Genital wart

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Genital wart(s)
Classification and external resources
Severe case of genital warts around the anus
ICD-10
A63.0
ICD-9
078.11
DiseasesDB
29120
eMedicine
derm/454 med/1037
MeSH
C02.256.650.810.217
Genital warts (or Condylomata acuminata, venereal warts, anal warts and anogenital
warts) is a highly contagious sexually transmitted disease caused by some sub-types of
human papillomavirus (HPV). It is spread through direct skin-to-skin contact during oral,
genital, or anal sex with an infected partner. Warts are the most easily recognized symptom of
genital HPV infection, where types 6 and 11 are responsible for 90% of genital warts cases.[1]
Whilst of those infected with genital HPV it is estimated that only a "small percentage"[2]
(between 1%[3] and 5%[4]) develop genital warts, those infected can still transmit the virus.
Other types of HPV also cause cervical cancer and probably most anal cancers, however it is
important to underline that the types of HPV that cause the overwhelming majority of genital
warts are not the same as those that can potentially increase the risk of genital or anal cancer.
[5][6][7][8][9]
HPV prevalence at any one time has been observed in some studies at 27% over all
sexually active people, rising to 45% between the ages of 14 and 19.[1]

Contents

1 Signs and symptoms

2 Diagnosis

3 Prevention

4 Management

5 Epidemiology

6 References

7 External links

When present. they usually are seen on the tip of the penis. HPV can last for several years without a symptom.Signs and symptoms Genital warts often occur in clusters and can be very tiny or can spread into large masses in the genital or penis area. a latency (quiet) period of months to years (decades) may occur. genital warts also can develop in the mouth or throat of a person who has had oral sex with an infected person. If an individual has unprotected sex with an infected partner. The immune system eventually clears the virus through interleukins. on the opening (cervix) to the womb (uterus). In women they occur on the outside and inside of the vagina. on the scrotum. which recruit interferons. Rarely. or around (or inside) the anus.[11] Having sex with a partner whose HPV infection is latent and demonstrates no outward symptoms still leaves one vulnerable to becoming infected.[12]  Severe case of genital warts on a female  Severe case of genital warts on a male Diagnosis . In other cases they look like small stalks.[10] The viral particles are able to penetrate the skin and mucosal surfaces through microscopic abrasions in the genital area. They also may be found on the shaft of the penis. or around (or inside) the anus. They are approximately as prevalent in men but the symptoms may be less obvious. which occur during sexual activity. Once cells are invaded by HPV. there is a 70% chance that he or she will also become infected. which slow viral replication.

[17] Almost all treatments can potentially cause depigmentation or scarring.[12] Magnifying glasses or colposcope may also be used to aid in identifying small warts.[18] it can be applied by the patient to the affected area and is not washed off.[12] Depending on the sizes and locations of warts (as well as other factors). koilocytes. Prevention See also: HPV vaccine Gardasil (sold by Merck & Co.[19] Its use is cycled (2 times per day for 3 days then 4–7 days off). and 11. Types 6 and 11 cause genital warts. The vaccine is preventive.Micrograph of a genital wart with the characteristic changes (parakeratosis. Genital warts. and must be given before exposure to the virus type to be effective.[18] Skin erosion and pain are more commonly reported than with imiquimod and sinecatechins.[16] Genital warts may disappear without treatment. 6.15%) and Warticon (0.15%).15% – 0.) is a vaccine that protects against human papillomavirus types 16. small raised growth.[15]  A 0. Marketed as Condylox (0. but sometimes eventually develop a fleshy.5% podophyllotoxin (also called podofilox) solution in a gel or cream.5%). Podofilox is safer and more effective than podophyllin. Management There is no cure for HPV. Wartec (0. It causes less local irritation than podofilox but may cause fungal infections (11% in package insert) and flu-like symptoms (less than 5% disclosed in package insert). while 16 and 18 cause cervical cancer. Americans spend $200 million on the treatment of genital warts. histopathologically. the US and Canada. applied to the affected area. but this method is not recommended on the vulva because microtrauma and inflammation can also show up as acetowhite. it is being tested for young men. although there are no trials studying the effectiveness of removing visible warts in reducing transmission. Podofilox is the first-line treatment due to its low cost.[20]  Imiquimod (Aldara) is a topical immune response cream.[15] Every year. not therapeutic.[13][14] and has been approved for males in some areas. which could reduce infectivity. Warts can sometimes be identified because they show up as white when acetic acid is applied. H&E stain.[19]  Sinecatechins (marketed as Veregen and Polyphenon E) is an ointment of catechins (55% epigallocatechin gallate[12]) extracted from green tea and other components. such as the UK. It is the purified and standardized active ingredient of the podophyllin (see below). The vaccine is widely approved for use by young women. one review states that it should only be used for four cycles. characteristically rise above the skin surface due to enlargement of the dermal papillae. ideally before the beginning of sexual activity. but there are methods to treat visible warts. a doctor will offer one of several ways to treat them. 18. papillomatosis). . have parakeratosis and the characteristic nuclear changes typical of HPV infections (nuclear enlargement with perinuclear clearing). There is no way to predict whether they will grow or disappear.

