Skip to Content

Sinecatechins

Medically reviewed by Drugs.com. Last updated on Aug 15, 2020.

Pronunciation

(sin e KAT e kins)

Index Terms

  • Catechins
  • Kunecatechins
  • Polyphenols
  • Polyphenon E

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Ointment, External:

Veregen: 15% (30 g) [contains propylene glycol]

Brand Names: U.S.

  • Veregen

Pharmacologic Category

  • Keratolytic Agent
  • Topical Skin Product

Pharmacology

The mechanism by which sinecatechins ointment aids in the clearance of genital and perianal warts is unknown. Antioxidant properties have been demonstrated in vitro; however, the significance of this finding is not known.

Absorption

Topical: Not sufficiently studied; based on limited data, minimal systemic absorption is expected.

Use: Labeled Indications

External genital and perianal warts (Condyloma acuminatum): Treatment of external genital and perianal warts (Condyloma acuminatum) in immunocompetent patients ≥18 years of age.

Contraindications

There are no contraindications listed in the prescribing information.

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to the extract from green tea leaves or any component of the formulation.

Dosing: Adult

External genital and perianal warts (Condylomata acuminata): Topical: Apply a thin layer (~0.5 cm strand) 3 times daily to all external genital and perianal warts until all warts have been cleared (maximum duration: 16 weeks)

Administration

Wash hands before and after application; apply with fingers, leaving a thin layer of ointment; do not wash ointment off affected area after application. Discontinue treatment if the severity of local skin reactions becomes unacceptable. Do not apply internally; do not apply to open wounds; do not apply occlusive dressing. Sexual contact should be avoided while ointment is on skin. For females requiring tampon use during treatment, tampon should be inserted prior to application of ointment to prevent accidental application of ointment into the vagina. May stain clothing or bedding.

Storage

Store at 2°C to 8°C (36°F to 46°F) until dispensed; after dispensing, patient may store under refrigeration or up to 25°C (77°F). Do not freeze.

Drug Interactions

There are no known significant interactions.

Adverse Reactions

>10%:

Central nervous system: Localized burning (67%), local discomfort (≤56%)

Dermatologic: Erythema (70%), pruritus (69%), skin erosion (≤49%), skin sclerosis (35%), vesicular eruption (20%)

Local: Local pain (≤56%), dermal ulcer (≤49%), localized edema (45%)

1% to 10%:

Dermatologic: Desquamation (5%), dermatological reaction (2%), scarring (1%), skin rash (1%)

Genitourinary: Foreskin irretraction (3%; uncircumcised males)

Hematologic & oncologic: Lymphadenitis (3%; local), local hemorrhage (2%)

Hypersensitivity: Hypersensitivity reaction (2%)

Local: Application site discharge (3%), local irritation (1%)

<1%, postmarketing, and/or case reports: Dyschromia, eczema, facial rash, hyperesthesia, infection (perianal), local discoloration, local dryness, local tissue necrosis, papule, pelvic pain, staphylococcal bacteremia, urethritis, vulvitis

Warnings/Precautions

Concerns related to adverse effects:

• Skin irritation: Local skin reactions are common (eg, erythema, erosion, edema, itching, and burning); women may be at increased risk. If possible, continue treatment; severe reactions may require treatment interruption or discontinuation.

Disease-related concerns:

• HPV infection: Not intended for the treatment of urethral, intravaginal, cervical, rectal, or intra-anal human papilloma viral disease.

Special populations:

• Immunosuppressed patients: Safety and efficacy have not been established in immunosuppressed patients.

Other warnings/precautions:

• Appropriate use: For topical use only; ointment is not intended for internal use; avoid contact with eyes, nostrils, lips and mouth; avoid topical application to open wounds; has been shown to increase the risk of adverse reactions. The use of occlusive dressings should be avoided; do not bandage, cover or wrap. Avoid exposure of treated area to sun and/or UV-light.

• Duration of therapy: Continue treatment until all warts have been cleared (maximum duration: 16 weeks); the safety and efficacy of treatment lasting >16 weeks have not been established.

Monitoring Parameters

Application site reactions

Reproductive Considerations

Sinecatechins ointment may weaken condoms and diaphragms.

Pregnancy Considerations

Sinecatechins should not be used during pregnancy (CDC [Workowski 2015])

Patient Education

What is this drug used for?

• It is used to treat genital warts.

• It is used to treat perianal warts.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Redness

• Burning

• Stinging

• Itching

• Pain

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:

• Severe skin irritation

• Blisters

• Skin sores

• Oozing

• Bleeding

• Painful urination

• Trouble urinating

• Groin or pelvic pain

• Swelling

• 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, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.