sinecatechins topical (Rx)

>10%

Erythema (70%)

Pruritus (69%)

Burning (67%)

Pain/discomfort (56%)

Erosion/ulceration (49%)

Edema (45%)

Induration (35%)

Vesicular rash (20%)

1-10%

Phimosis (3%)

Inguinal lymphadenitis

Desquamation (5%)

Discharge (3%)

Bleeding (2%)

Scarring (1%)

Irritation (1%)

Rash (1%)

< 1%

Facial rash

Vulvitis

Eczema

Hyperesthesia

Pigmentation changes

Discoloration

Necrosis

Papules

Pelvic pain

Perianal infection

Contraindications

Hypersensitivity

Cautions

Not evaluated for urethral, intravaginal, cervical, rectal, or intra-anal HPV disease and should not be used to treat these conditions

Avoid application to open wounds, eyes, and nose

Wash hands before and after application

Severe reactions reported more commonly in women

Severe reactions may require treatment interruption or discontinuation

Avoid sexual contact while ointment is on skin

Ointment not intended for internal use (avoid applying to open wounds)

Avoid exposure of treated areas to UV-light

Continue treatment until all warts have been cleared; not to exceed 16 weeks

Pregnancy

There are no available data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

Animal data

• In animal reproduction studies, drug did not cause malformations, but did affect the developing fetus in presence of maternal toxicity when given to pregnant rabbits and rats by intravaginal or systemic routes of administration during period of organogenesis; available data do not allow calculation of relevant comparisons between systemic exposure of drug observed in animal studies to systemic exposure that would be expected in humans after topical use

Lactation

There are no data on presence of sinecatechins in human or animal milk, effects on breastfed child, or on milk production; after topical application, product concentrations in plasma are low and therefore concentrations in human breast milk are likely to be low

Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breast-fed child from product or from underlying maternal condition

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Botanical for topical use consisting of extract from green tea leaves; mode of action unknown, but does elicit antioxidant activity in vitro

Pharmacokinetics

Absorption: Minimal