Mode of action is undetermined.[20] and is not recommended for use in the vagina. urethra. In a small-scale study. renal failure. Epidemiology . treatment may require general or spinal anesthesia. but recurrence is 38% to 73% 6 months after treatment. perianal area. podofilox and Isotretinoin should not be used during pregnancy. it is effective.[12] Local infections have been reported. vomiting. or application on mucous membranes.[12]  Surgical excision is best for large warts.[12] and must be applied by a physician. cervix. but it is no longer considered an acceptable treatment due to the side-effects. this crude herbal extract is not recommended for use on vagina.[12]  Interferon can be used. but it is also expensive and its effect is inconsistent. confusion. coma. or cervix.[3] but is often used as a last resort and is extremely expensive.[12] Podophyllin. This is a surgical procedure.[12]  Trichloroacetic acid (TCA) is less effective than cryosurgery. and has a greater risk of scarring.[15]  Laser ablation does not seem to be any more effective than other physician-applied methods. it is an older procedure but recovery time is generally longer.[19]  Liquid nitrogen cryosurgery is safe for pregnancy.[20]  Electrocauterization can be used. fever. In severe cases of genital warts. low dose oral isotretinoin showed considerable efficacy and may represent an alternative systemic form of therapy for Genital Warts. but is rarely used due to potentially severe side effects.[22]'[23] Discontinued  A 5% 5-fluorouracil (5-FU) cream was used. Yet. More effective than cryosurgery and recurrence is at a much lower rate. It kills warts 71–79% of the time. but clearance takes longer than with imiquimod. as they could cause birth defects in the fetus.[12]  A 20% podophyllin anti-mitotic solution.  Oral Isotretinoin is a therapy that has proven effective in experimental use. or urinary meatus. applied to the affected area and later washed off. and leukopenia. However. ileus. In most countries this therapy is currently unapproved and only used as an alternative therapy if other therapies failed. albeit this indicative evidence not many studies have been conducted to further confirm the findings.[18] Reported reactions include nausea.[21] It appears to have higher clearance rates than podophyllotoxin and imiquimod and causes less local irritation. death has been reported with extensive topical application.

PMID 18596459. ^ http://www. Retrieved 2008-09-10.com/sexual-conditions/hpv-genital-warts/hpv-virusinformation-about-human-papillomavirus ^ http://www. Gill. so warts can recur after treatment (about 50–73% of the time[24]). ^ "American Cancer Society: "Can Anal Cancer Be Prevented?"".org/public/publications/pamphlets/viral_genital. doi:10.cdc. "Genital warts". BBC.org/126/original/HPV/payal. However.php 10.10. Dunton C (July 2008).[20] Traditional theories postulated that the virus remained in the body for a lifetime. new studies using sensitive DNA techniques have shown that through immunological response the virus can either be cleared or suppressed to levels below what polymerase chain reaction (PCR) tests can measure. ^ http://www.uk/type/cervical-cancer/about/cervical-cancerrisks-and-causes#hpv 9.cancerhelp.[20] US incidence of HPV infection has increased between 1975 and 2006.edu/Student_Services/Health_Services/Health_Education/sexual_health/ sexually_transmitted_infections/hpv. One study testing genital skin for subclinical HPV using PCR found a prevalence of 10%.Genital HPV infections have an estimated prevalence in the US of 10–20% and clinical manifestations in 1% of the sexually active adult population. Shannon.[20] About 80% of those infected are between the ages of 17–33. they do not remove the HPV. ^ http://www. Am J Clin Dermatol 6 (4): 239–243. ^ Genkins.92/hpv_diagnosing. Michelle Fay and Pettypiece. 11.[20] Although treatments can remove the warts.aad.gov/std/hpv/stdfact-hpv.html 5. ^ a b O'Mahony C (2005).cdlib. ^ a b c d e f g h i j k Mayeaux EJ.7. 13. ^ http://brown. ^ Cortez.edu/Handouts/genital_warts. Bloomberg News.htm 8. (Bloomberg.mckinley.com) 13 Nov 2008. ^ a b http://www. "Merck Cancer Shot Cuts Genital Warts.illinois.0b013e31815dd4b4. Lesions in Men".html 7. J Low Genit Tract Dis 12 (3): 185–192. Warts can also spontaneously regress (with or without treatment).webmd. Retrieved 17 November 2011. PMID 16060711. "Modern management of external genital warts".[20] References 1.org.[dead link] 12. 2.shtml 6. 4.html 3.1097/LGT. ^ http://dermatology. ^ http://96. . "Genital warts: current and future management options".

