Dosing & Uses
Dosage Forms & Strengths
topical ointment
- 15%
Condylomata Acuminatum
Indicated for topical treatment of external genital and perianal warts (condylomata acuminatum) in immunocompetent patients
Immunocompetent patients: Apply topically q8hr; use approximately a 0.5-cm strand of ointment for each external genital or perianal wart; continue treatment until complete clearance of all warts, but not to exceed 16 wk
Immunosuppressed patients: Safety and efficacy not established
Safety and efficacy not established
Adverse Effects
>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
Warnings
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 & Lactation
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.Pharmacology
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
Images
BRAND | FORM. | UNIT PRICE | PILL IMAGE |
---|---|---|---|
Veregen topical - | 15 % ointment | ![]() |
Copyright © 2010 First DataBank, Inc.
Formulary
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