Another commonly used name is podophyllotoxin.
Podofilox (po-do-FIL-ox) is used to remove certain types of warts
on the outside skin of the genital areas (penis or vulva). The
gel is used also to treat warts between the genitals and the rectum,
the solution is not. Neither the gel nor the solution is used
to treat warts that occur inside the rectum, vagina, or urine
passageways inside the penis (male) or the vulva (female). Podofilox
works by destroying the skin of the wart.
This medicine is available only with your doctor's prescription,
in the following dosage form(s):
Topical
- Gel (U.S.)
- Solution (U.S.)
In deciding to use a medicine, the risks of using the medicine
must be weighed against the good it will do. This is a decision
you and your doctor will make. For podofilox, the following should
be considered:
Allergies—Tell your doctor if you have ever
had any unusual or allergic reaction to podofilox. Also tell your
health care professional if you are allergic to any other substances,
such as foods, preservatives, or dyes.
Pregnancy—Podofilox has not been studied in
pregnant women. However, studies in rats have shown that podofilox
causes problems during pregnancy when injected at high doses.
Topical podofilox may be absorbed into the skin at certain doses.
Before using this medicine, make sure your doctor knows if you
are pregnant or if you may become pregnant.
Breast-feeding—It is not known whether topical
podofilox passes into breast milk. Although most medicines pass
into breast milk in small amounts, many of them may be used safely
while breast-feeding. Mothers who are using this medicine and
who wish to breast-feed should discuss this with their doctor.
Children—Studies of this medicine have been
done only in adult patients, and there is no specific information
comparing use of podofilox in children with use in other age groups.
Older adults—Many medicines have not been studied
specifically in older people. Therefore, it may not be known whether
they work exactly the same way they do in younger adults or if
they cause different side effects or problems in older people.
There is no specific information comparing use of podofilox in
the elderly with use in other age groups.
Other medicines—Although certain medicines
should not be used together at all, in other cases two different
medicines may be used together even if an interaction might occur.
In these cases, your doctor may want to change the dose, or other
precautions may be necessary. Tell your doctor and pharmacist
if you are using any other prescription or nonprescription (over-the-counter
[OTC]) medicine.
A paper with information for the patient will be given to you
with your filled prescription and will provide many details concerning
the use of podofilox. Read this paper carefully and
ask your health care professional if you need additional information.
Also, keep podofilox away from the eyes and mucous membranes,
such as the inside of the penis, rectum, or vagina. This medicine
may cause severe irritation. If you get this medicine in your
eyes or on one of these areas, immediately flush the area with
water for 15 minutes.
Use podofilox only as directed, no more than 3 days a week
and no more than 4 treatment cycles. Do not use more of it,
do not use it more often, and do not use it for a longer time
than your doctor ordered. To do so may increase the chances that
this medicine is absorbed into the body and that side effects
could occur.
Do not apply the medicine to any other wart until you
discuss it with your doctor. The total dose of podofilox used
on all warts should not exceed that which would cover an area
measuring 1.6 square inches (10 square centimeters), about the
size of a dollar coin.
To use:
- To apply the solution, use the applicators that come with
the solution or a cotton-tipped applicator. To apply the gel,
use a cotton-tipped applicator or your finger. Never reuse
an applicator or dip a used applicator into the bottle.
- Apply podofilox only to the wart(s) discussed with your
doctor.
- Podofilox can cause severe irritation of normal skin.
If you get medicine on normal skin, wash it off immediately.
- Make sure the treated area is dry before allowing
the treated skin to come in contact with normal, untreated skin.
- Immediately after applying this medicine, wash your hands
to remove any medicine. Properly discard used applicator(s).
Dosing—
The dose of podofilox will be different for different patients.
Follow your doctor's orders or the directions on the label.
The following information includes only the average doses of podofilox.
If your dose is different, do not change it unless your
doctor tells you to do so.
- For topical dosage form (gel):
- For warts on penis or vulva (genitals) or on skin between
genitals and rectum:
- Adults—Apply to the wart(s) two times a day for three
days in a row using an applicator tip or finger. Skip
four days by not applying any medicine for four days
in a row. If the wart can still be seen, this application
cycle may be repeated each week for up to four weeks,
until the wart is gone. No more than 0.5 grams of gel
should be used each day of treatment.
- Children—Use and dose must be determined by the doctor.
- For topical dosage form (solution):
- For warts on penis or vulva (genitals) only:
- Adults—Apply to the wart(s) two times a day (every
twelve hours) for three days in a row using applicator
tip. Skip four days by not applying any medicine for
four days in a row. If the wart can still be seen, this
application cycle may be repeated each week for up to
four weeks, until the wart is gone. No more than 0.5
milliliters of solution should be used each day of treatment.
- Children—Use and dose must be determined by the doctor.
Missed dose—
If you miss a dose of this medicine, apply it as soon as possible.
Then go back to your regular dosing schedule.
Storage—
To store this medicine:
- Keep out of the reach of children.
- Store away from heat and direct light.
- Keep top tightly closed.
- Do not keep outdated medicine or medicine no longer needed.
Be sure that any discarded medicine is out of the reach of children.
Podofilox may not be able to prevent previously healed warts
from reappearing or stop new warts from growing.
This medicine contains alcohol and therefore may be flammable.
Do not use near heat, near open flame, or while smoking.
Side Effects of This Medicine
Along with its needed effects, a medicine may cause some unwanted
effects. Although not all of these side effects may occur, if
they do occur they may need medical attention.
Check with your doctor as soon as possible if any of the following
side effects occur:
- More common
- Bad odor (solution only); bleeding of treated skin;
blistering, crusting, or scabbing of treated skin;
bloody urine (solution only); burning feeling of treated
skin; dizziness (solution only); headache (gel
only); itching of treated skin; pain during
sexual intercourse (solution only); pain of treated
skin; problems with foreskin of penis (solution only)
; redness or swelling of treated skin; scarring
of treated skin (solution only); skin ulcers of treated
skin; vomiting (solution only)
- Symptoms of overdose--in order of occurrence
- Nausea; vomiting; diarrhea ; chills;
fever; sore throat; unusual bleeding or bruising
; oral ulcers
Other side effects may occur that usually do not need medical
attention. These side effects may go away during treatment as
your body adjusts to the medicine. However, check with your doctor
if any of the following side effects continue or are bothersome:
- More common
- Dryness of treated skin; peeling of treated skin;
soreness or tenderness of treated skin ; stinging
or tingling of treated skin; trouble in sleeping (solution
only)
- Less common
- Changes in color of treated skin (gel only); skin
rash (gel only)
Other side effects not listed above may also occur in some patients.
If you notice any other effects, check with your doctor.
