Condylox

Contraindications

Hypersensitivity

Cautions

Keep product away from open flame

Avoid contact with eyes

It is not likely that other drugs you take orally or inject will have an effect on topically applied podofilox. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Storage

Topical

15–30°C.1 2 8 Keep away from open flames;1 do not expose to excessive heat; avoid freezing.1 2 8

15–30°C.1 2 8 44 Do not expose to excessive heat; avoid freezing.1 2 8 44

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

In the first multicenter clinical study in 326 patients with anogenital warts, Condylox Gel 0.5% and its vehicle were applied in a double-blind fashion to comparable patient groups. Of the 260 patients with efficacy data, 176 were treated with Condylox Gel 0.5%. Patients applied Condylox Gel 0.5% twice daily for three consecutive days followed by a 4 day “rest” period.

At the end of 4 weeks, 38.4% of the patients had complete clearing of the wart tissue when treated with Condylox Gel 0.5%.

In the second multicenter clinical trial in 108 evaluable patients with anogenital warts, Condylox (podofilox) Topical Solution 0.5% was compared with Condylox Gel 0.5% for efficacy. As in the first clinical trial, patients applied Condylox Gel 0.5% twice daily for three consecutive days followed by a four day “rest” period.

Similar clearance rates were observed. At the end of 4 weeks, 25.6% of the patients had complete clearing of the wart tissue when treated with Condylox Gel 0.5%.

1. Von Krogh G. Podophyllotoxin in serum: Absorption subsequent to three day repeated applications of a 0.5% ethanolic preparation on condylomata acuminata. Sex Trans Disease 1982: 9: 26-33.
   
2. Berenblum I. The effect of podophyllotoxin on the skin of the mouse, with reference to carcinogenic, cocarcinogenic, and anticarcinogenic action. J Cancer Inst 11:839-841, 1951.
   
3. Kaminetzky HA, Swerdlow M. Podophyllin and the mouse cervix: assessment of carcinogenic potential. Am J Obst Gyn 95:486-490, 1965.
   
4. McGrew EA, Kaminetzky HA. The genesis of experimental cervical epithelial dysplasia. Am J Clin Path 35:538-545, 1961.
   
5. Roe FJC, Salaman MH. Further studies on incomplete carcinogenesis: triethylene melamine (T.E.M.) 1,2 benxanthracene and beta-propiolactone as initiators of skin tumor formation in the mouse. Brit J Cancer, 9:177-203, 1955.
   
6. Taper HS. Induction of the deficient acid DNAase activity in mouse interfollicular epidermis by croton oil as a possible tumor promoting mechanism. Zeitschrift fur Krebsforschung and Klinisch Onkologie (Cancer Research and Clinical Oncology, Berlin) 90:197-210, 1977.
   
7. Kaminetzky HA, McGrew EA, Phillips RL. Experimental cervical epithelial dysplasia. J Obst Gyn 14:1-10, 1959.
   
8. Kaminetzky HA, McGrew EA: Podophyllin and mouse cervix: Effect of long term application. Arch Path 73:481-485, 1962.
   
9. Thiersch JB. Effect of podophyllin (P) and podophylotoxine (PT.) on the rat litter in utero. Soc Exptl Biol Med Proc. 113:124-127, 1963.
   
10. Savel H.: Clinical experience with intravenous podophyllotoxin. Proc Amer Assoc Cancer Res, 1964; 5: 56.
    
11. Cassidy DE, Dewry J and Fanning JP: Podophyllum toxicity: A report of a fatal case and a review of the literature. J Toxicol Clinic Toxicol 1982: 19: 35-44.

For all medical inquiries contact:
ACTAVIS
Medical Communications
Parsippany, NJ 07054 USA
1-800-272-5525

Distributed By:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Manufactured By:
DPT Laboratories, Ltd.
San Antonio, TX 78215

140348
Content Updated: August 2014

Condylox Gel
3.5 g
NDC 52544-045-13

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.