Veregen
Loading...Veregen Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Veregen® is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older.
The safety and effectiveness of Veregen® have not been established for treatment beyond 16-weeks or for multiple treatment courses.
The safety and effectiveness of Veregen® in immunosuppressed patients have not been established.
History
There is currently no drug history available for this drug.
Other Information
Veregen® (sinecatechins) Ointment, 15% is a botanical drug product for topical use. The drug substance in Veregen® is sinecatechins, which is a partially purified fraction of the water extract of green tea leaves from Camellia sinensis (L.) O Kuntze, and is a mixture of catechins and other green tea components. Catechins constitute 85 to 95% (by weight) of the total drug substance which includes more than 55% of Epigallocatechin gallate (EGCg), other catechin derivatives such as Epicatechin (EC), Epigallocatechin (EGC), Epicatechin gallate (ECg), and some additional minor catechin derivatives i.e. Gallocatechin gallate (GCg), Gallocatechin (GC), Catechin gallate (Cg), and Catechin (C). In addition to the known catechin components, it also contains gallic acid, caffeine, and theobromine which together constitute about 2.5% of the drug substance. The remaining amount of the drug substance contains undefined botanical constituents derived from green tea leaves.
The structural formulae of catechins are shown below.
General Structure of Catechins
Each gram of the ointment contains 150 mg of sinecatechins in a water free ointment base consisting of isopropyl myristate, white petrolatum, cera alba (white wax), propylene glycol palmitostearate, and oleyl alcohol.
Sources
Veregen Manufacturers
-
Pharmaderm A Division Of Fougera Pharmaceuticals Inc.
![Veregen (Sinecatechins) Ointment [Pharmaderm A Division Of Fougera Pharmaceuticals Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Veregen | Pharmaderm A Division Of Fougera Pharmaceuticals Inc.
2.1 General Dosing InformationVeregen® 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.
2.2 Treatment PeriodTreatment 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.
Login To Your Free Account