Sinecatechins

Antioxidant; a green tea extract consisting predominantly of catechins.1 2

External Genital and Perianal Human Papillomavirus Warts

Treatment of external genital and perianal warts (condylomata acuminata) caused by human papillomavirus (HPV) in immunocompetent patients.1 4

CDC recommends that external HPV genital warts be treated with a self-administered topical therapy (imiquimod, podofilox, sinecatechins), a topical therapy administered by a health-care provider (podophyllum resin, trichloroacetic acid [TCA], bichloroacetic acid [BCA]), or a surgical technique (cryotherapy, electrosurgery, surgical excision).4

Should not be used for treatment of urethral, intravaginal, cervical, rectal, or intra-anal HPV disease; safety and efficacy not established.1

Contraindications

• No known contraindications.1

Warnings/Precautions

Other Forms of HPV Disease

Safety and efficacy not established for treatment of urethral, intravaginal, cervical, rectal, or intra-anal HPV disease.1

Dermatologic Effects

Do not apply to open wounds.1 Local skin reactions occur frequently.1 2 (See Common Adverse Effects under Cautions.) Continue therapy when severity of the local skin reaction is acceptable.1 In case of severe local reactions (i.e., pruritus), wash area with mild soap and water to remove the ointment; withhold further doses and notify clinician.1

Avoid exposure of the genital and perianal area to sunlight or ultraviolet light; effects of such light not studied.1

Immunologic Effects

Safety and efficacy in immunosuppressed patients not established.1

Specific Populations

Category C.1

Not known whether topical sinecatechins is distributed into human milk.1

Safety and efficacy not established in pediatric patients.1 Consult a clinician before using in children <12 years of age.3

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.1

Common Adverse Effects

Erythema, pruritus, burning, pain/discomfort, erosion/ulceration, edema, induration, vesicular rash.1

No formal drug interaction studies to date.1

• A botanical drug product; a partially purified fraction of the water extract of green tea leaves from Camellia sinensis (L.) O Kuntze.1

• Mechanism of action in treatment of external genital and perianal HPV warts is unknown.1 Antioxidant activity demonstrated in vitro; the clinical importance of this finding is unknown.1 Green tea catechins may have immunostimulant, antitumor, and potent antiviral properties that may contribute to the therapeutic effect of sinecatechins ointment.2

• Consists principally of catechins (85–95% by weight), including more than 55% epigallocatechin gallate (EGCg); other catechin derivatives present include epicatechin (EC), epigallocatechin (EGC), epicatechin gallate (ECg), gallocatechin gallate (GCg), gallocatechin (GC), catechin gallate (Cg), and catechin (C).1 2 Also contains gallic acid, caffeine, and theobromine (together account for 2.5% of total drug substance) plus undefined botanical constituents.1

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

• If you have an allergy to sinecatechins or any other part of this medicine (sinecatechins).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad skin irritation.
• Blisters or sores.
• Oozing or bleeding.
• Pain when passing urine.
• Trouble passing urine.
• Groin or pelvic pain or swelling.

• Store at room temperature or in a refrigerator. Do not freeze.
• Protect from heat.
• Keep lid tightly closed.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

There are no known significant interactions.