Monograph: |
PODIPHYLLUM RESIN
DESCRIPTION:
PODOWART is composed of Podophyllin (Podophyllum Resin) 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. (REF. 1) The podophyllum 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).
ACTIONS/CLINICAL PHARMACOLOGY:
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. (REF. 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. (REF. 3)
NOTE: PODOWART IS TO BE APPLIED ONLY BY A PHYSICIAN. IT IS NOT TO BE DISPENSED
TO THE PATIENT.
INDICATIONS AND USAGE:
PODOWART (25% podophyllin in benzoin tincture) is indicated for the removal of
soft genital (venereal) warts (condylomata acuminata). (REF. 4)
CONTRAINDICATIONS:
PODOWART is contraindicated in diabetics, patients using steroids or with poor
blood circulation. PODOWART should not be used on bleeding warts, moles,
birthmarks or unusual warts with hair growing from them. It is recommended that
PODOWART not be used during pregnancy (see Pregnancy warning below).
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.
PRECAUTIONS:
Do not use PODOWART 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.
ADVERSE REACTIONS:
The use of topical podophyllin has been known to result in paresthesia,
polyneuritis, paralytic ileus, pyrexia, leukopenia, thrombocytopenia, coma and
death. (REF. 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 still birth. (REF. 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.
DOSAGE AND ADMINISTRATION:
PODOWART IS TO BE APPLIED ONLY BY A PHYSICIAN. IT IS NOT TO BE DISPENSED TO
THE PATIENT. Thoroughly cleanse affected area. Use supplied applicator to apply
PODOWART 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 PODOWART be left in contact for only a short time (30 to 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 own experience and technique. Large areas or numerous warts
should not be treated at once.
After treatment time has elapsed, remove dried PODOWART THOROUGHLY with
alcohol or soap and water.
************************************************************************
|