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Veregen® is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older.
Limitations of Use
The safety and effectiveness of Veregen® have not been established for treatment beyond 16weeks or for multiple treatment courses.
The safety and effectiveness of Veregen® in immunosuppressed patients have not been established.
DOSAGE AND ADMINISTRATION
General Dosing Information
Veregen® is to be applied three times per day to all external genital and perianal warts.
Apply about an 0.5 cm strand of the Veregen® to each wart using the finger(s), dabbing it on to ensure complete coverage and leaving a thin layer of the ointment on the warts. Patients should wash their hands before and after application of Veregen®.
It is not necessary to wash off the ointment from the treated area prior to the next application.
Veregen® is not for ophthalmic, oral, intravaginal, or intra-anal use.
Treatment with Veregen® should be continued until complete clearance of all warts, however no longer than 16 weeks.
Local skin reactions (e.g. erythema) at the treatment site are frequent. Nevertheless, treatment should be continued when the severity of the local skin reaction is acceptable.
Dosage Forms And Strengths
Ointment, 15% w/w. Each gram of Veregen® Ointment, 15% contains 150 mg of sinecatechins in a brown ointment base.
Storage And Handling
Veregen® is a brown ointment and is supplied in an aluminum tube containing 15 grams (NDC # 10337-450-15) of ointment per tube or 30 grams (NDC # 10337-450-03) of ointment per tube.
Prior to dispensing to the patient, store refrigerated 2°C to 8°C (36°F to 46°F). After dispensing, store refrigerated or up to 25°C (77°F). Do not freeze.
Keep out of reach of children.
Manufactured for: PharmaDerm, A division of fougers Pharmaceuticals Inc., Melville, New York 11747. Manufactured by: C.P.M. Contract Pharma GmbH & Co. KG Frühlingstrasse 7 D-83620 Feldkirchen-Westerham Germany. Revised: 11/2012This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/7/2012
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