Podofilox (Topical)

Podofilox is used to remove certain types of warts on the outside of the genital areas (penis or vulva). The gel is also used to treat warts between the genitals and the rectum, but 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.

Podofilox may not prevent warts that have healed from coming back or stop new warts from forming.

This medicine contains alcohol and can catch fire. Do not use it near heat, open flames, or while smoking.

In deciding to use a medicine, you and your doctor must consider the risks of taking the medicine against the benefits it may provide. Here are some important points to think about for this medicine:

Allergies

Let your doctor know if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your health care professional about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies of this medicine have only been conducted in adult patients, and there is no specific information comparing the use of podofilox in children to its use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known if they work the same way in older adults as they do in younger adults, or if they cause different side effects or problems in older people. There is no specific information comparing the use of podofilox in the elderly to its use in other age groups.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to adjust the dose, or other precautions may be needed. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used at or around the time of eating food or certain types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

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

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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 may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Condylox

In Canada

• Condyline

Available Dosage Forms:

• Gel/Jelly
• Solution

Therapeutic Class: Keratolytic

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 this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• 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, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.