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CONDYLOX DRUG INFORMATION, ABOUT CONDYLOX®

In the U.S.

• Condylox

Another commonly used name: podophyllotoxin.

CATEGORY

• Antimitotic agent (topical)

USES

Condylox is used to remove certain types of genital warts on the outside skin of the genital areas (vulva or  penis). The gel form is also used  to treat warts between the genitals and  rectum. The solution form is not for that use. Neither the solution nor the gel  is used to treat warts that form  inside the rectum, vagina or urine passageways inside the vulva (female) or the penis (male). Condylox  works by destroying the skin of the wart.

This medicine is available only with a physician's prescription, in the following dosage form(s):

Topical


• Solution (U.S.)
• Gel (U.S.)

BEFORE YOU BUY CONDYLOX

The risks of using Condylox  must be weighed against the good it will do. Discuss this with your doctor. The following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to Condylox (podofilox). Also tell your doctor if you are allergic to any other substances, such as foods, preservatives or dyes.

Condylox and Pregnancy

 Condylox (podofilox) has not been studied in pregnant women. Studies in rats, however, have shown that Condylox causes problems during pregnancy when injected at high doses. Topical Condylox may be absorbed into the skin. Before using Condylox, make sure your doctor knows if you are pregnant or if you may become pregnant.

Condylox (podofilox) and Breast-feeding

It is not known whether topical Condylox passes into breast milk. Most medicines pass into breast milk in small amounts, however, many of them may be used safely while breast-feeding. Mothers who are using Condylox and who wish to breast-feed should discuss this with their doctor.

Children and  Condylox (podofilox)

Studies of this medicine have been done only in adult patients. There is no specific information on the use of Condylox in children.

Older adults and  Condylox (podofilox)

There is no specific information comparing use of  Condylox (podofilox) in the elderly with use in other age groups.  Therefore, it is not be known whether it works exactly the same way it does in younger adults or if it causes different side effects or problems in older people.

Other medicines

Tell your doctor and pharmacist if you are using any other prescription or nonprescription (over-the-counter [OTC]) medicine.

HOW TO USE CONDYLOX

Carefully read the information sheet which comes with your prescription.  Ask your doctor or pharmacist if you have any questions.

Also, keep  Condylox (podofilox) away from the eyes and mucous membranes, such as the inside of the rectum, penis or vagina. Condylox may cause severe irritation. If you get it in your eyes or on one of these areas, immediately flush the area with water for 15 minutes.

Use Condylox (podofilox) only as directed. Do not use more than 3 days a week and no more than 4 treatment cycles. Do not use more, do not use it more often and do not use it  longer than your doctor ordered. To do so may increase the chances that (Condylox) podofilox is absorbed into the body and that side effects could occur.

Do not apply the medicine to any other wart unless your doctor advises you to. The total dose of  Condylox (podofilox) used on all warts should not exceed the amount that would cover an area measuring 1.6 square inches (10 square centimeters) or about the size of a dollar coin.

To use:

• Use the applicators that come with the solution or use a cotton-tipped applicator to apply. Use a cotton-tipped applicator or your finger to apply the gel. Never reuse an applicator or dip a used applicator back into the bottle.
  
  
• Apply  Condylox (podofilox) only to the wart(s) discussed with your doctor.
  
  
•  Condylox (podofilox) can cause severe irritation of normal skin. If you get medicine on normal skin, wash it off immediately with soap and water.
  
  
• Be sure the treated area is dry before allowing the treated skin to come in contact with untreated, normal skin.
  
  
• Wash your hands immediately after applying this medicine. Properly discard used applicator(s).

CONDYLOX DOSAGE

The dose of Condylox (podofilox)  will be different for different people. Follow your doctor's directions or the directions on the label. The following information includes only the average doses. If your dose is different, do not change it unless your doctor tells you to.

• Topical dosage form (gel):
  
  
  • For warts on penis or vulva (genitals) or on skin between rectum and genitals:
    
    
    • Adults—Apply to the wart(s) two times a day for three days in a row using the applicator or your finger. Do not apply any medicine for four days in a row. If the wart can still be seen, this application cycle can be repeated  for up to four weeks until the wart(s) is gone. No more than 0.5 grams of gel should be used each day during treatment.
      
      
    • Children—Discuss use and dose with your doctor.
      
      
• Topical dosage form (solution):
  
  
• For warts on penis or vulva (genitals) only:
  
  
  • Adults—Apply to the wart(s) twice a day (every twelve hours) for three days in a row using the applicator tip. Do not apply any medicine for four days in a row. If the wart can still be seen, this application cycle can 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 during treatment.
    
    
  • Children—Discuss use and dose with your doctor.
    
    

If you miss a dose of Condylox, apply it as soon as possible. Then go back to your regular dosing schedule.

PRECAUTIONS

Condylox (podofilox) might not prevent previously healed warts from reappearing or stop new ones from growing.

This medicine contains alcohol and therefore could be flammable. Do not use near open flame, near heat or while smoking.

CONDYLOX SIDE EFFECTS

Call your doctor as soon as possible if any of the following Condylox side effects occur:

• More common

Solution Only:

• bad odor
• bloody urine
• dizziness
• pain during sexual intercourse
• problems with foreskin of penis
• scarring of treated skin
• vomiting

Gel Only:

• headache

Both:

• bleeding of treated skin
• blistering, crusting, or scabbing of treated skin
• burning feeling of treated skin
• itching of treated skin
• pain of treated skin
• redness or swelling of treated skin
• skin ulcers of treated skin

• Symptoms of overdose--will occur in this order:
  • Nausea;  vomiting;  diarrhea ;  chills;  fever; sore throat;  unusual bleeding or bruising ;  oral ulcers 

These Condylox side affects may go away during treatment as your body adjusts. However, call your doctor if any of the following  effects continue or become bothersome:

• More common
  
  
  • dryness of the treated skin
  • peeling of the treated skin
  • soreness or tenderness of the treated skin
  • stinging or tingling of the treated skin
  • difficulty sleeping (solution only)

• Less common (gel only)
  
  
  • changes in color of the treated skin
  • skin rash

If you notice any other effects not listed here, check with your doctor.

STORAGE

To store Condylox (podofilox):

• Keep it out of the reach of children.
• Store it away from heat and direct light.
• Keep the lid tightly closed.
• Discard outdated medicine or medicine that is no longer needed. Be sure that when medicine is discarded it is out of the reach of children.