sinecatechins

REMS

Treatment of external genital and perianal warts (
Condylomata acuminata
caused by
human papillomavirus
[HPV]) in immunocompetent patients 18 years and older (.

Action ⬆ ⬇

Beneficial effects may be due to antioxidant properties; made from extract of green tea.

Therapeutic effects:

Regression of warts.

Pharmacokinetics ⬆ ⬇

Absorption: Minimal systemic absorption (less than that of a cup of green tea).

Distribution: Unknown.

Metabolism/Excretion: Unknown.

Half-Life: Unknown.

Time/Action Profile ⬆ ⬇

ROUTE	ONSET	PEAK	DURATION
TOP	unknown	unknown	unknown

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Not to be used for urethral, intravaginal, cervical, rectal, or intra-anal human papilloma viral disease or on open wounds;
OB: Pregnancy.

Use Cautiously in:

Immunosuppressed patients;
Lactation: Use during breastfeeding only if benefit to patient outweighs potential risk to infant;
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

Local: burning, edema, erosion/ulceration, erythema, induration, pain/discomfort, pruritus, vesicular rash, bleeding , desquamation, discharge, irritation, phimosis, rash, regional lymphadenitis, scar

Interactions ⬆ ⬇

Drug-drug:

None reported.

Route/Dosage ⬆ ⬇

PO (Adults >18 yr): Apply to warts 3 times daily for up to 16 wk.

Availability ⬆ ⬇

Ointment: 10%; 15%

Assessment ⬆ ⬇

Assess affected area(s) prior to and periodically during therapy.

Implementation ⬆ ⬇

Apply about 0.5 cm strand of brown ointment to each wart using finger(s), dabbing it on to ensure complete coverage and leaving a thin layer of ointment on warts. Uncircumcised males treating warts under the foreskin should retract foreskin and clean area daily. Avoid application to open wounds, eyes, vagina, or anus. Ointment does not need to be washed off prior to next application. When area is washed or a bath is taken, reapply ointment.

Patient/Family Teaching ⬆ ⬇

Instruct patient to wash hands before and after application and on how to apply ointment. Avoid bandages or occlusive dressings; loose fitting clothing may be worn. Instruct patient to read Patient Information prior to application. Continue therapy up to 16 wks or until complete clearance of all warts. Inform patient that sinecatechins is not a cure. New warts may develop during 16–wk treatment period and may be treated with ointment. If warts do not go away or return after 16 wks, contact health care professional.
Inform patient that genital warts are sexually transmitted and may infect partners. Advise patient to avoid sharing this medication with others, even with same symptoms.
Inform patient that local skin reactions (erythema, erosion, edema, itching, burning) frequently occur. Continue treatment when severity is acceptable. If severe reactions occur, wash ointment off with mild soap and water, withhold further doses and notify health care professional.
Advise patient to avoid exposure of treated areas to sun and UV light.
Advise patient to avoid sexual contact while ointment is on skin. Ointment may weaken condoms and vaginal diaphragms. Wash prior to sexual contact.
Advise female patients to insert tampon prior to applying ointment. If tampon is changed while ointment is on skin, avoid accidental application of ointment to the vagina.
Inform patient that ointment may stain clothing and bedding.
Advise female patients to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes ⬆ ⬇

Healing of external genital and perianal warts. Treatment is continued until warts are healed or up to 16 wks.

US Brand Names ⬆ ⬇

Code ⬆

NDC Code

10337- PharmaDerm a division of Fougera Pharmaceuticals Inc.
- 10337-450- Veregen
  - 10337-450-03- 1 TUBE in 1 CARTON (10337-450-03) > 30 g in 1 TUBE

10337- PharmaDerm a division of Fougera Pharmaceuticals Inc.
- 10337-450- Veregen
  - 10337-450-08- 1 TUBE in 1 CARTON (10337-450-08) > 2 g in 1 TUBE

10337- PharmaDerm a division of Fougera Pharmaceuticals Inc.
- 10337-450- Veregen
  - 10337-450-15- 1 TUBE in 1 CARTON (10337-450-15) > 15 g in 1 TUBE

10337- PharmaDerm a division of Fougera Pharmaceuticals Inc.
- 10337-450- Veregen
  - 10337-450-99- 1 TUBE in 1 CARTON (10337-450-99) > 4 g in 1 TUBE

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