What is Podocon-25 and how is it used?
Podocon-25 is a prescription medicine used to treat the symptoms of genital warts (Condyloma Acuminata). Podocon-25 may be used alone or with other medications.
Podocon-25 belongs to a class of drugs called Keratolytic Agents.
What are the possible side effects of Podocon-25?
- change in your mental state,
- loss of consciousness,
- weak or shallow breathing,
- severe constipation,
- little or no urination,
- weakness, numbness, tingling in your arms or legs,
- easy bruising or bleeding (nosebleeds, bleeding gums),
- bloody or tarry stools,
- coughing up blood,
- vomit that looks like coffee grounds,
- upper stomach pain,
- loss of appetite,
- chest pain,
- pounding heartbeats,
- fluttering in your chest, and
- shortness of breath
Get medical help right away, if you have any of the symptoms listed above.
The most common side effects of Podocon-25 include:
- swelling, redness, or tenderness of treated skin,
- itching, and
- burning pain
Tell the doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Podocon-25. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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 CLINICAL PHARMACOLOGY section).
DOSAGE AND ADMINISTRATION
PODOCON-25® (podophyllin) 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® (podophyllin) 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® (podophyllin) 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. Large areas or numerous warts should not be treated at once.
After treatment time has elapsed, remove dried Podocon-25® (podophyllin) thoroughly with alcohol or soap and water.
Podocon-25® (podophyllin) is available in 15-ml bottles with tapered tip applicator attached inside cap. NDC 0574-0601-15
Store at room temperature 15°-30° C (59°-86° F) in tight, light-resistant containers.
4) Medical Letter; Vol 26, New Rochelle, N.Y., 1984, p10.
Paddock Laboratories, Inc. Minneapolis, MN 55427. (08-05). FDA Rev date: n/a
No information provided.
5) Fisher: Severe Systemic and Local Reactions to Topical Podophyllum Resins; Cutis, Volume 28, 1981.
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.
Do not use Podocon-25® (podophyllin) 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: 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.
6) Zackheim: Hazards of Topical Mitotic-Blocking Agents; Arch. Dermat. Volume 113, 1977.
No information provided.
Podocon-25® (podophyllin) is contraindicated in diabetics, patients using steroids or with poor blood circulation. Podocon-25® (podophyllin) should not be used on bleeding warts, moles, birthmarks or unusual warts with hair growing from them. It is recommended that Podocon-25® (podophyllin) not be used during pregnancy (see Pregnancy warning section).
Podophyllin is a 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® (podophyllin) IS TO BE APPLIED ONLY BY A PHYSICIAN. IT IS NOT TO BE DISPENSED TO THE PATIENT.
2) Green, L.K., Klima, M., Burns, T.; Arch Dermatol. Vol 124,
Nov 1988, p. 1718.
3) Martindale, 28th Ed. London, 1982, pp. 1366, 1367.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.