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of excellent [12:<25 C. 1 Do not freeze. 1 Actions A botanical drug product; a partially purified fraction of the water extract of green tea leaves from Camellia sinensis (L.) O Kuntze . 1 Mechanism of action in treatment of external genital and perianal HPV warts is unknown. 1 Antioxidant activity demonstrated in vitro; the clinical importance of this finding is unknown. 1 Green tea catechins may have immunostimulant, antitumor, and potent antiviral properties that may contribute to the therapeutic effect of sinecatechins ointment. 2 Consists principally of catechins (85 95% by weight), including more than 55% epigallocatechin gallate (EGCg); other catechin derivatives present include epicatechin (EC), epigallocatechin (EGC), epicatechin gallate (ECg), gallocatechin gallate (GCg), gallocatechin (GC), catechin gallate (Cg), and catechin (C). 1 2 Also contains gallic acid, caffeine, and theobromine (together account for 2.5% of total drug substance) plus undefined botanical constituents. 1 Advice to Patients Importance of reading manufacturer s patient information. 1 Importance of using only as directed by clinician. 1 Importance of applying externally only; importance of avoiding contact with the eyes or application into the vagina or anus. 1 Importance of advising patients that sinecatechins ointment is not a cure for external genital and perianal warts. 1 New warts may appear during therapy and also should be treated. 1 Local skin reactions are common. 1 (See Dermatologic Effects under Cautions.) If severe skin reactions occur, contact clinician, wash treatment area with mild soap and water, and withhold further application. 1 Importance of advising patients to avoid sexual (genital, anal, or oral) contact while the ointment is on the skin. 1 4 The ointment must be washed off carefully before having protected sexual contact, since the ointment may weaken condoms and vaginal diaphragms. 1 Importance of advising patients that the effect of sinecatechins on the transmission of genital and perianal warts is unknown. 1 Importance of advising female patients using tampons that a tampon should be inserted before applying the ointment; avoid accidental application of the ointment into the vagina if the tampon is changed while the ointment is on the skin. 1 Importance of advising uncircumcised males to retract the foreskin and clean the area daily. 1 Importance of advising patients to avoid exposure of the genital and perianal area to sunlight or ultraviolet light. 1 Importance of advising patients not to bandage, cover, or wrap the treatment area. 1 (See Topical Administration under Dosage and Administration.) Importance of advising patients that the ointment may stain clothing or bedding. 1 Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed. 1 Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses. 1 Importance of informing patients of other important precautionary information. 1 (See Cautions.) Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Sinecatechins Routes Dosage Forms Strengths Brand Names Manufacturer Topical Ointment 15% Veregen PharmaDerm AHFS DI Essentials. Copyright 2017, Selected Revisions April 4, 2011. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. References 1. PharmaDerm. Veregen (sinecatechins) ointment, 15% prescribing information. Melville, NY; 2008 Sep. 2. Tatti S, Swinehart JM, Thielert C et al. Sinecatechins, a defined green tea extract, in the treatment of external anogenital warts: a randomized controlled trial. Obstet Gynecol . 2008; 111:1371-9. [PubMed 18515521] 3. PharmaDerm, Melville, NY: Personal communication. 4. Workowski KA, Berman S, Centers for Disease Control and Prevention (CDC). Sexually transmitted diseases treatment guidelines, 2010. MMWR Recomm Rep . 2010; 59(RR-12):1-110. Next Pregnancy Warnings Print this page Add to My Med List More about sinecatechins topical Side Effects During Pregnancy Dosage Information Support Group En EspaƱol 0 Reviews Add your own review/rating Drug class: anorectal preparations Consumer resources Polyphenon E ... +3 more Professional resources Sinecatechins (Wolters Kluwer) Other brands: Veregen Related treatment guides Condylomata Acuminata> ] FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class Anorectal preparations Topical anti-infectives Related Drugs Condylomata Acuminata imiquimod topical , Aldara , Intron A , Condylox , Zyclara , Veregen , interferon alfa-2b , podofilox topical , Alferon N , More... 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