Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
podophyllotoxin
GlaxoSmithKline Australia Pty Ltd
podophyllotoxin
Registered
WARTEC CREAM ® 1 WARTEC CREAM ® _0.15% w/v podophyllotoxin _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Wartec Cream. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the benefits of you using Wartec Cream against the risks they expect it may have for you. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT WARTEC CREAM IS USED FOR Wartec Cream contains podophyllotoxin, a plant extract that has antiwart properties. It works by destroying the skin of the wart. Wartec Cream is used on the skin to treat warts that are found in the external genital region (penis or vulva) or around the anus. It should not be used to treat warts that are found inside the anus or urinary canals of the penis or the vulva. These types of warts are commonly referred to as anogenital or venereal warts. They are caused by the Human Papilloma Virus (HPV). Up to half of sexually active adults are infected with HPV but only a small percentage will show outward signs of the virus. Anogenital warts are usually soft and skin coloured with a fleshy appearance. They are contagious and infection can occur through direct skin-to-skin contact. In adults, infection commonly occurs through sexual contact. Anogenital warts generally appear about 3 months after infection occurs; however they may not show themselves for over a year. Wartec Cream is not addictive. Wartec Cream is only available with a doctor's prescription. BEFORE YOU USE WARTEC CREAM DO NOT USE WARTEC CREAM IF YOU HAVE AN ALLERGY TO: any medicine containing podophyllotoxin any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: shortness of breath wheezing or difficulty breathing swelling of the face, lips, tongue or other parts of the Lesen Sie das vollständige Dokument
1 PRODUCT INFORMATION WARTEC ® CREAM NAME OF THE MEDICINE WARTEC Cream contains podophyllotoxin as the active ingredient. CAS number:518-28-5 DESCRIPTION WARTEC Cream is a white cream for topical use. WARTEC Cream contains 0.15% w/w podophyllotoxin. WARTEC Cream also contains purified water, stearyl alcohol, cetyl alcohol, isopropyl myristate, liquid paraffin, medium chain triglycerides, butylated hydroxyanisole (BHA), steareth-7, steareth-10, phosphoric acid, methyl hydroxybenzoate, propyl hydroxybenzoate and sorbic acid. PHARMACOLOGY Podophyllotoxin is a metaphase inhibitor in dividing cells binding to at least one binding site on tubulin. Binding prevents tubulin polymerisation required for microtubule assembly. At higher concentrations, podophyllotoxin also inhibits nucleoside transport through the cell membrane. The chemotherapeutic action of podophyllotoxin is assumed to be due to inhibition of growth and the ability to invade the tissue of the viral infected cells. PHARMACOKINETIC PROPERTIES ABSORPTION / DISTRIBUTION / METABOLISM / EXCRETION Systemic absorption of podophyllotoxin after topical application of 100 mg of 0.3% cream or 100 µL of 0.5% solution has been studied (extravaginally in 10 healthy females (mean age 24 years), and within the preputial cavity in 10 healthy males (mean age 24 years), each on 2 occasions separated by 8 hours).C max was at or below 4.7 ng/mL following all doses and T max ranged from 0.5 to 36 hrs; in some subjects 2 concentrations were below the limit of detection. The C max and T max were comparable for the 0.3% cream and 0.5% solution in both males and females. It can be concluded that systemic absorption of recommended doses of podophyllotoxin cream or solution is expected to be low. In a study, a total of 69 patients received 0.5% podophyllotoxin (Wartec) solution. The toxin was not detected in the serum of patients treated with less than 50 µL. Out- patients who received less than 100 µL gave rise to peak levels of podophyllotoxin of ≤5.0 ng/mL. In the serum of 7 Lesen Sie das vollständige Dokument