In the U.S.—

Condylox

Another commonly used name is podophyllotoxin.

• Antimitotic agent (topical)

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 MedicineAlong 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.