Kabir Sardana MD (May 2006). Gynecol. ^ a b c d e f g h Scheinfeld N. J. Sehgal MD. doi:10.2008. Penile warts. Am Fam Physician 70 (12): 2335–2342.warts. ^ a b c Meltzer SM. ^ CDC.x. (2004). REPORT TO CONGRESS: Prevention of Genital Human Papillomavirus Infection.1365-4632. Dermatol. Retrieved 2012-04-20. A Mortakis (November 2004).M. Venereal warts. Retrieved 2008-08-18. Sex Transm Infect 77 (6): 409–412. 2011. Condyloma. 2012-04-18. A. "Green tea catechins for treatment of external genital warts".ajog. 20. "An evidence-based review of medical and surgical treatments of genital warts". Sex Transm Infect 80 (3): 216–218. Genital warts Condylomata acuminata. Men by WebMD Health News. Obstet. ^ a b c Kodner CM. PMID 15617297. ^ Virendra N. PMID 16638419.D. PMID 11714936. 24. E Bozi. Lehman DS (2006). ^ "Veragen package insert" (PDF). International Journal of Dermatology 45 (6): 772–777. HPV DNA test. 200 (3): 233.006841. PMID 16343025. 2008 15.1016/j. doi:10. 17. Low-grade dysplasia-HPV.A. "Management of genital warts". 19. Medical Encyclopedia. Tung MY (2005). Sexually transmitted disease (STD) . "Human papillomavirus: burden of illness and treatment cost considerations". LSIL-HPV. 23. A C Katoulis. Nasraty S (December 2004). 16. Planned Parenthood Advocates of Arizona.064. PMID 19019336.02830.2003. Am. Longstaff E (December 2001).14. HPV Last reviewed: November 7. HSIL-HPV.1136/sti. Nov 13. Human papilloma virus (HPV). ^ HPV Vaccine Gardasil May Help Boys. doi:10. ^ "STI Awareness: Genital Warts". Monk BJ. doi:10.77. "Podophyllin office therapy against condyloma should be abandoned".07.409. "Isotretinoin – unapproved indications/uses and dosage: a physician's reference". 18. Tewari KS (March 2009).1111/j.[dead link] 22. Am J Clin Dermatol 6 (6): 365–381. 21. ^ S Georgala. 12 (3): 5. ^ Fox PA.6.2006. . PMC 1744412.e1–7. C Georgala. High-grade dysplasia HPV. "Oral isotretinoin in the treatment of recalcitrant condylomata acuminata of the cervix: a randomised placebo controlled trial".1136/sti. Govind Srivastava MD. Online J. ^ a b c von Krogh G.

