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sinecatechins topical (Veregen)

 

Classes: Topical Skin Products

Dosing and uses of Veregen (sinecatechins topical)

 

Adult dosage forms and 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 tid; 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

 

Pediatric dosage forms and strengths

<18 years: Safety and efficacy not established

 

Veregen (sinecatechins topical) adverse (side) effects

>10%

Erythema

Pruritus

Burning

Pain/discomfort

Erosion/ulceration

Edema

Induration

Vesicular rash

 

1-10%

Phimosis

Inguinal lymphadenitis

Desquamation

Discharge

Bleeding

Scarring

Irritation

Rash

 

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

Avoid sexual contact while ointment is on skin

 

Pregnancy and lactation

Pregnancy category: C

Lactation: Unknown whether distributed in breast milk, caution advised

 

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 of Veregen (sinecatechins topical)

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