Veregen

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Veregen

Classes

Other Topical Agents Used In Viral Infections

Administration
Topical Administration

For topical use to external areas only; avoid ocular, intra-vaginal, urethral and intra-anal exposure; avoid application onto open wounds.
Wash hands before and after applying ointment.
Using a fingertip, apply approximately a 0.5 cm strand of ointment to each wart. Ensure that each wart is completely covered leaving a thin layer of ointment on top.
It is not necessary to wash ointment off of a treated area prior to the next application. When the treatment area is washed, the ointment should be applied afterwards.
For females using tampons, insert tampon before applying ointment.
For uncircumcised males treating warts under the foreskin, pull back the foreskin and clean the area daily.
Do not use occlusive dressings.
Avoid sexual contact while ointment is on skin.

Adverse Reactions
Severe

phimosis / Delayed / 3.0-3.0
skin necrosis / Early / 0-1.0

Moderate

erythema / Early / 70.0-70.0
skin ulcer / Delayed / 49.0-49.0
skin erosion / Delayed / 49.0-49.0
edema / Delayed / 45.0-45.0
lymphadenopathy / Delayed / 3.0-3.0
bleeding / Early / 2.0-2.0
hyperesthesia / Delayed / 0-1.0
cervical dysplasia / Delayed / 0-1.0
superinfection / Delayed / 0-1.0
dysuria / Early / Incidence not known
contact dermatitis / Delayed / Incidence not known

Mild

pruritus / Rapid / 69.0-69.0
vesicular rash / Delayed / 20.0-20.0
pelvic pain / Delayed / 0-1.0
skin irritation / Early / 0-1.0
rash / Early / 1.0-1.0
infection / Delayed / 0-1.0
skin discoloration / Delayed / 0-1.0

Common Brand Names

Veregen

Dea Class

Rx

Description

Self-administered green tea ointment for the treatment of external genital and perianal warts; does not eradicate HPV; recurrence rate is unknown.

Dosage And Indications
For the treatment of external genital and perianal warts (condylomata acuminata).
NOTE: Sinecatechins has not been evaluated for the treatment of urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease and is not recommended for these conditions.
NOTE: Sinecatechins has not been evaluated for treatment beyond 16 weeks, for multiple treatment courses, or for use in immunocompromised patients.
Topical dosage Adults

0.5 cm topically to each wart 3 times daily until complete clearance of all warts or for a maximum of 16 weeks.

Children weighing 45 kg or more† and Adolescents†

0.5 cm topically to each wart 3 times daily until complete clearance of all warts or for a maximum of 16 weeks.

Dosing Considerations
Hepatic Impairment

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Renal Impairment

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

Drug Interactions

There are no drug interactions associated with Sinecatechins products.

How Supplied

Sinecatechins/Veregen Topical Ointment: 15%

Maximum Dosage
Adults

3 applications/day topically.

Geriatric

3 applications/day topically.

Adolescents

Safety and efficacy have not been established; however, up to 3 applications/day topically is recommended off-label.

Children

Safety and efficacy have not been established; however, up to 3 applications/day topically is recommended off-label in older children weighing 45 kg or more.

Mechanism Of Action

Mechanism of Action: The exact mechanism of action of sinecatechins ointment is unknown; although the manufacturer states that the ointment has demonstrated in vitro antioxidative activity. Systemically administered green tea extracts have demonstrated antioxidant, antiplatelet, antihyperlipidemic, antihypertensive, fibrinolytic, anticarcinogenic, anticariogenic, antimicrobial, and thermogenic actions (see green tea monograph). Of particular importance, epigallocatechin gallate (EGCG), a major component of both green tea and sinecatechins ointment, has been shown to suppress the growth of human papilloma virus (HPV)-infected cervical cancer cell lines ; HPV is the same virus that is usually responsible for genital and perianal warts.

Pharmacokinetics

Sinecatechins are administered topically.

Topical Route

Percutaneous absorption of the sinecatechins is minimal. One study compared systemic exposures of four catechin components [epigallocatechin gallate (EGCg), epigallocatechin (EGC), epicatechin gallate (ECg), and epicatechin (EC)] following topical application of the 15% sinecatechins ointment (250 mg applied three times daily for 7 days) against oral ingestion of a green tea beverage (500 ml PO three times daily for 7 days). In this study, the topically applied ointment failed to produce quantifiable plasma concentrations (>= 5 ng/ml) for any of the four catechins on day 1; however on day 7, measurable plasma concentrations of EGCg were detected in 2 of 20 subjects. In these 2 subjects, the EGCg mean Cmax was 10.1 ng/ml and the mean AUC was 52.2 ng x hr/ml. Following oral ingestion of the green tea beverage, plasma concentration of EGCg were measurable in all subjects on both day 1 and day 7, with a mean Cmax of 23 ng/ml and mean AUC of 104.6 ng x hr/ml on day 7.

Pregnancy And Lactation
Pregnancy

Data are limited regarding use of sinecatechins ointment during human pregnancy. Animal studies have been conducted in rats and rabbits, but have reported conflicting results. Oral doses of up to 86-times the maximum recommended human dose (MRHD) in rats and 173-times the MRHD in rabbits given during organogenesis did not cause adverse effects on embryo-fetal development or teratogenicity. Subcutaneous doses of 0.7-times MRHD administered to pregnant rabbits during organogenesis also did not cause adverse effects on embryo-fetal development or teratogenicity. Daily vaginal administration of 8-times the MRHD to rats from day 4 before mating through organogenesis (day 17 of gestation) resulted in no treatment-related effects on the fetus or teratogenicity. However, in another study using vaginal administration, those rats that received 8-times the MRHD had more birthing complications and stillbirths. No other effects on pre- or postnatal development and growth were noted. Lastly, in rabbits given subcutaneous doses during the period of organogenesis, in the presence of maternal toxicity (local irritation at administration sites, decreased body weight and decreased food consumption), reduced fetal weights and delayed skeletal ossification were found. There are no adequate and well-controlled studies in pregnant women; however, the ointment is a water extract of green tea leaves which, according to the Natural Medicines Comprehensive Database, is thought to be safe in pregnancy following moderate consumption. The risk to the fetus appears to be low at the recommended dose.[42880] [49215]

Data are limited regarding use of sinecatechins ointment during breast-feeding, and excretion of the major ointment components, such as catechins, in human milk is unknown. However, the ointment is a water extract of green tea leaves which, according to the Natural Medicines Comprehensive Database, is thought to be safe when systemically consumed in moderate amounts during breast-feeding; systemic exposure following topical administration is expected to be less than drinking 400 ml of green tea. Thus, the risk to a nursing infant appears to be low at the recommended dose. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.