vulva. This article focuses on warts on the genitals. Other types of HPV cause warts on other parts of the skin. However. More than 70 different types of HPV exist. You can spread the warts even if you do not see them. and risk factors The virus that causes genital warts is called human papilloma virus (HPV). They are not easy to see without special procedures. You are more likely to get genital warts and spread them more quickly if you:  Have multiple sexual partners  Do not know if you had sex with had STIs  Are sexually active at an early age  Use tobacco and alcohol  Have a viral infection such as herpes and are stressed at the same time  Are pregnant  Have a weakened immune system due to an illness or medication If a child has genital warts. cervical cancer. Not all types of HPV cause genital warts. Important facts about HPV:  HPV infection spreads from one person to another through sexual contact involving the anus. . HPV can spread to areas inside the walls of the vagina and cervix. such as the hands. They may be found on the penis. Genital warts are a sexually transmitted infection (STI). or vagina. Causes. mouth. You may not notice them for years. incidence. These are called high-risk types of HPV. vagina.Genital warts are soft growths on the skin and mucus membranes of the genitals.  You may not see warts for 6 weeks to 6 months after becoming infected.  Not everyone who has come into contact with the HPV virus and genital warts will develop them. HPV infection around the genitals is common. most people have no symptoms. or anal cancer. cervix. urethra. and around and in the anus. In women. you should suspect sexual abuse as a possible cause. Certain types of HPV can lead to precancerous changes in the cervix.

genital warts may be found on the:  Penis  Scrotum  Groin area  Thighs  Inside or around the anus Genital warts may also occur on the  Lips  Mouth  Tongue  Throat Other symptoms are rare. or on nearby skin  On the cervix inside the body In males. but may include:  Increased dampness in the genital area near the warts  Increased vaginal discharge . you might not see them. The warts may look like:  Flesh-colored spots that are raised or flat  Growths that look like the top of a cauliflower In females.Symptoms Genital warts may be so tiny. genital warts may be found:  Inside the vagina or anus  Outside the vagina or anus.

Do NOT use over-the-counter medicines meant for other kinds of warts. This test may be done:  As a screening test for women over age 30  In women of any age who have a slightly abnormal Pap test result Treatment Genital warts must be treated by a doctor. Treatment may include:  A skin treatment done in the doctor's office  Prescription medicine that you apply at home several times per week Prescription medicines include:  Imiquimod (Aldara)  Podophyllin and podofilox (Condylox)  Trichloroacetic acid (TCA) The warts may be removed with surgery. this will include a pelvic examination. Your doctor may place watered-down vinegar (acetic acid) on the area. you will probably need more frequent Pap smears for a while. The virus that causes genital warts can cause abnormal results on a Pap smear. This helps better see any warts. An HPV DNA test can tell if you have a high-risk type of HPV known to cause cervical cancer. including:  Cryosurgery  Electrocauterization . In women. If you have these types of changes. Genital itching  Vaginal bleeding during or after sex Signs and tests The health care provider will perform a physical exam. Magnification (colposcopy) is used to spot warts that cannot be seen with the naked eye.

Even after you have been treated for genital warts. they can pass it on to current and sometimes future sexual partners. Complications Some types of HPV have been found to cause cancer of the cervix and vulva. Young women and girls ages 9 . Expectations (prognosis) Many sexually active young women become infected with HPV. even if they already have genital warts. all of your sexual partners must be examined by a health care provider and treated if warts are found. Even if you do NOT have symptoms. Regular Pap smears are recommended if you are a woman who has had genital warts. Calling your health care provider Call your doctor if:  A current or past sexual partner has genital warts . HPV goes away on its own. requiring more extensive treatment and follow-up procedures. Women with precancerous changes caused by HPV infection may need further treatment. You will need to return to your health care provider after treatment to make sure all the warts are gone. you may still infect others. you may need to have Pap smears every 3 to 6 months after the first treatment. However. you must be treated to prevent complications and spreading the condition to others. They are the main cause of cervical cancer. The types of HPV that can cause genital warts are not the same as the types that can cause penile or anal cancer. Most men who become infected with HPV never develop any symptoms or problems from the infection. The warts may become numerous and quite large. In many cases. If you had warts on your cervix. though the vaccine is somewhat less effective in preventing cervical cancer if you have already had an infection with high risk HPV.26 should be vaccinated against HPV. Laser therapy  Surgical excision (cutting them out) If you have genital warts. or if you parter had them.

