(sin-e-ka-tech-ins) ,


(trade name)


Therapeutic: antivirals
Pharmacologic: botanical agents
Pregnancy Category: C


Treatment of external genital and perianal warts (Condylomata acuminata caused by human papillomavirus[HPV]) in immunocompetent patients 18 years and older.


Beneficial effects may be due to antioxidant properties; made from extract of green tea.

Therapeutic effects

Regression of warts.


Absorption: Minimal systemic absorption (less than that of a cup of green tea).
Distribution: Unknown.
Metabolism and Excretion: Unknown.
Half-life: Unknown.

Time/action profile



Contraindicated in: Not to be used for urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease or on open wounds.
Use Cautiously in: Safe and effective use in immunosuppressed patients has not been established; Obstetric: Use during pregnancy only if potential maternal benefit justifies potential risk to the fetus.; Pediatric: Safe and effective use in patients <18 yr has not been established.

Adverse Reactions/Side Effects


  • burning (most frequent)
  • edema (most frequent)
  • erythema (most frequent)
  • induration (most frequent)
  • pain/discomfort (most frequent)
  • pruritis (most frequent)
  • erosion/ulceration (most frequent)
  • vescicular rash (most frequent)
  • bleeding
  • desquamation
  • discharge
  • irritation
  • phimosis
  • rash
  • regional lymphadenitis
  • scar


Drug-Drug interaction

None noted.


Oral (Adults >18 yr) apply to warts three times daily for up to 16 wk.


15% Ointment: 15–g tubes

Nursing implications

Nursing assessment

  • Assess affected area(s) prior to and periodically during therapy.

Potential Nursing Diagnoses

Risk for infection (Indications)


  • Topical: Apply about 0.5 cm strand of brown ointment to each wart using finger(s), dabbing it on to ensure complete coverage and leaving a thin layer of ointment on warts. Uncircumcised males treating warts under the foreskin should retract foreskin and clean area daily. Avoid application to open wounds, eyes, vagina, or anus. Ointment does not need to be washed off prior to next application. When area is washed or a bath is taken, re-apply ointment.

Patient/Family Teaching

  • Instruct patient to wash hands before and after application and on how to apply ointment. Avoid bandages or occlusive dressings; loose fitting clothing may be worn. Instruct patient to read Patient Information prior to application. Continue therapy up to 16 wks or until complete clearance of all warts. Inform patient that sinecatechins is not a cure. New warts may develop during 16–wk treatment period and may be treated with ointment. If warts do not go away or return after 16 wks, contact health care professional.
  • Inform patient that genital warts are sexually transmitted and may infect partners. Advise patient to avoid sharing this medication with others, even with same symptoms.
  • Inform patient that local skin reactions (erythema, erosion, edema, itching, burning) frequently occur. Continue treatment when severity is acceptable. If severe reactions occur, wash ointment off with mild soap and water, withhold further doses and notify health care professional.
  • Advise patient to avoid exposure of treated areas to sun and UV light.
  • Advise patient to avoid sexual contact while ointment is on skin. Ointment may weaken condoms and vaginal diaphragms. Wash prior to sexual contact.
  • Advise female patients to insert tampon prior to applying ointment. If tampon is changed while ointment is on skin, avoid accidental application of ointment to the vagina.
  • Inform patient that ointment may stain clothing and bedding.
  • Advise female patients to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

  • Healing of external genital and perianal warts. Treatment is continued until warts are healed or up to 16 wks.
Drug Guide, © 2015 Farlex and Partners
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References in periodicals archive ?
Mitran et al., "Gamma-glutamyl transpeptidase alteration as a biomarker of oxidative stress in patients with human papillomavirus lesions following topical treatment with sinecatechins," Farmacia, vol.
The therapy includes topical measures: immunomodulators (imiquimod), keratolitic agents (antimitotic podophyllotoxin 0.5% solution, trichloracetic solution, salycilic acid), antimetabolites (fluorouracil), sinecatechins. Two prophylactic HPV vaccines are licensed in Europe: a bivalent (HPV types 16 and 18) and quadrivalent vaccine (also against HPV 6 and 11), which have a good safety profile and protect against high risk (30).
Earlier that year, other investigators conducted in vitro and in vivo experiments to evaluate the effects against acne of polyphenon-60, which contains various green tea catechins (now referred to as sinecatechins in the United States).
* In November 2012, German Medigene AG and pan-European group Nordic Pharma entered into an exclusive agreement for the supply and marketing of Veregen (sinecatechins 15% ointment; formerly known as Polyphenon E) for the treatment of genital warts in the Czech Republic, Slovakia, Poland, Hungary, the Baltic countries, Georgia and the Commonwealth of Independent States (CIS).
Improper use may cause a hematologic remission while neurologic manifestations continue to progress' Explicit lack of evidence * Veregen (sinecatechins) ointment: ('not established'; 'The safety and effectiveness of 'not evaluated'; Veregen have not been established for 'not studied'; treatment beyond I6 weeks or for 'not determined') multiple treatment courses.
The list of patient-applied options for treating external genital warts now includes sinecatechins 15% ointment, a green-tea extract.
The most common side effects of sinecatechins 15% are erythema, pruritus/burning, pain, ulceration, edema, induration, and vesicular rash."
Both baseline and newly emerging external genital and perianal warts were completely cleared in 53.6 percent of all patients studied who received sinecatechins. Among patients receiving placebo, the warts were cleared in 35.3 percent of patients.
* In November 2012, German Medigene and pan-European group Nordic Pharma entered into an exclusive agreement for the supply and marketing of Veregen (sinecatechins 15% ointment, formerly known as Polyphenon E) for the treatment of genital warts in the Czech Republic, Slovakia, Poland, Hungary, the Baltic countries, Georgia and the CIS.
Langley, Ph.D., of the University of Minnesota, Minneapolis, used pharmacoeconomic modeling based on data from the two phase III, double-blind, vehicle-controlled, randomized trials of sinecatechins ointment 15% (Veregen) that included more than 1,000 patients, along with a systematic review of the published imiquimod (Aldara) literature, Dr.
WAIKOLOA, HAWAII -- Sinecatechins ointment 15%--the first botanical approved by the Food and Drug Administration for prescription use--outperformed imiquimod cream 5% for treatment of external genital warts in a cost-effectiveness analysis.
The drug substance in Veregen Ointment is sinecatechins, which is a partially purified fraction of the water extract of green tea leaves from Camellia sinensis (L.) O.