Drug Detail:Polyphenon e ointment (Green tea polyphenol extract)
Drug Class: Anorectal preparations Topical anti-infectives
Usual Adult Dose for Condylomata Acuminata
Apply a thin layer (0.5 cm) to all external genital and perianal warts 3 times a day
- Duration of therapy: Continue until complete clearance of all warts; not to exceed 16 weeks
Comments:
- It is not necessary to wash off ointment from treatment areas prior to next application.
- Localized skin reactions (e.g., erythema) at application site are common and treatment should continue when severity of the local skin reaction is acceptable.
- Safety and effectiveness have not been established for treatment beyond 16 weeks or for multiple treatment courses.
Use: For the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients
Renal Dose Adjustments
Data not available
Liver Dose Adjustments
Data not available
Precautions
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Data not available
Other Comments
Administration advice:
- For external use only; not for ophthalmic, oral, intravaginal, or intra-anal use.
- Wash hands before and after applications.
- Treatment area should not be bandaged or otherwise covered or wrapped as to be occlusive.
- Uncircumcised males treating warts under foreskin should retract foreskin and clean the area daily.
Storage requirements:
- Prior to dispensing, store in refrigerator at 2C to 8C (36F to 46F); after dispensing, store refrigerated or up to 25C (77F); do not freeze.
General:
- Clinical studies did not include a sufficient number of patients older than 65 years and it is therefore unknown if they respond differently.
- Safety and effectiveness in immunosuppressed patients have not been established.
Patient advice:
- This drug may weaken condoms and vaginal diaphragms; this combination should be avoided.
- Female patients using tampons should insert the tampon prior to ointment application; accidental application into the vagina while changing the tampon must be avoided.
- This drug may stain clothing and bedding.
- Avoid exposure of the genital and perianal area to sun/ultraviolet light.
- All sexual contact should be avoided while ointment is on skin, or ointment should be washed off prior to activities.