Human papilloma virus: prevention and treatment. MD. 3.D. Hanley J. 2. You have visible warts on your external genitals. Kahn JA.  You think a young child might have genital warts Women should begin having Pap smears at age 21.361:271-278.A. Review Date: 11/7/2011. Medical Director. Duarte-Franco E. N Engl J Med. discharge. N Engl J Med. condoms reduce your risk and you should still use them at all times. See: Safe sex Two vaccines are available that protect against four of the HPV types that cause most cervical cancers in women.. Inc. Ferenczy A. itching. Clinical Teaching Faculty. Eastside Department of Obstetrics and Gynecology. et al. Prevention Not having sexual contact is the only foolproof way to avoid genital warts and other STIs.357:1579-1588. References 1. Male and female condoms cannot fully protect you.M. Washington. Diaz ML.. Reviewed by: David Zieve. You can also decrease your chance of getting an STI by having a sexual relationship with only one partner who you know is disease-free. 2008. . Bellevue.Obstet Gynecol Clin North Am. It is recommended for girls and women ages 9 to 26. The vaccine is given as a series of three shots. Nonetheless. Keep in mind that genital warts may not appear for months to years after having sexual contact with an infected person. MD. HPV can be passed from person to person even when there are no visible warts or other symptoms. 2007. 2009. or abnormal vaginal bleeding. Mayrand MH. Department of Obstetrics and Gynecology. Rodrigues I. Human papillomavirus DNA versus Papanicolaou screening tests for cervical cancer. A. Walter SD. University of Washington School of Medicine. because the virus or warts can be on nearby skin. FACOG. Group Health Cooperative of Puget Sound. See: HPV vaccine for more detailed information. MHA. HPV vaccination for the prevention of cervical intraepithelial neoplasia.35(2):199-217. Susan Storck. Chief.

Diagnosis Although genital warts have a characteristic appearance..M. Dosage In order to ensure that the patient is fully aware of the correct method of therapy and to identify which specific warts should be treated. histopathologic confirmation should be obtained if there is any doubt of the diagnosis. Differentiating warts from squamous cell carcinoma (so-called "Bowenoid papulosis") is of particular concern.A. This product is not indicated in the treatment of perianal or mucous membrane warts (seePRECAUTIONS). Disclaimer Copyright © 2012.A.D.D.. A.M. If there is incomplete response after four treatment .Detailed Prescribing Information > > > > > > Manufacturer Contents Indications Dosage Overdosage Contraindications > Warnings > Adverse Drug Reactions > Description > Mechanism of Action > Presentation/Packing Related monographs See related Condylox Solution information Manufacturer Watson Pharmaceuticals Inc Contents Topical Solution (52544-046) podofilox 5 milligram in 1 milliliter Indications Condylox 0. Inc. then withhold use for 4 consecutive days. Condylox Solution .5% Solution is indicated for the topical treatment of external genital warts (Condyloma acuminatum). the technique for initial application of the medication should be demonstrated by the prescriber.A. This one week cycle of treatment may be repeated up to four times until there is no visible wart tissue. for 3 consecutive days. Squamous cell carcinoma may also be associated with human papillomavirus but should not be treated with Condylox 0. Apply twice daily morning and evening (every 12 hours).5% Solution.

peripheral neuropathy. Condylox 0. Treatment should be limited to less than 10 cm2 of wart tissue and to no more than 0. respiratory failure. See the "Diagnosis" subsection of theINDICATIONS AND USAGE statement. Following 5 to 10 daily intravenous doses of 0. Toxicity reported following systemic administration of podophyllum resin included: nausea. significant hematological toxicity occurred but was reversible. If eye contact occurs. After each treatment. pancytosis. tachypnea. Warnings Correct diagnosis of the lesions to be treated is essential. There is no evidence to suggest that more frequent application will increase efficacy. Overdosage Topically applied podofilox may be absorbed systemically (seeCLINICAL PHARMACOLOGY section). leukocytosis. vomiting.5% Solution is contraindicated for patients who develop ns hypersensitivity or intolerance to any component of the formulation. the used applicator should be carefully disposed of and the patient should wash his or her hands. coma. Avoid contact with the eye. and seizures.5 to 1 mg/kg/day. Care should be taken to allow the solution to dry before allowing the return of opposing skin surfaces to their normal positions. Condylox 0. Treatment of topical overdosage should include washing the skin free of any remaining drug and symptomatic and supportive therapy. applying the minimum amount of solution necessary to cover the lesion.5% Solution is applied to the warts with a cotton-tipped applicator supplied with the drug. Special General . fever.weeks. and oral ulcers. fever. renal failure. altered mental status. patients should immediately flush the eye with copious quantities of water and seek medical advice. bone marrow depression. Toxicity reported following systemic administration of podofilox in investigational use for cancer treatment included: nausea. alternative treatment should be considered. Contraindicatio Condylox 0. but additional applications would be expected to increase the rate of local adverse reactions and systemic absorption. The drug-dampened applicator should be touched to the wart to be treated. diarrhea. vomiting. Safety and effectiveness of more than four treatment weeks have not been established. Other toxicities occurred at lower doses. hematuria.5% Solution is intended for cutaneous use only.5 mL of the solution per day. diarrhea. lethargy.

