the-Counter (OTC)

Brand Names:

Podocon 25

DESCRIPTION: Podocon-25 ® 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 ( Podophyllum peltatum Linne’ ), a 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 a reduced level of podophyllotoxin (see below).

Overview

DESCRIPTION: Podocon-25 ® 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 ( Podophyllum peltatum Linne’ ), a 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 a reduced level of podophyllotoxin (see below).

Uses

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

Dosage

DOSAGE AND ADMINISTRATION: PODOCON-25 ® IS TO BE APPLIED ONLY BY A PHYSICIAN. IT IS NOT TO BE DISPENSED TO THE PATIENT. SHAKE WELL. Thoroughly cleanse affected area. Use supplied applicator to apply Podocon-25 ® sparingly to lesion. Avoid contact with healthy tissue. Allow to dry thoroughly. Only intact (no bleeding) lesions should be treated. As podophyllin is a powerful caustic and severe irritant, it is recommended the first application of Podocon-25 ® be left in contact for only a short time (30-40 minutes) to determine patient’s sensitivity. To avoid systemic absorption, time of contact should be minimum time necessary to produce the desired result (1 to 4 hours, depending on condition of lesion and of patient), the physician developing his/her own experience and technique.

Side Effects

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.

Warnings

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

Pregnancy

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.

Storage

HOW SUPPLIED: Podocon-25® is available in 15-mL bottles with tapered tip applicator attached inside cap. NDC: 71335-2925-1: 15 mL in a BOTTLE, WITH APPLICATOR Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] in tight, light-resistant containers. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

Frequently Asked Questions

What is Podophyllum Resin used for?

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

What are the side effects of Podophyllum Resin?

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.

Can I take Podophyllum Resin during pregnancy?

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.

What are the important warnings for Podophyllum Resin?

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

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.