Class: Skin and Mucous Membrane Agents, Miscellaneous
CAS Number: 188265-33-0
Uses for Sinecatechins
External Genital and Perianal Human Papillomavirus Warts
CDC recommends that external HPV genital warts be treated with a self-administered topical therapy (imiquimod, podofilox, sinecatechins), a topical therapy administered by a health-care provider (podophyllum resin, trichloroacetic acid [TCA], bichloroacetic acid [BCA]), or a surgical technique (cryotherapy, electrosurgery, surgical excision).4
Should not be used for treatment of urethral, intravaginal, cervical, rectal, or intra-anal HPV disease; safety and efficacy not established.1
Sinecatechins Dosage and Administration
Uncircumcised males treating warts under the foreskin should retract the foreskin and clean the area daily.1
External Genital and Perianal HPV WartsTopical
Safety and efficacy of multiple treatment courses not established.1
External Genital and Perianal HPV WartsTopical
No special population dosage recommendations.1
Cautions for Sinecatechins
No known contraindications.1
Other Forms of HPV Disease
Safety and efficacy not established for treatment of urethral, intravaginal, cervical, rectal, or intra-anal HPV disease.1
Do not apply to open wounds.1 Local skin reactions occur frequently.1 2 (See Common Adverse Effects under Cautions.) Continue therapy when severity of the local skin reaction is acceptable.1 In case of severe local reactions (i.e., pruritus), wash area with mild soap and water to remove the ointment; withhold further doses and notify clinician.1
Avoid exposure of the genital and perianal area to sunlight or ultraviolet light; effects of such light not studied.1
Safety and efficacy in immunosuppressed patients not established.1
Not known whether topical sinecatechins is distributed into human milk.1
Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.1
Common Adverse Effects
Erythema, pruritus, burning, pain/discomfort, erosion/ulceration, edema, induration, vesicular rash.1
Interactions for Sinecatechins
No formal drug interaction studies to date.1
Pharmacokinetics after topical application not fully characterized.1 Data suggest that systemic exposure to catechins following repeated topical application of sinecatechins ointment probably is less than that observed after single ingestion of 400 mL of green tea.1
Not known whether distributed into milk following topical application.1
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 ©).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
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.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2013, Selected Revisions April 4, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
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.