sinecatechins

sinecatechins

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

Veregen

(trade name)

Classification

Therapeutic: antivirals
Pharmacologic: botanical agents
Pregnancy Category: C

Indications

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

Action

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

Therapeutic effects

Regression of warts.

Pharmacokinetics

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

ROUTEONSETPEAKDURATION
TOPunknownunknownunknown

Contraindications/Precautions

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

Local

  • 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

Interactions

Drug-Drug interaction

None noted.

Route/Dosage

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

Availability

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)

Implementation

  • 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.
Mentioned in ?
References in periodicals archive ?
Drugs profiles discussed in this report are sterol, estradiol hemihydrates, oxytocin, prasterone, RES-102, sinecatechins, TX-004HR, WC-3011.
Drug profiles mentioned in this research include aminolevulinic acid hydrochloride, BIL-010t, BMS-833923, CIGB-128, CS-S/BCC-1, CS-TATI-1, DAC-060, erismodegib, interferon alfa-2b (recombinant), LEQ-506, Oshadi D + Oshadi R, Poly-ICLC, sinecatechins, Small Molecule to Inhibit Smoothened Receptor for Basal Cell Carcinoma, Small Molecules to Inhibit Casein Kinase 1 for Cancer and TG-1042.
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.
from Bogota, Colombia, evaluated the possible benefits of sinecatechins for treating anogenital warts.
6 percent of all patients studied who received sinecatechins.
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.
The active ingredient in Veregen(TM) is sinecatechins, a proprietary mixture of 8 catechins, the primary phenols found in green tea leaves.
Veregen(TM)'s novel active ingredient, sinecatechins, is derived from the extract of green tea.