Precautions Data are not available on the safe and effective use of this product for treatment of warts occurring in the perianal area or on mucous membranes of the genital area (including the urethra.5% solution in concentrations up to 25 mg/kg.3.2. Mutagenesis. Daily topical application of Condylox 0.008 μg/mL without metabolic activation and 12 μg/mL podofilox with metabolic activation. podofilox. Podofilox was not mutagenic in the Ames plate reverse mutation assay at concentrations up to 5 mg/plate. Published animal studies. mating. frequency of application. Pregnancy Category C: Podofilox was not teratogenic in the rabbit following topical . gestation. The recommended method of application. have not shown the drug substance. rectum and vagina).2 mg/kg (5 times the recommended maximum human dose) to rats throughout gametogenesis.6 These changes were reversible at five weeks after cessation of treatment. indicate that podofilox should be considered a potential clastogen (a chemical that induces disruption and breakage of chromosomes).5% Solution at doses up to the equivalent of 0. crude podophyllin resin (containing podofilox) applied topically to the cervix produced changes resembling carcinoma in situ. in mouse studies. No cell transformation related to potential oncogenicity was observed in BALB/3T3 cells after exposure to podofilox at concentrations up to 0. Results from the mouse micronucleus in vivo assay using podofilox 0. to be carcinogenic.5 There are published reports that. Impairment of Fertility Reports of lifetime carcinogenicity studies in mice are not available. epidermal carcinoma of the vagina and cervix was found in 1 out of 18 mice after 120 applications of podophyllin7 (the drug was applied twice weekly over a 15-month period). in general. with and without metabolic activation. Information for Patients The patient should be provided with a Patient Information leaflet when a Condylox prescription is filled.1. parturition and lactation for two generations demonstrated no impairment of fertility. and duration of usage should not be exceeded (seeDOSAGE AND ADMINISTRATION). In one reported experiment. Carcinogenesis.4.

Description Condylox is the brand name of podofilox. chafing. tingling.9 Teratogenicity and embryotoxicity have not been studied with intravaginal application. foreskin irretraction. taking into account the importance of the drug to the mother. There are no adequate and well-controlled studies in pregnant women. vomiting and ulceration. a decision should be made whether to discontinue nursing or to discontinue the drug. malodor. dryness/peeling. tenderness. Adverse Drug Reactions In clinical trials. The scientific literature contains references that podofilox is embryotoxic in rats when administered systemically in a dose approximately 250 times the recommended maximum human dose. Nursing Mothers It is not known whether this drug is excreted in human milk. crusting edema. the following local adverse reactions were reported at some point during treatment. Adverse effects reported in less than 5% of the patients included pain with intercourse.21 mg/kg (5 times the maximum human dose) once daily for 13 days. vesicle formation. bleeding. dizziness. scarring. an antimitotic drug which can . Adverse Experience Males Females Burning 64% 78% Pain 50% 72% Inflammation 71% 63% Erosion 67% 67% Itching 50% 65% Reports of burning and pain were more frequent and of greater severity in women than in men. hematuria. Many antimitotic drug products are known to be embryotoxic.application of up to 0. Pediatric Use Safety and effectiveness in pediatric patients have not been established.8. Podofilox should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Because of the potential for serious adverse reactions in nursing infants from podofilox. insomnia.

