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 Condylox. Read this paper carefully and ask your health care professional if you need additional information.
Also, keep Condylox 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 Condylox in your eyes or on one of these areas, immediately flush the area with water for 15 minutes.
Use Condylox 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 Condylox to any other wart until you discuss it with your doctor. The total dose of Condylox 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 Condylox:
* 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 Condylox only to the wart(s) discussed with your doctor.
* Condylox 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 Condylox. Properly discard used applicator(s).
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Store Condylox 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Do not keep outdated Condylox or Condylox no longer needed.
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If you miss a dose of Condylox, 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.
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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.
* Dosing for Condylox topical dosage form (gel):
o For warts on penis or vulva (genitals) or on skin between genitals and rectum:
+ Adults dosing—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 dosing—Use and dose must be determined by the doctor.
* Dosing for Condylox topical dosage form (solution):
o For warts on penis or vulva (genitals) only:
+ Adults dosing—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 dosing—Use and dose must be determined by the doctor.
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Condylox 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). Condylox works by destroying the skin of the wart.
This medicine is available only with your doctor’s prescription.
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Condylox Gel 0.5% is supplied as 3.5 g of clear gel in aluminum tubes with an applicator tip. NDC 52544-045-13. Store at controlled room temperature between 15 – 30°C (59 – 86°F). Avoid excessive heat. Do not freeze.
Keep out of reach of children.
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The prescriber should ensure that the patient is fully aware of the correct method of therapy and identify which specific warts should be treated.
Apply twice daily for 3 consecutive days, then discontinue for 4 consecutive days. This one week cycle of treatment may be repeated until there is no visible wart tissue or for a maximum of four cycles. If there is incomplete response after four treatment cycles, discontinue treatment and consider alternative treatment. Safety and effectiveness of more than four treatment cycles has not been established. There is no evidence to suggest that more frequent application will increase efficacy, but additional applications would be expected to increase the rate of local adverse reactions and systemic absorption.
Condylox Gel 0.5% should be applied to the warts with the applicator tip or finger. Application on the surrounding normal tissue should be minimized. Treatment should be limited to 10 cm2 or less of wart tissue and to no more than 0.5 g of the gel per day.
Care should be taken to allow the gel to dry before allowing the return of opposing skin surfaces to their normal positions. Patients should be instructed to wash their hands thoroughly before and after each application.
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Topically applied Condylox may be absorbed systemically. Toxicity reported following systemic administration of Condylox in investigational use for cancer treatment included: nausea, vomiting, fever, diarrhea, bone marrow depression, and oral ulcers. Following 5 to 10 daily intravenous doses of 0.5 to 1 mg/kg/day, significant hematological toxicity occurred but was reversible. Other toxicities occurred at lower doses. Toxicity reported following systemic administration of podophyllum resin included: nausea, vomiting, fever, diarrhea, peripheral neuropathy, altered mental status, lethargy, coma, tachypnea, respiratory failure, leukocytosis, pancytosis, hematuria, renal failure and seizures. Treatment of topical overdosage should include washing the skin free of any remaining drug and symptomatic and supportive therapy.
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Data are not available on the safe and effective use of this product for treatment of warts occurring on mucous membranes of the genital area (including the urethra, rectum and vagina). The recommended method of application, frequency of application, and duration of usage should not be exceeded.
Condylox Information for Patients
Patients using Condylox Gel 0.5% should receive the following information and instructions. This information is intended to aid in the safe and effective use of this medication. It is not intended to disclose all possible adverse or intended effects.
1. This medication should be used only as directed by the health care provider. Patients should be instructed to wash their hands thoroughly before and after each application. It is for external use only. Avoid contact with the eyes.
2. Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
3. Patients should report any signs of adverse reactions to the health care provider.
4. If no improvement is observed after 4 weeks of treatment, discontinue the medication and consult the health care provider.
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An 80-week carcinogenicity study in the mouse was performed using a 0.5% Condylox solution applied dermally at 0.04, 0.2 and 1.0 mg/kg/day. There were no differences between the Condylox treated mice at any dose level and vehicle control in the incidence of neoplasia. Published animal studies, in general, have not shown the drug substance, Condylox, to be carcinogenic.2,3,4,5,6 There are published reports that, in mouse studies, crude podophyllin resin (containing Condylox) applied topically to the cervix produced changes resembling carcinoma in situ.7 These changes were reversible at five weeks after cessation of treatment. In one reported experiment, epidermal carcinoma of the vagina and cervix was found in 1 out of 18 mice after 120 applications of podophyllin8 (the drug was applied twice weekly over a 15-month period).
Condylox was not mutagenic in the Ames plate reverse mutation assay at concentrations up to 5 mg/plate, with and without metabolic activation. No cell transformation related to potential oncogenicity was observed in BALB/3T3 cells after exposure to Condylox at concentrations up to 0.008 μg/mL, without metabolic activation and 12 μg/mL Condylox with metabolic activation. Results from the mouse micronucleus in vivo assay using Condylox 0.5% solution at doses up to 25 mg/kg (75 mg/m2), indicate that Condylox should be considered a potential clastogen (a chemical that induces disruption and breakage of chromosomes).
Daily topical application of 0.5% Condylox solution at doses up to the equivalent of 0.2 mg/kg (1.18 mg/m2, approximately equivalent to the human daily dose) to rats throughout gametogenesis, mating, gestation, parturition and lactation for two generations demonstrated no impairment of fertility.
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