Presentation and Status in Health Basket
Treatment is carried out twice daily (at an interval of 12 hours) on three consecutive days. Then a treatment-free interval of four days should be observed. Therapy should be repeated until the condylomata disappear; the maximum duration of administration is four weeks. If no success in treatment can be achieved after four treatment cycles, a different from of therapy must be chosen. Prior to application, the body parts to be treated must be washed carefully with water and soap and subsequently dried with caution. The solution is applied with a cotton tipped applicator on the condylomata. The cotton pad may be used only once! Take care that podophyllotoxin does not reach the surrounding healthy skin and/or mucosa. This drug should not be applied to non-genital warts. After application, let it dry for a few minutes. The solution is left at the site of application and must not be washed off again. The treated spots must have dried before coming in contact with clothing. After each treatment hands should be cleaned thoroughly. Therapy with this solution may be carried out at home by the patients themselves. However, lesions in the female and lesions greater than 4cm² in the male should be treated under direct medical supervision.
Children: The solution is contraindicated in children under the age of 12.
Treatment of external genital warts (Condylomata Acuminatum).
Over-sensibility to podophyllotoxin or another excipient of the solution. Inflamed or bleeding pointed condylomata, or open wounds following surgical procedures. Simultaneous administration of other preparations containing podophylline . Pregnancy and lactation. Children under the age of 12.
There are no data available on the administration of this solution in young adults between 12 and 18 years. The solution must not come in contact with the eyes. However, if podophyllotoxin gets into the eye, immediate rinsing with water should be carried out and a doctor should be consulted. The drug is exclusively used for the therapy of condylomata and must not be applied to other warts or naevi. Contact with healthy skin is to be avoided. Lesions in the female and lesions greater than 4 cm2 in the male should be treated under direct medical supervision. Male patients should wear condoms until healed completely. The partners should be requested to have themselves examined by a doctor.
Disorders of the reproductive system and breast: Podophyllotoxin may induce balanoposthitis.
Skin and subcutaneous tissue disorders: Local irritation symptoms of the area treated such as itching, burning, Phimoses, erosions and ulcerations have been observed. The frequency of these side effects is unknown.
Simultaneous treatment with other preparations containing podophylline should be avoided, since these also contain podophyllotoxin.
Pregnancy and Lactation
This drug causes serious damage to the unborn child if used during pregnancy, It is contraindicated during pregnancy and lactation.
The risk of systemic toxicity after topical administration is increased with large-area treatment using excessive quantities for a longer period, or when treating bleeding or recently eliminated pointed condylomata, and with unintentional administration on intact skin or mucosa. Symptoms include nausea, vomiting, abdominal pain and diarrhoea; thrombocytopenia, leukopenia, hepatotoxicity or renal failure may occur. CNS-related adverse events are delayed in onset and prolonged in duration and include acute psychotic reactions, hallucinations, confusion, dizziness, stupor, ataxia, hypotonia, seizures and coma. Peripheral and autonomic neuropathies develop later and may result in paraesthesias, reduced reflexes, muscle weakness, tachycardia, apnoea, orthostatic hypotension, paralytic ileus and urinary retention. After topical overdose the skin is to be cleaned thoroughly with soap and water, Eyes are to be rinsed thoroughly with water or if available, with an appropriate eye-cleaning solution. If accidentally ingested, give stomach washout and monitor electrolyte balance, blood gases, liver function and blood picture.
Self-life: 2 years. Shelf life after first opening: 6 weeks or expiry date whichever comes first.
Storage and handling: Do not store above 25ºC. Light protection required. The solution is flammable and should be kept away from naked flames.