INFORMATION FOR HEALTH PROFESSIONALS
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CONDYLINE is a topical solution which contains as its active ingredient 5mg/ml podophyllotoxin in an ethanol solution. A clear, colourless solution with a smell of alcohol.
Podophyllotoxin is the most active component of podophyllin which is prepared from plant extracts. It has marked antimitotic and cytolytic activities which induce necrosis of condylomata acuminata. CONDYLINE works more rapidly and reliably than podophyllin due to the purified and standardized form of podophyllotoxin. As CONDYLINE can be accurately dosed, there is a reduced risk of severe side-effects and treatment at home is possible. High cure rates are obtained.
Absorption tests in patients treated with 0.5% podophyllotoxin showed that the application of 0.01-0.05 ml for 3 days to 10 patients, produced no demonstrable levels of podophyllotoxin in the serum 1/2-1 hour after treatment.
A dose of 0.1 ml (condylomata with a total surface of >4cm2) produced a serum level of ≤ 5ng/ml after 1-2 hours which decreased to ≤ 3ng/ml after 4 hours. With a dosage of 0.15ml, nearly comparable values were obtained, however, a level of ≤ 1ng/ml remained (in 5 patients) 12 hours after application. In 7 patients with extremely large lesions who applied 0.1-1.5ml, peak levels of 1-17ng/ml were noted after 1-2 hours. Tests in 52 patients showed that concentrations greater than 0.1ml are rarely necessary for the treatment of condylomata.
A relatively long clearance after application of 0.1 ml of 0.5% podophyllotoxin twice daily may be an indication that distribution occurs according to the 2 compartment model.
From the data obtained from absorption tests it may be concluded that the serum half-life of podophyllotoxin is somewhere between 1 and 4½ hours. Accumulation of podophyllotoxin did not occur.
External condylomata acuminata.
Apply CONDYLINE carefully on the condylomata with one of the plastic stick applicators enclosed in the package, and allow to dry.
Take care that the preparation does not come into contact with the healthy skin.
CONDYLINE should be applied twice a day for 3 consecutive days. This treatment can be repeated every week, for a maximum of 5 successive weeks.
CONDYLINE should not to be used during pregnancy and lactation or in children. CONDYLINE may not be used in combination with any other podophyllin preparation because of possible symptoms of toxicity.
CONDYLINE should be allowed to dry thoroughly after application in order to avoid inadvertent spreading. This particularly applies to condylomata which are localized on the preputium. CONDYLINE should not come into contact with the eyes as it will cause very severe irritation. Should this accidentally happen rinse the eyes immediately and for a long time with water.
Local irritation and/or ulceration of healthy mucosae of the skin in the vicinity or at the base of the condylomata through inadvertent contact with CONDYLINE can be prevented by applying a protective layer of neutral cream, vaseline or zinc ointment on the surrounding skin prior to treatment.
Application of this preparation on relatively large mucosal surfaces may lead to general reactions and should be avoided. In addition (as has been mentioned under (Dosage and Administration) contact of the substance with the healthy surrounding skin or mucosa should be avoided.
Human studies have indicated that the compound may be harmful during pregnancy. Therefore, CONDYLINE should not be used during pregnancy.
It is unknown whether podophyllotoxin and/or its metabolites are excreted via breast-milk. In view of the cytostatic properties of podophyllotoxin, harm to the infant cannot be ruled out. Therefore, CONDYLINE should not be used during breast-feeding.
There is no data concerning the effect of CONDYLINE on the ability to drive and use machines, but CONDYLINE is not expected to exert any influence.
Local side-effects do occur, mainly with an optimal therapeutic effect and usually on the second or third day of treatment when necrosis of the condylomata starts. These adverse reactions are generally mild and well tolerated by the patients if this possibility is discussed with them beforehand. Redness with slight pain and/or superficial ulceration of the epithelium in the treated area can be expected and the application of CONDYLINE may therefore be painful. Oedema and balanoposthitis have been observed in some patients with large warts in the preputial cavity. Such local effects improve after a few days of anti-inflammatory therapy, i.e. with a topical corticosteroid.
Nil
Overdosage may result in systemic toxicity. Systemic toxicity is only to be expected if more than one bottle is used. Symptoms of intoxication include: nausea, vomiting, diarrhoea, tachycardia, hypotension, tachypnea (also espiratory insufficiency) and CNS symptoms like dizzines, stupor, coma and peripheral neuropathy. Symptomatic treatment is indicated in such cases. If coma occurs hemoperfusion over active charcoal maybe useful, although its effectiveness has not been proven sufficiently.
CONDYLINE will keep at room temperature (below 25°C) until the date indicated on the package.
Prescription Medicine.
Bottles containing 3.5ml CONDYLINE.
Ethanol, lactic acid, sodium lactate and purified water.
CSL Biotherapies (NZ) Limited
666 Great South Rd
Central Park
Auckland
New Zealand
Ph: 0800 502 757
29 February 2008
CONDYLINE® is a registered trademark of Astellas Pharma Europe BV.