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  • CLASSES

    Other Topical Agents Used In Viral Infections

    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.

    COMMON BRAND NAMES

    Veregen

    HOW SUPPLIED

    Veregen Topical Ointment: 15%

    DOSAGE & INDICATIONS

    For the treatment of external genital and perianal warts (Condylomata acuminata).
    NOTE: Sinecatechins ointment 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 ointment has not been evaluated for treatment beyond 16 weeks, for multiple treatment courses, or for use in immunocompromised patients.
    Topical dosage
    Adults

    Apply approximately a 0.5 cm strand of sinecatechins 15% ointment three times a day to each wart. Ensure that each wart is completely covered leaving a thin layer of ointment on top. Continue therapy until there is a total clearance of warts or for a maximum of 16 weeks.

    Children weighing 45 kg or more† and Adolescents†

    Apply approximately a 0.5 cm strand of sinecatechins 15% ointment three times a day to each wart. Ensure that each wart is completely covered leaving a thin layer of ointment on top. Continue therapy until there is a total clearance of warts or for a maximum of 16 weeks.

    MAXIMUM DOSAGE

    Adults

    3 applications/day topically.

    Elderly

    3 applications/day topically.

    Adolescents

    Safety and efficacy have not been established.

    Children

    Safety and efficacy have not been established.

    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.

    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.

    STORAGE

    Veregen:
    - After dispensing, store refrigerated or up to 77 degrees F
    - Do not freeze
    - Prior to dispensing, store in refrigerator (36 to 46 degrees F)

    CONTRAINDICATIONS / PRECAUTIONS

    General Information

    Sinecatechins ointment is contraindicated in patients with a known hypersensitivity to the product, any of its components, or green tea.
     
    Sinecatechins ointment has not been evaluated for treatment beyond 16 weeks or for multiple treatment courses.
     
    Patients should be advised that sinecatechins ointment may stain clothing or bedding.

    Accidental exposure, ocular exposure, vaginal administration

    Mild to moderate local skin reactions to the drug are common, and treatment should be continued as long as the reaction is tolerable. Should a severe local skin reaction occur, the entire treatment area should be washed with mild soap and water and future doses held. Sinecatechins 15% ointment is for topical external use as directed only; avoid accidental exposure to other areas, including ocular exposure, vaginal administration or rectal administration. Avoid application to open wounds.

    Immunosuppression

    The safety and efficacy of sinecatechins ointment use in patients with immunosuppression have not been established.

    Sunlight (UV) exposure

    During treatment, sunlight (UV) exposure to the genital and perianal area should be avoided, as sinecatechins ointment has not been evaluated under this condition.

    Contraceptive devices

    Sinecatechins ointment may weaken barrier contraceptive devices such as condoms and vaginal diaphragms. Therefore, reliance on these devices for birth control is not recommended during the treatment of genital/perianal warts. Sexual contact should be avoided while the ointment is on the skin; should sexual contact occur, the sinecatechins ointment should be removed by washing prior to contact. In addition, the effects of sinecatechins ointment on the transmission of genital/perianal warts are not known.

    Occlusive dressing

    An occlusive dressing should not be applied to the treatment area during sinecatechins therapy.

    Geriatric

    It is not known if geriatric patients respond differently than younger patients to sinecatechins ointment. During clinical trials, only 7 (1.4%) patients were over the age of 65 years.

    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]

    Children, infants, neonates

    Safe and effective use of sinecatechins 15% ointment have not been established in neonates, infants, children and adolescents < 18 years of age.

    Breast-feeding

    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.

    Viral infection

    Although green tea extract formulations have been investigated for the treatment of human papilloma virus (HPV) viral infection, specifically infected cervical lesions , the manufacturer of sinecatechins 15% ointment (Veregen) states that this product has not been evaluated for the treatment of internal urethral, intra-vaginal, cervical, or rectal HPV. Such use is not recommended.

    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

    DRUG INTERACTIONS

    There are no drug interactions associated with Sinecatechins products.

    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.

    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.