Condylox 0.0 to 4. Its chemical name is 5. and is soluble in alcohol and sparingly soluble in water. Patients were treated for two to four weeks. USP.5 hours. the test product and its vehicle were applied in a double-blind fashion to comparable patient groups.1 to 1.4':6. topical application of 0. and reevaluated at a two-week follow-up examination.9Tetrahydro-9-hydroxy-5-(3.be chemically synthesized or purified from the plant families Coniferae and Berberidaceae (e.4.g. Podofilox has the following structural formula: Mechanism of Action CLINICAL PHARMACOLOGY Mechanism of Action Treatment of genital warts with podofilox results in necrosis of visible wart tissue. the results among .3.5 mL resulted in peak serum levels of 1 to 17 ng/mL one to two hours after application.5% Solution is formulated for topical administration. Although the number of patients and warts evaluated at each time period varied. 3-dioxol-6(5aH)-one. Podofilox has a molecular weight of 414.d]-1. Pharmacokinetics In systemic absorption studies in 52 patients. The drug was not found to accumulate after multiple treatments. Each milliliter of solution contains 5 mg of podofilox.4 daltons.05 mL of 0. in a vehicle containing lactic acid and sodium lactate in alcohol 95%.8a. species of Juniperus and Podophyllum). Applications of 0.7] naphtho[2. CLINICAL STUDIES In clinical studies with Condylox Solution.5% podofilox solution to external genitalia did not result in detectable serum levels. The elimination half-life ranged from 1.8. The exact mechanism of action is unknown.5-trimethoxyphenyl)furo[3'.

The genesis of experimental cervical epithelial dysplasia. 2.5% Solution is supplied as a clear liquid in amber glass bottles with child-resistant screw caps. 1961.86°F). The following table represents the responses noted in terms of frequency of response by lesions treated and the overall response by patients. Do not freeze. with reference to carcinogenic. cocarcinogenic.investigators were relatively consistent. Kaminetzky HA. 3. Am J Clin Path 35:538-545. Podophyllin and the mouse cervix: assessment of carcinogenic potential. Further studies on incomplete . Swerdlow M. Berenblum I. The effect of podophyllotoxin on the skin of the mouse.5 mL of Condylox 0.30°C (59 . J Cancer Inst 11:839-841. 1951. Data are presented for the 2-week follow-up only for those patients evaluated at that time point. McGrew EA. Responses in Treated Patients Initially Recurred after Cleared Cleared* Clearing* at 2-Week Follow-up *Cleared and clearing mean no visible wart tissue remained at the treated sites % Warts 79% 35% 60% (n=524) (412/524) (146/412) (269/449) % Patients 50% 60% 25% (n=70) (35/70) (21/35) (14/57) Presentation/Pa HOW SUPPLIED cking 3. 1965. Am J Obst Gyn 95:486-490. Salaman MH. Rx only REFERENCES 1. 4. Store at controlled room temperature between 15 . Kaminetzky HA. Roe FJC. and anticarcinogenic action. NDC 52544-046-13. Avoid excessive heat.

McGrew EA: Podophyllin and mouse cervix: Effect of long term application. for Watson Pharmaceuticals. Phillips RL.2 benxanthracene and beta-propiolactone as initiators of skin tumor formation in the mouse. J Obst Gyn 14:1-10.M. CA 92880 USA by DPT Labs. 90:197-210.5 milliliter in 1 bottle. Effect of podophyllin (P) and podophylotoxine (PT) on the rat litter in utero. Brit J Pharmacol 11:437441.. 1959. 6. Ltd. 7. Arch Path 73:481-485. Inc. 1963. Thiersch JB. Kaminetzky HA.carcinogenesis: triethylene melamine (T. Jackson D. Berlin). Robson JM. Induction of the deficient acid DNAase activity in mouse interfollicular epidermis by croton oil as a possible tumor promoting mechanism. The action of some nucleotoxic substances on pregnancy.E. 1955. Kaminetzky HA. 5. Didcock K. Zeitschrift fur Krebsforschung and Klinisch Onkologie (Cancer Research and Clinical Oncology. Corona.) 1. San Antonio. Taper HS. 1977. glass Manufactur Watson Pharmaceuticals Inc er: . Experimental cervical epithelial dysplasia. Brit J Cancer. 8. TX 78215 128715-1107 S1107 Presentation/Packing Form Packing Topical Solution 3. 9. 113:124-127. 9:177-203. Mfd. 1956. McGrew EA. 1962. Soc Exptl Biol Med Proc.